Performance Work Statement.docx

PERFORMANCE WORK STATEMENT

GENERAL INFORMATION

1.0 SCOPE OF CONTRACT

1.1 Contractor will provide an innovative system to perfuse cadavers, enabling life-like medical training and R&D device testing. It will provides life-like tissue integrity, anatomic accuracy and a functional circulatory system. This effort is inclusive of FY24 and includes four (4) three-day events that consist of the perfusion of two (2) government-procured cadavers per day, and one (1)) two-day event that consist of the perfusion of (5) government-procured cadavers per day in FY24, with contractor provided technicians. Training execution will be static in nature with hospitalization and surgical training in a fixed facility. Training shall take place at the Medical Simulation Training Center (MSTC) located on Fort Cavazos, Texas, 76544.

1.2. The contractor shall provide the non-personal Blood Perfusion services, to include providing support personnel, supplies and all necessary equipment in order to perform the services.

1.3 Contractor shall abide by the MSTC rules, regulations and by laws, including applicable standing operating procedures established by the MSTC. The quality of care shall meet or exceed all recognized standards established by the Joint Commission (JC).

2.0 BACKGROUND

2.1 Reduced exposure to live tissue training, open surgical techniques and restrictions on work hours has negatively impacted current traditional training models.

2.2 This training is absolutely vital to ensuring that Carl R. Darnall Army Medical Center (CRDAMC) Soldiers are equipped with the most cutting edge and up-to-date training, designed to save the lives of the warfighters when needed most on the battlefield.

CONTRACTOR REQUIREMENTS

3.0 TECHNICAL REQUIREMENTS/TASKS

3.1 Contractor will provide sufficient pulsatile pumps to emulate heart function and hemodynamics for each cadaver.

3.2 Contractor will provide sufficient fluid reservoirs, cannulas, tubing and consumable supplies necessary to perfuse two (2) cadavers during four, three (3) days, and six (6) cadavers for one two-day event.

3.4 Contractor will provide 7 liters of bovine whole blood or proprietary blood substitute per cadaver per day.

3.5 Contractor will provide sufficient technician to support, prepare, and perfuse two (2) cadavers during four, three

(3) day events, and (6) cadavers for one (2) day event.

3.6 Contractor will provide reanimated tissue training (RITT) services.

4.0 CONDUCT

4.1 Contractors shall comply with MTF policies regarding personal appearance, and personnel identification and access requirements.

4.2 Inquires. Contractor shall ensure that its personnel do not respond to any media inquiries. Any inquiries from the media shall be immediately relayed to the contracting officer representative (COR), who will relay them to the CRDAMC Commander. There shall be no interviews, comments, or any other response without the knowledge and approval of the CRDAMC Commander. Other than routine inquiries from external agencies, all other inquiries and complaints shall be brought to the attention of the Government.

5.0 GOVERNMENT/CONTRACTOR FURNISHED PROPERTY

5.1 The Government will provide two (2) deeded human cadavers for ICTL labs each quarter, and (6) deeded cadavers for the Joint Medical Exercise (JMEX) that do not have a medical history of vascular disease and/or calcification of the arteries, or traumatic cause of death in order to ensure successful perfusion.

5.2 The Government will provide sufficient personnel to support and instruments to create injury patterns consistent with trauma training requirements and Army policy.

5.3 The Government will provide a concept of perfusion support outlining all requirements for Contractor personnel including but not limited to dates, times, locations, and no later than ten (10) days prior to start date.

5.4 The Government will provide all onsite support needed to move and store cadavers during prep, setup, training execution, and recovery/closeout.

5.5 The Government will provide all training devices, equipment and Class VIII (8) supplies required for training.

5.6 The Government will provide all training and Government-provided support personnel with Personal Protective Equipment (PPE).

5.7 The Government will provide the contractor with access to Fort Cavazos and the Fort Cavazos MSTC and any other required training areas.

5.8 Contractor will supply, maintain and store all materials associated with preparing and perfusing the cadavers.

5.9 The Government will provide all site preparation, trash removal and clean-up of training site.

5.10 The Government will provide all necessary transport and staging tables for each cadaver (i.e. litter, Surgical Tables, etc.)

6.0 DELIVERABLES/ SCEDULES

Key Deliverables

Item No.

Deliverable

Objective

Due

PERIOD OF PERFORMANCE (Schedule):

CRDAMC

Personnel Surgical, Nursing Personnel, equipment, training and supplies for cadaver perfusion

III Corps MSTC, Fort Cavazos, Texas, 76544

TBD

Dates to be determined

Dates to be determined

7.0 SCOPE OF WORK 7.1Contractor shall be fully responsible for the security and maintenance of their equipment.

7.2Contractor will be notified when perfusion services are needed prior to the date of training. Contractor shall provide a confirmation to the COR.

7.3Contractor is required to coordinate travel to and from Fort Cavazos, TX for the training event.

7.4Contractor will provide sufficient technician support all scheduled events.

7.5Contractor personnel shall report to the MSTC the day of the training and prepare equipment for the exercise.

7.6Contractor shall set up the perfusion equipment for the training and stay for the duration of the exercise.

7.7Combat Medical shall not be held liable if the Government supplied cadaver is unable to be professed properly due to vascular disease or trauma.

The following minimum performance requirements apply. The Government may modify inspection methods in accordance with site specific requirements.

The Contractor delivers all personnel and equipment necessary to successfully operate the perfusion and are ready to begin at 07:00 a.m. in the morning

index Review of COR Monitors

END OF THE PERFORMANCE WORK STATEMENT SUPPLEMENT TO THE PERFORMANCE WORK STATEMENT

1. GOVERNMENT HOLIDAYS

The following Government Holidays are observed:

New Year’s Day Martin Luther King Jr.’s Birthday President’s Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above. Closures of the installation due to inclement weather or other such acts of God shall be handled in the same manner.

2. Invoicing and Payment The contractor shall submit monthly, in arrears, itemized invoices in accordance with DFARS 252.232-7003 & 252.232-7006, for services rendered under this contract. Information regarding Wide Area Workflow is available on the Internet at https://piee.eb.mil

3. TOBACCO FREE MEDICAL CAMPUS (TFMC)

The Contractor shall ensure that all contract personnel comply with the U.S. Army Medical Command and MTF smoking policies while performing services under this contract. Smoking restrictions will apply at any location or building where health care activities are performed under this contract.

In accordance with Army Regulation 600-63, paragraph 7-3, 14 April 2015; Operations Order 15-48 (Army Medical Command (MEDCOM) Tobacco Free Living – USAMEDCOM), 8 May 2015; and any Operations Order, regulation or other instruction implementing, defining or otherwise addressing the Tobacco Free Medical Campus (TFMC) on any military installation or DoD-controlled location, Contractor personnel are prohibited from using any tobacco product on or within any TFMC while performing under this contract. TFMCs are established at each installation or DoD-controlled location and include: (1) any property or non-residential building that is operated, maintained or assigned to support medical activities, including but not limited to, hospitals, medical laboratories, outpatient clinics (including medical, dental, and veterinary facilities), or aid stations operating for the primary purpose of delivering medical care and services for DOD eligible beneficiaries and /or meeting the mission of the Army Medical Command; (2) all other facilities in which medical activities or administration take place, to include HQ MEDCOM and Defense Health Headquarters; (3) all internal roadways, sidewalks and parking lots; and (4) all sidewalks, parking lots and grounds external but adjacent to the building or related to the migratory corridors surrounding the medical facility. The contractor shall obtain from the COR any orders, regulations, instructions or other documents implementing, defining or otherwise addressing the TFMC for any given installation or DoD-controlled location where contractor personnel may perform under this contract and shall instruct contractor personnel on the TFMC limitations for installations or DoD-controlled locations where they may perform under this contract.

4. EXCLUSION FROM PARTICIPATION IN FEDERAL HEALTH CARE PROGRAM Exclusion from Participation in Federal Health Care Programs (October 2015)

1. The Contractor shall not employ or contract with any individual or entity (hereinafter collectively referred to as “person”) to provide items or services that will be included in invoices submitted to the Government under this contract if such person is listed on the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) List of Excluded Individuals and Entities (LEIE) or the TRICARE Sanctioned Provider List. The Government is legally prohibited from paying for provision of items or services by such persons. The prohibition extends to services beyond direct patient care, such as services of persons in executive or leadership roles and administrative and management services, whether or not such services are billed separately. The LEIE may be found at h ttp://oig.hhs.gov/fraud/exclusions.asp, and the TRICARE Sanctioned Provider list at h ttp://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Quality-And-Safety-of- H ealthcare/Program-Integrity/Sanctioned-Providers. The LEIE and TRICARE Sanctioned Provider List are hereinafter collectively referred to as “the Lists.”

2. Prior to start of contract performance, the Contractor shall (a) query the Lists to determine whether the name of any person the Contractor employs or contracts with to provide services or items for which payment may be made under this contract appears on the Lists, and (b) certify to the Contracting Officer that the Contractor has queried the Lists and no such names appear on either of the Lists.

3. During performance of the contract, and prior to persons other than those whose names were queried in accordance with paragraph 2, above, (hereinafter “new persons”) providing services or items under the contract, the Contractor shall (a) query the Lists as in paragraph 2, and (b) certify to the Contracting Officer that the names of such new persons do not appear on either of the Lists.

4. The Contractor is advised that during performance of the contract, MTF personnel will perform a recurrent recheck of the names of contractor personnel working in the MTF against the Lists, as specified in OTSG/MEDCOM Policy Memo 15-037. The Government will notify the Contractor in the event any contractor personnel working in the MTF appear on either of the Lists.

5. Should any person providing items or services under the contract appear on either of the Lists at any time during contract performance, the Contractor shall (a) in cases where the Contractor identified the person, notify the Contracting Officer, and (b) promptly remove that person from the contract.

6. Violation of any aspect of the above paragraphs shall be considered a material breach of the contract and may result in termination of the contract.

7. The Contractor is further advised that, in accordance with Civil Monetary Penalties Law [CMP] (codified at 42 USC § 1320a- 7a):There are steep civil monetary penalties associated with billing the Government for providing items or services by a person on either of the Lists, and with failing to return to the Government any overpayments received for provision of such items or services.

Billing under the contract for provision of items or services by a person on either List may also result in exclusion of the person that employs or contracts with such person.

HHS OIG has issued a Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs with additional information on the CMP. The Special Advisory Bulletin may be found at hh hhttp://oig.hhs.gov/exclusions/files/sab-05092013.pdf.

PUBLICATIONS: In addition to the publications listed in the contract, the Contractor shall abide by the following applicable regulations, publications or manuals;

Department of Defense Directive (DoDD) 6459.01, Sexual Assault and Response (SAPR) Program