PWS Qiagen Master Service Agreement.docx

PERFORMANCE WORK STATEMENT (PWS)

U.S. Criminal Investigation Laboratory Center Qiagen Master Service Agreement

Part 1 General Information

1. GENERAL: This is a non-personnel services contract to provide annual preventive maintenance and service repair for Qiagen instruments operated by the U.S. Army Criminal Investigation Laboratory (USACIL) and the Office of Forensic research (OFR). 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 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform the needed service and repair of the instrumentation covered as defined in this Performance Work Statement except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

1.2 Background: The Qiagen Master Service Agreement plan provides technical support and maintenance for Qiagen instrumentation. The service includes annual preventative maintenance service and onsite technical support for instrument failures or needed repairs. The service covers the cost of the materials/parts needed and the service engineer who performs the tasks.

1.3 Objectives:

· To maintain the instrumentation in-line with the FBI Quality Assurance Standards and ISO 17025 ANSI- ASQ

· To ensure proper functioning of instrumentation used in DNA processing.

· To repair broken or damaged equipment quickly and accurately to limit disruption to USACIL workflow.

1.4 Scope: Qiagen maintenance service shall be performed for all covered equipment. Services include one annual preventative maintenance service which covers all the required maintenance outlined in the instrument handbook provided by the instrument manufacturer. Included are the costs for any parts which need to be replaced and the consumables needed to perform the maintenance. The service also covers any repairs that are needed on the instrument during the covered period. Repairs include the cost of the parts and labor associated with the repair. The technical support line is also available for use by the customer in troubleshooting possible instrumentation problems. The contractor shall accomplish all the needed repairs and preventative maintenance as well as provide the parts needed to perform said tasks. See Quotation for Service Support Agreements - 230915US01694892CA for specifics and instruments covered.

1.5 Period of Performance: The period of performance shall be for one (1) Base Year of 12 months.

Base year: 1 JAN 2025 – 31 DEC 2025

1.6 General Information

1.6.1 Quality Control: The contractor shall engage in an effective quality control program to ensure services are performed in accordance with this PWS. The contractor’s quality control program is the means by which he assures himself that his work complies with the requirement of the contract. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor’s quality control program is the means by which he assures himself that his work complies with the requirement of the contract. A copy of the Contractor’s basic Quality Control Plan shall be provided to the Contracting Officer for approval not later than 10 calendar days after receipt of award. An updated copy shall be provided to the Contracting Officer and COR as changes occur.

1.6.2 Quality Assurance: The government shall evaluate the contractor’s performance under this contract in accordance with the quality assurance surveillance plan. These standards primarily focus on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. The standards define how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.6.3 Federal Government Holidays:

The contractor is not required to perform services on holidays.

Juneteenth 19th day of June

1.6.4 Hours of Operation: The contractor is responsible for conducting business, between the hours of 0800-1700 Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons. The Contractor must always maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

1.6.5 Place of Performance: The work to be performed under this contract will be performed at the US Army Criminal Investigation Laboratory located on Gillem Enclave, Forest Park GA.

1.6.6 Type of Contract: Qiagen Inc. is the only source for required maintenance and repairs, factory recommended replacement parts, proprietary hardware and software upgrades, and training. Mission and Installation Contracting Command, Fort Gordon, GA intends to negotiate/award a sole-source firm fixed contract to Qiagen Inc. to perform maintenance, services and repairs of instruments listed in this PWS owned by Department of Defense (DoD) and specifically designed by the manufacturer who provides the sole training for factory authorized engineers certified to perform maintenance. The specific terms of the agreement fall under the quote specifications.

1.6.7 Security Requirements: Contractor personnel performing work under this contract are not required to have a personal security clearance. A USACIL employee (ID card holder) will escort the Contractor always providing on-site service.

Installation Access: All contractor employees, including subcontractors, shall always comply with applicable installation and facility access security policies and procedures. All contractors and subcontractors will be issued an Installation Pass issued through the Automated Installation Entry (AIE) Security System to access the installation. The Gillem Enclave installation is a limited access post. Unscheduled gate closures by the Gillem Enclave security manager may occur at any time. In accordance with Army Regulation 525-13, paragraph 5-19, all prospective contractors will undergo a verification process by the installation Provost Marshal Office, Director of Emergency Services to determine the trustworthiness and suitability prior to being granted access to federal property. This will be accomplished using the National Crime Information Center (NCIC) Interstate Identification Index (III). This is the minimum baseline background check for entrance onto Army Installations for non-CAC holders to include entrance of visitors (Ref AR 190-13, paragraph 8-2). All personnel entering or exiting the installation may experience a delay due to vehicle inspections, registration checks, verification of seat belt use, etc. All vehicles and personnel are subject to search and seizure. The search and seizure provisions shall apply to contractor personnel while within Fort Gordon's area of jurisdiction. Contractor personnel shall comply with all entry control requirements and security policies/procedures in effect. Security procedures may change without notice. The contractor and all associated sub‐contractors shall brief all employees on the local iWATCH Army 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 15 calendar days of contract award and within 30 calendar days of new employees commencing performance with the results reported to the COR NLT calendar days after contract award. The contractor shall develop an OPSEC Standing Operating Procedure (SOP)/Plan within 90 calendar days of contract award, to be reviewed and approved by the responsible Government OPSEC officer. This plan will include a process to identify critical information, where it is located, who is responsible for it, how to protect it and why it needs to be protected. The contractor shall implement OPSEC measures as ordered by the commander. In addition, the contractor shall have an identified certified Level II OPSEC coordinator per AR 530‐1. 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. For all contractors with security clearances. Per AR 381-12 Threat Awareness and Reporting Program (TARP), contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.

1.6.7.1 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

1.6.7.2 Key Control: N/A.

1.6.7.3 Lock Combinations. N/A.

1.6.7.4 Training. Contractors may be required to complete Anti-terrorism (AT)/Force Protection (FP)/Operations Security (OPSEC) and IWATCH training prior to arrival or within 30 days of arrival and complete on-going training as needed. The training websites will be listed in the contract cover sheet.

1.6.6 Special Qualifications: Contractor service engineers are Qiagen trained and certified for these instruments.

1.6.7 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

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

1.6.9 Key Personnel: The following personnel are considered key personnel by the government: Contract manager/Alternate contract manager. The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 a.m. to 5:00 p.m., Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons.

1.6.10 Identification of Contractor Employees: The Contractor (to include subcontractors) shall provide each employee an Identification (ID) Badge, which includes at a minimum, the Company Name, Employee Name, and a color photo of the employee. ID Badges for Key Personnel shall also indicate their job title. ID Badges shall be always worn during which the employee is performing work under this contract. Each Contractor (to include subcontractors) employees shall wear the ID Badge in a conspicuous place on the front of exterior clothing and above the waist except when safety or health reasons prohibit. The Contractor (to include subcontractors) shall be responsible for collection of ID Badges upon completion of the contract or termination of employee. A listing of issued identification cards shall be furnished to the Contracting Officer prior to the contract performance date and updated as needed to reflect Contractor and Subcontractor personnel changes. All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

1.6.11 Contractor Travel: Contractor Employee travel and labor expenses will be covered under the terms of the contract.

1.6.12 Other Direct Costs: NA

1.6.13 Data Rights: The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.6.14 Organizational Conflict of Interest: Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

1.6.15 PHASE IN /PHASE OUT PERIOD: NA

1.6.16 Supervision of Contractor Employees: The Government will not exercise any supervision or control over Contractor or subcontractor employees while performing work under the contract. Such employees shall be accountable solely to the Contractor, not the Government. The Contractor, in turn, shall be accountable to the Government for Contractor or subcontractor employees.

1.6.17 Safety: Contractors will be expected to conform to the USACIL requirements for employee safety including, but not limited to, OSHA, post fire safety requirements, general laboratory safety protocols, etc.

PART 2

DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1 DEFINITIONS:

2.1.1 ASCLD-LAB. American Society of Criminal Laboratory Directors- Laboratory Accreditation Board. The certifying board under which the U.S. Army Criminal Investigation Laboratory maintains certification.

2.1.2 CONTRACT ADMINISTRATOR. The official Government representative delegated authority by the Contracting Officer to administer a contract. This individual is normally a member of the appropriate Contracting/Procurement career field and advises on all technical contractual matters.

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

2.1.4 CONTRACTING OFFICER. A person with authority to enter, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

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

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

2.1.7 DELIVERABLE. Anything that can be physically delivered but may include non-physical things such as meeting minutes.

2.1.8 GOVERNMENT-FURNISHED PROPERTY (GFP) OR GOVERNMENT PROPERTY (GP). Property in the position of, or directly acquired by, the Government and subsequently made available to the Contractor.

2.1.9 ISO. Certifying body under which the laboratory has certification.

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

2.1.11 N.I.S.T. National Institute of Standards and Technology.

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

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

2.1.14 QUALITY ASSURANCE Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.15 QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of a product or service shall meet contract requirements.

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

2.1.17 WORKDAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.18 WORK WEEK. Is defined as Monday through Friday, unless specified otherwise.

2.2. ACRONYMS:

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

3.1. Service: It is anticipated that all work performed will be conducted at the government site. If the contractor has to perform work on site, then the Government will provide the equipment to be maintained/repaired and personal protective equipment (lab coats, masks, gloves) required by the USACIL DNA section.

3.2 . Facilities: The Government will provide access to the technical areas which contain the instrumentation in covered and access to any other technical areas required for the performance of the maintenance/repairs required.

3.3 . Utilities: The Government will ensure that all utilities in the facility will be available for the contractor’s use in performance of tasks outlined in this PWS. The Contractor (to include subcontractors) shall instruct employees in utilities conservation practices. The contractor shall be responsible for operating under conditions that preclude the waste of utilities, which include turning off the water faucets or valves after using the required amount to accomplish cleaning vehicles and equipment.

3.4 . Equipment: The Government will provide access to equipment necessary to perform the required work. This can include printers, computers, pipettes, centrifuges, balances, hoods, holder trays, beakers, and any other technical equipment on site at the laboratory needed for the completion of the repairs and/or check of the instrument.

3.5 . Materials: The Government will provide consumable materials needed in the performance of the required services. This can include: chemwipes, pipette tips, water, buffer, gloves, lab coats, face masks, and any other consumable equipment on site at the laboratory needed for the completion of the repairs and or check of the instrument.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1. General: The Contractor shall provide a Project Manager (PM) who shall be responsible for the performance of the work. The name of this person and alternate who shall act for the Contractor when the manager is absent shall be designated in writing to the contracting officer. The PM or alternate shall have full authority to act for the Contractor on all contract matters relating to daily services as defined in this PWS. Contract manager or alternate shall be available 8:00 a.m. through 4:30 p.m., Monday thru Friday except Federal holidays or when the Government facility is closed for administrative reasons.

4.1.1. The contractor shall provide all necessary trained experienced technical personnel, tools, parts, travel, materials and supplies to perform onsite maintenance and unlimited on-site repair service.

4.1.2. The Contractor shall provide the Contracting Officer and the Contracting Officer’s Representative a list of telephone numbers where the primary service representative may be contacted during normal working hours and for emergency service calls. The Contractor shall have communication services with his/her own Contractor’s service representative, the COR and ACOR at all times.

4.1.3. The contractor shall furnish the Contracting Officer’s Representative (COR) a signed copy of service reports including quality assurance and certification for each instrument per repair and services, showing maintenance performed, listing dates and specific tasks, along with remarks noting any deficiencies found and repaired. The detailed report is due within two (2) weeks after the service visit.

4.2. Secret Facility Clearance: N/A

4.3. Materials: The Contractor shall provide the required parts for repair and equipment necessary to perform the repair or maintenance (i.e. temperature probe, filters, screwdrivers, etc).

4.4. Equipment: N/A

PART 5 SPECIFIC TASKS

5. Specific Tasks:

5.1. Basic Services. The contractor shall provide warranty services for government owned Qiagen Instruments as defined in the quotation. Services include annual preventative maintenance service which covers all of the required maintenance outlined in the instrument handbook provided by the instrument manufacturer. Included are the costs for any parts which need to be replaced and the consumables needed to perform the maintenance. The service also covers any required software updates and repairs that are needed on the instrument during the covered period. Repairs include the cost of the parts and labor associated with the repair. The technical support line is also available for use by the customer in troubleshooting possible instrumentation problems.

5.2. Task Heading:

5.2.1 The contractor shall provide coverage for the repair, parts, labor, travel as well as one planned preventive maintenance activity at the customer’s facility. A Qiagen field service engineer will be dispatched to the equipment’s location after contacting the Service Department to schedule service.

5.2.2 The contractor shall respond to unlimited emergency service calls within 48 hours (excluding weekends and federal holidays) to schedule proper time for onsite service. This applies to maintenance, services and emergency repair requests.

5.2.3 The contractor shall provide detailed service reports including quality assurance and certification for each instrument operations to original equipment manufacturer specifications per repair and services request within two (2) weeks after the visit.

5.3 CONTRACTOR MANAGEMENT REPORTING (CMR): The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the Contractor shall report ALL Contractor manpower (including subcontractor manpower) required for performance of this contract. The Contractor shall completely fill in all the information in the format using the following web address https://beta.SAM.gov The required information includes: (1) Contracting Office, Contracting Officer, Contracting Officer’s Technical Representative (COTR) or also known as the Contracting Officer’s Representative (COR); (2) Contract number, including task and delivery order number; (3) Beginning and ending dates covered by reporting period; (4) Contractor's name, address, phone number, e-mail address, identity of Contractor employee entering data; (5) Estimated direct labor hours (including sub-Contractors); (6) Estimated direct labor dollars paid this reporting period (including sub-Contractors); (7) Total payments (including sub-Contractors); (8) Predominant Federal Service Code (FSC) reflecting services provided by Contractor (and separate predominant FSC for each sub- Contractor if different); (9) Estimated data collection cost; (10) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the Contractor with its UIC for the purposes of reporting this information); (11) Locations where Contractor and sub-Contractors perform the work (specified by zip code in the United States and nearest city, country, when in an overseas location, using standardized nomenclature provided on website); (12) Presence of deployment or contingency contract language; and (13) Number of Contractor and sub-Contractor employees deployed in theater this reporting period (by country). As part of its submission, the Contractor shall provide the estimated total cost (if any) incurred to comply with this reporting requirement. Reporting period shall be the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. Contractors may use a direct XML data transfer to the database server or fill in the fields on the website. The XML direct transfer is a format for transferring files from a Contractor’s system to the secure website without the need for separate data entries for each required data element at the website. The specific formats for the XML direct transfer may be downloaded from the website.

PART 6 APPLICABLE PUBLICATIONS

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS)

6.1. The Contractor must abide by all DoD, Army, CIDC and DFSC applicable regulations, publications, manuals, and policies and procedures when performing all services pursuit to this PWS and contract.

Requirements Manual

OSHA

PART 7 ATTACHMENT/TECHNICAL EXHIBIT LISTING

7. Attachment/Technical Exhibit List:

7.1. Attachment 1/Technical Exhibit 1 – Performance Requirements

7.2. Attachment 2/Technical Exhibit 2 – Deliverables Schedule

TECHNICAL EXHIBIT 1

Performance Requirements Metrics

The Contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

100% compliance

Periodic inspection Contractor performance will be documented in CPARS.

Monthly Rate.

PRS #2. PWS 5.2.1 The contractor shall provide repair service in the event that a QIAGEN instrument does not operate. EZ1 Advanced XL, QIAcube, QIAgility HEPA VU (including laptop), Rotor-Gene Q 5plex HRM Platform.

Repairs meet or exceed the manufacturer’s specifications

100% inspection, Pre-Inspection & Final Inspection; Instruments performance check Contractor performance will be documented in CPARS.

Monthly Rate.

PRS #3. PWS 5.2.1 Provide on-site preventive maintenance service visits for the EZ1 Advanced XL, QIAcube, QIAgility HEPA VU (including laptop), Rotor-Gene Q 5plex HRM Platform.

Meet or exceed service contract terms and limitations

100% 100% inspection

Validated Customer Complaints received by COR Contractor performance will be documented in CPARS.

Monthly Rate.

100% 100% inspection

Validated Customer Complaints received by COR Contractor performance will be documented in CPARS.

Monthly Rate.

onsite service

100% inspection

Validated Complaints received by COR Contractor performance will be documented in CPARS.

PRS #6. PWS 5.2.3 Provide detailed service reports per repair and services request

Within 2 weeks after the on-site visits and repairs

100% inspection

Validated Complaints received by COR Contractor performance will be documented in CPARS.

TECHNICAL EXHIBIT 2 DELIVERABLES SCHEDULE

One (1) Original

Paper (hard copy) or electronic delivered via email

KO

receipt of the award One (1) Original; update as changes occur Paper (hard copy) or electronic delivered via email

KO

List of the primary service representative with contact information, PWS Para 4.1.2 Not later than 10 calendar days after receipt of the award

electronic delivered via email

KO / COR

of work

One (1) Original Paper (hard copy) or electronic delivered via email

COR