W81XWH18R0118_Maintenance_and_Repair_Support_Services.pdf

Section SF 1449 - CONTINUATION SHEET

PWS

Performance Work Statement (PWS)

Maintenance Support Services of Synapt G2 MALDI, Ultra Performance Liquid Chromatography (UPLC), Supercritical fluid chromatography (SFC), and

UltraPerformance Convergence Chromatography (UPC2))

Vision Statement (United States Army Medical Research Institute of Chemical Defense) (USAMRICD):

The mission of the United States Army Medical Research Institute of Chemical Defense (USAMRICD) requires a maintenance services contract to provide qualified personnel in support of the United States Army Medical Research Institute of Chemical Defense (USAMRICD) and provide the required staffing resources as necessary to allow the USAMRICD to continue to be a recognized leader in the development of chemical warfare countermeasures.

1.0. Introduction

This is a maintenance services contract to provide offsite skilled professional personnel in accordance with the requirements of the USAMRICD and its mission. The Contractor shall provide the support services required to perform all of the tasks and deliverables listed in this Performance Work Statement (PWS). The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

1.1. Mission – The USAMRICD's mission is to discover and develop medical products and knowledge solutions against chemical and biochemical threats through research, education and training, and consultation. As a part of the mission, the USAMRICD offers a wide variety of events and courses to first responders and throughout the Department of Defense (DoD) community.

1.2. Background:

1.2.1 The USAMRICD is a world leader in the discovery and development of medical products and knowledge solutions against chemical threats through research, education and training, and consultation. It is through successful partnerships with outside agencies that we are able to maintain our high level of excellence. This non-personal based service contract will provide the USAMRICD with the required resources in order to maintain mission critical operations. Failure to provide the support services needed to carry-out and complete routine requirements would be extremely detrimental to the mission.

1.3. Scope:

1.3.1. This PWS contains no services that are inherently governmental functions, as defined in the FAR Subpart 2.1.

The Government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks to or prepare work schedules for an individual contractor employee. It shall be the responsibility of the contractor to manage its employees and to guard against any actions that are of the nature of personal services or 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 Contracting Officer (KO) immediately. Performance will be at the United States Army Medical Research Institute of Chemical Defense (USAMRICD), Aberdeen Proving Grounds, Maryland.

1.3.2. The contractor shall provide preventative maintenance services to the United States Army Medical Research Institute of Chemical Defense (USAMRICD). Annual preventative maintenance services are to be performed.

Contractor shall respond within 24-48 hours during normal duty hours (Monday – Friday 0800-1700) to all requests for technical assistance and service, to include telephone inquiries to answer user questions, troubleshoot performance and maintenance problems and schedule on-site maintenance. The Contractor shall require an escort for onsite visits. The USAMRICD requires onsite support services for the USAMRICD’s core competencies in its daily business operations. The Contractor shall accomplish the assigned work by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience. The Contractor shall match personnel skills to the work or task with a minimum of under/over employment of resources. The Contractor shall ensure the labor categories, labor rates, and man-hours utilized in the performance of contract will be the minimum necessary to accomplish the tasks. The Contractor shall provide the necessary resources and infrastructure to manage, perform, and administer the contract.

1.4. Organizational Conflicts of Interest (OCI) (Deliverable 1) (Attachment 01)

1.4.1. The USAMRMC has categorized all service procurements into one of the following three categories as defined below, for the purpose of identifying, avoiding or mitigating Organizational Conflicts of Interest (OCI) in accordance with (IAW) Federal Acquisition Regulation (FAR) Subpart 9.5. These categories are defined as follows:

Category 1: Command Wide Internal Support: Services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating. Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts with subordinate directorates/Commands.

Category 2: Program Management Support: Services which assist USAMRMC in planning and managing an organization’s activities and programs. These include, for example: requirements analysis, acquisition support, budget planning and management, business process reengineering, program planning and execution support, and independent technical management support. Services would be characterized as having access to only Directorate or Subordinate Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/Subordinate Commands.

Category 3: Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs. These include, for example: concept exploration and development, system design, system development and integration, COTS procurement and integration, internal development testing, deployment, installation, operations, and maintenance. Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

1.4.2. OCI Certification (Deliverable 1, Attachment 1). USAMRMC OCI Category 2 is applicable for this acquisition. The Contractor shall perform a thorough comparative analysis of the potential new work against all current and previous works performed in support of the USAMRICD organization and ascertain whether they have a possible conflict of interest. If there is a conflict of interest or the appearance of a conflict of interest, the Contractor shall provide a comprehensive OCI Mitigation Plan (See PWS Section 5.1). The Contractor shall complete the OCI Certification at time of proposal submission.

2. General Requirements:

a. Place of Performance. All work contained in this PWS shall be performed at the United States Army Medical Research Institute of Chemical Defense (USAMRICD), E2900 8350 Ricketts Point Road, Aberdeen Proving Grounds, Maryland, 21010.

b. Period of Performance. Base year will be from date of award of contract for one (1) twelve month base period and four (4) twelve month option periods.

2.1. Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by FAR Part 37 and to ensure there is not an appearance of such this contract will have an identified COR. The Government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual contractor employees.

It shall be the responsibility of the contractor to manage its employees and to guard against any actions that are of the nature of personal services, or 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 Contracting Officer (KO) immediately.

2.2. Business Relations

2.2.1. The contractor shall successfully integrate and coordinate all activity needed to execute the requirement. The contractor shall manage the timelines, completeness, and quality of problem identification. The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel. The Contracting Officer’s Representative (COR), with the approval of the KO, may require the contractor to remove from the job site any employee working under the influence of alcohol, drugs, or other incapacitating agents.

Contract employees will be subject to dismissal from the premises upon determination by the COR and the KO that such action is in the best interest of the Government.

2.3. Contract Management and Administration

2.3.1. Contract Management

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor must maintain continuity between the support operations at stated on-site and the contractor’s corporate offices. No off-site work is authorized.

2.3.1.1. Contract Management Activities.

a. Government Management of the Contract. The KO will officially designate a Contracting Officer’s Representative (COR) to oversee this Contract. The Government’s COR will have responsibility for:

(1) Ensuring that the Surveillance Plan is developed and executed by the COR and any other involved USAMRICD representative who may have responsibilities monitoring and managing the contract.

(2) Providing advice and assistance in resolving any performance issues that may arise during the life of the order.

(3) Initiating and coordinating global contract changes such as changes in the paying office.

(4) Conducting other activities as specified in their appointment memorandum.

(5) Elevating to the KO any problems that cannot be addressed by the COR.

(6) COR does not have the 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.

(7) The COR DOES NOT have the authority to change the terms and conditions of the contract.

b. Contractor Management of the Contract. The contractor shall designate a single program manager to oversee the contract. The Contractor’s designated program manager shall serve as the single point of contact for addressing contract issues, quality issues, and overall contractor performance. This may 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. Contract management activities may include:

(1) Non-Disclosure Statement (Deliverable 1, Attachment 02). The Contractor shall sign the Non- Disclosure Statement and ensure that all staff including all employees, subcontractors, and consultants assigned to or performing under the contract, execute, sign, and adhere to the terms of the Non-Disclosure Statement. The Contractor and Employee shall also execute a Non-Disclosure Agreement during in-processing to the USAMRICD.

2.3.2. Contract Administration.

The contractor shall establish processes and assign appropriate resources to effectively administer the requirement.

The Contractor shall respond to Government requests for contractual actions in a timely fashion. The contractor shall have a single point of contact between the Government and Contractor personnel assigned to support the contract. The contractor shall assign work effort and maintaining proper and accurate time keeping records of personnel assigned to work on the requirement. The Contract Administration Team will consist of the following members:

2.3.2.1 The KO will have overall responsibility for administering the contract. The KO is the only person authorized to obligate the Government and make changes to the contract. The KO will manage contract administration and ensure COR responsibilities are being performed.

2.3.2.2. The COR will be appointed in writing and will be directly responsible to the KO. The COR serves as the Government’s point of contact for contract-level coordination of administration and technical performance matters.

The COR will assist in resolving performance issues; initiate and coordinate contract-level changes; notify the KO of any disputes, performance issues, or contractual issues that cannot be resolved at the COR level; and conduct other activities as specified by appointment.

2.3.2.3. The COR has specific technical, functional and oversight responsibilities. The assigned COR will serve as the official point of contract for coordination for the contract; approve or disapprove contractor invoices; review and accept or reject all contractor technical deliverables; monitor funds obligated and disbursed; complete Contractor Manpower Reporting (CMR); conduct surveillance by uploading a monthly report in the Contracting Officer Representative Tracking (CORT) tool; and conduct other activities as may be specified by the COR appointment letter.

2.3.2.4. The Contractor’s Program Manager is the point of contact with the COR. This position is responsible for the overall management of the contract. Responsible for formulating and enforcing work standards, assigning contractor schedules, reviewing work quality.

2.3.2.5 Personnel Conduct. The COR, with the approval of the Contracting Officer, may require the contractor to remove from the job site any employee working under this contract for reasons of misconduct or security, or found or suspected to be under the influence of alcohol, drugs, or other incapacitating agents. Contract employees will be subject to dismissal from the premises upon determination by the COR and the Contracting Officer that such action is in the best interests of the Government.

2.3.2.6 After performing Calibration/Verification/Certification services, the Contracting Officer’s Representative (COR) will affix and/or update DD Form 2163 (Medical Equipment Verification/Certification) in accordance with the instructions provided in Technical Bulletin TB38-750-2, or by the activities internal Standard Operating Procedure (SOP).

2.3.3. Personnel Administration

The contractor shall provide management and support as required. The contractor shall provide notifications for employees during designated Government non-work days or other periods where Government offices are closed due to weather or security conditions.

2.4. Location and Hours of Work

2.4.1. Location of Work:

2.4.1.1. Primary Location. United States Army Medical Research Institute of Chemical Defense (USAMRICD), E2900 8350 Ricketts Point Road, Aberdeen Proving Grounds, Maryland, 21010.

2.4.1.2. Telecommuting. IAW FAR 7.108, telecommuting is not permitted because Government will be adversely impacted due to mission readiness and because the maintenance will be performed primarily at the Government’s facility.

2.4.2. Hours of Work:

2.4.2.1. Normal workdays are Monday through Friday except U.S. Federal holidays. Contractors shall typically work eight (8) hours per day, 40 hours per week. USAMRICD's core hours of work are between 0800 to 1630 daily.

Contractor is expected to be available during core hours. Contractor employees shall coordinate with their company on-site supervisor and designated COR for those situations where contractor is not able to be available during designated core hours from Monday through Friday.

2.4.2.2. Holidays Any of the listed below holidays falling on a Saturday will be observed on the preceding Friday;

holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed below.

• New Year’s Day, 1 January

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

• President’s Day, 3rd Monday in February

• Memorial Day, last Monday in May

• Independence Day, 4 July

• Labor Day, 1st Monday in September

• Columbus Day, 2nd Monday in October

• Veteran’s Day, 11 November

• Thanksgiving Day, 4th Thursday in November

• Christmas Day, 25 December

2.4.2.3. Contractor shall not report to work on the days the Government or installation is closed due to safety conditions, inclement weather conditions, national emergencies, energy conservation or by direction of the Installation Commander (or by USAMRICD Commander’s reporting official chain of command) for any other reason. During periods of closure, the Contractor employees not designated as essential, shall not report for work.

In the event the Government grants administrative leave to its Government employees at the Government site, on-site Contractor personnel shall also be dismissed if the on-site location is being closed. However, the Contractor shall continue to provide sufficient staff personnel to perform around-the-clock requirements of the Firm-Fixed Price critical efforts already in progress or scheduled and shall be guided by the instruction issued by the Contracting Officer and/or the Contracting Officer’s Representative (COR) except during government holidays and inclement weather where non-essential personnel are not required to come to the installation.

2.5. Travel / Temporary Duty (TDY): N/A

3.0. Performance Requirements

3.1. The Contractor shall provide a workforce possessing the skills, knowledge and training to satisfactorily perform the services required under this contract.

3.1.1. The Contractor shall accomplish the assigned work by employing and utilizing qualified personnel with the appropriate combinations of education, training, and experience. The contractor shall match personnel skills to the work or task with a minimum of under or over employment of resources. Representatives must be OEM certified and have competency to perform preventative maintenance service experience working on the contracted Medical Device/Medical Device System to meet the institute's needs and satisfaction to perform preventative maintenance services and/or replace OEM parts and shall be a citizen of the United States.

3.1.2. The Contractor shall submit invoicing through Wide Area Work Flow (WAWF).

3.1.3 Personnel Conduct. The COR, with the approval of the Contracting Officer, may require the contractor to remove from the job site any employee working under this contract for reasons of misconduct or security, or found or suspected to be under the influence of alcohol, drugs, or other incapacitating agents. Contract employees will be subject to dismissal from the premises upon determination by the COR and the Contracting Officer that such action is in the best interests of the Government.

3.2. The Government will review performance, progress reports and will attend regular task performance review meetings with the Contractor to survey quality of products and services according to the Quality Assurance Surveillance Plan (QASP) – (See Attachment 3, QASP).

3.3. Objective 1– The contractor shall provide all necessary personnel required to perform services in support of USAMRICD. The Contractor shall provide Preventative Maintenance Services. The following section specifies the performance objectives and performance elements for the contract. The contractor shall provide all maintenance for Waters (Synapt G2-MALDI, Ultra Performance Liquid Chromatography (UPLC), Supercritical fluid chromatography (SFC), and UltraPerformance Convergence Chromatography (UPC2)) systems with 2 PMs for the Synapt G2-MALDI & 1 PM for the UPLC, the SFC and the two (2) UPC2 systems.

3.3.1 Key Task 1 – The Contractor shall provide 2 PMs for the Synapt G2-MALDI and the 1 PM for the UPLC, SFC and the two UPC2 systems. The contractor shall respond within 24-48 hours during normal duty hours (Monday-Friday 0800-1700) in addition to telephone inquiries to answer user questions, troubleshoot performance and maintenance problems and schedule on-site maintenance. The Contractor’s service representative shall report in person or telephonically notify the maintenance manager or COR at BLDG E2900, prior to commencing services during normal duty operating hours. During other than normal operating hours, the contractor’s representative shall report to the maintenance manager.

3.3.2 Key Task 2 – The Contractor shall provide service within a timely manner: The contractor shall reply to service requests within 24-48 hours and must schedule a time to be on-site within 36-hours of the initiation of a service request. Coordination with the customer to provide field service engineers as these services must be performed on-site, within three business days of the initiation of a request, to assess and resolve service requests for system breakdown or faculty system operation with objective to minimize instrument downtime.

3.3.2.1 - Telephone service support must be available during normal business hours, excluding federal holidays.

3.3.2.2 - The contractor shall have original manufacturer parts on hand or can obtain and install original manufacturer parts within 36-hours.

3.3.2.3 - If timelines cannot be fulfilled, the Contractor shall provide reasoning that must be approved by the COR.

3.3.2.4 – The Government and the contractor’s service representative will exchange hazard communication information before the commencement of any work.

3.3.2.5 – When required, the contractor’s service representative shall comply with the Office of Safety and Health Administration (OSHA) lockout/tag-out standards while performing maintenance on Medical Device/Medical Device System.

3.3.3 Key Task 3 - Contract shall cover instruments and parts: The service contract shall include comprehensive coverage. The contractor shall be responsible for all training, labor, travel, and parts costs regardless of frequency during the contract term. The scope of the contract includes the following instruments and associated parts: (1) Synapt G2-MALDI System; (2) Ultra Performance Liquid Chromatography (UPLC) System; (3) Supercritical fluid chromatography (SFC) system; and (4) two UltraPerformance Convergence Chromatography (UPC2) system instruments and items listed under the scope of the contract. The contractor shall have original manufacturer parts on hand or can obtain and install original manufacturer parts within 36-hours.

3.3.4 Key Task 4 - Service technicians and engineers must be Waters Certified: All technicians and engineers must be factory trained and certified to work on Waters equipment (Synapt G2-MALDI, Ultra Performance Liquid Chromatography (UPLC), Supercritical fluid chromatography (SFC), and UltraPerformance Convergence

Chromatography (UPC2)) and instruments. Training records shall be provided to the COR. Technicians and engineers must have instant access to current hardware and software updates to maximize service life.

3.3.5 Key Task 5 – The Contractor shall schedule a minimum of one on-site maintenance visits every 12 months for the UPLC, SFC and the two UPC2 systems and two preventative maintenances visits every 6 months for the Synapt G2-MALDI per calendar year at the request of the customer, to achieve the following:

3.3.5.1 – Provide instrument performance testing and optimization to OEM’s specifications and standards.

3.3.5.2 – Provide software updates and upgrades that are due and give instructions on the impact and use the new software features.

3.3.6 Key Task 6 – The Contractor shall furnish all software upgrades/updates issued by the Medical Device/Medical Device System manufacturer, and shall have access to all necessary diagnostic software (if applicable). Only OEM new or OEM refurbished parts shall be used. Maintenance will be performed in accordance with the manufacturer’s specifications.

3.3.7 Key Task 7 – Services shall include all parts, labor and travel expenses. Required forms and extracts from pertinent directives will be furnished to the contractor’s services representative by the Government. To include equipment and attachments list below.

Item Systems Serial #

TAP 3100 MASS DETECTOR SFC MBA480-EI10 740002618

TAP S-PrepMD SFC/MS w/o Waters MS

SFC 740003990

TAP ACQUITY 30cm Single Zone CM

UPC2 F14AZ3011N 740005130

TAP ACQUITY UPC2 BSM UPC2 H14C2B535M 740004307

TAP ACQUITY UPC2 Converg Mgr

UPC2 H14C2M502M 740004313

TAP ACQUITY UPC2 Samp Mgr-FL

UPC2 H14C2S486M 740004661

TAP ACQUITY 30cm Single Zone CM

UPC2 J14AZ3039N 740005130

TAP ACQUITY Isocratic Solvent Mgr

UPC2 M13QDI117N 740005036

TAP XEVO TQD UPC2 QCA763 740004520

TAP ACQUITY Isocratic Solvent Mgr

UPC2 A14QDI161N 740005036

TAP ACQUITY UPC2 Samp Mgr-FL

UPC2 D14C2S442M 740004661

TAP ACQUITY UPC2 Converg Mgr

UPC2 E14C2M480M 740004313

TAP ACQUITY UPC2 BSM UPC2 F14C2B499M 740004307

TAP XEVO TQD UPC2 QCA759 740004520

MassLynx Software 1 Year Plan MALDI SYNAPT G2 MS9SN01581 740002548

TAP MALDI SYNAPT G2 MALDI SYNAPT G2 UCA086 740003458

TAP ACQ BIO SAMPLE

MANAGER-FTN

UPLC E11BDI190M 740004107

TAP Column Manager UPLC E11CMP002G 740004248

TAP ACQUITY TUV

DETECTOR

UPLC D11TUV123A 740001650

TAP ACQ BIO QUATERNARY

SOLVNT MGR

UPLC E11BQM177M 740004092

3.8 Objective 1 Deliverables

3.8.1 Upon Completion of Services by the contractor’s service representative, a service report shall be provided to the COR and Medical Maintenance Department. The service report shall provide detailed information regarding the cause of the Medical Device/Medical Device System malfunction and corrective action taken. It will include, at a minimum, the time required to complete the work and a list of parts replaced with part numbers and prices for each part prior to leaving the facility.

3.8.1.1 In the event that all information is not available to the contractor’s service representative when services are performed, the initial service report/invoice shall include all available information to close work order within 5 days.

The contractor shall provide the balance of the required information to the medical maintenance department no later than 2 days after services are completed.

3.8.2 The Contractor shall provide monthly reports to the Government as well as an annual report at the end of the year to show all services provided.

3.9. Contractor Manpower Reporting (Deliverable 5)

"The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the US Army Institute of Surgical Research 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 2015. Contractors may direct questions to the help desk at help desk at: http://www.ecmra.mil.

3.10 Contractor Performance Assessment Reporting System (CPARS) (June 2015) (USAMRAA)

A CPAR assesses a contractor's performance and provides a record, both positive and negative, on a given contractor during a specific period of time. Each assessment is based on objective facts and supported by program and contract management data, such as cost performance reports, customer comments, quality reviews, technical interchange meetings, financial solvency assessments, construction/production management reviews, contractor operations reviews, functional performance evaluations, and earned contract incentives. Performance evaluations are transmitted into the Past Performance Information Retrieval System (PPIRS) which is used by government agencies to assess contractor past performance for future acquisitions. The contractor shall appoint a Contractor Representative (CR) and provide this information to the Contracting Officer (KO) within 10 calendar days of award.

The contractor POC shall have the authority to comment on the CPAR assessment on behalf of their company and within the timeframes established.

A CPARS assessment must be completed within 120 calendar days after the evaluation. Evaluations are sent to PPIRS within 14 calendar days after the government Assessing Official (AO) has submitted the rating. If the CR has not concurred/non-concurred with the rating; PPIRS will show the government evaluation as “Contractor Comment Pending Review”. The CR has a total of 60 calendar days to concur/non-concur with the assessment. After 60 days, the CR can either concur/non-cur. The CR has the authority to: access the Government evaluation;

review/comment/concur or non-concur with the assessment within 60 calendar days after notification of the government’s assessment. The CR has the right to request a meeting (in writing) with the government within 7 calendar days of notification of an assessment. Once the government and the CR complete the evaluation; an automatic update will be sent to PPIRS and visible for Source Selection. If the CR fails to respond within 60 days, the assessment will be finalized. Training for CPARS can be found on the CPARS website:

https://www.cpars.gov/index.htm.

To access CPARS, the contractor must have a Public Key Infrastructure (PKI). It is suggested an ECA certificate of Medium Assurance should be purchased. This should be a Department of Defense identity certificate, not an e-mail certificate.

3.11 Sexual Assault and Sexual Harassment Reporting

The contractor shall comply with OTSG/MEDCOM Policy Memo 16-033, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP). The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this task order.

The contractor shall require all contractor personnel with knowledge of an incident of sexual assault or sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this task order, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the Government’s COR-TO or Contracting Officer. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals. (This becomes a Conditional Deliverable due only in the event of an incident).

3.12 Contractor Identification

Contractor personnel must clearly identify themselves as a contractor employee. The name of their company must be part of their email signature block, all correspondence, and on all identification badges, desk plates, etc.

Additionally, contractor personnel are required to identify themselves as contractor personnel when attending meetings, answering Government telephones, or working in situations where their status as contractor employees may not be obvious.

4. Special Requirements

This section describes the special requirements and the subsections provide details of various considerations for this requirement.

4.1. Security and Safety

The contractor shall comply with all Department of Defense, Army, Institute, and other governmental regulatory requirements with special emphasis on safety and security.

4.1.1. Access and general protection/security policy and procedures. Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office corresponding to the location of performance detailed in the contract. 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.

4.1.1.1. Force Protection Condition (FPCON) impact on work levels. The Contractor employees must comply with all personal identity verification requirements as directed by DoD, 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 DoDI 2000.16, the FPCON is defined as follows:

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 THREATCONS resulting from intelligence received or as a deterrent. The measures in this THREATCON must be capable of being maintained indefinitely.

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.

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.

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.

4.1.1.2. During FCONs Charlie and Delta, non-essential service contracts are placed under a stop work order.

Designated essential service contracts will resume when the FPCON level is reduced to level Bravo or lower.

4.1.1.3. When Contractor employees are considered mission essential, all Contractor employees are required to report for duty and remain on duty during declared emergencies or elevated FPCON levels unless otherwise directed by the KO via the COR.

4.1.1.4. Access to DoD-controlled installations, facilities, and personnel badging. Applicable for all Contractor employees with an area of performance within a DoD- controlled installation, facility or area. The Contractor and all associated subcontractors’ employees shall comply with applicable installation, facility, and area commander installation and facility access and local security policies and procedures provided by the Government representative. For Contractor’s furnished facility, controlled access to the office space shall be provided to protect GFE and information.

4.1.2. USAMRICD Security Requirements. The Government will provide the USAMRICD ID Building badges which will be worn/displayed per local policy. Upon notification, the Contractor employee who is cleared to commence work shall complete an in-processing checklist and submit the forms in person to the S2, before security/photo ID badges will be issued. Contractors must be escorted prior to completion of all in-processing requirements.

4.1.2.2. The Contactor and all associated subcontractors' employees shall comply with applicable installation, facility, and area commander installation local security policies and procedures (provided by the Government representative).

The Contactor shall provide all information required for the completion of background checks to be accomplished by the Installation Provost Marshal Office, Director of Emergency Services, or the USAMRICD S2. The Contractor and all associated subcontractors’ employees must comply with all personal identity verification requirements as directed by the DoD, HQDA, and/or local policy. Should the Force Protection Condition (FPCON) at the facility or installation change, the Government may require changes in Contactor’s security processes.

4.1.2.3. Visitor Group Security Agreement Not Applicable.

4.1.2.4. Security and Identification (ID) Badges. The Government will provide the USAMRICD ID Building badges which will be worn/displayed per local policy. Upon notification, the Contractor employee who is cleared to commence work shall complete an in-processing checklist and submit the forms in person to the S2, before security/photo ID badges will be issued. Contractors must be escorted prior to completion of all in-processing requirements.

4.1.3. Property Security. The Contractor employee is responsible for safeguarding all Government equipment, information, and property provided for their use. At the close of each work period and when the area is vacant of personnel, Government facilities, rooms, laboratories, equipment, and materials shall be secured. At no time is Government equipment, information, or property to be taken out of the USAMRICD facilities without express written permission from the Commander.

4.1.4. Facility Security. Contractor employees are not authorized access to the USAMRICD buildings before 0600 and /or after 1800 pm ET, Monday through Friday. For access to the buildings during unauthorized hours, Contractor employee will submit a request for extended hours through the appropriate chain of command. Contractor employees are not authorized in the USAMRICD facilities without a Government employee present. The Government employee is responsible for ensuring that the Contractor employee is appropriately supervised by a Government employee while in the USAMRICD facilities.

4.2. Antiterrorism / Operations Security

4.2.1 AT Level I training. – Not applicable to this requirement.

4.3. Access and general protection/security policy and procedures. Not Applicable

4.4. For contractor employees requiring Common Access Card (CAC). Not applicable to this requirement.

4.5 For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated subcontractor 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.

4.6. iWATCH Training. Not applicable to this requirement.

4.7. Army Training Certification Tracking System (ATCTS) Not applicable to this requirement.

4.8. For contracts that require OPSEC Training. Not applicable to this requirement.

4.9. For information assurance (IA)/information technology (IT) training. Not applicable to this requirement.

4.10. Proprietary Information Assurance and Security. Not applicable for this requirement

4.11 Government Furnished Facilities, Supplies, and Equipment: There are no Government Furnished Facilities, Supplies, and Equipment for this requirement.

4.12. Contractor Furnished Equipment – The Contractor shall furnish all supplies, materials and equipment required to perform work under this contract that are not listed under Section 3 of this PWS. It will be left to the Contractor’s discretion with security facility clearance of their facilities and employees.

4.13 Applicable Publications. The Contractor shall abide by all applicable regulations, publications, manuals, and local policies and procedures.

AR 25-2 Information Assurance AR 40-61 Medical Logistics Policies and Procedures.

AR 525-13 Antiterrorism AR 530-1 Operations Security AR 70-1 Army Acquisition Policy AR 735-5 Policies and Procedures for Property Accountability Army FAR Supplement (AFARS) Army Medicine (http://www.armymedicine.army.mil/) Department of Defense FAR Supplement (DFARS) Deputy Secretary of Defense Memorandum, Control of Planning, Programming, Budgeting and

Execution (PPBE) Documents and Information DoD 4120.24-M Defense Standardization Program Policies & Procedures DoD 5200.01 V2 Information Security Program - Marking Classified Information DoD 5200.01 V3 Information Security Program - Protection of Classified Information DoD 5220.22-M National Industrial Security Program Operating Manual DoD 7000.14-R Financial Management Regulation DoD 8570.01-M Information Assurance Workforce Improvement Program DoD and Army Environmental Program and Regulations, https://aec.mil/usaec/ DoD Unique Identification (UID) Program (DoDD 8320.03 and DoDI 8320.04 DoDD 70.45.14 Planning, Programming & Budgeting System DoDD 85701.1 Information Assurance Training, Certification and Workforce Management DoDI 2000.16 DoD Antiterrorism Standards

Federal Acquisition Regulation (FAR) Health Insurance Portability and Accountability Act (HIPAA) Medical Directory Circular 40-1 MHS Information Assurance (http://www.health.mil/MHSCIO/programs_products/ia.aspx) U.S. Army Medical Research and Materiel Command (https://mrmc.amedd.army.mil/index.cfm)

5. DELIVERABLES

5.1 Delivery Address

All deliverables shall be submitted to the COR designated in the COR appointment letter.

5.2 Deliverable/Delivery Schedule

The Contractor shall provide deliverables as described in Table 2.

The following abbreviations are used in the delivery/deliverable schedule:

Abbreviation Definition KO Contracting Officer COR Contracting Officer's Representative CS Contract Specialist DA Days after DACA Days after contract award (award of this order) DAEOM Days after end of month Days Calendar Days unless otherwise specified E Electronic Copy H Hard Copy NLT No Later Than PWS Ref Performance Work Statement Reference (paragraph number)

A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file (E), and/or hard copy (H).

Table 2: Deliverables

E: Electronic H: Hard Copy TBD: To be determined

Del # PWS Ref Title Distribution E H Initial Subsequent

1 1.4.

Organizational Conflicts of Interest

COR / KO 1 0

The Contractor shall complete the OCI Certification at time of proposal submission.

2 2.3.1.1..b(1) Non-Disclosure Statement

COR / KO 1 1

Signed statements are due, from each employee assigned, prior to performing ANY work.

3 3.8.1 Service Report COR/KO 1 Upon Completion of Services by the contractor’s service representative

4 3.8.2 Monthly Report COR 1 0 Monthly

5 3.9.

Contractor Manpower Reporting

Notify COR and KO upon final input of data for a government fiscal year.

1 0

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 2015. Contractors may direct questions to the help desk at help desk at: http://www.ecmra.mil.

5.3 Method of Delivery

Electronic copies shall be delivered using Microsoft Office suite of tools (for example, MS WORD, MS EXCEL, MS POWERPOINT, MS PROJECT, or MS ACCESS format), unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR.

5.4 Shipping

The Contractor shall use the U.S. Postal Service standard delivery for delivery of materials, equipment, or required hardcopy documents. The COR must approve all exceptions to this requirement.

5.5 Government Acceptance Period

5.5.1. The COR will have ten (10) workdays to review draft deliverables and make comments. The Contractor shall have five (5) workdays to make corrections. Upon receipt of the final deliverables, the COR will have two (2) workdays 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) work 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 days.

5.5.2. 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) workdays to correct the rejected deliverable and return it per delivery instructions.

5.6. Government Requirements/Support

5.6.1 Representatives must have OEM certification and experience working on the contracted Medical Device/Medical Device System and shall be a citizen of the United States.

5.6.2 Government-directed training. Contractors are expected to have the skills to perform their contractual duties. If they must train to maintain the required skills, it is not to be done on Government time. Change in technical requirements and Command determination for total team training are conditions that permit contractor training at Government time or expense.

5.6.3. The contractor employee is responsible for maintaining the work place and the equipment assigned to them by the Institute for the completion of assigned tasks in a safe, secure and orderly manner.

QASP

Quality Assurance Surveillance Plan (QASP)

Maintenance and Repair Support Services of Synapt G2 MALDI, Ultra Performance Liquid Chromatography

(UPLC), Supercritical fluid chromatography (SFC), and UltraPerformance Convergence Chromatography (UPC2))

1. Vision

The mission of the United States Army Institute of Surgical Research (USAISR) is to be the nation’s premier joint research organization planning and executing registry-based and translational research providing innovative solutions for burn, trauma, and combat casualty care from the point of injury through rehabilitation.

2. Mission

The USAISR’s mission is to provide combat casualty care medical solutions and products for wounded warriors, from self-aid through definitive care across the full spectrum of military operations; provide state-of-the-art trauma, burn, and critical care to Department of Defense beneficiaries and civilians; and provide Burn Flight Teams. The USAISR does this through three unique missions: (1) To provide requirements driven innovations in combat casualty care advance medical care for injured services members; (2) as the only Burn Center in the DoD provide state of the art burn, trauma and critical care to injured war fighters and DoD beneficiaries around the world; (3) through the Joint Trauma System, provide a performance improvement system dedicated to ensuring that medical care is organized according to the needs of the patient.

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. Program / Project Manager

The Program / Project Manager (PM) provides primary program oversight, nominates the COR, ensures the COR is trained before performing any COR duties and supports the COR's performance assessment activities. While the PM may serve as a direct conduit to provide Government guidance and feedback to the Contractor on technical matters, they are not empowered to make any contractual commitments or any CONTRACT changes…