PWS Perfusion Services.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 device testing. The training will provide life-like tissue integrity, anatomic accuracy and a functional circulatory system. The system must provide for a realistic, functioning vascular system that presents and responds to treatment as a living trauma patient would. This effort is inclusive of FY23 and includes four (4) three-day event 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 (6) government-procured cadavers in FY23, 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 Hood, 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 realistic training is absolutely vital to ensure that Carl R. Darnall Army Medical Center (CRDAMC) Soldiers, Medics and Surgeons are equipped with the most cutting edge and up-to-date realistic training. This training is designed to replicate battlefield wounded personnel in order to prepare the military personnel 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 per day during four (4) three-day event.

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

3.4 Contractor will provide sufficient technician to support, prepare, and perfuse two (2) cadavers per day during four (4), three-day event, and six (6) cadavers for one (1) two-day event.

3.5 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 six (6) 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 Hood and the Fort Hood 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/ SCHEDULES

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 Hood, Texas, 76544

TBD

Dates to be determined

Dates to be determined

7.0 SCOPE OF WORK

7.1 Contractor shall be fully responsible for the security and maintenance of their equipment.

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

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

7.4 Contractor will provide sufficient technician support all scheduled events.

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

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

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

CONTRACTOR MANAGEMENT REPORTING (CMR).The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the Contractor will report ALL contractor 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://www.sam.gov 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 (including sub-contractor);

(6) Estimated direct labor dollars paid this reporting period (including sub-contractor);

(7) Total payments (including sub-contractor);

(8) Predominant Federal Service Code (FSC) reflecting services provided by contractor (and separate predominant FSC for each sub-contractor if different); Q517

(9) 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); W2P4AA

(10) 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);

(11) Presence of deployment or contingency contract language, and,

(12) Number of Contractor and sub-contractor employees deployed in theater this reporting period (by country).

(13) As part of its submission, the Contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement.

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 PERFORMANCE WORK STATEMENT

The following Government Holidays are observed:

New Year’s Day, January 1 Martin Luther King, Jr.’s Birthday, 3rd Monday in January President’s Day, 3rd Monday in February Memorial Day, Last Monday in May Juneteenth Day, June 19 Independence Day, July 4 Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran’s Day, November 11 Thanksgiving Day, 4th Thursday in November Christmas Day, December 25

INVOICES AND PAYMENT INFORMATION:

Payment will be made by Defense Finance and Accounting Service, (DFAS Indianapolis), Indianapolis, IN (address in Block 18a), after receipt of services. Contractor submits their 2-n-1 invoice in the Wide Area Work Flow (WAWF) system for payment. The Contracting Officer’s Representative (COR) shall verify for acceptance to be submit to DFAS Indianapolis. Government Payment will only be authorized for services actually rendered. Advance payments under this contract are not authorized.

ANTITERRORISM/OPERATIONS SECURITY:

Contractor and all associated sub-contractor's employees shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative). The contractor shall also provide all information required for background checks to meet installation and MTF access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or MTF Security Office. Contractor workforce must comply with all personal identity verification requirements as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

Access and general protection/security policy and procedures. This standard language is for contractor employees with an area of performance within Army controlled installation, facility, or area. Contractor and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

iWatch Training. The contractor and all associated sub-contractors shall brief all employees on the local watch program. All personnel will view theIWatch video on at http://www.crdamc.amedd.army.mil/videos/iwatch.aspx . All personnel on CRDAMC property must understand to contact 288-COPS (288-2677) or the CRDAMC Provost Marshal Office at 553-9832 if any suspicious activity is observed. This training will be completed by all contractors working in CRDAMC facilities for any period of time. This training shall be completed within 14 calendar days of contract award or within 14 calendar days of new employees commencing performance with the results reported to the COR within 5 days of completion.

SEXUAL ASSAULT PREVENTION AND RESPONSE PROGRAM (SHARP):

The contractor shall comply with OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP), 12 Nov 2013. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract. 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. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals. 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. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

1. Government Unique Training: The contractor shall ensure all service providers receive Sexual Harassment/Assault Response and Prevention (SHARP) training not later than 60 calendar days after contractor personnel begins performance under this contract. Training can be obtained either online or in person. Contractor personnel can attend SHARP training provided by William Beaumont Army Community Hospital, Fort Campbell, KY. If the employee has an AKO account, they can access online the Team Bound Self Study course through Army Learning Management System (ALMS) at http://www.atsc.army.mil/tadlp/delivery/alms.asp

2. Advisory Publications: Army Regulation 600-20, Army Command Policy, 20 Sep 2012 3. Government Unique Training The contractor shall ensure all service providers receive Sexual Harassment/Assault Response and Prevention (SHARP) training not later than 60 calendar days after contractor personnel begins performance under this contract. Training can be obtained either online or in person. Contractor personnel can attend SHARP training provided by Munson Army Health Center, Fort Leavenworth, KS. If the employee has an AKO account, they can access online the Team Bound Self Study course through Army Learning Management System (ALMS) at http://www.atsc.army.mil/tadlp/delivery/alms.asp 4. Advisory Publications Army Regulation 600-20, Army Command Policy, 20 Sep 2012 OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Responses Program (SHARP), 12 Nov 2013

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 http://oig.hhs.gov/fraud/exclusions.asp, and the TRICARE Sanctioned Provider list at http://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Quality-And-Safety-of-Healthcare/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):

a. 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.

b. 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.

8. 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 http://oig.hhs.gov/exclusions/files/sab-05092013.pdf.

TOBACCO FREE MEDICAL CAMPUS (TFMC)

The Contractor shall ensure that all employees 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.

END OF SUPPLEMENT TO THE PERFORMANCE WORK STATEMENT