C-ARM_PWS_v5.doc

PERFORMANCE WORK STATEMENT (PWS)

(Cover Page) Siemen’s ARCADIS Avantic C-Arm Calibration/Maintenance Services United States Army Aeromedical Research Laboratory (USAARL)

USAARL

25 April 2019

SECTION 1 PURPOSE

1.1. Introduction

USAARL is a subordinate Command of the United States Army Medical Research and Materiel Command (USAMRMC). USAARL is one of USAMRMC’s six research laboratories in the continental United States, responsible for planning and executing basic and applied medical research. USAARL is located at Fort Rucker, Alabama, the home of Army Aviation and the U.S. Army Aviation Center of Excellence (USAACE).

1.2. Mission

The Commander, USAARL, directs the management of a number of medical research, development, and acquisition programs related to aeromedical and ground ambulance evacuation and the prevention of injury. USAARL’s military applied research primarily supports USAMRMC’s Military Operational Medicine Research Program (MOMRP) and the Joint Program Committee 5 (JPC-5) research objectives. The mission of the USAARL is to preserve and enhance the health, safety, combat effectiveness, and survivability of the U.S. Army aviator and Soldier. USAARL is the U.S. Army’s lead lab for research in combat injury prevention, head injury prevention, visual performance and protection, acoustic performance and protection, and operator performance under stress.

USAARL's research includes developing injury prevention and health performance standards, determining the effectiveness of life support equipment and personnel protective equipment, and preventing and mitigating ground and aircrew biomechanical injuries. The USAARL’s facilities and scientific experience and expertise specialize in human protection through development, test, and evaluation of helmets, restraints, and medical equipment.

USAARL has maintained a reputation as an honest broker of Soldier safety, and by combining basic science, technology, medicine, and engineering, USAARL continues to enhance the safety and performance of mounted and dismounted Service Members.

1.3. Background

The U.S. Army Medical Research Acquisition Activity (USAMRAA) on behalf of its customer activity, the U.S. Army Aeromedical Research Laboratory (USAARL) located at Fort Rucker, Alabama has a recurring requirement for annual calibration and maintenance of an existing Siemen’s ARCADIS Avantic C-Arm. The Injury Biomechanics and Protection Group’s (IBPG) mission is to develop biomedical assessment tools and performance standards for the prevention and mitigation of Soldier injuries. The primary threat-based competency is Blunt, Blast, and Accelerative Injury and Protection with a focus to the head and spine and overall whole body response.

1.4. Scope

One Siemen’s ARCADIS Avantic C-Arm was procured by USAARL in 2012, and delivered and installed in 2013. At present, this C-Arm works appropriately; there are no issues with functionality, nor have any parts needed replacement or repair. The C-Arm has had annual maintenance inspection in accordance with the company’s recommended maintenance schedule. USAARL requires continued services for inspection, calibration, and/or maintenance/repair/replacement of parts for future years. The purpose of this procurement is to obtain annual services to inspect, calibrate, and/or maintain (i.e. repair/replacement of parts) one Siemen’s ARCADIS Avantic C-Arm. The inspection, calibration, maintenance services shall be performed at USAARL.

1.5. Organizational Conflict of Interest (OCI) (Deliverable 1, Exhibit 1).

This contract will be used to procure U.S. Army Medical Research and Material Command (USAMRMC) OCI Category 3 Product Support that falls within the scope of the PWS. The contractor shall provide an OCI certification with their proposal. If there is an OCI, the contractor shall provide a draft OCI Mitigation Plan with their proposal.

1.6. Non-Disclosure Statement (NDS) (Deliverable 2, Exhibit 2).

The contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets. The contractor personnel may be required to sign specific non-disclosure statements as required by the contract. The contractor shall provide signed non-disclosure statements from each personnel assigned, prior to performing any services.

SECTION 2 GENERAL REQUIREMENT

2.1. Performance

2.1.1. Place of Performance

2.1.1.1. Primary On-Site Government Location:

USAARL, Building 8825 Andrews Avenue, Fort Rucker, AL 36362.

2.1.1.2. Secondary On-Site Government Locations (NA)

2.1.1.3. Other On-Site Government Locations (NA)

2.1.2. Period of Performance. This contract is for one (1) twelve (12) month Base Period and four (4) twelve (12) month Option Periods. The periods of performance for this contract are as follows:

2.1.3.. Duty Hours.

2.1.3.1. Contractor personnel shall schedule calibration and maintenance services during regular duty hours from 0730 to 1730 hours, Monday through Friday.

2.1.3.2. The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander. The following is a list of legal federal holidays that services shall not be performed:

2.1.3.2.1. New Year’s Day, 1 January

2.1.3.2.2. Martin Luther King’s Birthday, 3rd Monday in January

2.1.3.2.3. President’s Day, 3rd Monday in February

2.1.3.2.4. Memorial Day, last Monday in May

2.1.3.2.5. Independence Day, 4 July

2.1.3.2.6. Labor Day, 1st Monday in September

2.1.3.2.7. Columbus Day, 2nd Monday in October

2.1.3.2.8. Veteran’s Day, 11 November

2.1.3.2.9. Thanksgiving Day, 4th Thursday in November

2.1.3.2.10. Christmas Day, 25 December

2.1.3.3. The contractor shall not perform services or report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, energy conservation. During these periods of closure, the contractor personnel who are not designated as essential personnel IAW this contract shall not report for work nor shall they be compensated for those days.

2.2. Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contractor Officer (KO) immediately.

2.3. Contract Management

2.3.1. Government Management. The Contracting Officer’s Representative (COR) and Alternate Contracting Officer’s Representative (ACOR) for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. In the event that the COR is not available, the ACOR will assume the COR’s responsibilities.

2.3.2. Contractor Management. The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract. The PM shall demonstrate capability in the overall management of complex tasks, and strong team building skills.

2.3.2.1.

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

2.3.2.2.

The contractor shall provide a draft Quality Control Plan (QCP) (Deliverable 3) with their proposal and a final QCP no later than 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP.

2.3.3. Subcontract Management. The subcontractor shall be:

2.3.3.1. Responsible for any subcontract management necessary to integrate services performed on this contract.

2.3.3.2. Responsible and accountable for subcontractor performance on this contract.

2.3.3.3. Responsible to manage task distribution to ensure there are no OCI considerations.

2.3.3.4. Contractors may add subcontractors to their team after notification and approval from the PCO and COR. Cross teaming shall be permitted.

2.4. Reports

2.4.1. Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable FAR clause 52.227-14, Rights in Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

2.4.2. Calibration Report (Deliverable 4). The contractor shall provide documentation of successful calibration. Documentation shall include at a minimum: date, contract number, model number/description, serial number, general description of work completed, and status of equipment. See 3.1.1.

2.4.3. Failure Report (Deliverable 5). The contractor shall provide documentation of any failure and quote to repair and/or replace parts not covered by warranty. Documentation shall include at a minimum: date, contract number, model number/description, serial number, general description of failure, status of equipment, and recommended repair/replacement. See 3.1.2.1.

2.4.4. Modification Report (Deliverable 6). The contractor shall provide documentation of any modifications or updates to maintain operation and optimize safety features. Documentation shall include at a minimum: date, contract number, model number/description, serial number, general description of modification, status of equipment, and work completed. See 3.1.4.2.

2.4.5. Contract Manpower Reporting (Deliverable 7). This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

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

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. Contractors may direct questions to the help desk at:

http://www.ecmra.mil/.

SECTION 3 PERFORMANCE REQUIREMENTS

3.1.

The contractor shall provide all necessary resources required to perform services in the United States Army Aeromedical Research Laboratory (USAARL). The contractor shall provide Maintenance and Calibration Support Services. All Contractor technicians shall be factory trained, or equivalent, in the servicing of this equipment. The following section specifies the Performance Objectives and Performance Elements for the contract.

3.1.1. Objective 1 – Calibration. The Contractor shall inspect and calibrate the equipment identified above in accordance with manufacturer specification of operational performance and in conformance with Federal Radiation Performance Standards 21 CFR Subchapter J Paragraph 1020.30 (h). The Contractor shall provide a “calibration” report (Deliverable 4) within 15 days of successful calibration.

3.1.2. Objective 2 – Repair. The Contractor shall identify hardware/software failures during calibration or service calls, recommend repairs, and implement corrective action upon COR direction.

3.1.2.1.

After calibration, the Contractor shall provide a “failure” report (Deliverable 5) AND a written estimate of cost (i.e. quote) (Deliverable 9) for any repair/replacement of parts not covered by the warranty to the COR within 15 calendars days of inspection and/or calibration. The Contractor shall wait for COR instruction/approval prior to taking any action regarding the repair or replacement of any part. The COR will provide direction to the Contractor within 15 calendars days of receipt of quote. Repairs shall be completed within 3 business days of part availability.

3.1.2.2.

The Contractor shall be onsite to inspect the equipment within eight (8) hours after a call for service.

3.1.2.3.

After a service call, the Contractor shall verbally provide diagnosis, corrective action, and cost (i.e. quote) for any repair/replacement parts at completion of inspection. A quote must be provided (electronic or hard copy) (Deliverable 9) within 1 day of diagnosis. The Contractor shall wait for COR instruction/approval prior to taking any action regarding the repair or replacement of any part. The COR will provide direction to the Contractor within approximately 1 business day of receipt of quote. Repairs shall be completed within 3 business days of part availability.

3.1.3. Objective 3 – Warranty. The Contractor shall provide warranty and part replacement of the following: Monitor, Power C-arm Tube, Image Intensifier, and general spare parts. General Spare Parts excludes high-vacuum components, consumables, shock wave components, transducers, TEE’s and specialty proves, flat panel detectors, MMLC, and Waveguides. The Contractor shall provide warranty for parts determined defective by the Manufacturer.

3.1.4.

Objective 4 – Maintenance and Support. The Contractor shall provide maintenance and support as necessary.

3.1.4.1.

The Contractor shall provide software updates as they become available.

3.1.4.2.

The Contractor shall provide modifications or enhancements to equipment to improve safety and/or performance. The Contractor shall provide a written “modification” report (Deliverable 6) within 15 calendar days of modification or enhancement to the equipment to improve safety and/or performance.

3.1.4.3.

The Contractor shall provide off-site support services, such as phone and/or email technical support, remote diagnostics, etc. during normal business hours.

3.2. Performance Requirement Summary Matrix

3.1.2.3

a. Upon inspection, the Contractor shall identify hardware/software failures and provide failure report and quote to COR.

3.1.2.1

3.1.2.3

The contractor shall provide onsite service as requested by the Government.

Types of Surveillance

Methods of Surveillance Customer Complaints

Management Information Systems

Random Sampling

Observation of Trask Attributes

100% Inspection

Observation of Performance Periodic Surveillance

3.3. Quality Assurance Surveillance Plan. Every DoD contract awarded for services in excess of $2,500.00 shall contain a Quality Assurance Surveillance Plan (QASP) as discussed in the FAR 46, Government Contract Quality Assurance. A QASP is a plan that specify the particular services the COR will inspect and the method(s) used to complete that surveillance. Each offeror shall digest the PWS in this RFP and offer a QASP associated therewith. The QASP shall be submitted as part of the offeror’s technical proposal. It will not be subjectively evaluated and rated. However, it may be discussed during the pre-award period for finalization prior to its inclusion in the awarded contract.

SECTION 4

SPECIAL REQUIREMENT

4.1. Government Furnished Property

NA

4.2. Contractor Furnished Property

4.3. Security and Safety

4.3.1. Access and General Protection/Security Policy and Procedures. The contractor and all associated subcontractors’ personnel shall comply with applicable installation, facility, and area commander installation and facility access and local security policies and procedures (provided by the Government representative). The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office. The contractor workforce shall 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.

4.3.2. Contractors Requiring Common Access Card (CAC). Before CAC issuance, the contractor personnel requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation IAW Army Directive 2014-05, Policy and Implementation Procedures for Common Access Card Credentialing and Installation Access for Uncleared Contractors. The contractor personnel will be issued a CAC only if duties involve one of the following:

4.3.2.1. Both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely;

4.3.2.2. Remote access, via logon, to a DoD network using DoD-approved remote access procedures; or

4.3.2.3. Physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

4.3.3. 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, IAW status of forces agreements and other theater regulations.

4.3.4. Contractor Personnel Who Require Access to Government Information Systems.

All contractor employees with access to a government information system must be registered in the ATCTS (Army Training Certification Tracking System) at commencement of services and must successfully complete the DoD Information Assurance Awareness training prior to access to the information system and then annually thereafter.

4.3.5. Prior to commencement of services, the contractor shall provide the COR, within thirty (30) calendar days in advance of the event, full names, date of birth, place of birth and identification numbers for non-U.S. citizen personnel who will be entering Army-controlled installation and facilities.

4.3.6. The contractor shall ensure that its personnel entering Army-controlled installations or facilities have obtained access badges and passes IAW facility regulations and that these badges and passes are obtained in advance so as not to delay the accomplishment of contracted services. The contractor shall contract COR or designated Government Trusted Associate Sponsorship System (TASS) Trusted Agent who is responsible to facilitate and sponsoring contractor’s Army Knowledge Online (AKO) registration and TASS in-processing and out-processing, to include approval, rejection and re-verification.

4.3.7. Force Protection Condition (FPCON) impact on work levels. The contractor workforce shall comply with all personal identity verification requirements as directed by DoD, Headquarters Department of the Army (HQDA), and local policy. In addition to the changes otherwise authorized by the changes clauses of this contract, should the FPCON at any individual facility or installation change, the Government may require changes in contractor security matters or process. IAW Department of Defense Instructions (DoDI) 2000.16, DoD AT Standards, the FPCON is defined as follows:

4.3.7.1. FPCON ALPHA. This condition applies when there is a general threat of possible terrorist activity against personnel and facilities, the nature and extent of which are unpredictable, and circumstances do not justify full implementation of FPCON BRAVO measures. However, it may be necessary to implement certain measures from higher the Terrorist Threat Conditions (THREATCONS) resulting from intelligence received or as a deterrent. The measures in this THREATCON must be capable of being maintained indefinitely.

4.3.7.2. FPCON BRAVO. This condition applies when an increased and more predictable threat of terrorist activity exists. The measures in this THREATCON must be capable of being maintained for weeks without causing undue hardship, affecting operational capability, and aggravating relations with local authorities.

4.3.7.3. FPCON CHARLIE. This condition applies when an incident occurs or intelligence received indicating some form of terrorist action against personnel and facilities is imminent. Implementation of measures in this THREATCON for more than a short period probably will create hardship and affect the peacetime activities of the unit and its personnel.

4.3.7.4. FPCON DELTA. This condition applies in the immediate area where a terrorist attack has occurred or when intelligence has been received that terrorist action against a specific location or person is likely. Normally, this THREATCON is declared as a localized condition. See also anti-terrorism

4.3.7.5. During FPCONs Charlie and Delta, non-essential services are discontinued. Designated essential service will resume when the FPCON level is reduced to level Bravo or lower.

4.3.7.6. When contractor personnel are considered mission essential, all contractor personnel are required to report for duty and remain on duty during declared emergencies or elevated FPCON levels unless otherwise directed by the contracting officer via the appropriate COR.

4.3.7.7. Generation, handling and storage of classified material. The contractor shall not generate, handle or store classified material for this contract.

4.4. Security Requirements. The contractor shall not possess or store classified information at the contractor’s facility; therefore, level of safeguarding required is not applicable to this contract.

4.4.1. Unclassified Contract Security Requirements: The contractor shall ensure all personnel performing under this contract have a favorable National Agency Check with written inquires (NACI), including a favorable completion of Federal Bureau of Investigation (FBI) fingerprint check, which the ACOR will coordinate with the United States Army Garrison (USAG) Fort Detrick Security office prior to performance start date. The security requirements shall be maintained for the life of the contract, and citizenship shall be verified by presenting an original birth certificate or a U.S. passport or the original Naturalization Certificate to the USAG Fort Detrick Security office at the time of in processing for all contract personnel assigned to the contract. In order to maintain the security requirements any derogatory information, to include law enforcement issues, mental health issues, or alcohol/drug related issues shall be reported to the COR, ACOR, and USAG Fort Detrick Security Office.

4.5. Proprietary Information Assurance and Security. The contractor shall comply with Office of Management and Budget (OMB) Circular A-130, “Management of Federal Information Resources,” which requires Certification and Accreditation (C&A) of all federal information systems every three (3) years at a minimum or as changes that require re-accreditation occur. This C&A requirement ensures the effective safeguarding of sensitive but unclassified (SBU) data against unauthorized modification, disclosure, destruction, and denial of service, as directed by the DoD.

4.5.1. The contractor shall protect all data in the strictest confidence; prevent the unauthorized duplication, use and disclosure of information that is subject to the Privacy Act of 1974, HIPAA IAW applicable statutory, regulations, local policies and procedures.

4.5.2. All data received, processed, evaluated, loaded, and created as a result of this contract shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract unless the contracting officer grants specific exception.

4.5.3. The contractor is prohibited from appropriation, disclosure, or unauthorized use of proprietary information that is acquired in the execution of this contract.

4.5.4. All products including files, software, and other information, which are created, produced or developed during the period of performance is the property of the Government and shall be returned unless the Government grants the contractor permission to retain the materials and products for continued development or publication.

4.7. Other Direct Costs

4.7.1. ODCs shall be billed on a cost reimbursable basis. Costs are defined as the purchase price of materials or service plus General and Administrative charges (G&A) or material and handling charges (M&H) in accordance with FAR 31.205-26, Material Cost.

4.7.2. All ODCs shall be reported as stated in the quote as required.

SECTION 5 DELIVERABLES

5.1. Deliverables. The contractor shall provide the following deliverable as listed.

3.1.1

3.1.2.1

3.1.4.2

3.1.2.3

SECTION 6 APPLICABLE DIRECTIVES, REGULATIONS, AND POLICIES

6.1. Environmental Requirements

6.1.1. Mandatory Compliance. Occupational Safety and Health Act and AR 200-1 Environmental Protection and Enhancement.

6.1.2. Non Mandatory Documents. Additional DoD and Army environmental program and regulations are available on-line at http://aec.army.mil.

6.2. Applicable Directives. The contractor shall comply with all documents listed below as mandatory and referenced under paragraph 3 Performance Requirements.

6.3. Mandatory Compliance

SECTION 7 DEFINITIONS AND ACRONYMS

7.1. Definitions

7.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

7.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and/or terminate contracts, and make related determinations and findings on behalf of the government. The Contracting Officer is the only individual who can legally bind the government.

7.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

7.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

7.1.5. DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

7.1.6. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

7.1.7. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

7.1.8. QUALITY ASSURANCE. The government procedures to verify that services being performed by the contractor are performed according to acceptable standards.

7.1.9. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

7.1.10. QUALITY CONTROL. All necessary measures taken by the contractor to assure that the quality of an end product or service shall meet contract requirements.

7.1.11. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

7.1.12. WORK DAY. The number of hours per day the contractor provides services IAW the contract.

7.1.13. WORK WEEK. Monday through Friday, unless specified otherwise.

7.2. Acronyms

The acronyms listed below will assist in recognizing certain key words, phrases, or departments as defined in the contract, as well as any forthcoming dialogue with the contractor.

7.3. Related Documents (List of attachments)