PWS_ATTD_Final.pdf

Performance Work Statement (PWS) Trauma Education and Training Support Services to Include Laboratory Support in support of the U.S. Army Trauma Training Detachment (ATTC)

1. General: This is a non-personal services contract to provide trauma education, skills labs and training support services involving the use of live animals and Human Cadavers in support of the U.S. Army Trauma Training Course (ATTC). The Government shall not exercise any supervision or control over the contract service providers (CSPs) performing the services herein. Such CSPs shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1. Background: Department of the Army Regionally Aligned Forces (RAF) Training Requirements mandate pre-deployment trauma training (PDTT) for all deploying medical providers (e.g. physicians, physician assistants, oral surgeons, dentists and nurse practitioners), nurses (including registered nurses and certified resident nurse anesthetists) and military occupational specialty (MOS) 68W-Health Care Specialist, 68C-Practical Nursing Specialists and 68D-Operating Room Specialist. The Army Medical Center of Excellence (MEDCoE) remains the sole authorized provider of this training, which has proven to be a major contributor to dramatically increased survival rates for wounded soldiers in various theaters of operation. Current Army training doctrine, in conjunction with an increasing expeditionary focus of the Army, such as the Global Response Force, requires these same personnel to maintain their perishable medical skill sets, to ensure they remain highly trained and qualified, to the fullest extent possible, in the most current state-of-the-art medical techniques and procedures.

1.1.1. Mission: The Army Trauma Training Detachment (ATTD) mission is to train Army Forward Resuscitative Surgical Detachments (FRSDs) for combat deployment. Currently, the training program is conducted in two phases at the University of Miami (UofM) Miller School of Medicine Medical Campus and the Level 1 Ryder Trauma Center at Jackson Memorial Hospital in Miami, Florida. Phase one of the training program consists of 40 hours of combined didactic and skill training facilitated by Army personnel at the University of Miami Gordon Center on the UofM medical campus. The second phase of the training program consists of 72 contact hours of clinical application training at the Level 1 Ryder Trauma Center.

1.1.2. Currently, the ATTD does not have the certified staff necessary to facilitate the Advanced Surgical Skills for Exposure in Trauma (ASSET Plus) course and Central Line course. In addition, the ATTD does not have certified veterinary staff and an approved Institutional Animal Care and Use Committee (IACUC) Animal Use in Training protocol, which is required for the facilitation of the ATTD’s Situational Training Exercise (STX). The required training courses are a component of phase one of the training program which consists of 40 hours of combined didactic and skill training facilitated by Army personnel at the Gordon Center on the UM campus. The required training courses occur on various days and times throughout the first week of the training rotation. There is limited time between each class for students to travel from one training location to the next. To maximize the time available to train students the contractor’s facility must be within a 10-minute walking proximity to the ATTD training facility.

1.1.3. To fulfill this requirement the Government intends to establish a contract with an accredited university capable of providing the required services that is located within a 10-mile radius of the ATTD headquarters, at 1800 NW 10th Ave, Miami, FL 33136. The facility must be within close proximity (walking) distance to all ATTD training areas. The facility must have a large enough to accommodate 30 plus students and staff, secured training space to care for 5-7 pigs from delivery/arrival till the MASCAL training exercise (2 – 3 days).

1.2. Scope of Work.

The Contractor shall provide qualified personnel, services, materials, equipment, supplies and facilities necessary to provide trauma education, skills labs and training support services, to include laboratory support. The training will include a full array of educational modalities to include didactic instruction, practical application classes, and exercises to test operational medical readiness skills, to include the use of Human Cadaver and live animal models, in accordance with the U.S. Army’s Trauma Training Course Curriculum Exhibit A of this PWS. Animal models will be limited to porcine (pig) species.

1.2.1. The training program will consist of eleven (11) Trauma Training Course iterations per year. Due to force restructuring and the needs of US Army Forces Command (FORSCOM) this may need to expand in the future. Any course expansion necessary will be agreed upon as an addendum to any service requirement. The ATTD will provide a schedule of the anticipated training iterations to the Contractor, at the beginning of every year and confirm scheduled training no later than 30 days in advance of each iteration start date. However, the Government reserves the right to issue notification(s) of changes to the schedule in a shorter period if required. All changes to the provided training schedule will be provided no later than 5 days to the affected training rotation.

1.3. The Contractor shall ensure that all personnel, including CSP and course participants, strictly adhere to all laws, rules, regulations, policies, and guidelines, applicable to the services performed under this contract. This includes the care, handling and use of animals and whole Human Cadavers the maintenance, accuracy and availability of records, logs, and personnel qualifications, euthanasia, and disposal.

1.4. Safety Requirements: The Contractor shall maintain safety and health standards compliant with requirements of the Occupational Safety and Health Administration (OSHA). In addition, the Contractor shall be compliant with their State and local health and safety standards.

1.4.1. No potentially hazardous medical procedures will be demonstrated by a Contract Service Provider (CSP) on a trainee. However, Government trainees shall be allowed to perform minimally invasive procedures on Government personnel as a part of training application. All minimally invasive training procedure application will be under the direction and supervision of the ATTD Director or designee.

1.4.2. Use of Government personnel for demonstration purposes is authorized, given that the demonstration does not include medically invasive procedures and the individual willingly agrees to participate in the demonstration. All demonstrations shall be under the direction and supervision of the ATTD Director or designee.

1.4.3. Human subjects shall not be used for advanced medical invasive procedures without prior consultation and approval by the Director, U.S. Army Medical Research and Material Command (USAMRMC) Office of Research Protections. All requests for approval shall be coordinated through the Contracting Officer’s Representative (COR) prior to the start of the training session.

1.5. Security Requirements:

1.5.1. The Contractor shall not require direct access to any secure data systems or materials in support of this contract.

1.5.2. The Contractor shall be responsible for the security of all service member information IAW the Privacy Act of 1974, Public Law 93-579.

1.5.3. Neither the Contractor nor any of its CSPs shall disclose or cause to disseminate any information concerning operations of military activities. Such action(s) could result in violation of the contract and possible legal actions.

Due to the sensitive nature of certain aspects of this training, Contractor personnel shall refrain from discussing this training with anyone not directly involved in the training.

1.5.4. All inquiries, comments or complaints arising from any matter observed, experienced, or learned of because of or in connection with the performance of this contract, the resolution of which may require the dissemination of official information, shall be directed to the contracting officer representative (COR) and the contracting officer.

1.5.5. The Contractor shall only conduct business with designated Government personnel listed as POCs. Names of authorized personnel shall be provided to the Contractor by the Government, in writing, and updated as necessary throughout the contract period.

1.5.6. U.S. Government records, copies of original results and reports, verified original data, corrected data, and corrected supporting final reports are maintained by the Contractor, but remain the property of the U.S. Government.

These files/results must be surrendered to the COR.

1.5.7. Identification of the Privacy Act. This contract requires the development of a system of records in accordance with the Privacy Act of 1974. The Contractor shall protect user data and not share, release, exchange, sell, or transfer any student and user data collected with any third party, Government agency, department, activity, organization, or individuals. This includes Social Security number and other personal information gathered and kept on file.

1.5.8. Photography or use of audio or video recording devices by any personnel, including mobile phones, is strictly prohibited for any training event unless coordinated with the ATTD Director and approved in writing by the Government Public Affairs Office (PAO).

1.5.9. All training shall be conducted in a secure, controlled access area.

1.5.10. If training involves the use of live animals or Human Cadavers or Human Cadaver Extremities and occurs in an outdoor environment, the Contractor shall utilize active security to be established and employed, at a minimum, up to the line-of-sight perimeter to include from above preventing photography, video recording, or unauthorized observation.

1.5.11. No visitors will be present during the training or during the performance of any services outlined in this PWS without the ATTD Director’s written or verbal authorization. The Contractor shall receive approval from the ATTD Director or designee, before any visitors are allowed in the classroom/training area during utilization or while performing any of the services outlined in this PWS.

1.5.12. All media, organizational, and congressional inquiries involving animal and Human Cadaver use, including Freedom of Information Act (FIOA) requests, will be immediately directed to the COR. The COR will notify the Office of the Assistant Secretary of Defense for Research and Engineering (ASDR&E) Public Affairs Office (PAO) with a copy furnished to the Commanding General (CG), USAMRMC Animal Care and Use Office (ACURO).

1.6. Appropriate Conduct. CSPs shall conform to standards of conduct and code of ethics, consistent with those applicable to Government employees as provided for in the Joint Ethics Regulation 5500.7-R.

1.7. Government Quality Assurance. The quality of services provided by the Contractor, and any documentation or written material in support of services shall be subject to continuous inspection, surveillance, and review for acceptance by the COR. The Contractor shall submit all deliverables to the attention of the COR. The Contractor is subject to announced or unannounced audits, inspections, or site visits by the Government.

1.8. Quality Control Plan (QCP). The Contractor shall maintain a complete QCP that shall ensure the requirements of the contract are provided as specified in the PWS. A comprehensively written QCP shall be submitted to the COR within 30 calendar days after contract award. Changes made thereafter shall be submitted within 5 working days.

1.9. The Contractor shall identify, appoint and retain a Primary Point of Contact (POC) with full authority to act for the Contractor on all matters relating to contract performance, in writing. A copy of this appointment shall be provided to the Government COR within ten (10) business days of contract award.

1.10. Sexual Harassment/Assault Response and Prevention (SHARP).

1.10.1. Sexual Harassment/Assault Response and Prevention (SHARP). The Contractor shall comply with OTSG/MEDCOM Policy Memo 19-019, Sexual Harassment/Assault Response and Prevention Program, 21 March 2019, or superseding DHA or policy once issued and provided to the Contractor. The SHARP reporting requirements apply only to knowledge obtained by Contractor personnel while performing services under this contract.

1.10.2. The Contractor shall require all Contract Service Providers (CSP) with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the Contractor is providing services under this contract, to report the incident to the Contractor who shall immediately (within 24 hours) report the incident in writing to the Government's COR. This reporting policy also applies to sexual assault incidents involving MEDCOM personnel that occur on the Contractor’s owned or leased facility under this contract.

All incidents shall be reported whether they involve Contractor personnel or Government personnel, or other individuals, when the incidents occur on a Government facility, or a Government leased facility.

1.10.3. The Contractor shall require all CSPs with knowledge of an incident of sexual harassment occurring on a Government facility, to include a Government leased facility, where the Contractor is providing services under this contract, to report the incident to the Contractor who shall immediately (within 24 hours) report the incident in writing to the Government's COR. This reporting policy also applies to sexual harassment incidents involving MEDCOM personnel that occur on the Contractor’s owned or leased facility under this contract. All incidents shall be reported whether they involve Contractor personnel or Government personnel, or other individuals, when the incidents occur on a Government facility, or a Government leased facility.

2. Definitions and Acronyms:

2.1. Definitions:

2.1.1. Airway Station. The current DoD techniques and equipment to assess the airway and intubate a patient when needed, as well as emergency/surgical airway techniques will be taught.

2.1.2. Army Forward Surgical Team (FST). The FST is a surgical unit capable of providing emergency resuscitative surgery and orthopedic stabilization with Two (2) operating beds and has critical care nursing capability.

The Army Forward Surgical Team is organized into four functional areas:

1. Headquarters – Communications, Command and Control, and administrative functions.

2. ATLS (advanced trauma life support) – Triages and prepares multiple casualties for surgery or transport and has a total of up to Four (4) beds or treatment areas with litter stands.

3. OR (operating room) – Sets up and begins surgery within one hour, can be at full functioning capacity within two hours of establishing an area of operations. The OR has two (2) separate OR tables that can be used at the same time allowing treatment for a greater number of casualties in a given time.

4. Recovery post-anesthesia care unit (PACU) – Number of beds available varies based on mission, deployment and available resources, for post-surgical care; Most beds will be for patients awaiting medical evacuation.

FSTs forward deployed typically do not hold patients beyond recovery.

The FST consists of 20 personnel including:

Three (3) General Surgeons One (1) Orthopedic Surgeon Two (2) Certified Registered Nurse Anesthetists (CRNAs) Three (3) Registered Nurses (RNs) Three (3) Licensed Practical Nurses (LPNs) Three (3) Operating Room Surgical Technicians Three (3) Combat Medics One (1) Health Care Administrator One (1) Detachment Sergeant.

The FST has no organic logistical support. It has no x-ray, and limited laboratory and pharmacy capability. It is 100% mobile, and usually co-locates with forward support medical company.

2.1.3. Army Forward Resuscitations Surgical Detachments (FRSD). The FRSD model is similar to the FST model but has the additional operational requirements and personnel changes.

The Army Forward Resuscitations Surgical Detachments (FRSD) is organized into three functional areas:

1. Administrative and supply

2. Surgical

3. Resuscitation The FRST consists of 20 personnel including:

Two (2) General Surgeons Two (2) Orthopedic Surgeons Two (2) Emergency Room Physicians Two (2) Certified Registered Nurse Anesthetists (CRNAs) Two (2) Critical Care Nurses (CCRNs) Two (2) Emergency Room Nurses Two (2) Operating Room Surgical Technicians Two (2) Licensed Practical Nurses (LPNs) Two (2) Combat Medics One (1) Field Medical Assistant One (1) Detachment Sergeant

FRSD Capabilities:

a. A complete FRSD (when all 20-team members are present) can provide emergency medical treatment, triage, preparation for surgery, and surgical intervention for up to thirty (30) incoming patients over a 72-hour period.

b. When split into two ten (10) Soldier sections, an FRSD can provide emergency medical treatment, triage, preparation for surgery, and surgical intervention for up to 12 incoming patients over a 72-hour period. With its redesigned medical equipment set the FRSD can provide required surgery for critically wounded or injured patients, continued postoperative care, and manage up to four critically wounded or injured patients for over six hours of postoperative recovery and stabilization to enable patients to survive further evacuation.

c. Each of the FRSD’s two 10-Soldier sections can detach a six-Soldier surgical element (leaving the four Soldier resuscitative element behind) to provide surgical support at two geographically dispersed locations for very short durations (24 hours). In this configuration, each surgical element is capable of providing emergency medical treatment to receive, triage, and perform surgery and limited continued postoperative care for up to four critically wounded or injured patients over a period of 24 hours with its organic medical equipment set. The teams are capable of setting up in close proximity to a supported unit to provide prompt forward DCR and DCS.

d. Postoperative nursing care for up to eight (8) patients simultaneously for up to six hours prior to further evacuation.

2.1.4. Army Trauma Training Detachment (ATTD). The ATTD trains surgical teams to provide safe and effective combat casualty care to wounded soldiers on the battlefield.

2.1.5. Breathing Station. The current DoD techniques and equipment for patient ventilation, needle decompression, chest seals, and the insertion of chest tubes are taught.

2.1.6. Circulation Station. The current DoD techniques and equipment for placing limb tourniquets, junctional tourniquets, wound packing, hemostatic agents and dressings; starting intravenous infusions (IVs), intraosseous infusions (IO), and central venous catheters; techniques for drawing blood for labs, evaluation, testing, collecting and transfusion of fresh whole blood; and insertion of indwelling (Foley) catheters are taught.

2.1.7. Contractor. The term as used in this contract refers to the prime.

2.1.8. Contracting Officer (KO). A person with authority to enter into contract, administer, or terminate contracts.

Make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

2.1.9. Contracting Officer's Representative (COR). An employee of the U.S. Government appointed by the contracting officer to monitor Contractor performance. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.10. Disability Station. The current DoD techniques and equipment for placing limb splints, casts, and slings;

pelvic binders; and noninvasive traction devices,

2.1.11. Institutional Animal Care and Use Committee (IACUC) – A board that is charged with evaluating an institution’s care, treatment, housing and use of animals, and with assuring compliance with guidance.

2.1.12. Physical Security. Actions that prevent the loss or damage of Government property.

2.1.13. Quality Assurance. The Government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.14. Quality Control. All necessary measures taken by the Contractor to assure that the quality of a product or service shall meet contract requirements.

2.1.15. Roles Station. The proper duties and responsibilities of each MOS/AOC when functioning as an inter-professional trauma team in the resuscitation bay, operating room, and recovery area IAW ATTC concepts and philosophy.

2.1.16. Surgical Station. The proper techniques for suturing minor lacerations and performing other trauma associated bedside procedures using various techniques are taught.

2.1.17. Work Day. The number of hours per day the Contractor provides services.

2.1.18. Work Week. Is defined as Monday through Sunday (dependent on workload and mobilization requirements).

2.2. Acronyms:

AAALAC Association for Assessment and Accreditation of Laboratory Animal Care AAR After Action Report ACURO Animal Care and Use Review Office AR Army Regulation

AT ANTITERRIOISM

ATTD Army Trauma Training Detachment ASD (HA) Assistant Secretary of Defense (Health Affairs) ASSET+ Advanced Surgical Skills for Exposure in Trauma AVMA American Veterinary Medical Association CFR Code of Federal Regulations CG Commanding General CHEA Council for Higher Education Accreditation COR Contracting Officer’s Representative COTR Contracting Officer Technical Representative CMR Contract Manpower Reporting DA Department of the Army DEA Drug Enforcement Agency DoD Department of Defense DVM/VMD Department of Veterinary Medicine/Veterinary Medical Doctor ETT Endotracheal Tube FST Forward Surgical Team FRST Forward Resuscitation Surgical Team HA Health Affairs HIV Human Immunodeficiency Virus HQDA Headquarters Department of the Army IACUC Institutional Animal Care and Use Committee IAW In Accordance With

KO Contracting Officer LMA Laryngeal Mask Airway MEDCOM U.S. Army Medical Command MEDCoE Medical Center of Excellence OSHA Occupational and Health Administration OTSG Office of The Surgeon General, U.S. Army PAO Public Affairs Office PHTLS Pre-Hospital Trauma Life Support POC Point of Contact POI Program of Instruction PWS Performance Work Statement QASP Quality Assurance Surveillance Plan QCP Quality Control Program SME Subject Matter Expert STX Situational Training Exercise UIC Unit Identification Code USDA U.S. Department of Agriculture USAMRMC U.S. Army Medical Research and Material Command USAMRMC ACURO U.S. Army Medical Research and Material Command Animal Care and Use

Review Office USSOCOM U.S. Special Operations Command

3. Government Furnished Services and Items:

3.1. Personnel: The Government will provide ATTD cadre to augment CSPs as required during the preparation and facilitation of the ASSET+ course, Central Line course, and the Situational Training Exercise (STX).

3.2. Supplies/Equipment. None.

3.3. Government Unique Training.

3.3.1. The Government will provide any mandatory training, which is offered through Government sources to CSPs who are performing services under this contract. The Government may elect to provide unique optional Government training to CSPs to enhance or improve services offered under this contract. The Government will provide such training at no additional expense to the Contractor or to the CSP. When directed by the KO, CSPs shall attend all such training in a paid status as part of the normal services required and billed under the contract.

Such training shall require a performance commitment by the Contractor and the Contractor shall reimburse the Government (by means of a reduction in an invoice) if a CSP fails to satisfy the performance commitment after the CSP receives the unique Government training. The amount of the reimbursement shall be the prorated cost of training, calculated based on the total cost of the training and the number of months by which the CSP fails to complete the performance commitment. The length of the performance commitment shall be 12 months or until the end of all performance under this contract, whichever occurs first.

3.3.2. Government unique training may consist of: SHARP, iWatch, Anti-Terrorism, Information Awareness, Personally Identification Information training or other training deemed mandatory for those performing services under this contract.

3.3.3. Anti-Terrorism (AT) Training. The Government will provide AT Level 1 training. All CSPs, including subcontractor CSPs, who require access to Army installations, facilities, or controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or CSP employment start date, then annually thereafter. The Contractor shall submit certificates of completion for each affected CSP to the COR within 30 calendar days after completion. Online AT Level I awareness training is available at l.

4. Contractor Furnished Items and Responsibilities

4.1. Accreditation. The Contractor shall possess regional accreditation from an approved accreditation authority recognized by the Council for Higher Education Accreditation (CHEA).

4.2. Animal Use Protocol. The Contractor shall possess an animal use protocol that complies with the Animal Welfare Act (Title 7 U.S.C., Section 2131-2158), as amended and Animal Welfare Regulations (Title 9 CFR, Parts 1-4), as amended. The animal use protocol shall be approved by the Contractor’s applicable Institutional Animal Care and Use Committee (IACUC) and maintain an approved status for the entire duration of the contract.

4.2.1. The Contractor shall submit their approved IACUC animal use protocol to the U.S. Army Medical Research and Materiel Command (USAMRMC) Animal Care and Use Review Office (ACURO) via email to:

usarmy.detrick.medcom-usamrmc.other.acuro@health.mil (301) 619-6694 within 30 days of contract award.

4.2.2. The Contractor shall provide a weekly status update on the USAMRMC ACURO animal use protocol approval process to the Contracting Officer’s Representative (COR), until animal use protocol, approval is obtained.

4.2.3. The Contractor shall provide a copy of the approved USAMRMC ACURO animal use protocol within 5 days of completion, via email to the COR and the AMEDDC&S/CPHM Director.

4.2.4. The Contractor’s animal-use protocol shall maintain an USAMRMC ACURO approved status for the entire duration of the contract.

4.2.5. The Contractor shall possess current full accreditation awarded by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC).

4.2.6. The Contractor shall procure and use porcine specimens in accordance with (IAW) Army Regulation (AR) 40- 33: The Care and Use of Laboratory Animals in DoD Programs.

4.2.7. The Contractor shall ensure that all procured porcine specimens are obtained from a source that is approved by the U.S. Department of Agriculture (USDA). The Contractor shall provide proof of USDA approval and the results of the two (2) most recent USDA site inspections, within 5 days of request to the COR via email.

4.2.8. Procurement. Ordering, shipping, transportation, delivery, receiving, housing, storage, handling, husbandry and care of animals, to include euthanasia, final disposition and carcass disposal shall be the sole responsibility of the Contractor, Incineration is the recommended method for carcass disposal at the conclusion of training.

However, any disposal method that prevents introduction of carcasses into the human or animal food The Contractor’s procurement of animals shall be IAW DODI 3216.01 and legally obtained from suppliers licensed by the United States Department of Agriculture (USDA). If any supplier claims exemption to USDA licensure, the Contractor shall convey the claim to the USAMRMC ACURO.

4.2.9. Preparation. The porcine specimens shall be prepared with traumatic injuries that will be specified by the ATTD Cadre staff. No more than Four (4) animals shall be prepared concurrently for simultaneous presentation to the training personnel. All animals shall be prepared with IV/IO access to be left in place for presentation.

Preparation shall retain the flexibility to leave all/some animals intubated or all/some animals extubated for presentation.

4.2.10 Delivery. The Contractor shall be responsible for the delivery of live animals to the designated laboratory.

advanced coordination for arrival shall be conducted through the ATTD Director or his designee. The number of live animals to be utilized shall be determined by the ATTD Director or designee, and expressed to the Contractor in adequate time to ensure delivery is successful in preparation for the Situational Training Exercise Training Event.

4.2.11. Maintenance and Storage. The Contractor is responsible for the maintenance and storage of any ancillary equipment associated with providing the live animal services as described in this PWS.

4.2.12. Liability Insurance. The Contractor shall have sufficient insurance coverage (based on memorandum of understanding and training agreement memo to support the legal conduct of this training.

mailto:usarmy.detrick.medcom-usamrmc.other.acuro@health.mil

4.3. Human Cadaver Use in Medical Training.

4.3.1. Human Cadavers - The Contractor shall be required to provide two (2) whole Human Cadaver for each course iteration with the following specifics:

4.3.2. Procurement. The Contractor shall be responsible for locating and purchasing fresh adult whole Human Cadavers. The specific gender provided by the Contractor is subject to availability without preference of the Government.

4.3.3. Procurement. Ordering, shipping, transportation, delivery, receiving, housing, storage, handling, and care of whole Human Cadavers, to include final disposition and disposal shall be the sole responsibility of the Contractor.

Incineration is the recommended method for whole Human Cadavers, disposal at the conclusion of training.

However, any disposal method that prevents introduction of whole Human Cadavers, into the human or animal food supply, and is compliant with federal, state, and local or host-nation laws, as applicable, and is considered acceptable.

4.3.4. Preparation. The Contractor shall be responsible for all testing of whole Human Cadavers for HIV and Hepatitis.

4.3.5. Delivery. The Contractor shall be responsible for delivery to the designated laboratory and return to the designated storage facility of all whole Human Cadavers used in accordance with the Program of Instruction (POI).

4.3.6. Maintenance and Storage. The Contractor shall be responsible for providing maintenance and appropriate climate controlled storage of each whole Human Cadaver per course iteration, to include any ancillary equipment associated with providing the Cadaver services as described in this PWS.

4.3.7. Access to Cadavers. The Contractor shall provide ATTD Director or designee with 24-hour access to whole Human Cadavers for the duration of each course iteration.

4.3.8. Disposal. The Contractor shall be responsible for Occupational Safety and Health Administration (OSHA) compliant disposal of all Bio-Infectious and hazardous waste materials resulting from the services provided within the scope of this PWS, at the conclusion of each course iteration.

4.3.9. Personal Protective Equipment. The Contractor shall provide Occupational Safety and Health Administration (OSHA) compliant personal protective equipment for 40 personnel. To be utilized during Lab rotations or when the potential exists for students to be exposed to Bio-Infectious material, Human or animal tissue, blood, bodily fluids or waste. Personal Protective Equipment at a minimum shall include the following:

a. Appropriate over garment IE; Surgical gown, scrubs

b. Disposable Surgical Gloves

c. Disposable Eye Protection / Face Shield

d. Disposable Respiratory protection mask IE; Surgical Mask

e. Disposable foot protection

f. Disposable Headgear / Hairnet protection

4.4. Services

4.4.1. ASSET+ Course. The Contractor shall provide the American College Of Surgeons course of instruction on ASSET+. The Course shall be conducted in accordance with the American College Of Surgeons standardized requirements resulting in the participants obtaining Continuing Medical Education (CME) Credits through the Accreditation Council for Continuing Medical Education (ACCME). The Contractor shall provide all necessary materials, books, handouts, supplies, equipment, lab/classroom space, and Certified Instructors required to facilitate this training.

4.4.2. Situational Training Exercise Support Services.

4.4.2.1. The Contractor shall provide a qualified Doctor of Veterinary Medicine/Veterinary Medical Doctor (DVM/VMD) to provide on-site oversight of the porcine animal usage in training. The Contractor provided DVM/VMD shall be trained and experienced with the species of animal being used. The DVM/VMD shall be appropriately licensed for the specific training location and possess documentation of current registration with the Drug Enforcement Administration (DEA), if applicable.

4.4.2.2. The Contractor shall provide 2-4 veterinarian services/support and care to include constant anesthetic services/support and care for the duration of each 6-hour situational training exercise/physiology lab.

4.4.2.3. The Contractor shall provide administrative services for all procedural exercises involving the animal models.

4.4.2.4. The Contractor shall provide laboratory support services for the duration of each situational training exercise, which includes but is not limited to managing, removing and disposal of all bio-hazardous and medical waste produced resulting from the situational training exercise.

4.4.2.5. The Contractor shall ensure that a surgical plan of anesthesia is maintained during all procedures involving animal models. Animals will be euthanized immediately upon completion of approved training procedures IAW the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals: 2013 Edition (or most current version), without regaining consciousness.

4.4.2.6. The Contractor shall provide animal modeling of traumatic injuries with strict adherence to the U.S. Army Medical Research and Materiel Command Animal Care and Use Review Office (USAMRMC ACURO) approved animal-use protocol and the MEDCoE approved POI. All Contractor proposed changes involving animal use must be reviewed and approved by the ACURO prior to implementation.

4.4.2.7.The Contractor shall ensure that all animal care and use procedures, to include housing and husbandry methods, are IAW the approved animal-use protocol and all applicable references listed in this PWS.

4.4.2.8. The Contractor shall ensure course participants are briefed prior to initiation of training and include, at a minimum, the following topics: the justification and intrinsic merits of using live animal models, the applicable DoD policies governing their use, the absolute respect that must be demonstrated during their use, and the established mechanism for the reporting of any complaints or animal welfare concerns.

4.4.2.9. The Contractor shall maintain all documentation and records, including but not necessarily limited to, the following items: roster of course participants for each training event, animal procurement records, veterinary medical records, IACUC records, anesthesia logs, controlled substance logs, and records of personnel qualifications (indicating training and experience).

4.4.3. Central-line Course. The Contractor shall provide central line instruction for a maximum of four students, by the anesthesia department. Instruction shall include a lecture, which covers a review of anatomy and techniques for obtaining central line access and hands on training utilizing ultrasound for obtaining central line access. The Contractor is responsible for providing all training mannequins required to conduct the training. A minimum of two mannequins and one ultrasound is required for each training class.

4.5. Facilities.

4.5.1. Situational Training Exercise Support Facilities

4.5.1.1. Situation Training Exercise (STX) Simulation Training Lab. The Contractor shall provide two training simulation rooms to be utilized by the ATTD staff and students for training simulations in preparation for the STX.

One room shall be fully furnished with a desk and chairs for the purpose of simulation observation. The other room will be for the setup for a patient simulator and necessary accessories. Included in this are medical gases (02, Nitrogen, CO2 and medical air) for the purpose of running the simulator. The Contractor on an as necessary basis will refill medical gas containers.

4.5.1.2. Situational Training Exercise Applied Physiology Lab. The Contractor shall provide a secured on-site training area to be utilized for conducting the Situational Training Exercise (STX) involving the use of live animal models. This facility shall be such as to prevent direct visual access to persons not involved with this exercise. This facility shall be located on the ground floor and in close walking proximity to allow utilization of porcine specimens as required for this exercise. The Contractor shall make reasonable attempts to employ physical barriers and security personnel to prevent unauthorized persons from gaining access to the STX exercise. This facility shall be large enough to accommodate approximately 30 personnel and all necessary equipment.

4.5.1.3. At a minimum, the provided training area shall be at least 300 sq. ft. with-in a close walking proximity of all ATTD training areas, and have the following: physical security controlled access with 24-hour accessibility every day of the week; two entry doors; appropriate ventilation and lighting; climate control; tables and chairs to accommodate 30 personnel; restrooms available on the same floor as the lab and maintained by host facility; water supply; sinks and drainage for utilization of cleaning medical equipment; proper ventilation for animal experiments;

two (2) operating beds, two (2) ICU beds, and emergency treatment areas with two (2) beds and a morgue, two rooms for animal preparations that can accommodate at least four animals simultaneously and are in close proximity to the area to be used for the STX exercise. The provided training area shall include an outside receiving area at least 20X20 feet with portable canopy or tent coverage in close proximity for receiving live animals for the STX.

4.5.2. Central-line Course Support Facilities; The Contractor shall provide a training area to be utilized by the ATTD staff and students for conducting Central-line training. The provided training area shall be large enough to support 8 personal, student, instructor and support personal . At a minimum, the provided training area shall include two tables used as training aids.

4.5.2.1. Resuscitative Skills Lab. The Contractor shall provide a training area to be utilized by the ATTD staff and students for conducting resuscitative skills in conjunction with the Central-line Course. The training area shall be large enough to accommodate up to six (6) different stations for demonstration and skills practice supporting team training for a maximum of six (6) students and one (1) instructor per station.

4.5.3. ASSET+ Course/Combat Extremity Course Support Facilities

4.5.3.1. The Contractor shall provide a Human Anatomy Lab that will be utilized for conducting the ASSET+ Course, involving the use of two (2) whole Human Cadavers. The facility shall be large enough to accommodate approximately fifteen (15) personnel and all necessary equipment. At a minimum the lab shall have physical security controlled access with 24-hour accessibility every day of the week, two entry doors, appropriate ventilation and surgical specific lighting, climate control, tables and chairs to accommodate 15 personnel, restrooms available on the same floor as the lab and maintained by host facility, water supply, sinks and drainage for utilization of cleaning medical equipment, climate controlled dedicated cadaver storage, and audiovisual equipment to support lectures.

4.5.3.2. The Contractor shall provide a Human Extremity Lab that will to be utilized for conducting the Combat Extremity Course, involving the use of Human Cadaver extremities. The facility shall be large enough to accommodate approximately five (5) personnel and all necessary equipment. At a minimum the lab shall have physical security controlled access with 24-hour accessibility every day of the week, two entry doors, appropriate ventilation and surgical specific lighting, climate control, tables and chairs to accommodate 5 personnel, restrooms available on the same floor as the lab and maintained by host facility, water supply, sinks and drainage for utilization of cleaning medical equipment, climate controlled dedicated cadaver storage, and audiovisual equipment to support lectures.

4.6. Personnel Qualification

4.6.1. The Contractor provided CSP shall be Subject-Matter-Expert(s) (SME) in the medical care of trauma, with particular focus on Level I and II trauma.

4.6.2. The Contractor CSP shall have knowledge of a range of teaching methods and tools to effectively and efficiently conduct training in the classroom and laboratory environments. The Contractor shall maintain documentation of all CSP’ credentials, including current certifications. The Contractor is solely responsible for identifying and selecting instructional staff who meet the qualification standards cited herein. The Contractor shall ensure all instructor certifications are current and that copies are provided to the Government Upon request.

4.6.3. The Contactor and its CSP shall be able to speak and write English fluently.

4.7. Supplies/Equipment.

4.7.1. ASSET+ Course/Combat Extremity Course

4.7.1.1. The Contractor shall provide two (2) whole Human Cadaver for each course iteration.

4.7.1.2. At a minimum, the Contractor shall provide the supplies listed in Exhibit C – Contractor Provided Human Anatomy Lab Supplies and Equipment for each training iteration.

4.7.1.2. At a minimum, the Contractor shall provide the supplies listed in Exhibit D – Contractor Provided Human Extremity Lab Supplies and Equipment for each training iteration.

4.7.2. Situational Training Exercise.

4.7.2.1. The Contractor shall provide no less than five (5) and no greater than ten (10) anesthetized Porcine specimens (pigs), weighing at least 50 kg each for utilization during the Situational Training Exercise. Each porcine specimen shall be prepared with traumatic injuries, that will be specified by the ATTD staff. No more than four (4) animals shall be prepared concurrently for simultaneous presentation to the training personnel. Animals shall be prepared with IV access to be left in place for presentation. Preparation shall retain the flexibility to leave all/some animals intubated or all/some animals extubated for presentation.

4.7.2.2. At a minimum, the Contractor shall provide the supplies listed in Exhibit E – Contractor Provided Situational Training Exercise Supplies and Equipment for each training iteration.

4.7.3. Applied Physiology Lab.

4.7.3.1. At a minimum, the Contractor shall provide the supplies listed in Exhibit B – Contractor Provided Applied Physiology Lab Supplies and Equipment for each training iteration

4.7.4. Resuscitative Skills Lab.

4.7.4.1. At a minimum, the Contractor shall provide the supplies listed in Exhibit A – Contractor Provided Resuscitative Skills Lab Supplies and Equipment

4.7.5. All Contractor provided Supplies, equipment and training aids shall be located in the designated classroom and laboratory space and maintained in usable condition. The ATTD Director or designee will receive, inventory and accept all supplies and equipment prior to each rotation.

4.7.6. All Contractor provided medical supplies and equipment shall be current, in good working condition and commercially available. If applicable, the Contractor shall ensure that all biomedical equipment utilized during the training sessions are maintained in accordance with the manufacturer’s recommendation for serviceability. The ATTD Director or designee in writing prior to conducting each course iteration shall approve all equipment utilized during the training session for use.

5. Description of Work.

5.1. The Contractor shall provide qualified personnel, services, materials, equipment, supplies and facilities necessary to meet the requirements for the provision of services identified in this PWS.

6. Deliverables.

6.1. After-Action-Reports (as prescribed by DA ALARACT 173/2013, "Army Medical Readiness Training Involving Use of Live Animals").

6.1.1. The Contractor shall provide an AAR within thirty (30) days of course completion. The AAR(s) shall be provided for each separate training event and must be sent to the following offices:

(1) MEDCoE, G3/5/7, Assistant Chief of Staff, COM: COL Samuel S. Shrader (210) 823-2528, e-mail:

Samuel.s.shrader.mil@army.mil, g357admin@army.mil.

(2) Sponsoring Unit’s Component Surgeon’s Office; and

(3) Contracting Officer (CO) or Contracting Officer’s Representative (COR).

6.1.2. Reports shall be signed and dated by the onsite medical officer/medic and onsite veterinarian. All reports will be maintained by the Contractor and the above designated offices/individuals for a period of no less than three (3) years from the corresponding date of training.

6.1.3. AAR’s must include the following information:

(1) Contracting Office, Contracting Officer, Contracting Officer’s Representative;

(2) Contract number, including task and delivery order number;

(3) Beginning and ending dates covered by contract period;

(4) Contractor name, address, phone number, e-mail address, identity of Contractor employee entering data;

(5) Sub-Contractor’s name (if applicable), address, phone number, e-mail address;

(6) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity

(Unit/DoD-sponsor);

(7) Name, phone number, e-mail of Army Requiring Activity (Unit) representative;

(8) Dates and locations where Contractor and sub-Contractors (if applicable) will perform work (specified by zip code in the United States and nearest City, Country, when in an overseas location);

(9) Name of course conducted;

(10) Total number of course participants categorized by medical MOS/AOC;

(11) Species and actual number of animals used for each training event;

(12) Name, address, phone number, e-mail address of onsite medical officer / medic responsible for oversight of medical training;

(13) Name, address, phone number, e-mail address of onsite veterinarian responsible for oversight of animal care and use;

(14) Verification statement indicating that animal acquisition and animal disposal methods was IAW all applicable directives, laws, and regulations; and

(15) Detailed description of any unexpected or adverse events that occurred during or after the training event.

6.2. DoD Annual Report Of Animal Use.

6.2.1. For the life of the award, the Contractor shall provide animal usage data, upon request, for inclusion in the DoD Annual Report on Animal Use. Data shall be compiled for each fiscal year (FY) and include the following information:

(1) species of animals used;

(2) number of each species used;

(3) USDA Pain Category for all animals used.

6.2.2. Data must be maintained separately for each contract.

6.2.3. All adverse events concerning or potentially impacting DoD-funded or supported training will be reported, in writing, within five (5) business days, to (1) the Sponsoring Unit’s Component Surgeon’s Office; (2) the Contracting Officer or Contracting Officer’s Representative. If the adverse event involves animals, it should similarly be reported, in writing, within five (5) business days, to the ACURO (usarmy.detrick.medcom-usamrmc.other.acuro@health.mil) (301-619-6694). At a minimum, adverse events include the following: loss of or change in AAALAC accreditation status, adverse findings from any compliance inspection / site evaluation, a mailto:Samuel.s.shrader.mil@army.mil change in USDA registration status, any animal-use protocol deviation, misconduct or non-compliance, or any non-compliant action reported to the Contractor’s IACUC or AAALAC.

6.3. Contractor Manpower Reporting (CMR).

6.3.1. The Contractor shall report ALL Contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract via a secure data collection site. The Contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/.

6.3.2. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2019. Contractors may direct questions to the help desk at: https://www.sam.gov.

6.4. Sexual Assault Reporting. The Contractor will immediately (within 24 hours of gaining knowledge of the incident) report an incident of sexual assault to the COR.

6.5. Sexual Harassment Reporting. The Contractor will immediately (within 24 hours of gaining knowledge of the incident) report an incident of sexual harassment to the COR.

7. Applicable Regulations and Manuals:

7.1 Advisory Regulation and Manuals.

7.1.1. Army Regulation 600-20, Army Command Policy, 20 Sep 2012

7.2. Mandatory Regulations and Manuals.

7.2.1. Animal Welfare Act (Title 7 U.S.C., Section 2131-2158), as amended, and Animal Welfare Regulations (Title 9 CFR, Parts…