MODIFICATION
65 -- DRAFT Statement of Work (SOW) for U.S. Army Medical Simulation Training Center (MSTC) High Fidelity Tetherless Mannequins (HFTM)
- Notice Date
- 10/18/2011
- Notice Type
- Modification/Amendment
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- PEO STRI Acquisition Center, 12350 Research Parkway, Orlando, FL 32826-3276
- ZIP Code
- 32826-3276
- Solicitation Number
- PEOSTRI11W101
- Archive Date
- 10/17/2012
- Point of Contact
- Chi Pham, 407-208-3339
- E-Mail Address
-
PEO STRI Acquisition Center
(chi.pham@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Draft Statement of Work For The Medical Simulation Training Center (MSTC) Virtual Patient System (VPS) Tetherless Mannequin Acquisition Prepared by: U.S. Army Program Executive Office Simulation, Training and Instrumentation (PEO STRI) 12350 Research Parkway Orlando, FL 32826-3276 14 October 2011 Version 1.2 MSTC VPS Tetherless Mannequin SOW NOTICE OF REVISIONS & CHANGES VersionPublication DateAuthorDescription of Change 1.027 September 2011Susan KerrInitial Release 1.129 September 2011Susan KerrUpdated Document with Comments from Contracts Review 1.214 October 2011Susan KerrUpdated Document with Comments from Legal Review Contents 1.SCOPE4 1.1.BACKGROUND4 2.APPLICABLE DOCUMENTS4 2.1.DEPARTMENT OF DEFENSE STANDARDS5 2.2.OTHER GOVERNMENT DOCUMENTS5 3.REQUIREMENTS5 3.1.SYSTEM DESCRIPTION5 3.2.INTEGRATED PRODUCT TEAM6 3.3.MEETINGS AND REVIEWS6 3.4.CONSUMABLES LIST6 3.5.COMMERCIAL OFF-THE-SHELF (COTS) MANUALS6 3.6.INFORMATION ASSURANCE (IA)6 3.7.WARRANTY SUPPORT7 3.7.1.WARRANTY7 3.8.PREVENTIVE MAINTENANCE8 3.9.TRAINING8 3.9.1.NEW EQUIPMENT TRAINING (NET)8 3.10.SITE INSTALLATION AND ACCEPTANCE TEST8 3.11.EQUIPMENT SAFETY9 3.12.ELECTROMAGNETIC SPECTRUM MANAGEMENT9 3.13.ELECTROMAGNETIC INTERFERENCE9 3.14.ITEM UNIQUE IDENTIFICATION (IUID)9 3.15.CONTRACTOR MANPOWER REPORTING10 APPENDIX A - VPS TETHERLESS MANNEQUIN REQUIREMENTS12 APPENDIX B - VPS TETHERLESS MANNEQUIN EQUIPMENT LIST16 1.SCOPE This Statement of Work (SOW) defines the effort required for procuring, documenting, and delivering Virtual Patient System (VPS) Tetherless Mannequins that are required to enhance the medical training capability that currently exists at the Medical Simulation Training Centers (MSTCs). This procurement includes all items listed in VPS Tetherless Mannequin Equipment List found in Appendix B at the end of this SOW. 1.1.BACKGROUND The Medical Simulation Training Centers (MSTCs) are standardized Army training assets located at various military installations worldwide, delivering effective medical training with a standardized training platform to better prepare Soldiers to apply medical interventions under combat conditions. The MSTC provides medical training and education on new battlefield procedures and equipment, while affording Soldiers the ability to receive comprehensive training in several formats such as the classroom setting, practical hands-on training simulation, trauma lanes, and distance learning. Each MSTC configuration consists of a Virtual Patient System (VPS) that contains all of the MSTC training devices and critical technologies. Training devices include but are not limited to, patient mannequins, dead-weighted mannequins, airway management mannequins, and various part task trainers. Most of the MSTC training devices Soldier scenarios emphasize the need to diagnose and stabilize a wounded Soldier within the first ten (10) minutes after injury for bleeding, a compromised airway, or lung injury. Based on the consistent occurrences of highly traumatic injuries in the combat environment, Soldiers must be trained to quickly stop the bleeding and become accustomed to performing in various horrific scenarios. The Tetherless Mannequin requirements contained in this SOW will technically and psychologically prepare the Soldier to treat wounds in the combat environment. 2.APPLICABLE DOCUMENTS Applicable documents supporting work to be performed are listed below. 2.1.DEPARTMENT OF DEFENSE STANDARDS DoD 5200.1-RInformation Security Program DoD 8500.1Information Assurance (IA) DoDI 8510.01 DoD Information Assurance Certification and Accreditation Process (DIACAP) DoDI 8500.2Information Assurance Implementation DoDI 8580.1Information Assurance (IA) in the Defense Acquisition System DoDI 8320.04Item Unique Identification (IUID) Standards for Tangible Personal Property 2.2.OTHER GOVERNMENT DOCUMENTS MSTCCapability Production Document (CPD) 23 June 09 MIL-STD-882DStandard Practice for System Safety MIL-STD-130N Identification Marking of US Military Property Copies of the DoD documents are available on the World Wide Web (www) at URL: http://www.dtic.mil/whs/directives/. Copies of the other documents are available from APM MedSim, 12350 Research Parkway, Orlando, FL 32826-3276. ATTN: Ms. Susan Kerr, susan.r.kerr@us.army.mil 3.REQUIREMENTS 3.1.SYSTEM DESCRIPTION The Contractor shall deliver Tetherless Mannequin Systems that meet the requirements as defined in this SOW and the VPS Tetherless Mannequin Requirements appended to this document (Appendix A). The Contractor shall provide all commercial products and services necessary to complete the tasks in this SOW. The Contractor shall perform all activities to assemble the hardware to achieve a fully functional system, with all support systems, that performs and operates in accordance with this SOW. The Contractor shall ensure that all products and equipment are Latex Free. 3.2.INTEGRATED PRODUCT TEAM The Contractor shall participate in Integrated Product Team (IPT) meetings as required to be conducted throughout the life of the contract. IPT meetings shall provide a forum suitable for maintaining a continuous interchange of ideas, issues, and to identify and resolve potential problem areas. 3.3.MEETINGS AND REVIEWS The Contractor shall attend and conduct meetings; reviews and working groups as required. The Contractor shall document action items, coordinate resolutions and track action items until closure and deliver monthly progress reports. The Contractor shall create and maintain an Integrated Master Schedule for procurement and delivery of all contract deliverable items. DI-MGMT-80227Contractor's Progress, Status and Management Report DI-MGMT-81650Integrated Master Schedule (IMS) 3.4.CONSUMABLES LIST The Contractor shall provide a consumables list identifying all consumables used by the system. DI-ILSS-80867Special Equipment Consumable/Durable Support Lists 3.5.COMMERCIAL OFF-THE-SHELF (COTS) MANUALS The Contractor shall provide COTS manual(s) for all equipment used in the system, to include the equipment list in Appendix B of this SOW. DI-TMSS-80527BCommercial Off-The-Shelf (COTS) Manual and Associated Supplemental Data 3.6.INFORMATION ASSURANCE (IA) The Contractor shall develop and maintain a robust information assurance process to guide management, design actions, document decisions, specify and track IA requirements, configuration management of the baseline product, document certification tailoring and level of effort, identify possible solutions, and maintain operational systems security for sustainment. The Contractor shall acquire the necessary software tools (e.g., Gold disk, eRetina). The Contractor shall periodically scan the computer operating system using the latest DoD Approved scan tool and provide those scan results to the government upon request. All the operating systems shall also be configured in accordance with the latest DISA Security Technical Implementation Guide (STIG) written for that operating system. The Contractor shall provide a DoD Information Assurance Certification and Accreditation Process (DIACAP) Package to support the system's Certification & Accreditation (C&A) effort before contract award. The system shall be subject to a final, Contractor-conducted IA scan one month prior to the system's Test Readiness Review (TRR). The Contractor shall provide the scan results to the government at least 2 weeks prior to the TRR. The Contractor shall support an IA TRR that is held prior to the Certification and Accreditation event (C&A). All vulnerabilities discovered during the C&A event shall be addressed to the Government's satisfaction. DI-MISC-80711A Scientific and Technical Reports 3.7.WARRANTY SUPPORT 3.7.1.WARRANTY The Government shall accept the Contractor's Warranty, but will need additional support. The Contractor shall provide all parts, labor and shipping costs for the VPS Tetherless Mannequins, back to the manufacturer for a period of 1 year after Government acceptance. 3.7.1.1.HELP DESK SUPPORT The warranty shall include help desk support, which shall be the first line of support. The Contractor shall respond within one eight-hour work day. If the problem cannot be repaired through the use of the help desk support, the Contractor shall send someone to the site to resolve the problem. 3.7.1.2.ON-SITE SUPPORT Also included in the warranty shall be on-site support, which shall be the second line of support. The Contractor shall respond within 5-7 work days and shall send a trained specialist to the site to correct the issue. 3.7.1.3.SHIPPING SUPPORT The warranty shall include shipping support which shall be the third line of support. The Contractor shall respond within 5-7 work days for CONUS deliveries and 7-10 work days for OCONUS deliveries, and shall provide parts and/or device replacement to correct an issue. 3.8.PREVENTIVE MAINTENANCE The Contractor shall provide preventive maintenance which shall consist of annual on-site inspection and replace/repair of damaged parts not covered under the Tetherless Mannequin Simulators and their extended warranties. This preventive maintenance shall also include travel and all associated expenses. 3.9.TRAINING 3.9.1.NEW EQUIPMENT TRAINING (NET) The Contractor shall plan and conduct one (1) New Equipment Training (NET) course per installation site after Government acceptance of all training devices. The maximum class size is estimated to be no more than 10 personnel at each site. The course shall provide scenario development and familiarization with simulator operating techniques related to the operation and use of the Tetherless Mannequin as described in Appendix A, as well as operator maintenance and troubleshooting techniques. The course shall also provide instruction on preventive maintenance such as flushing the blood system, removal of batteries after training is completed, etc. The NET training shall address the physical and functional descriptions and operation of the equipment. After successful completion of the NET training course, all personnel shall be capable of operating the device. The NET training shall include a classroom presentation and practical exercises. The Contractor shall begin NET the day following government acceptance of all devices. After the NET has been completed, a copy of the NET training materials will be left at each site. DI-ILSS-80872Training Materials 3.10.SITE INSTALLATION AND ACCEPTANCE TEST The Contractor shall provide the necessary resources to deliver and install the training devices meeting the performance criteria specified in this document. The Contractor shall coordinate with the appropriately appointed Government personnel so as not to interfere with ongoing training at the site. The Contractor shall perform a preliminary inspection and test of the equipment to ensure it is functioning properly. The Government will verify that the installed configuration item operates to the specified performance requirements. 3.11.EQUIPMENT SAFETY All identified safety hazards associated with the operation, maintenance, or support activities of all equipment identified in Appendices A and B will be eliminated or reduced to the lowest acceptable risk level to the Government. Equipment must not emit harmful levels of radiation. All electrical connections shall be constructed to prevent the possibility of electrical shock to users/operators. (MIL-STD 882D, Standard Practice for System Safety) DI-SAFT-80102B Safety Assessment Report (SAR) 3.12.ELECTROMAGNETIC SPECTRUM MANAGEMENT The Contractor shall ensure compliance with the policies and procedures for the Army Frequency Allocation to Equipment (Army J/F-12) Program as described in AR 5-12, Chapter 4 for any system that operates in an electromagnetic spectrum. The Contractor shall ensure that an approved DD Form 1494 (Application for Frequency Allocation) is obtained before contract award, and that the equipment can operate in spectrum bands per the national and international tables of spectrum allocation. The Contractor shall integrate existing Army approved spectrum/EMC hardware and software tools into system procurements whenever possible. 3.13.ELECTROMAGNETIC INTERFERENCE The Contractor shall ensure that the system electronic or electrical hardware configuration is not a source of Electromagnetic Interference (EMI) or a victim of EMI in the intended operational environment in which it is installed or at its operational locations. The Contractor shall ensure that the system operations are not affected by EMI. 3.14.ITEM UNIQUE IDENTIFICATION (IUID) The Contractor shall coordinate with the Government to determine which items require unique identification including embedded subassemblies, components and parts, and identify the IUID to be used for each item. The Contractor shall provide unique item identification, or a DoD recognized unique identification equivalent, for all identified items delivered. IUID marking design for each item shall be both machine readable and human readable in accordance with MIL-STD-130N, paragraph 5.2. DI-MISC-80711A Scientific and Technical Reports 3.15.CONTRACTOR MANPOWER REPORTING The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the Contractor shall report ALL contactor manpower (including subcontractor manpower) required for performance of this contract. The Contractor is required to completely fill in all the information in the format using the following web address: https://cmra.army.mil. The required information includes: (1)Contracting Office, Contracting Officer, Contracting Officer's Technical representative (2)Contract number, including task and delivery order number (3)Beginning and ending dates covered by reporting period (4)Contractor name, address, phone number, e-mail address, identity of Contractor employee entering data (5)Estimated direct labor hours paid this reporting period (including sub-contracts) (6)Estimated direct dollars paid this reporting period (including sub-contractors) (7)Total payments (including sub-contractors) (8)Predominant Federal Service Code (FSC) reflecting services provided by contractor (and separate predominant FSC for each sub-contractor if different) (9)Estimated data collection cost (10)Organizational title associated with the Unit Identification Code (UIC) for the Army requiring Activity (the Army Requiring Activity is responsible for providing the contractor with its UIC for the purposes of reporting this information) (11)Locations where contractor and sub-contractors perform the work (specified by zip code in the United States and nearest city, country, when in an overseas location, using standardized nomenclature provided on website) (12)Presence of deployment or contingency contract language (13)Number of contractor and sub-contractor employees deployed in theater this reporting period (by country). As part of its submission, the contractor shall also provide the estimated total cost (if any) incurred to comply with this reporting requirement. Reporting period shall be the period of performance not to exceed 12 months ending September 30 of each Government fiscal year and shall be reported by 31 October of each calendar year. Contractors may use a direct XML data transfer to the database server or fill in the fields on the website. The XML direct transfer is a format for transferring files from a contractor's systems to the secure web site without the need for separate data entries for each required data element at the web site. The Specific formats for the XML direct transfer may be downloaded from the web site. DI-FNCL-80912Performance and Cost Report, Contractor Manpower Reporting APPENDIX A - VPS TETHERLESS MANNEQUIN REQUIREMENTS A.1TETHERLESS MANNEQUIN The Tetherless Mannequin simulators are required to fully give the trainee a realistic patient care scenario for both training and skills validation. This high fidelity Tetherless Mannequin shall allow complete evaluation in a trauma casualty assessment and the continuation of critical patient treatment across the continuum of care within the multiple pre-surgical environments encountered by our forces. Description of Performance: The Tetherless Mannequin System and its associated equipment and accessories shall include the following capabilities: General A.1.1Shall be composed of a ruggedized, tetherless system with system remote control unit that shall include all supporting equipment required to ensure that the system is fully functional. A.1.2System controls shall be remote from the Simulator, and be ruggedized, water resistant, and viewable in direct sunlight. A.1.3Shall provide consumable parts necessary for continuous training that will support the training of 2500 students per year utilizing Army Medical Department Center and School approved MSTC curriculum for Combat Medic sustainment and Combat Lifesaver (CLS). Each MSTC curriculum stresses the high utilization rate of training aids, devices, simulations and simulators during training with minimal didactic during each training event. A.1.4Shall provide and replicate realistic convulsive reactions. A.1.5Shall allow for ground, rotary and fixed-wing evacuation from point of injury through evacuation, to include dragging, all device and non-device assisted military carries. A.1.6Shall be made of a specially formulated reusable synthetic tissue with realism and durability to create the most authentic simulations of severe single and multi-trauma battlefield injuries. A.1.7Shall be realistically ruggedized for use in indoor and outdoor conditions for hot/cold, dry/sandy, wet/snowy/muddy environments and shall be resistant to contact with a minimum of 2 inches of water, contain rust resistant joints and have no pinch joints. A.1.8Shall be fully operational in temperatures ranging from -15 degrees Fahrenheit to 110 degrees Fahrenheit for a minimum of 4hours. A.1.9Shall be radio controlled compatible with current software and hardware fielded at the MSTCs and shall allow radio operation from a minimum distance of 200 feet that is not direct line of sight. A.1.10 Shall be fully functional and operate continuously for a minimum of six (6) hours tetherlessly. A.1.11 Shall provide physiologically correct representations of single and multiple amputations for legs. A.1.12 Shall provide physiologically correct representations of single and multiple amputations for arms. A.1.13 Shall include hard-sided transit cases, for each Mannequin and all associated support items of equipment. Airway Features A.1.14 Shall include nose and nasal cavities capable of secreting and accepting nasal intubation, airways and suctioning. A.1.15 Shall include an airway that accurately represents the human anatomy to include the following: tongue, teeth, vocal cords, epiglottis, vallecula, oropharynx and nasopharynx. A.1.16 Shall simulate difficult airways to include swollen/injured tongue, facial injuries and laryngeal spasms. A.1.17 Shall be capable of being used to demonstrate the proper use of airway adjuncts including but not limited to, the nasopharyngeal airway, oropharyngeal airway, combi-tube, King LT, endotracheal tube and laryngeal mask airway with appropriate physiological response. A.1.18 Shall include break-away teeth to simulate obstructed airway. A.1.19 Shall be capable of simulating respiratory patterns to include apnea to tachypnea. A.1.20 Shall include the simulation of the chest wall rising and falling when all types of ventilation are correctly administered. A.1.21 Shall be capable of simulating gastric dissention with esophageal intubation. Facial Features A.1.22 Shall include blinking and reactive eyes to environmental conditions with simulated secretions, as well as remotely react to conditions physiologically including, but not limited to: blown, dilated and pin-point pupils. A.1.23 Shall include life-like ears with the capability to ooze simulated blood and cerebrospinal fluid appropriate to related injuries. Trauma Features A.1.24 Shall provide the capability to perform bilateral chest tube training. A.1.25 Shall be capable of being used to demonstrate the surgical cricothyroidotomy, while simulating correctly and incorrectly performed responses. A.1.26 Shall simulate physiological responses to correctly and incorrectly performed hemorrhage control and symptom treatment procedures. A.1.27 Shall be responsive to hand and knee pressure for immediate bleeding control to include pressure points, tourniquet and restrictive flow procedures. Cardiac Features A.1.28 Shall simulate EKG monitoring by the use of a minimum of 5 leads. A.1.29 Shall be capable of simulating defibrillation and pacing. Pulses A.1.30 Shall include the following anatomically correct pulse sites: brachial, radial, pedal, femoral and carotid artery. These pulse sites shall be directly correlated with the simulated blood pressure in a clinically accurate manner. Blood Pressure A.1.31 Shall simulate arterial bleeding from two different locations, at physiologically correct points on the exterior of the body with a computer controlled bleeding flow rate that responds to varying pressures introduced by tourniquets, immediate flow restriction procedures and dressings. A.1.32 Shall provide realistic training in reading blood pressure from a minimum of 1 arm to include palpitation and auscultation. Needle Features A.1.33 Shall include needle decompression sites for tension pneumothorax in the appropriate locations that can withstand a minimum of 15 punctures before replacement parts are needed. A.1.34 Shall simulate bi-lateral tension pneumothorax. A.1.35 Shall simulate human responses to both correctly and incorrectly performed needle decompression procedures. A.1.36 Shall include sternal IO acceptance sites for IO trainers with the ability to provide fluid resuscitative treatment. A.1.37 Shall include the ability to perform intramuscular injections to include bilateral deltoids and bilateral thighs. Sounds A.1.38 Shall be capable of simulating vocal sounds. A.1.39 Shall be capable of simulating breath sounds to include absent, clear, rails, rhonchi, wheezes, and striders in all anatomically correct positions for each lobe, both anterior and posterior. A.1.40 Shall be capable of simulating normal and abnormal heart sounds in the physiologically correct locations. A.1.41 Shall be capable of simulating hypo and hyper-active bowel sounds in all 4 abdominal quadrants. A.1.42 Shall be capable of simulating normal and abnormal throat sounds in the physiologically correct locations, to include minimal stridor. Intravenous A.1.43 Shall be capable of being used to demonstrate the proper procedure for insertion of an IV in the arm and hand with initial flash cue in multiple locations. A.1.44 Shall be capable of being used to demonstrate the proper procedure for insertion of an IV in the femoral vein with initial flash cue A.1.45Shall be capable of being used to demonstrate the proper procedure for insertion of an IV in both the internal and external jugular veins with initial flash cue A.1.46be capable of being used to demonstrate the proper procedure for insertion of an IV in subclavian veins with initial flash cue Genitourinary A.1.47Shall simulate catheterization of male and female genitalia with urine and urine/blood mix output. A.1.48 Shall replicate a physiologically correct, full-sized human (with a minimum 180 lbs (male) and 135 lbs (female), with anatomically correct features. APPENDIX B - VPS TETHERLESS MANNEQUIN EQUIPMENT LIST U.S. Army PEOSTRI Medical Simulation Training Centers (MSTC) Draft Equipment List Virtual Patient System (VPS) Tetherless Mannequin - Key Equipment Components QTYUnitItem Description Consumables - Medical Training (Initial Set Up for 1000 Uses) 10eaPneumothorax Replacement Skin 10eaNeck Skin Replacement 40eaCoagulant Make-Up Blood 10ea IV Trainer Replacement Vein 10ea IV Trainer Replacement skin 5eaBlood Fluid 1 gallon (128 oz) 5eaBlood Fluid 4oz 10eaLung Bag Replacements Simulators 5eaTetherless Mannequin 5eaMannequin Hard Transit Case
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