Combined_synopsis_19-Q-0015_ECLS.pdf

COMBINED SYNOPSIS/SOLICITATION INSTRUCTIONS

1. Issue Date: 6 February 2019 2. Close Date: 15 February 2019 3:00 PM EST

3. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA) located at 820 Chandler

Street, Fort Detrick, MD 21702

4. Requiring Activity: U.S. Army Medical Materiel Development Agency (USAMMDA)

5. Subject: Extracorporeal Life Support (ECLS) Lung/Renal (L/R) Devices, associated consumables, and ECLS

Device On-Site Training

6. Solicitation Number: W81XWH-19-Q-0015

7. Description of Requirement: The U.S. Army Medical Research and Materiel Command (USAMRMC) manages and executes research in five basic areas: military infectious diseases, combat casualty care, military operational medicine, chemical biological defense, and clinical and rehabilitative medicine. The USAMRMC is program coordinator for Department of Defense (DoD) medical research programs focused on the prevention, mitigation and treatment of blast injuries as well as the manager for the Joint Trauma Analysis and Prevention of Injury in Combat

(JTAPIC) program which informs solutions that prevent or mitigate injury during the full range of military operations, by collaborative collection, integration, analysis and storage of data from operations, intelligence, materiel and medical sources. The U.S. Army Medical Materiel Development Activity (USAMMDA) is an

USAMRMC tenant agency. Within the USAMMDA is the Combat Trauma and Acute Rehabilitation (CTAR). The

Combat Trauma and Acute Rehabilitation, Project Management Office (PMO) was formed in July 2018, with the end goal of fielding U.S. Food and Drug Administration-cleared or approved medical devices, drugs, and biologics that fulfill the unmet requirements identified by the Service end user. This is accomplished either through the development of a new capability or by improving upon existing capabilities. USAMMDA Develops and delivers quality medical capabilities to protect, treat, and sustain the health of U.S. Service Members. USAMMDA has a requirement for seven (7) brand name or equal Extracorporeal Life Support (ECLS) devices with 14 sets of associated device consumables, which will be used on patients suffering from multi-organ failure, specifically patients with lung and kidney injuries. The ECLS devices will also provide similar function to dialysis machines for patients with acute kidney injuries. The ECLS devices will also be used for purposes as a bridge to long term therapy, mostly applied in prolonged care scenarios where evacuation times are extended. The Minimum Essential

Characteristics (MECs) for the ECLS devices and consumables are included below in Table 1 of this Request for

Quote (RFQ). This is a Brand Name or Equal requirement

7.1. This is a combined synopsis/solicitation issued as a Request for Quote (RFQ) for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will be not be issued.

7.2. This solicitation document and incorporated provisions and clauses are those in effect through Federal

Acquisition Circular (FAC) 2019-01; effective 22 January 2019.

7.3. This acquisition is full and open competition issued as a brand name or equal. The North American Industry

Classification System (NAICS) code is 339112 – Surgical and Medical Instrument Manufacturing with a size standard of 1,000 employees.

7.4. Contract award shall be made on a competitive best value basis using Lowest Price Technically Acceptable

“LPTA” approach.

7.5. The Contract Line Item Numbers (CLINs) numbers and items, quantities units of measure, and description are identified under the Supplies/Services Section of the RFQ.

7.6. The anticipated date of delivery is 30 days ADC with shipping Free On Board (FOB) Destination IAW FAR

52.247-34 to:

U.S. Army Medical Materiel Development Activity (USAMMDA)

Biomedical Engineer / Product Manager

Combat Trauma and Acute Rehabilitation

BLDG # 1430, Veterans Drive

Fort Detrick, MD 21702-5009

U.S. Army Medical Department (AMEDD) Board

2377 Greeley Road, Building 4011

Suite T JBSA

Fort Sam Houston, TX 78234-7584

U.S. Army Aeromedical Research Laboratory USAARL

6901 Andrews Ave.

Fort Rucker, AL 36362

7.7. Offerors responding to this combined synopsis/solicitation shall include a completed copy of the provision at

52.212-3 Offeror Representations and Certifications—Commercial Items with its quote.

8. Point-of-Contact: The point-of-contact for this acquisition is Ms. Maribel C. Fratina, Contract Specialist, maribel.c.fratina.civ@mail.mil. No telephone calls will be accepted.

9. Instructions for the Preparation and Submission of Quotes

9.1. shall be prepared in accordance with this solicitation and FAR provision 52.212 -1 Instructions to

Offerors- Commercial Items including the Addendum which is included with the attached RFQ.

9.2. All quotes shall be evaluated in accordance with the evaluation criteria identified in Addendum M to

FAR 52.212-2 Evaluation—Commercial Items included with the attached RFQ.

9.3. The FAR clause 52.212-4 Contract Terms and Conditions-Commercial Items applies to this acquisition.

Additional contract requirements and terms and conditions are identified in the attached RFQ.

9.4. The FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders

– Commercial Items, applies to this acquisition. See the clause for additional FAR clauses cited and marked which are applicable to this acquisition.

9.5. The Government reserves the right to reject any or all quotes, and to award no contract at all, depending on the quality of the quote(s) submitted and the availability of funds.

9.6. Questions: Questions shall be submitted via e-mail to Ms. Maribel C. Fratina, Contract Specialist, maribel.c.fratina.civ@mail.mil, no later than 12 February 2019 at 3:00 PM EST. Questions received after this date will not be accepted. An Amendment to this RFQ will be posted to FedBizOpps with responses to the questions received. Only one set of questions per Contractor will be accepted. No telephone calls will be accepted.

9.7. Quotes: Quotes in response to this RFQ are due via e-mail no later than 15 February2019 at 3:00 PM EST to

Ms. Maribel C. Fratina, Contract Specialist, maribel.c.fratina.civ@mail.mil.

9.8. The Offeror shall agree to honor proposed prices for 45 calendar days from the due date for receipt of quotes.

mailto:maribel.c.fratina.civ@mail.mil

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 5 Each Extracorporeal Life Support (ECLS)

FFP

The Contractor shall provide brand name or equal Extracorporeal Life Support

(ECLS) Lung/Renal (L/R) Devices in accordance with PWS, MECs (Table 1), and this RFQ. See “Additional Delivery Instructions” below for specific addresses and quantities:

Ft. Detrick, MD; Ft. Sam Houston, TX; and Ft. Rucker, AL.

FOB: Destination

PSC CD: 6515

NET AMT

0002 10 Each ECLS Consumables

FFP

The Contractor shall provide brand name or equal ECLS associated consumables

(catheters, dialysate, oxygen, etc.) in accordance with PWS, MECs (Table 1), and this RFQ. See “Additional Delivery Instructions” below for specific addresses and quantities: Ft. Detrick, MD; Ft. Sam Houston, TX; and Ft. Rucker, AL.

0003 1 Each Installation, Training and Travel

FFP

In accordance with PWS, MECs (Table 1), and this RFQ. See “Additional

Delivery Instructions” below for specific addresses and quantities: Ft. Detrick, MD; Ft. Sam Houston, TX; and Ft. Rucker, AL.

0004 1 Each

CMR

FFP

The Contractor shall report ALL Contractor labor hours (including subcontractor labor) required for performance of services provided under this contract for the

U.S. Army Medical Materiel Development Agency (USAMMDA) via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: www.ecmra.mil. 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 2013.

The four Service-specific CMRA systems have been merged into one combined application. All user accounts and system data were transferred to the new consolidated Enterprise Contractor Manpower Reporting Application (ECMRA) at www.ecmra.mil.

Contractors may direct questions to the new ECMRA Support Desk at dod.ecmra.support.desk@mail.mil or obtain detailed instructions from the CMR

Contractor Manpower Reporting User Guide available on the new eCMRA website

The Order Data tab on the CMRA Contractor Data Entry website will ask for the

“Requiring Activity Unit Identification Code” (UIC). The Unit Identification Code

(UIC) of the Requiring Activity that would be performing the mission if not for the contractor. This is not necessarily the Contracting Office, Contracting

Administrative Office, or Funding Source. The UIC is not the same as the

Department of Defense Activity Address Code (DODAAC).

The UIC of the Requiring Activity for this Call Order is W4QFAA

1001 2 Each OPTION Extracorporeal Life Support (ECLS)

FFP

The Contractor shall provide brand name or equal Extracorporeal Life Support

(ECLS) – Lung/Renal (L/R) Devices in accordance with PWS, MECs (Table 1), and this RFQ. See “Additional Delivery Instructions” below for specific addresses and quantities: Ft. Detrick, MD; Ft. Sam Houston, TX; and Ft. Rucker, AL.

1002 4 Each OPTION ECLS Consumables

FFP

The Contractor shall provide brand name or equal ECLS associated consumables

(catheters, dialysate, oxygen, etc.) in accordance with PWS, MECs (Table 1), and this RFQ. See “Additional Delivery Instructions” below for specific addresses and quantities: Ft. Detrick, MD; Ft. Sam Houston, TX; and Ft Rucker, AL.

1004 1 Each

OPTION CMR

The Contractor shall report ALL Contractor labor hours (including subcontractor labor) required for performance of services provided under this contract for the

U.S. Army Medical Materiel Development Agency (USAMMDA) via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: www.ecmra.mil. 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 2013.

The four Service-specific CMRA systems have been merged into one combined application. All user accounts and system data were transferred to the new consolidated Enterprise Contractor Manpower Reporting Application (ECMRA) at

Contractors may direct questions to the new ECMRA Support Desk at dod.ecmra.support.desk@mail.mil or obtain detailed instructions from the CMR

Contractor Manpower Reporting User Guide available on the new eCMRA website

The Order Data tab on the CMRA Contractor Data Entry website will ask for the

“Requiring Activity Unit Identification Code” (UIC). The Unit Identification Code

(UIC) of the Requiring Activity that would be performing the mission if not for the contractor. This is not necessarily the Contracting Office, Contracting

Administrative Office, or Funding Source. The UIC is not the same as the

Department of Defense Activity Address Code (DODAAC).

The UIC of the Requiring Activity for this Call Order is W4QFAA

MINIMUM ESSENTIAL CHARACTERISTICS

Minimum Essential Characteristics (MECs) Brand Name or Equal Extracorporeal Life Support (ECLS)

The U.S. Army Medical Materiel Development Activity (USAMMDA) / Combat Trauma and Acute Rehabilitation

(CTAR) Program Management Office (PMO) requires a total of seven (7) brand name or equal Extracorporeal Life

Support (ECLS) – Lung/Renal (L/R) devices that support lung and kidney function as well as 14 sets of their associated consumables (catheters, dialysate, oxygen, etc.) in order to carry out USAMMDA mission to develop and deliver quality medical capabilities to protect, treat, and sustain the health of Our Service Members. The seven (7)

ECLS devices that support lung and kidney function as well as14 sets of their associated consumables (catheters, dialysate, oxygen, etc.) shall meet the following minimum essential characteristics (MECs).

Table 1

1. ECLS Device

a. Ability to provide lung support via extracorporeal carbon dioxide removal (ECCO2R)

b. Ability to provide renal support via continuous renal replacement therapy (CRRT)

c. Ability to provide renal and lung support at the same time

d. Ability to provide renal support without also having to provide lung support

e. Ability to provide lung support without also having to provide kidney support

f. Shall weigh less than 74lbs.

g. Shall be able to operate on 110/220Volt alternate current (AC) and/or 11-28 Volt direct current (DC) power

h. Shall be Good Manufacturing Practices (GMP) manufacturing representative units (ISO 9001 and/or ISO

13485 compliant)

i. Shall be monitored by a regulatory body and approved for human use

2. Oxygen

a. The oxygen tanks shall be compatible with the ECLS device

3. Dialysate

a. The dialysate shall be industry standard composition

b. The dialysate shall be compatible with the ECLS device

4. Catheters

a. The catheters shall be compatible with the ECLS Device, the oxygen tanks, and the dialysate

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

EXTRACORPOREAL LIFE SUPPORT (ECLS) – LUNG/RENAL (L/R) DEVICE PROCUREMENT & TRAINING

1.0. The Combat Trauma and Acute Rehabilitation Project Management Office (CTAR PMO), United States Army

Medical Materiel Development Activity (USAMMDA), located at Fort Detrick, MD, has a requirement for seven

(7) brand name or equal ECLS devices along with 14 sets of their associated additional equipment and consumables to operate the devices (oxygen tanks, dialysate, etc.), in hardened cases, and installation and on-site training.

Additional information can be found in the Minimum Essential Characteristics (MECs) identified in Table 1.

1.1. PURPOSE/OBJECTIVE

Obtain manufacturing representative, test ready Extracorporeal Life Support (ECLS) devices that support both the lung and renal systems, consumable kits for the devices, associated additional equipment to operate the devices

(oxygen tanks, dialysate, etc.), system set-up, performance calibration, and on-site operation and maintenance training.

2.0. BACKGROUND

Current military conflicts have exposed service members to complex injuries and combat polytrauma. The signature injuries currently seen are combinations of blast injuries (improvised explosive devices), penetrating wounds

(projectiles and gunfire), and blunt force trauma, often accompanied by hemorrhagic shock and infection. Each of these injuries individually puts casualties at risk of multisystem organ failure (MOF), but in combination they have led to alarming rates of respiratory and renal failure. The use of conventional lung rescue strategies on standard ventilators, including lung protective ventilation, airway pressure release ventilation (APRV- a “rescue” ventilator mode), and placing patients in a prone position, are ineffective in most severe cases. Additionally, the lack of expertise, equipment, and resources limit the ability to treat patients effectively.

Recent data from the US Army Institute of Surgical Research (USAISR) shows that 30% of mechanically ventilated combat casualties develop acute respiratory distress syndrome (ARDS) and incur 15-40% mortality depending on

ARDS severity. The physiologic burden of injury-related sequela are not limited to the lungs, as renal failure occurs in up to 12.5% of patients and contributes to mortality in nearly 30% of combat casualties. A combination of shock, prolonged hypotensive resuscitation, and tissue damage from a blast leads to rhabdomyolysis, acute kidney injury (AKI), and death. Temporary renal replacement therapy (RRT) can be lifesaving in these cases, as untreated traumatic renal failure has an unacceptably high mortality.

Future combat operations will likely require medical personnel to provide prolonged care for sicker patients who present to forward-deployed Military Treatment Facilities (MTF). These patients have potential for significant ischemia-reperfusion injury with resultant AKI and ARDS. Therefore, there is a critical need for a single “bridge”

ECLS device that can be used in patients with both AKI and ARDS. The goal of this “bridge” therapy is to keep patients alive until more definitive support and transport can be achieved. The ECLS device must be able to fully support CO2 removal while replacing the function of the kidneys through a standard dialysis catheter.

The military would most likely use the bridge ECLS device at a level 3 hospital facility, where more robust resources allow for adequate staffing and logistical support.

3.0. SCOPE OF EFFORT

3.1. Base Period:

3.1.1. The Contractor shall produce and hold ready four (4) ECLS devices, and eight (8) consumable kits, and associated additional equipment and consumables to operate the device (oxygen tanks, dialysate, etc.), in hardened cases, to be incrementally shipped for testing to up to two (2) Continental United States (CONUS) military installations to be identified by the Government from the following: FT Detrick, MD; FT Rucker, AL;

or Joint-Base San Antonio, TX. Notification of dates and locations will be provided by the Government no later than 60 days prior to required arrival date.

3.1.2. Shipments of five (5) devices, ten (10) consumable kits, and associated additional equipment to run the device (oxygen tanks, dialysate, etc.) shall continue over the course of the award in quantities to be determined by the Government.

3.1.3. The Contractor shall be responsible for shipment of the devices, consumables, and associated additional equipment to operate the device (oxygen tanks, dialysate, etc.) in accordance with manufacturer specifications.

Any delays due to shipping, customs, or other factors will be notified to the Government within 48 hours.

Devices must arrive in working, test ready condition or must be immediately replaced prior to testing event.

3.1.4. The Contractor shall provide operational and maintenance training along with disposal instructions through ARL SAFE (https://safe.arl.army.mil/) prior to conducting training at each installation.

3.1.5. The Contractor shall provide operation and maintenance training on the ECLS devices to on-site personnel at the locations the devices, consumables, and associated additional equipment to operate the device

(oxygen tanks, dialysate, etc.) are shipped. System set-up and device calibration shall be included in the operation and maintenance training.

3.1.6. The Contractor shall produce and ship one (1) ECLS device, two (2) consumable kits, and associated additional equipment and consumables to operate the device (oxygen tanks, dialysate, etc.), in hardened cases, to FT Detrick, MD, in test ready condition no later than 100 days after contract award.

3.1.7 The Contractor shall fill out a Government provided Risk Management Framework (RMF) questionnaire no later than 90 calendar days after contract award.

3.2. Option Period 1:

3.2.1. The Contractor shall produce and hold ready two (2) ECLS devices, four (4) consumable kits, and associated additional equipment and consumables to operate the device (oxygen tanks, dialysate, etc.), in hardened cases, to be incrementally shipped for testing to up to one (1) Continental United States (CONUS) military installations to be identified by the Government from the following: FT Detrick, MD, or FT Rucker, AL. Notification of dates and locations will be provided by the Government no later than 60 days prior to required arrival date.

3.2.2. The Contractor shall be responsible for shipment of the devices, consumables, and associated additional equipment to operate the device (oxygen tanks, dialysate, etc.) in accordance with manufacturer specifications.

Any delays due to shipping, customs, or other factors will be notified to the Government within 48 hours.

Devices must arrive in working, test ready condition or must be immediately replaced prior to testing event.

3.2.3. The Contractor shall provide operational and maintenance training along with disposal instructions through ARL SAFE (https://safe.arl.army.mil/) prior to conducting training at each installation.

3.2.4. The Contractor shall provide operation and maintenance training on the ECLS devices to on-site personnel at the locations the devices, consumables, and associated additional equipment to operate the device

(oxygen tanks, dialysate, etc.) are shipped. System set-up and device calibration shall be included in the operation and maintenance training.

4.0. PLACE AND PERIOD OF PERFORMANCE

4.1. The Contractor shall manage most tasks from its normal work site. The operation and maintenance training shall take place at each CONUS military installation where the devices, consumables, and associated additional equipment to operate the device (oxygen tanks, dialysate, etc.) are shipped.

4.2. The estimated period of performance for this contract is as follows (actual dates will be specified in the contract at time of award):

Base Period: Date of award through one (1), 12 month period- of-performance.

Option Period 1: Date of option period: award of one (1), 12 month period-of -performance.

5.0. DELIVERABLES

The Contractor shall use appropriate, cGMP-compliant refrigerated shipping carriers for drug product shipments

(FedEx, World Courier, or similar, as agreed to by the COR), and appropriate shipping methods for all other materials, equipment, and hard copy documents. In the United States, the contractor shall use the US Postal Service standard delivery for delivery of all such shipments.

The COR will have ten (10) business days to review draft deliverables and make comments. The Contractor shall have five (5) business days to make corrections. Upon receipt of the final deliverables, the COR will have two (2) business days for final review prior to acceptance or providing documented reasons for non-acceptance. Should the

Government fail to complete the review within the review period the deliverable will become acceptable by default, unless prior to the expiration of the ten (10) business days the Government notifies the Contractor in writing to the contrary. The final submission should be deemed approved if the Government has not rejected it in 30 calendar days.

The COR will have the right to reject or require correction of any deficiencies found in the deliverables that are contrary to the information contained in the Contractor’s accepted proposal. In the event of a rejected deliverable, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The Contractor shall have five (5) business days to correct the rejected deliverable and return it per delivery instructions.

5.1. Deliverable/Delivery Schedule:

A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file (E) unless otherwise stated.

Deliverable Chart

Item Ref. Title Distribute To Initial Subsequent

Deliverable 1

PWS

Section

3.1.1

ECLS

devices, consumable kits, and associated additional equipment

(oxygen tanks, dialysate, etc.)

CONUS

military installations

Throughout the course of the award

Throughout the course of the award

Deliverable 2

PWS

Section

3.1.4

Operation and

Maintenance

Training &

Disposal

Instruction

Packages

COR via

ARL SAFE

No Later

Than (NLT)

90 calendar days prior to date of training

NLT 90 calendar days prior to date of additional training

Deliverable 3

PWS

Section

3.1.5

Operation and

Maintenance

Training

Identified users at agreed upon military installations

On training date provided by the

Government

On training date provided by the

Government

Deliverable 4

PWS

Section

3.1.6

ECLS

devices, consumable kits, and associated additional equipment

(oxygen tanks, dialysate, etc.)

FT Detrick, MD

NLT 100

days after contract award

As required

Deliverable 5

PWS

Section

3.1.7

Risk

Management

Framework

Questionnaire

COR

NLT 90

calendar days after contract award

N/A

Deliverable 6

PWS

Section

7.2

Contract

Kick-Off

Meeting

COR

NLT 15

business days after contract award

N/A

Deliverable 7

PWS

Section

7.3

Telephone

Progress

Updates

COR

NLT 30

calendar days after contract award

NLT the 15th day of every month, or as needed throughout the award and option periods

Deliverable 8

PWS

Section

7.4

Monthly

Progress

Reports

COR

NLT the 10th day of every month throughout the award and option periods

Deliverable 9

PWS

Section

7.5

Contractor

Manpower

Reporting https://www.e cmra.mil/Logi n.aspx;

Inform COR

31 October

31 October of subsequent reporting years

Deliverable 10

PWS

Section

8.3 iWATCH

Training

COR

NLT 30

calendar days after award

NLT 30 calendar days of new employees commencing performance on the contract

Deliverable 11

PWS

Section

3.2.1

ECLS

devices, consumable kits, and associated additional equipment

(oxygen tanks, dialysate, etc.)

CONUS

military installations

Throughout the course of the award

N/A https://www.ecmra.mil/Login.aspx https://www.ecmra.mil/Login.aspx https://www.ecmra.mil/Login.aspx

Deliverable 12

PWS

Section

3.2.3

Operation and

Maintenance

Training &

Disposal

Instruction

Packages

COR via

ARL SAFE

NLT 90

calendar days prior to date of training

N/A

Deliverable 13

PWS

Section

3.2.4

Operation and

Maintenance

Training

Identified users at agreed upon military installations

On training date provided by the

Government

N/A

5.1.2. Deliverable Descriptions

Base Period:

Deliverable 1: Device Delivery (a). The Contractor shall produce and hold ready four (4) ECLS devices, eight (8) consumable kits, and associated additional equipment and consumables to operate the device (oxygen tanks, dialysate, etc.), in hardened cases, to be incrementally shipped for testing to up to two (2) Continental United States

(CONUS) military installations to be identified by the Government from the following: FT. Detrick, MD, FT.

Rucker, AL, or Joint-Base San Antonio, TX. Notification of dates and locations will be provided by the

Government no later than 60 days prior to required arrival date.

Deliverable 2: Training Packages (a). The Contractor shall provide operational and maintenance training and disposal instruction packages through ARL SAFE (https://safe.arl.army.mil/) prior to conducting training at each installation.

Deliverable 3: Training (a). The Contractor shall provide operation and maintenance training on the ECLS devices to on-site personnel. System set-up and device calibration shall be included in the operation and maintenance training.

• Anticipated training length:

• 1 week at Ft. Rucker, AL; length includes travel time.

• 1 week at Ft. Sam Houston, TX; length includes travel time

Deliverable 4: Device Delivery (b). The Contractor shall produce and ship one (1) ECLS device, two (2) consumable kits, and associated additional equipment and consumables to operate the device (oxygen tanks, dialysate, etc.), in hardened cases, to FT Detrick, MD, in test ready condition no later than 100 days after contract award.

Deliverable 5: RMF Questionnaire. The Contractor shall fill out a Government provided Risk Management

Framework (RMF) questionnaire no later than 90 calendar days after contract award.

Deliverable 6: Contract Kick-Off Meeting. The Contractor shall begin the proposed work with a kick-off meeting with Government representatives, which shall be conducted via teleconference. The Contractor shall provide required kick-off meeting documentation to the COR.

Deliverable 7: Progress Updates. The Contractor shall hold progress update teleconferences with the COR every month, or as needed, following the kick-off meeting for the purpose of discussion, collaboration, and reporting progress towards deliverables. The Contractor shall provide agendas and minutes for all meetings.

Deliverable 8: Monthly Progress Reports (MPR). The Contractor shall provide an MPR that describes the progress made within the reporting period. At a minimum in the MPR, the Contractor shall provide status of work in progress, problems or constraints encountered, suggested solutions, travel summary, and status on iWatch training, using a format agreed upon by the COR and Contractor. The report shall also provide a spend plan and subsequent updates, if needed, detailing how all costs/invoices will occur monthly (e.g., labor hours expended, by labor category and Contract Line Item Number [CLIN], and estimated cost to completion). The Contractor shall require all subcontractors to provide input to the MPR where there are critical or significant tasks related to the prime contract. Critical or significant tasks shall be defined by mutual agreement between the Government and

Contractor.

Deliverable 9: Contractor Manpower Reporting. 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: https://www.ecmra.mil/Login.aspx. 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 applicable help desk at:

https://www.ecmra.mil/Login.aspx.

Deliverable 10: iWATCH Training. The contractor and all associated sub-contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new employees commencing performance with the results reported to the COR no later than 30 calendar days after contract award.

Option Period 1:

Deliverable 11: Device Delivery (c). The Contractor shall produce and hold ready two (2) ECLS devices, four (4) consumable kits, and associated additional equipment and consumables to operate the device (oxygen tanks, dialysate, etc.), in hardened cases, to be incrementally shipped for testing to up to one (1) Continental United States

(CONUS) military installations to be identified by the Government from the following: FT Detrick, MD, or FT

Rucker, AL. Notification of dates and locations will be provided by the Government no later than 60 days prior to required arrival date.

Deliverable 12: Training Packages (b). The Contractor shall provide operational and maintenance training and disposal instruction packages through ARL SAFE (https://safe.arl.army.mil/) prior to conducting training at each installation.

Deliverable 13: Training (b). The Contractor shall provide operation and maintenance training on the ECLS devices to on-site personnel. System set-up and device calibration shall be included in the operation and maintenance training.

6.0. PERFORMANCE REQUIREMENTS SUMMARY

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the

Contractor’s performance. The oversight provided shall help to ensure that service levels reach and maintain the required levels throughout the contract term. Further, the QASP provides the Contracting Officer’s Representative

(COR) with a proactive way to avoid unacceptable or deficient performance, and provides verifiable input for the required Past Performance Information Assessments. The QASP shall be finalized immediately following award and a copy provided to the Contractor after award. The QASP is a living document and may be updated by the

Government, as necessary.

7.0. ADDITIONAL REQUIREMENTS

7.1. Program Management: The Contractor shall provide sufficient management to ensure that all tasks described in this PWS are performed efficiently, accurately, on time, and in compliance with the requirements of this document. The Contractor shall designate a Contract Task Manager to oversee this work and supervise staff assigned to this contract.

7.2. Kick-Off Meeting: The Contractor shall begin the proposed work with a kick-off meeting with Government representatives, which shall be conducted via teleconference. The Contractor shall provide required kick-off meeting documentation to the CTAR PMO.

7.3. Progress Updates: The Contractor shall hold progress update teleconferences with the COR every month, or as needed, following the kick-off meeting for the purpose of discussion, collaboration, and reporting progress towards deliverables. The Contractor shall provide agendas and minutes for all meetings.

7.4. Monthly Progress Report (MPR): The Contractor shall provide a MPR that describes the progress made within the reporting period. At a minimum in the MPR, the Contractor shall provide status of work in progress, problems or constraints encountered, suggested solutions, travel summary, and status on iWatch training, using a format agreed upon by the COR and Contractor. The report shall also provide a spend plan and subsequent updates, if needed, detailing how all costs/invoices will occur monthly (e.g., labor hours expended, by labor category and

Contract Line Item Number [CLIN], and estimated cost to completion). The Contractor shall require all subcontractors to provide input to the MPR where there are critical or significant tasks related to the prime contract.

Critical or significant tasks shall be defined by mutual agreement between the Government and Contractor.

7.5. Contractor Manpower Reporting: 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: https://www.ecmra.mil/Login.aspx. 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 applicable help desk at:

https://www.ecmra.mil/Login.aspx.

8.0. PERFORMANCE CONSTRAINTS

8.1. Access and general protection policy and procedures: Contractor and all associated sub-contractors 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.

8.2. 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.

8.3. iWATCH training: The contractor and all associated sub-contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new employees commencing performance with the results reported to the COR no later than 30 calendar days after contract award.

9.0. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The COR will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the Contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor the Contractor’s performance and notify both the Contracting Officer and Contractor of any deficiencies; coordinate availability of Government furnished property, and provide site entry of Contractor personnel. A COR appointment letter will issued to the COR, a copy of which will be sent to the Contractor, stating the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

QUALITY ASSURANCE AND SURVEILLANCE PLAN (QASP)

1. Vision

The Department of Defense (DoD) U.S. Army Medical Materiel Development Activity (USAMMDA) vision is to be the premier developer of world class military medical solutions.

2. Mission

USAMMDA’s core mission is to develop and deliver quality medical solutions to protect, treat, and sustain the health of Our Service Members.

3. Purpose

3.1. This Quality Assurance Surveillance Plan (QASP) is a Government-developed document used to determine if the contractor's performance meets the performance standards contained in the contract. The

QASP establishes procedures on how this assessment/inspection process will be conducted. It provides the detailed process for a continuous oversight process:

3.1.1. What will be monitored?

3.1.2. How monitoring will take place.

3.1.3. Who will conduct the monitoring.

3.1.4. How monitoring efforts and results will be documented.

3.2. The contractor is responsible for implementing and delivering performance that meets contract standards using its Quality Control Plan (QCP). The QASP provides the structure for the Government's surveillance of the contractor's performance to assure that it meets contract standards. It is the Government's responsibility to be objective, fair and consistent in evaluating contractor performance.

3.3. The QASP is not part of the contract nor is it intended to duplicate the contractor's QCP. This QASP is a living document. Flexibility in the QASP is required to allow for an increase or decrease in the level of surveillance necessary based on contractor performance.

3.4. The Government shall provide a copy of the QASP to the contractor to facilitate open communication. In addition, the QASP should recognize that unforeseen or uncontrollable circumstances might occur that are outside the control of the contractor.

The QASP shall ensure early identification and resolution of performance issues to minimize impact on mission performance.

4. Authorities

The authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation (FAR), Inspection of Services clauses, which provide for inspection, acceptance and documentation of the service called for in the contract or task order. This acceptance is to be executed by the Contracting Officer or the Contracting

Officer’s Representative (COR).

5. Roles and Responsibilities

The following Government personnel shall oversee and coordinate surveillance activities.

5.1. Contracting Officer

The Contracting Officer shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The Contracting Officer shall also ensure the Contractor receives impartial, fair, and equitable treatment under this contract, and document the final assessment of the contractor's performance in the Government

Contracting Performance Assessment Reporting System (CPARS).

Assigned Contracting Officer: TBD

Organization or Agency: U.S. Army Medical Research Acquisition Activity (USAMRAA)

Telephone: TBD

Email: TBD

5.2. Contracting Officer's Representative

The COR is responsible for providing continuous technical oversight of the contractor's performance. The COR uses the QASP to conduct the oversight/surveillance process. The COR shall keep a Quality Assurance file that accurately documents the contractor's actual performance. The purpose is to ensure that the contractor meets the performance standards contained in the contract. The COR is responsible for reporting early identification of performance problems to the Contracting Officer. The COR is required to provide an annual performance assessment to the Contracting Officer which will be used in documenting past performance. The QASP is the primary tool for documenting contractor performance. The COR is not empowered to make any contractual commitments or to authorize any contractual change on the Government's behalf.

Assigned COR: TBD

Organization or Agency: USAMMDA

5.3. Other Key Government Personnel

This may include performance monitors, inspectors, technical experts, or others who provide information that helps the COR monitor contractor performance.

The designated technical quality assurance personnel are:

Name: Not Applicable mailto:evelyn.k.stephenson.civ@mail.mil

Telephone:

Email:

5.4. Contractor Representatives

The following employees of the contractor serve as the contractor's Program Manager and Task Manager for this contract.

5.4.1. Contractor Point-of-Contact

Name: TBD

Performance Requirements and Method of Surveillance

This section describes the special requirements for this effort. The following sub-sections provide details of various considerations on this effort.

5.5. Contract Surveillance

The goal of the QASP is to ensure that contractor performance is effectively monitored and documented. The

COR's contribution is their professional, relationships with the Contracting Officer, PM and the contractor, which enables positive, open and timely communications. The foundation of this relationship is built upon objective, fair, and consistent COR evaluations of contractor performance against contract requirements. The COR uses the methods contained in this QASP to ensure the contractor is in compliance with contract requirements. The COR function is responsible for a wide range of surveillance requirements that effectively measure and evaluate the contractor's performance. Additionally, this QASP is based on the premise that the contractor, not the Government, is responsible for management and Quality Control (QC)/Quality Assurance (QA) actions to successfully meet the terms of the contract.

5.6. Methods of QA Surveillance

Various methods exist to monitor performance. The COR will use the surveillance methods listed below in the administration of this QASP. Regardless of the surveillance method, the COR will contact the Contractor's task manager or on-site representative when a defect is identified and inform the manager of the specifics of the problem. The COR will be responsible for monitoring the Contractor’s performance in meeting a specific performance standard/AQL.

a. DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)

Operation and Maintenance training

Contract kick-off meeting

Option Period Operation and Maintenance training

b. 100% INSPECTION. (Evaluates all outputs. Most applicable to small quantity, but highly important services.

May be used where there are written deliverables and stringent requirements such as tasks required by law, safety, or security.)

Delivery of ECLS devices, consumables, and associated equipment

Operation and Maintenance training & Disposal instruction packages through ARL SAFE

Delivery of ECLS devices, consumables, and associated equipment

RMF Questionnaire

Contract kick-off meeting

Monthly Progress Report (MPR)

Contractor Manpower Reporting Application (CMRA) iWATCH training

Option Period Delivery and storage of ECLS devices, consumables, and associated equipment

Option Period Operation and Maintenance training package through ARL SAFE

c. Progress or status meetings.

Telephone Progress Update

d. Analysis of contractor's progress reports. (Evaluate cost, schedule, etc.)

Monthly Progress Report (MPR)

Surveillance results may be used as the basis for actions (to include payment deductions) against the contractor. In such cases, the Inspection of Services clause in the Contract becomes the basis for the KO’s actions.

6. RATINGS.

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

EXCEPTIONAL: Performance significantly exceeds contract requirements to the Government’s benefit.

SATISFACTORY: Performance meets contractual requirements.

UNSATISFACTORY: Performance does not meet contractual requirements.

7. DOCUMENTING PERFORMANCE.

a. ACCEPTABLE PERFORMANCE.

The Government shall document positive performance. A report will be generated each month in the Wide Area

Work Flow Contracting Officer’s Representative Tracking (CORT) Tool. Any report may become a part of the supporting documentation for fixed fee payments, award fee payments, or other actions.

b. UNACCEPTABLE PERFORMANCE.

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract

Discrepancy Report (CDR), and present it to the Program or Contracts Manager. A CDR template is attached to this

QASP.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for contract payment deductions, fixed fee deductions, award fee nonpayment, or other actions deemed necessary by the KO.

8. FREQUENCY OF MEASUREMENT.

a. Frequency of Measurement.

During contract performance, the COR shall take periodic measurements, as specified in the AQL column of the

Performance Standards Summary Matrix, and shall analyze whether the negotiated frequency of measurement is appropriate for the work being performed.

b. Frequency of Performance Assessment Meetings.

The COR shall meet with the contractor quarterly to assess performance and shall provide a written assessment.

9. REVISIONS.

The QASP is subject to change at any time at the Government’s discretion. The QASP is not incorporated into the contract order, therefore changes, if made, do not necessitate a contract modification. However, if there are changes to this QASP, the contractor will be notified promptly and provided a copy of the changes.

10. PERFORMANCE STANDARDS

10.1. Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

10.2. The Performance Requirements Summary Matrix, shown below, includes performance standards. The

Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Deliverable Indicator Standard Acceptable

Quality Level

Method of

Surveillance Incentive

Delivery of ECLS devices, consumables, and associated equipment

Delivered test ready in hardened cases at the direction of the

Government based on manufacturer specifications

Meet 95% of delivery requests; devices arrive test ready

& operational

100% Inspection

Positive past performance rating

Operation and

Maintenance

Training &

Disposal

Instruction

Packages

Provide ninety

(90) calendar days prior to conducting training

Not less than ninety (90) calendar days prior to conducting training

100% Inspection

Positive past performance rating

Operation and

Maintenance training

Conduct training on ECLS devices

100%

Direct observation

Positive past performance rating

Delivery of ECLS devices, consumables, and associated equipment

Delivered test ready in hardened cases at the direction of the

Government based on manufacturer specifications

Meet 95% of delivery requests; devices arrive test ready

& operational

100% Inspection past performance rating

RMF

Questionnaire

Completed RMF

Questionnaire no later than ninety

(90) calendar days after contract award

Completed RMF

Questionnaire provided to COR no later than ninety (90) calendar days after contractor award

100% Inspection

Positive past performance rating

Contract kick-off meeting

Provide required kick-off meeting materials within fifteen (15) business days of contract award

Kick-off meeting materials provided within fifteen (15) business…