Amendment 0002 to W81XWH21R0017.docx

W81XWH21R0017

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 16-Mar-2021 01:00 PM to 28-May-2021 10:00 AM.

The following have been modified:

ADDENDUM TO 52.212-1

ADDENDUM TO 52.212-1 INSTRUCTIONS TO OFFERS – COMMERCIAL ITEMS (OCT 2015)

In addition to FAR 52.212-1, this section specifies the format and content that offerors shall use in responding to this Request for Proposal (RFP). The intent is to ensure a certain degree of uniformity in the format in the response for evaluation purposes. The Proposal should be legible and comprehensive enough to provide the rating standards for a sound evaluation by the Government. Information provided should be precise, factual, and complete. Legibility, clarity, completeness, and responsiveness are of the utmost importance. If the Proposal does not provide, at a minimum, that which is required in this solicitation it may be determined to be substantially incomplete and not warrant any further consideration.

The contractor’s initial proposal should contain the contractor’s best terms from a cost or price and technical standpoint.

Award will be made on a best value basis. Evaluation will be made to identify the technical acceptability of the Proposal in relation to the RFP, and the evaluation criteria set forth in the Section labeled “Evaluation Factors for Award” of this solicitation. Technical acceptability will be determined by review of the contractor’s capability statement. Technical acceptability must be rated “Acceptable” to be considered for award.

SUBMISSION OF PROPOSALS: Proposals shall be submitted and received no later than 28 May 2021 by 10:00 AM (Eastern Time), Frederick, MD. All proposals shall be submitted electronically, via e-mail, to Mrs. Sharon R. Smith, Contract Specialist at sharon.r.smith.civ@mail.mil.

QUESTIONS: All questions shall be addressed in writing and submitted electronically to Mrs. Sharon R. Smith, Contract Specialist at sharon.r.smith.civ@mail.mil. Questions shall be submitted no later than 07 May 2021 by 10:00 AM (Eastern time), Frederick, MD.

Volume 1 – CAPABILITY STATEMENT

Volume 2 - PRICE PROPOSAL

1. Each volume shall be separate and complete, so that the evaluation of each one may be accomplished independently and concurrently with evaluation of the others. Each Volume shall be an independent document, labeled accordingly.

ELECTRONIC SUBMISSION: Proposals shall be electronically submitted to the POC above. Your submission should include two (2) separate parts: (1) Capability Statement and (2) Price Proposal. The Capability Statement shall be submitted in MS Word 2000 or searchable PDF format. The Price Proposal shall be submitted in MS Excel 2000 or higher, but not greater than MS Excel 2007 format or on the Price/Cost Schedule of the Standard Form (SF) 1449. The firewall utilized by the Government contracting office does not authorize or accept zip files.

2. Evaluation of Proposals: The Government will evaluate the Proposal in accordance with the evaluation criteria set forth in the Section labeled “Evaluation Factors” of this solicitation.

The Offeror’s proposal will become part of the official contract file.

B. PROPOSAL FORMATTING & PACKAGING GUIDELINES

1. Format. The submission should be clearly indexed and logically assembled. Each volume should be clearly identified and should begin at the top of a page. All pages of each volume should be appropriately numbered and identified by the complete company name, date and solicitation number in the header and/or footer. The proposal shall be clear and legible. Attachments shall conform to the following guidelines:

- Type Font: 12 point, 10 pitch (Times New Roman)

- Spacing: Single-spacing between lines of text

- Margins: 1.0 inches on all sides

- Acronyms: Spell out all acronyms the first time when they are used. One page following the proposal body is allocated to spell out acronyms, abbreviations and symbols.

- Language: English

- Format: Microsoft Office Applications (i.e. MS Word, Excel)

- Graphics & Tables: 8 point, 10 pitch (Time New Roman).

In addition, each paragraph should be separated by at least one blank line. A standard, 12-point minimum font size applies. Times New Roman font is preferred. Tables and illustrations may use a reduced font size not less than 8-point and may be landscape.

2. File Packaging. None of the proposal files shall be compressed (zipped). Zipped files cannot be opened by the Contracting Office.

3. Page Limitations. Capability Statement is limited to three (2) single-sided pages. Pages should be numbered consecutively throughout the document and not by sections. For any sections of a proposal with a defined page limit, pages exceeding the specified limit will be removed and not forwarded for evaluation.

C. VOLUME CONTENT

1. Volume 1 - CAPABILITY STATEMENT

The capability statement shall include sufficient detail that clearly demonstrates the capability to provide services outlined in the performance work statement with regards to technical capability, experience, and past performance.”

2. Volume 2 - PRICE PROPOSAL

The Price Proposal will be evaluated separately from the Capability Statement. Price will be evaluated for fairness and reasonableness.

Price Proposal shall consist of the following parts:

A price for all Contract Line Item Numbers (CLINS) in the Price/Cost Schedule of the Standard Form (SF) 1449, Solicitation/Contract/Order for Commercial Items.

Number of days, after receipt of award, before services will start.

Offeror Representations and Certifications. The offeror shall complete the annual representations and certifications electronically through betaSAM.gov at https://beta.sam.gov. The offeror shall also complete and return FAR 52.204-24, FAR 52.204-26 and FAR 52.212-6 Alt I.

Organizational Conflict of Interest (OCI). The offeror shall complete and return the OCI Certification included as Attachment 3 to this solicitation.

Signed SF 1449 and required acknowledged solicitation amendments (if applicable).

The Government will evaluate offers for award purposes by comparing the proposed prices for the base year and option years.

Solicitation, Offer and Award - Offeror shall complete Blocks 17a (Contractor/Offeror Name and Address including Cage Code and Telephone Number), 30A (Signature of Offeror/Contractor), 30b (Name and Title of Signer) and 30c (Date Signed) of the SF 1449 and submit with proposal. An authorized official of the firm shall sign the SF 1449 and acknowledge receipt of all amendments issued. An Acrobat PDF file shall be created to capture the signatures for submission.

The proposal should be specific and complete in every detail. The method of payment is to be Wide Area Workflow (WAWF).

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

PREVENTATIVE MAINTENANCE AND REPAIR OF USAMRIID STERILIZATION AND CENTRAL VACUUM EQUIPMENT IN BIOSAFETY LABS (BSL) 1, 2, 3 AND 4.

FOR THE

U.S. ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASE (USAMRIID)

Fort Detrick, Frederick, MD Version 7.0

SECTION 1 PURPOSE

1.0 Introduction:

The United States Army Medical Research Institute of Infectious Diseases (USAMRIID) is a subordinate laboratory of the U.S. Army Medical Research and Development Command (USAMRDC) at Fort Detrick, located in Frederick, MD. Since 1969, USAMRIID has served as the Department of Defense’s (DoD) lead laboratory for medical biological defense research.

1.1. Background:

USAMRIID’s core mission is to protect the warfighter from biological threats and also investigate disease outbreaks and threats to the general public. Research conducted at USAMRIID leads to medical solutions – therapeutics, vaccines, diagnostics, and information – that benefit both military personnel and civilians. USAMRIID must maintain support services and equipment that is essential to the sustainment of the Biosafety Labs (BSL) 1, 2, 3 and 4 labs to meet USAMRIID’s mission.

1.2. Scope:

Maintenance and Technical Support Services. The Contractor shall provide all preventive and repair service of the equipment in Attachment 3 with the manufacturer standards and those modifications required based on recommendations from the Centers for Disease Control and Prevention (CDC), including all technical data and parts. The contractor shall also be responsible to procure and have available the consumables listed in Attachment 4 required to utilize the equipment. Additionally, the vendor’s on site representative or appointed Subject Matter Expert (SME) will be required to attend meetings on site to assist with Biosafety questions pertaining to: Repair courses of action, Inspection teams DA (Department of the Army, Inspector General’s Office, Centers for Disease Control, Occupational Safety and Health Administration, Institutional Animal Care and Use Committee).

1.3. Organizational Conflict of Interest:

1.3.1. The USAMRDC 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 or could propose on within the next year. 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 USAMRDC 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, Common-Off-The-Shelf 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.

1.3.2. OCI Certification (Attachment 1, Deliverable 1). USAMRDC OCI Category 3 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 USAMRIID 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. The Contractor shall complete the OCI Certification at time of proposal submission. .

1.4. Non-Disclosure Statement

1.4.1. Non-Disclosure Statement (Attachment 2, Deliverable 2). The Contractor shall sign the Non-Disclosure Statement (NDS) 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. Assignment of staff who have not executed this statement or failure to adhere to this statement may constitute default on the part of the Contractor. NDS is required for each employee assigned performance on the task order prior to starting.

SECTION 2 GENERAL REQUIREMENT

2.1. Performance:

All work contained in this PWS shall be performed at USAMRIID, Bldgs. 1425, 1412, 1408 and 1301 Porter Street, Fort Detrick, MD 21702 all within the security perimeter of USAMRIID 1425 Porter Street, Fort Detrick, MD.

2.2. Period of Performance

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

2.3. Other Locations:

Not applicable at time of award.

2.4. Tele-commuting:

Not applicable at time of award.

2.5. 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 Contracting Officer (KO) immediately.

2.5.1. Severable / Non-Severable Services:

This award identifies services that are Non-severable in nature.

2.5.2. Inherently Governmental Functions:

This requirement has been reviewed and contains no services that are inherently governmental functions; as defined in FAR Part 2.1.

2.5.3. Acquisition Functions Closely Associated with Inherently Governmental Functions:

This requirement has been reviewed and contains no services that are closely associated with inherently governmental functions.

2.5.4. Personnel Conduct:

The Contracting Officer’s Representative (COR), with the approval of the KO, may require the contractor to remove from the Institute 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.

2.6. Business Relations:

The contractor shall successfully integrate and coordinate all activity needed to execute the requirement. The contractor shall manage the timeliness, completeness, and quality of problem identification. The contractor shall provide corrective action plans, proposal submittals, timely identification of issues, and effective management of subcontractors. The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel.

2.7. 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 as stated on-site and at the contractor’s corporate offices. No off-site work is authorized.

2.7.1. Contract Management Activities:

Government Management of the Contract. The KO will officially designate a 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 USAMRIID 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 contract.

(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.

(8) 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:

2.7.2. Contract Administration:

2.7.2.1. 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:

2.7.2.2. 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.

2.7.2.3. 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.

USAMRIID POCs/COR: Kevin Joyner (COR), Clinical Engineering Branch Supervisor or Chief of Equipment Management

2.7.2.4. 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; conduct surveillance by uploading a Monthly Report in the Procurement Integrated Enterprise Environment (PIEE), Surveillance and Performance Monitoring (SPM); and conduct other activities as may be specified by the COR appointment letter.

2.7.2.5. 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.

POCs:

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

2.7.3. Personnel Administration:

2.7.3.1. 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.

2.7.3.2. The Contractor shall maintain the currency of their employee’s skills/training by providing initial and refresher training as required to meet the PWS requirements. The Contractor shall make necessary travel arrangements for employees.

2.8. Hours of Work

2.8.1. Normal workdays are Monday through Friday except U.S. Federal holidays. Contractors shall typically work eight (8) hours per day, 40 hours per week.

2.8.2. USAMRIID's core hours of work are between the hours of 0600 to 1800 daily. Contractor is expected to be available during core hours. Contractor is expected to be available during core hours for the equipment and central vacuum system preventative maintenance and repair; however, on some occasions equipment maintenance or repairs may require completion after hours as dictated by risk assessment to ensure reduced numbers of personnel onsite.

2.8.3. 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 USAMRIID 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.

2.8.3.1 In the event the Government deems it necessary to request an emergency after hour’s service due to a reported failure of a contractually covered medical device system, the Contractor can be authorized to perform repairs to avoid catastrophic loss of government property or release of Select agent. Ensuring operation of the sterilizers also ensures the integrity of ongoing mission essential scientific studies.

2.8.3.2. 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).

2.8.3.3. In each instance when the on-site location is closed to Contractor personnel as a result of inclement weather, potentially hazardous conditions, or other special circumstances; the Contractor shall direct its staff and contractor employees as necessary to take actions such as reporting to an off-site(s) location or taking appropriate leave consistent with Contractor’s management plan and policies.

2.8.3.4. The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander.

2.8.4. Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall not be performed:

2.8.4.1. New Year’s Day, 1 January

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

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

2.8.4.4. Memorial Day, last Monday in May

2.8.4.5. Independence Day, 4 July

2.8.4.6. Labor Day, 1st Monday in September

2.8.4.7. Columbus Day, 2nd Monday in October

2.8.4.8. Veteran’s Day, 11 November

2.8.4.9. Thanksgiving Day, 4th Thursday in November

2.8.4.10. Christmas Day, 25 December

2.9. Reports:

2.9.1. Service Contractor Report (SCR) (Deliverable 3) - This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services. Refer to FAR 52.204-14

2.9.2. Monthly Summary Report (Deliverable 4) -The contractor shall document all quality checks performed on PMs and service orders. The contractor shall prepare and submit a report monthly providing the number of each type of work performed, the number of each checked the results of the quality checks, and status of contract funds.

2.9.3 Quarterly Summary Report (Deliverable 5) – The contractor shall document all verification of sterilization using biological indicators for sterilizers used for the decontamination of waste. The contractor shall prepare and submit a report providing the units verified or not verified during the quarter and reason if not verified.

2.10. Training Requirements:

2.10.1. Completion of Training Requirements (Deliverable 6). 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 five (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. The trainings listed in this section of the PWS refer only to standard physical and network access requirements of the site. Additional training will be listed in the BPRP requirement section.

2.10.1.1. Anti-Terrorism (AT) Level 1. All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and controlled-access areas shall complete AT Level I awareness training within 30 calendar days after the contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within five (5) calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website: http://jko.jten.mil.

2.10.1.2. iWATCH Training. The contractor and all associated sub-contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within five (5) calendar days of new employees commencing performance with the results reported to the COR NLT 30 calendar days after contract award.

2.10.1.3. Army Training Certification Tracking System (ATCTS). All contractor employees with access to a government info 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 prior to access to the IS and then annually thereafter.

2.10.1.4. Operations Security (OPSEC) Training. Per AR 530-1 Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

2.10.2 Personally Identifiable Information (PII) and Protected Health Information (PHI). The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with Defense Federal Acquisition Regulation Supplement Subpart (DFARS) 224.1 (Protection of Individual Privacy), which incorporates by reference Department of Defense (DoD) Directive 5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007. The contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 Code of Federal Regulations (CFR) Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoD 6025.18-R, "DoD Health Information Privacy Regulation," January 24, 2003, and DoD 8580.02-R, “DoD Health Information Security Regulation, July 12, 2007.

2.10.3 Biological Reliability Protection Program Training- The contractor once successfully enrolled in the program is responsible to attend and complete a series of trainings in order to comply with USAMRIID Pamphlet 389-69. This training and the corresponding documentation of mentored work to achieve a level of access where a mentor is not required are recommended for timely completion of work in the Biocontainment laboratories. If each employee of the company would be required to be escorted by another able to fulfill the requirements of the aforementioned pamphlet.

SECTION 3: PERFORMANCE REQUIREMENTS

3.1. The contractor shall be responsible for execution of the requirements outlined in this PWS for the repair of sterilization and central vacuum equipment.

3.1.1 The Contractor shall provide all necessary labor, tools, diagnostic equipment and software, materiel, supplies, parts, transportation and shipping, necessary to repair Government owned sterilization and central vacuum equipment. The service shall be provided within two (2) business days.

3.1.2 During the course of internal and external inspections, the contractor may be called upon to provide guidance of proper equipment operation for standard and custom built sterilization equipment. As stated in the remedial repairs section of the PWS, repairs of portions of the instrumentation that may contain potentially active organisms due to a failed run or other identified repair issue will be reported to the COR, their alternate, or the Biosafety Division. This will be at a minimum two annual inspections up to 4 hrs. total time of availability to discuss how the equipment on the contract functions and integrates with the facility. The listed time frame and frequency is for the CDC who offer known visits. We have multiple governing bodies who request annual and surprise visits and could request to speak with the Senior Service representative with questions.

3.1.3. The contractor must operate and maintain an appropriately rated repair facility in compliance with Federal, State and Local regulations and laws in accordance with Section 6 of the PWS.

3.1.4. It is the Contractor's responsibility to obtain any proprietary data and drawings that may be required to perform equipment overhaul and repair requirements.

3.1.5. All components and material utilized for overhaul and repair shall be new or refurbished and shall meet authorized parts manufacturer authorization (PMA) requirements.

3.1.6. The equipment repair and overhaul shall include receiving inspection, disassembly, inspection, refurbishment, reassembly, packaging, preservation, and all required and material included in the component maintenance manuals and consumables. Examples of parts considered consumable items include: nuts, bolts, washers, packing, dust boots, seals, paint, primer, preservation oil, hydraulic fluid, and sealant.

3.1.7. Components that are Beyond Economical Repair (BER) shall be replaced with new or refurbished parts. Component parts shall be considered BER at 80% of the equipment replacement costs and shall not be repaired or overhauled unless otherwise directed by a duly authorized COR/Technical Point of Contact (TPOC). If the component part is unavailable through an approved vendor, the contractor shall contact the COR/TPOC for further direction.

3.1.8. All test equipment used in the performance of this contract will be routinely calibrated and the calibration traceable to an equipment/industry national standard.

3.1.9. Turn-Around-Time (TAT) for components placed in-work at the contractor overhaul facility shall not exceed seven (7) calendar days from receipt at the contractor's overhaul and repair facility.

3.1.10. The contractor shall provide a standard commercial warranty covering workmanship, design, and performance for twelve months (12 months from date of delivery and install of the repaired equipment).

3.2. Maintenance and Technical Support Services:

3.2.1. Inclusions. The Contractor shall provide repair or replacement of all components including, but not limited to, photodiodes, laser and power supplies, light sources, optical components, panel meters, circuit boards, filters, prisms, amplifier boards, Personal Computer (PC) boards and switches; reconditioning or modifications to the equipment to assure satisfactory operating performance of the equipment; replacement of malfunctioning cables supplied with the equipment; software upgrades; technical service and support by means of telephone, fax, e-mail and conventional mail; annual instrument inspection (at Contractor's facility or onsite when available); all consumables including, but not limited to, detergents, disinfectants, biological integrators and indicators, sterilization monitors, charts, inks, paper rolls and door gaskets.

3.2.2. Exclusions. The following conditions are excluded from service under this contract: repair of damaged or malfunction of listed equipment resulting from abuse, accident, operator error, failure of other equipment or equipment operation in excess of design or environmental specifications; damage caused by acts of God; welding of American Society of Mechanical Engineers (ASME) coded vessels, door plates, or renovation of equipment; operator maintenance services or repair due to neglect or failure to perform operator level maintenance as outlined in the instruction manual.

3.2.3. Equipment. Equipment and associated components to be maintained and serviced are listed at Equipment List (Attachment 3). Equipment shall be maintained to meet or exceed the Original Equipment Manufacturers (OEM's) specifications. The Contractor shall provide services on all equipment, systems, and components in accordance with the terms and conditions described herein.

3.2.4. CONTRACTOR PERSONNEL. The contractor personnel shall have knowledge of codes, standards, directives and criteria governing the operation, maintenance and repair of medical research laboratories, including but not limited to NFPA, AAALAC, CDC, National Institute of Health (NIH), Biosafety in Microbiological and Biomedical Laboratories, Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency (EPA) and other applicable federal and local codes. The knowledge shall extend to applicable Department of Defense, Department of the Army, US Army Medical Command (MEDCOM) and US Army Medical Research & Development Command (USAMRDC) regulations, circulars, information bulletins and standard operating procedures as well. The contractor shall maintain a current reference library and remain abreast of any changes in standards and codes which impact any of the facilities covered under this contract, and shall notify, in writing the KO and the COR when modifications are required to maintain code compliance.

3.2.4.1 The contractor shall ensure that all Contractor personnel maintain open and professional communications with members of the facilities. All Contractor personnel dealing directly with Government personnel shall be English speaking. The Contractor shall ensure repair technicians have a certificate from an Original Equipment manufacturer for bulk steam sterilization equipment. An applications specialist shall be available to answer technical questions regarding system operation and applications. Contractor's service representative will be certified by the OEM and have a minimum of two (2) years of experience working on the contracted equipment. The contractor shall ensure all certificates are kept current through the life of this contract. Copies of all applicable qualifications shall be maintained on site and made available to the COR immediately upon request.

3.2.5. Contractor personnel shall wear an identification badge on their outer garment at all times when performing services at the Government site. The badge shall include, as a minimum, the employees name, the Contractor's company name, and title (e.g., regional field service engineer). When required and provided by the Government, the contractor shall wear an additional security identification badge during the performance of services at the Government site.

3.2.6. The Government will make available to the Contractor the equipment scheduled for servicing at such time and duration as required by the Contractor and as coordinated with the COR.

3.2.7. The Government will be responsible for maintaining the proper environment, including utili1ies and site requirements necessary for the equipment to function properly as specified by the OEM. The Government will operate the equipment in accordance with the instruction manual provided by the OEM.

3.2.8. The Government will not be responsible for damage or loss due to fire, theft, accident, or other disaster of Contractor supplies, materials, or for the personal belongings brought onto Government property by the Contractor's personnel.

3.2.9. The Contractor shall provide all service literature, reference publications, and diagnostic software to be used by contractor service technicians as required for the completion of the services in accordance with this PWS.

3.2.10. CONTRACTOR REPORTING REQUIREMENTS. During normal duty hours Contractor personnel shall report to the main entrance security desk and notify the COR upon arrival. Clinical Engineering Branch (CEB) personnel will escort the Contractor Field Service Engineers to the equipment site. The Contractor shall be escorted until the appropriate request for USAMRIID badge access is complete, then unescorted access will be available.

3.2.11. The service report shall provide detailed information regarding the cause of the equipment malfunction and corrective action taken to include, at a minimum, the time required to complete the work, price of labor (hourly rate), and a list of parts replaced with part numbers and prices for each part. At the end of each service call, the Contractor FSE shall notify the COR of any problems that result in the equipment being left non-operational as indicated by a physical lock-out/tag-out prior to. During other than normal working hours, Contractor FSE shall notify the COR /TPOC.

3.2.12. The Contractor shall provide the COR with a service report upon completion of all maintenance services. The service report shall include, but is not be limited to: Contract Number, contractor's service report/log number, a detailed description of the service(s) performed, replacement part information (part number, nomenclature, unit price, manufacturer if not OEM, and whether the part is new/used/ reconditioned), start date and time, the completion date and time, labor hours expended and the labor/hourly rate normally charged for the type of service performed, and the name of the technician performing the service. The Contractor shall provide all support in accordance with the PWS, and turned in by the end of the service month.

3.3. CONTRACTOR RESPONSIBILITY:

3.3.1. The Contractor accepts responsibility for the equipment described in Attachment 3 in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract.

3.3.2. The Contractor shall be responsible for all Government equipment and material throughout the contract Period of Performance. The Contractor shall be responsible for any damage to Government owned equipment and property and shall replace or repair any property damaged due to the fault of the Contractor. All such replacement or repair shall be at the Contractor's expense and approved by the KO.

3.3.2.1. The Contractor shall have procedures to record and report promptly to the COR all available facts relating to each instance of damage to Government property or injury to either Government or Contractor personnel. The Contractor shall immediately secure and protect any accident scenes or wreckage until released by the accident investigative authority through the COR. The Contractor shall cooperate and assist Government personnel in conducting an accident investigation.

3.3.3. The Contractor shall ensure all areas where equipment is serviced on site are left in a clean, neat, safe, and orderly condition. To prevent safety hazards, no equipment shall be left pulled out or apart upon contractor departure from the work site. Equipment being repaired shall be safely secured at all times.

3.3.4. The Contractor is not responsible for service required due to Government misuse, abuse, or damage to the system or its components when it has been determined that the damage resulted from an act of God. The Contractor must submit this determination to the COR for resolution.

3.4. SCHEDULED MAINTENANCE SERVICES:

3.4.1. The Contractor shall, at a minimum, perform all scheduled services in accordance with the OEMs' suggested service intervals or IAW AR 40-61 whichever is greater, and advise the COR of the anticipated intervals for service. When not specified by the OEM, the Government will establish the required intervals for the performance of scheduled services.

3.4.1.1 The minimum acceptable standard is one year (annual) for Calibration services.

3.4.1.2 The minimum acceptable standard is quarterly for Preventive maintenance and Inspection services.

3.4.2. The Contractor shall confirm scheduled dates with the COR at least fifteen (15) business days prior to performing scheduled services.

3.4.3 The Contractor shall, at a minimum, perform all scheduled services as prescribed by the OEM using a detailed services checklist. Before each Federal Select Agent Program registered biocontainment lab (BSL2 and BSL3, BSL4) entry, the Contractor shall report to the CEB office and complete the Suite Entry Authorization log. NO requirement for BSL1 as there are no PPE requirements for that level of access. After reviewing the appropriate slide deck and requesting signature from the CEB Manager, the Contractor may enter the suite with the required escort (if needed) based on authorized access. The Contractor shall don the correct PPE (IAW Policy USAMRIID PAM 385-69-16) for the work or anteroom planned for this service. After PPE is properly donned, the Contractor shall perform a suite safety walkthrough, ensuring no obvious safety issues are present and then document this action accordingly in the logbook located in the suite IAW USAMRIID REG 385-69. The completed checklist will be provided to the Government with the contractor's service report (Deliverable 7).

3.4.4 After performing Calibration/Verification/Certification services, the contractor's service representative will affix and/or update DD Form 2163 (Medical Equipment Verification/Certification). The contractor shall complete DD Form 2163 (Deliverable 8) in accordance with the instructions provided in Technical Bulletin (TB) 38-750-2, or by the maintenance activity's internal SOP.

3.4.5 Sterilization will be verified using biological indicators (for example Bacillus stearothermophilus (Geobacillus stearothermophilus) spores) at locations throughout the autoclave to include placement in the center of the test loads, when the autoclave is first put into service, after any maintenance or repairs and on a quarterly basis IAW DA-PAM 385-69. The Contractor shall comply with applicable SOPs for biological indicator testing (SOP SA-06-01) for all units used for decontamination of waste and provide quarterly update documentation for any sterilizers not completed each quarter (Deliverable 9).

3.4.6 All test equipment used in the performance of this contract shall be routinely calibrated and the calibration traceable to a national standard.

3.5. REMEDIAL REPAIRS:

3.5.1. Government requests for remedial repairs will be placed by the COR to the Contractors POC. The Contractor shall coordinate unscheduled services with the USAMRIID regulatory representatives through the COR/TPOC. .

3.5.2. The Contractor's response must be within two (2) business days of the request. Response for remedial repairs shall include telephone consultation between the equipment user /operator and a contractor FSE. The purpose or this telephone consultation shall be: 1) to provide instruction in determining operator error; 2) to determine the most likely cause or the problem; 3) to determine if the solution of the problem requires the dispatch of a FSE; 4) to identify replacement parts likely to be required in order to return the equipment to 100 % operational condition as specified by the OEM; and 5) to determine if the equipment must be shipped to the Contractor's facility for service or repair. On successful completion of the service, a service report (Deliverable 10) shall be provided to the Government with the explanation of the actions taken, time spent to repair the unit and a list of the parts used within three (3) business days of completion.

3.6. REMOVAL OF GOVERNMENT PROPERTY:

3.6.1. Whenever the equipment cannot be serviced at the Government site as determined by the Contractor, the Contractor shall notify the COR who will make arrangements for the Contractor to remove/ship the item to the Contractor's designated site. The Contractor will be required to sign a Government form accepting responsibility for the Government equipment. All charges resulting from a Contractor determined requirement to transport Government owned property covered by this contract to an alternate repair location shall be the responsibility of the Contractor.

3.7. REPLACEMENT PARTS:

3.7.1. Contractor installed replacement parts shall become the property of the Government and the replaced malfunctioning part shall become the property of the Contractor. Freight, postage, storage charges associated with shipment and receipt of replacement parts, and the return of worn or defective parts shall be the responsibility of the Contractor. The Contractor may use refurbished at OEM certification replacement parts which the quality is equal to or better than the OEM's original part. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality. Hardware and software changes not supported by the OEM are not authorized if required to accommodate the installation or replacement of other than OEM parts. Contractor shall furnish all software upgrades issued by the equipment manufacturer. The Contractor shall have replacement parts on hand in order to reduce down time.

3.8. SERVICES BEYOND THE SCOPE OF THE PWS:

3.8.1. The Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the COR of the existence or the development of any defects in, or repairs required to the listed equipment (Attachment 3) which the Contractor considers they are not responsible for under the terms of the contract. At the time of the notification, the Contractor shall furnish the COR with a written estimate of the cost to make necessary repairs.

3.9. TASK MEASUREMENT:

3.9.1. Acceptable performance of this contract will be based upon the successful inspection and acceptance by the Clinical Engineering Technicians upon return of equipment from the contractor's repair facility.

3.10. ACCEPTABLE QUALITY LEVEL:

3.10.1. The Government reserves the right, at its discretion, to observe/inspect all phases of the equipment overhaul/repair, to include teardown and inspection, build up and functional testing on a not-to-interfere basis.

3.10.2. The Contractor's Quality Assurance Program shall be in accordance with ANSI/ASQC Q9001 -2000, Quality Management System - Requirements Model for QA. Third party certification is not required. The Government may perform any necessary inspections, verifications and evaluations to ascertain conformance to requirements and perform follow ups at such times and places as may be necessary to ensure the adequacy of the quality system. The Contractor shall require of Subcontractors and vendors a quality system achieving control of the quality of the services and supplies they provide.

3.11. Performance Requirement Summary Matrix:

Performance Objective

Scheduled Service

3.4.1

All scheduled services will be completed in the month due.

100% annual completion rate

Observation and 100% Inspection by

COR/TCOR

Remedial Repair Unscheduled

3.5.2.

Respond within 2 business days

100% compliance with requirement

Observation and 100% Inspection by

COR

Monthly Summary Reports

2.9.2.

Provide monthly documentation on a services performed.

Inspection by the COR

W81XWH21R0017

3.12. Quality Assurance…