CARM Solicitation.docx

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C-Arm Solicitation Federal contract opportunity
Solicitation number
HT942524R0094
Issued by
Defense Health Agency

About this file

This document is a Performance Work Statement (PWS) and Quality Assurance Surveillance Plan (QASP) for the U.S. Army Aeromedical Research Laboratory's (USAARL) requirement to obtain annual calibration, maintenance, and repair services for a Siemen's ARCADIS Avantic C-Arm.

The PWS outlines the scope of work to inspect, calibrate, maintain, and repair the C-Arm located at USAARL in Fort Novosel, Alabama. It includes performance standards, surveillance methods, and incentives for the contractor. The QASP details the government's roles and responsibilities, performance standards, methods of quality assurance, and procedures for documenting performance. The period of performance is for a one-year base period and a five-month option period. The contractor shall provide all necessary resources, be factory trained on the equipment, and comply with various training requirements for accessing the government facility and information systems. The contractor shall provide deliverables such as calibration reports, failure reports, and modification reports. The government will evaluate offers on a Lowest Price Technically Acceptable (LPTA) basis.

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HT942524R0094

Section SF 1449 - CONTINUATION SHEET

QASP

Quality Assurance Surveillance Plan Siemen’s ARCADIS Avantic C-Arm Calibration/Maintenance Services

1. Purpose.

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

· What will be monitored?

· How Monitoring will take place?

· Who will conduct the monitoring?

· How monitoring efforts and results will be documented?

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. Government Roles and Responsibilities

a. Contracting Officer (KO) – The KO 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 KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

b. Contract Specialist (CS) – The CS 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 CS shall also assure that the contractor receives impartial, fair, and equitable treatment under the contract.

c. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

d. Contracting Officer’s Technical Representative (COTR). A COTR is a Government employee who is authorized to monitor the contractor’s performance under the contract, serve as technical liaison between the contractor and the COR, and perform other duties specified in this document. COTRs have no authority to change any of the terms or conditions of the contract.

3. Contractor Representatives. The contractor’s identified employee shall serve as the contractor’s Program Manager and Task Manager for the contract.

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

The below Performance Requirements Summary Matrix includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL). If the performance standards are not met in the performance requirement summary the government will document the contractor’s past performance, and may terminate the contract in accordance with FAR Clause 52.212-4 (m), Termination For Cause.

Task
Indicator
Standard
Acceptable Quality Level
Method of Surveillance
Incentive
Technical Requirements – Section 3.1.1.
Calibration
The system shall be inspected for general operational function.
Onsite to calibration of the system once annually.
Observation and 100% inspection by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.1.
Calibration
The C-arm calibration is in conformance with Federal Radiation Performance Standards 21 CFR Subchapter J Paragraph 1020.30 (h).
A calibration report provided within 15 days of successful calibration.
100% inspection by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.2.1, 3.1.2.3
Repairs
If hardware/software failures are identified during inspection, a failure report and quote will be provided.
A failure report and quote provided within 15 days of identification of failure.
100% inspection by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.2.1, 3.1.2.3
Repairs
Corrective action to repair the hardware/software failures will be completed upon approval of the COR.
Repairs completed within 3 days of part availability.
100% inspection by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.2.2
Service Calls
During system failure, onsite service shall be completed as requested by the Government.
The Contractor shall be onsite within 8 hours of service call.
Observation and 100% Inspection by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.3
Warranty
Warranty and part replacement of parts determined defective by the manufacturer or parts that failed inspection by the contractor and covered under warranty shall be completed.
Damaged parts covered by warranty shall be replaced/ repaired.
Observation and 100% Inspection by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.4.1
Maintenance and Support
Upgrades to the software shall be supplied as available.
Software upgrades, if available, shall be installed during annual calibration.
Observation by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.4.2
Maintenance and Support
Modifications or enhancements to equipment to improve safety and/or performance shall be provided.
The contractor shall provide a modification report within 15 days of updating.
Observation and 100% Inspection by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.4.3
Maintenance and Support
Telephone support during normal business hours for troubleshooting, technical support, and fast diagnosis will be provided.
The contractor shall respond within 1 hour to provide technical support over the phone.
Observation by the COR and Technical Representative.
Positive Past Performance Rating

5. Incentives. The Government shall use past performance as incentives. Incentives shall be based on exceeding, meeting, or not meeting performance standards.

6. Methods of Quality Assurance Surveillance.

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

Regardless of the surveillance method, the COR shall always contact the contractor's Program Manager and Task Manager when a defect is identified and inform the manager of the specifics of the problem. The COR, with assistance from the CS, shall 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.

· Periodically

b. Periodic Inspection. Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.

· As requested or required.

c. 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.

· Provide reports and documentation as specified in the PWS and the Performance Requirements Summary Matrix above.

d. Progress or status meetings.

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

7. 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

8. Documenting Performance.

a. Acceptable Performance. The Government shall document positive performance.

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 contractor's Program Manager and Task Manager or on-site representative.

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.

9. Frequency of Measurement.

a. 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 assess performance and provide a written assessment, and upload the assessment to Surveillance and Performance Monitoring Module on a monthly basis, no later than the 15th day of the following month.

The COR at a minimum will meet with the contractor on a quarterly basis and conduct a performance meeting.

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

Siemen’s ARCADIS Avantic C-Arm Calibration/Maintenance Services

SECTION 1 PURPOSE

1.1. Introduction

The United States Army Aeromedical Research Laboratory (USAARL) is a subordinate Command of the United States Army Medical Research and Development Command (USAMRDC). USAARL is one of USAMRDC’s six research laboratories in the continental United States, responsible for planning and executing basic and applied medical research. USAARL is located at Fort Novosel, 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 USAMRDC’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 Novosel, 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. 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 Development Command (USAMRDC) 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: USAARL, Building 8825 Andrews Avenue, Fort Novosel, AL 36362.

2.1.1. Period of Performance. This contract is for one (1) twelve-month Base Period and one (1) five-month Option Period. The periods of performance for this contract are as follows:

Base Year
15 August 24-14 August 25
Option Year Period 1
15 August 25 –31 December25

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. Juneteenth, 19 June

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 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.

2.3.3. 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 3). 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 4). 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 5). The contractor shall provide documentation of any modifications or upgrades 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. Services Contracting Reporting (Deliverable 6). This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services. Refer to FAR 52.204-14.

2.5. Training Requirements

2.5.1. Completion of Training Requirements (Deliverable 7). If the contractor is required to gain access to the facility or to a Government network, the contractor shall track and complete refresher training to maintain training compliance and readiness status. The contractor shall submit certificates of completion for each affected contractor and subcontractor personnel to the COR within 5 calendar days after completion of training by all personnel and subcontractor personnel. Contractor shall track and complete refresher training to maintain training compliance and readiness status as required.

2.5.1.1 Cyber Awareness Challenge (DOD-US1364-23). Applicable to all Contractor and Subcontractor employees who require access to Government Information Systems. All Contractor employees with access to a Government information system must successfully complete the Cyber Awareness training prior to access to the information system. This is a non-residential course and is required every 365 days. The course can be accessed on-line at https://jko.jten.mil/mhs. The course takes approximately one (1) hour to complete.

2.5.1.2 Health Insurance Portability and Accountability Act (HIPAA) and Privacy Act Security Training (DHA-US001). The Contractor and Subcontractor employees shall complete this required non-residential initial core training course and annual birth month refresher training thereafter, available on-line at https://jko.jten.mil/mhs. The course takes approximately two (2) hours to complete.

2.5.1.3 Acceptable Use Policy (DHA-US1124). The Contractor and Subcontractor employees shall complete this required non-residential initial core training course and annual refresher training thereafter, available online at https://jko.jten.mil/mhs. The course takes approximately 30 minutes to complete.

2.5.1.4 Using Mobile Devices in a DoD Environment (DISA-US130). Applicable to all Contractor and Subcontractor employees who require access to Government Information Systems. All Contractor employees with access to a Government information system must successfully complete the training prior to access to the information system. The course can be accessed on-line at https://jko.jten.mil/mhs and takes approximately one (1) hour to complete. This is a non-residential course.

2.5.1.5 Phishing and Social Engineering: Virtual Communication Awareness Training. Applicable to all Contractor and Subcontractor employees who require access to Government Information Systems. All Contractor employees with access to a Government information system must successfully complete the training prior to access to the information system. The course can be accessed on-line at https://jko.jten.mil/mhs and takes approximately one (1) hour to complete. This is a non-residential course.

2.5.1.6 Identifying and Safeguarding Personally Identifiable Information (PII). Applicable to all Contractor and Subcontractor employees who require access to Government Information Systems. All Contractor employees with access to a Government information system must successfully complete the PII training prior to access to the information system. The course can be accessed on-line at https://jko.jten.mil/mhs and takes approximately one (1) hour to complete. This is a non-residential course.

2.5.1.7 Collaborative Institutional Training Initiative (CITI). The Contractor and Subcontractor employees shall complete this required non-residential initial training course and refresher every three years or as required to be in regulatory compliance. The initial training and refresher course can be found at www.citiprogram.org. The course takes approximately eight (8) hours to complete.

2.5.1.8 Anti-Terrorism (AT) Level 1 (JS-US007). All Contractor and Subcontractor employees shall complete this required non-residential training course every 365 days. AT Level I awareness training is available on-line at https://jkodirect.jten.mil/Atlas2/page/login/Login.jsf. The course takes approximately one (1) hour to complete.

2.5.1.9 Operations Security (OPSEC) Training (EUC-ECJ6-110-N). The Contractor and all Subcontractors shall complete this required non-residential training course every 365 days. The OPSEC training can be accessed on-line at https://jkodirect.jten.mil/Atlas2/page/login/Login.jsf and takes approximately one (1) hour to complete.

2.5.1.10 Threat Awareness and Response Program (TARP). Training applies to those Contractor and Subcontractor employees who have a security clearance. Applicable Contractor employees shall complete this required training every 365 days. The course is offered as face-to-face training periodically throughout the year. Online training can be taken in place until face-to-face training is available. The online training can be found at https://jkodirect.jten.mil. The course takes approximately two (2) hours to complete.

2.5.1.11 DoD Mandatory Controlled Unclassified Information (CUI) Training. The Contractor and all Subcontractors shall complete this required non-residential training course every 365 days. The CUI training can be accessed on-line at https://securityawareness.usalearning.gov/cui/index.html, and takes approximately one (1) hour to complete.

2.5.1.12 Emergency Preparedness Response Course (EPRC) (US1358). Contractor and Subcontractor employees shall complete this required non-residential training. The EPRC training can be accessed on-line at https://jkodirect.jten.mil. The course takes approximately one (1) hour to complete.

2.5.1.13 Active Shooter Training. Contractor and Subcontractor employees shall complete this required non-residential training every three years. The Active Shooter training can be accessed on-line at https://jkodirect.jten.mil. The course takes approximately one (1) hour to complete.

2.5.1.14 Information Assurance and IT Training. In addition to completion of required DoD IA Awareness training, all Contractor and Subcontractor employees working IA and IT functions must comply with DoD training requirements in DoD Directive (DoDD) 8570.1 and, DoD 8570.01-M, within six (6) months of employment.

2.5.1.15 IA and IT Certification. Per DoD 8570.01-M and DFARS 252.239.700, the Contractor and Subcontractor employees’ supporting IA and IT functions shall be appropriately certified upon TASK ORDER award. The baseline certification as stipulated in DoD 8570.01-M must be completed upon TASK ORDER award.

2.5.1.16 AT Awareness Training for Contractor Personnel Traveling Overseas. Applicable to Task Orders requiring Contractor employees to perform in OCONUS. U.S.- based Contractor employees and Subcontractor employees to make available and to receive Government-provided AT awareness training specific to the Area of Responsibility (AOR). Specific AOR training content is directed by the combatant commander, with the unit AT Officer being the local point-of- contact.

2.5.1.17 Combat Trafficking in Persons (CTIP) General Awareness Course. Training applies to Contractor and Subcontractor personnel who perform CONTRACT requirements in OCONUS. Applicable Contractor shall complete this required non-residential training every 365 days. The training takes approximately 30 minutes to complete.

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 3) 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 4) AND a written estimate of cost (i.e. quote) (Deliverable 8) 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 8) 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 upgrades 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 5) 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

Task
Indicator
Standard
Acceptable Quality Level
Method of Surveillance
Incentive
Technical Requirements – Section 3.1.1.
Calibration
The system shall be inspected for general operational function.
Onsite to calibration of the system once annually.
Observation and 100% inspection by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.1.
Calibration
The C-arm calibration is in conformance with Federal Radiation Performance Standards 21 CFR Subchapter J Paragraph 1020.30 (h).
A calibration report provided within 15 days of successful calibration.
100% inspection by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.2.1, 3.1.2.3
Repairs
If hardware/software failures are identified during inspection, a failure report and quote will be provided.
A failure report and quote provided within 15 days of identification of failure.
100% inspection by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.2.1, 3.1.2.3
Repairs
Corrective action to repair the hardware/software failures will be completed upon approval of the COR.
Repairs completed within 3 days of part availability.
100% inspection by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.2.2
Service Calls
During system failure, onsite service shall be completed as requested by the Government.
The Contractor shall be onsite within 8 hours of service call.
Observation and 100% Inspection by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.3
Warranty
Warranty and part replacement of parts determined defective by the manufacturer or parts that failed inspection by the contractor and covered under warranty shall be completed.
Damaged parts covered by warranty shall be replaced/ repaired.
Observation and 100% Inspection by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.4.1
Maintenance and Support
Upgrades to the software shall be supplied as available.
Software upgrades, if available, shall be installed during annual calibration.
Observation by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.4.2
Maintenance and Support
Modifications or enhancements to equipment to improve safety and/or performance shall be provided.
The contractor shall provide a modification report within 15 days of updating.
Observation and 100% Inspection by the COR and Technical Representative.
Positive Past Performance Rating
Technical Requirements – Section 3.1.4.3
Maintenance and Support
Telephone support during normal business hours for troubleshooting, technical support, and fast diagnosis will be provided.
The contractor shall respond within 1 hour to provide technical support over the phone.
Observation by the COR and Technical Representative.
Positive Past Performance Rating
Types of SurveillanceMethods of Surveillance
Customer ComplaintsManagement Information Systems
Random SamplingObservation of Trask Attributes
100% InspectionObservation 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.

Item
PWS Ref
Title
Distribution
E
H
Initial
1
1.5
Oranizational Conflict of Interest (OCI)
KO, COR
1
0
With proposal submission
2
1.6
Non-Disclosure Statement (NDS)
KO, COR
1
0
As required
3
2.4.2

3.1.1

Calibration Report
COR
1
0
NLT 15 calendar days after successful calibration
4
2.4.3

3.1.2.1

Failure Report
COR
1
0
As required, NLT 15 calendar days after identification of part failure
5
2.4.4

3.1.4.2

Modification Report
COR
1
0
As required, NLT 15 calendar days after identification of requirement
6
2.4.5
Services Contract Reporting (SCR)
KO, COR
1
0
Data entered into the sam.gov NLT 31 October of each fiscal year
7
2.5
Training
COR
1
0
As required
8
3.1.2.1

3.1.2.3

Quotes
COR
1
1
As required, NLT 15 days after identification of part failure

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

Regulations and Policies
Titles
NRC 10 CFR 20
U.S. Nuclear Regulatory Commission Title 10 Code of Federal Regulations Part 20 – Standards for Protection Against Radiation
OSHA 29 CFR 1910.1096
Occupational Safety and Health Administration Title 29 Code of Federal Regulations Part 1910.1096 – Ionizing Radiation

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.

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