SOLICITATION W81K0023Q0118 Amendment 0001.pdf

0011966841

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to:

A. Provide answ ers to the questions submitted by industry. A question w as posed requesting clarification of the Performance Work Statement (PWS). PWS has been revised.

B. This ends the question and answ er period.

C. All other solicitation terms and conditions remain the same.

See SUMMARY OF CHANGES

1. CONTRACT ID CODE PAGE OF PAGES

J 1 8

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 28-Aug-2023

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81K0023Q0118

X 9B. DATED (SEE ITEM 11)

23-Aug-2023

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

28-Aug-2023

CODE

W40M USA HCA

MEDICAL READINESS CONTR OFFICE WEST

3160 MCINDOE BLDG 1103

JBSA FT SAM HOUSTON TX 78234-4504

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81K0023Q0118

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

QUESTIONS AND ANSWERS

Questions and Answers Solicitation W81K00-23-Q-0118

Reanimated Tissue Training with Perfusion Services

1. Question: The PWS states in paragraph 3.8 JMEX:

a) The cadavers require 6 hours for four days of continuous perfusion and 12 hours for four days.

The JMEX is only listed for 4 days and the solicitation specifies 6 hrs in another places, Would you please confirm the number of days for the JMEX and the Hours per day required as it lends to the number of personnel required.

Answer: Refer to revised PWS paragraphs 3.7 and 3.8.

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

PERFORMANCE WORK STATEMENT

Updated 28 August 2023.

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 Research and Development (R&D) device testing. The training will provide life-like tissue integrity, anatomic accuracy and a functional circulatory system with a period of performance of 1 October 2023 – 30 September 2024.

The required services consist of:

- Three-day training event conducted quarterly for perfusion of two (2) government-procured cadavers per day

- Four-day training event, Joint Medical Emergency Exercise (JMEX), for perfusion of six (6) government-procured cadavers

All training events shall include 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.

2.3 During training events contractor equipment may be stored in the government building.

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 support, prepare, and perfuse for all training events.

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(s) to support, prepare, and perfuse for all training events.

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

3.7 ICTL Rodeo:

a) Each cadaver requires a minimum of 8 hours of continuous perfusion per day for three days per quarter.

b) Both the venous and arterial circulatory systems are required to be perfused.

c) The contractor shall provide a battery or other power source for the perfusion pumps.

3.8 JMEX:

a) Each cadaver requires a minimun of 6 hours of continuous perfusion per day for four days.

b) Both the venous and arterial circulatory systems are required to be perfused.

c) The contractor shall provide a battery or other power source for the perfusion pumps.

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

1 Prepare six (6) Government-provided fresh human cadavers using proprietary flush and sealant

Facilitate the successful perfusion and simulated heart and circulatory function to support government training objectives at the Joint Medical Exercise (JMEX) four day training

Dates to be determined for Fiscal Year 2024

2 Prepare two (2) Government-provided fresh human cadavers using proprietary flush and sealant

Facilitate the successful perfusion and simulated heart and circulatory function to support government training objectives at the 4 quarterly training sessions ICTL Lab three day training

Dates to be determined for Fiscal Year 2024

PERIOD OF PERFORMANCE (Schedule):

Event

SUPPLY/

SERVICE

LOCATION

Grid/ Bldg #

START END

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

7.1 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 Cavazos, 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 Contractor shall not be held liable if the Government supplied cadaver is unable to be perfused 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

Services delivered as required.

Meets 99% based on the services being ready to operate from the start of training each day till index

Review of COR Monitors

Standard Measurement Past Performance Assessment

99% to 100% Excellent Document Past Performance Report, paying particular attention to performance that exceeds the standard.

96% to 98% Very Good

95% Satisfactory

92% to 94% Marginal

92% or less Unsatisfactory

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

4. Anti-Terrorism Operations Security

4.1Access and general protection/security policy and procedures. Contractor and all associated sub-contractor 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 and/or the CRDAMC.

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 all CRDAMC security requirements. 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.

4.2 Contractors that do not require CAC, but require access lo 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, facilily and area commander installation/facility access and local security policies and procedures (provided by government representative), or, al OCON US locations, in accordance with status of forces agreements and other theater regulations.

4.3iWatch Training. The contractor and all associated sub-contractors shall brief all employees on the local watch program. All personnel on Fort Cavasos 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.

5. 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.

6. 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

(End of Summary of Changes)