LAB_PWS.pdf

PERFORMANCE WORK STATEMENT (PWS)

FOR

LABORATORY ANALYSIS AND COLLECTION

PENTAGON FORCE PROTECTION AGENCY

(PFPA)

CHEMICAL BIOLOGICAL RADIOLOGICAL

PROTECTION DIVISION (CPD)

24 March 2017

PART 1

GENERAL INFORMATION

1. GENERAL: This is a non-personal services contract to provide laboratory analysis and collection. 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 analysis of environmental samples collected from the facilities and locations around and within the National Capital Region, as specified by the Government, or in support of other DoD missions as defined in this Performance Work Statement (PWS) except for those items specified in Part 3 of this PWS as government furnished property and services. The contractor shall perform to the standards in this contract.

1.2 Background: The Chemical, Biological, Radiological and Nuclear (CBRN) Protection Division of the Science, Integration and Technology Directorate of the Pentagon Force Protection Agency (PFPA) is responsible for providing biological monitoring capabilities to protect the facilities and personnel of the Pentagon and other DoD affiliated entities. As part of this mission, the CBR Protection Division (CPD) is responsible for testing environmental samples for biological agents. Polymerase Chain Reaction (PCR) and Immunoassay are proven methods and have been utilized since 2001 to test for the presence of a number of biowarfare/biothreat agents in environmental samples. CPD utilizes these methods to have samples analyzed at its on-site lab located on the Pentagon Reservation.

1.3 Objectives: This contract shall provide for accurate and timely analysis of daily environmental samples collected from the facilities and locations around and within the National Capital Region, as specified by the government, or in support of other DoD missions as defined in this Performance Work Statement except as specified in Section 11 of this document as government furnished property and services. This contract shall also provide database management services for the Information Management System that tracks CPD Laboratory samples. Additionally, this contract shall provide for equipment maintenance and the supplies necessary to support 24/7 CPD sample analysis operations.

1.4 Scope: The contractor shall provide all personnel, equipment, tools, materials, supervision, and other items and non-personal services necessary for a 24/7 operation to perform analysis of environmental samples collected from the facilities and locations around and within the National Capital Region, as specified by the government, or in support of other DoD missions as defined in this Performance Work Statement except as specified in Section 11 of this document as government furnished property and services. The core responsibilities are broken into three (3) separate groups, as follows:

1.4.1 Analysis Services: The contractor shall provide personnel capable of performing PCR and Luminex MAGPIX, or similar immunoassay procedure, to detect several biowarfare/biothreat agents. Contractor shall provide timely results in keeping with the Detect-to-Treat mission assigned to the Pentagon Force Protection Agency (PFPA). Testing will occur primarily at an existing 24 hour, 7 day (24/7) Biosafety Level (BSL) 2/3 laboratory located on the Pentagon Reservation but, the contractor shall also maintain an off-site BSL 2/3 laboratory for alternate laboratory capabilities and other duties.

1.4.2 Database Management: The contractor shall provide qualified personnel to manage, maintain, and repair the Laboratory Information Management System (LIMS) and the Sample Management Tracking System (SMS) and their respective replacements throughout the duration of the period of performance. The contractor shall maintenance and repair all related hardware and equipment associated with LIMS, SMS and future replacements.

1.4.3 Equipment Maintenance: The contractor shall provide and manage all equipment and instrument service maintenance agreements, service contracts and/or calibration services to ensure that all laboratory instruments, equipment, and devices utilized in the testing procedures are covered by a service contract that meets ISO 17025 Standards.

1.4.4 Supplies: The Contractor shall provide CBRNE Laboratory with the supplies, reagents and consumable materials (hereafter referred to as supplies) necessary for the laboratory to perform its daily operations. The price list of supplies shall be approved by the Contracting Officer to ensure fair and reasonable. Inventory shall be sufficient to meet a minimum of four (4) month supply and the Contractor shall ensure delivery of the items to the laboratory located on the Pentagon Reservation.

1.5 Period of Performance: The period of performance shall be for one (1) Base Year of 12 months and four (4) 12-month option years (plus a FAR 52.217-8 option to extend services up to six (6) months). The anticipated Period of Performance reads as follows:

Base Year 30 July 2017 – 29 July 2018 Option Year I 30 July 2018 – 29 July 2019 Option Year II 30 July 2019 – 29 July 2020 Option Year III 30 July 2020 – 29 July 2021 Option Year IV 30 July 2021 – 29 July 2022 FAR 52.217-8 Option 30 July 2022 – 29 January 2023

1.6 General Information:

1.6.1 Quality Control: The government Laboratory ha a well-established Quality Management System that is accredited to the ISO 17025 standard. The contractor shall follow, maintain and continuously improve Quality Assurance/ Quality Control programs, processes and procedures to ensure services are performed in accordance with this PWS and so that all laboratory accreditations and certifications can be maintained. 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.

1.6.2 Quality Assurance: The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.6.3 Recognized Holidays:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Independence Day Christmas Day

The Laboratory is open for business on all days throughout the year including recognized holidays. Typically, the same daily samples are received with the exception of daily mail samples due to there being no postal service on Federal Holidays.

1.6.4 Hours of Operation: The contractor is responsible for conducting business, on a 24 hours per day/7 days per week – 365 days per year (366 for leap years) basis except when the Government facility is closed due to local or national emergencies, administrative closings, similar Government directed facility closings. The Laboratory shall not be closed for the aforementioned reasons without decree from the Laboratory Director or other specified Government designee. 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 at all times 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 primarily at the PFPA- CPD government laboratory facility and the alternate laboratory support offsite laboratory where necessary.

1.6.6 Type of Contract: The government will award a single-award indefinite-delivery indefinite quantity (IDIQ) type-contract with firm-fixed-price (FFP) task orders issued from it.

1.6.7 Security Requirements: Contractor personnel performing work under this contract must have at least an interim SECRET security clearance at time of the proposal submission, and must maintain the level of security required for the life of the contract. The security requirements are in accordance with the attached DD254. The Contractor shall immediately report any situation that may influence the security clearance of any employee involved in laboratory testing operations.

Contractors are required to report to PFPA any derogatory information that may justify an unfavorable administrative action in a personnel security or building access determination. Derogatory information includes, but is not limited to, criminal conduct, illegal drug involvement, or psychological conditions that impair judgment, reliability or trustworthiness. Derogatory information must be provided to the COR and Contracting Officer as promptly as possible, but in no event later than three (3)business days after the contractor becomes aware of the information.

PFPA reserves the right and prerogative to deny and/or restrict facility and information access of any Contractor employee determined by PFPA at any time during performance to be unsuitable for access and/or present a risk of compromising sensitive Government information to which they would have access under this contract.

A determination by PFPA that a person is not suitable to perform work under this contract is not a denial, suspension or revocation of a previously granted security clearance by another agency, nor shall it be interpreted as a direction or recommendation to the Contractor regarding the suitability of an affected individual for employment outside the scope of PFPA.

The Contractor shall prohibit the use of Government-issued badges/parking passes by any persons other than the Contractor’s employees. The Contractor shall ensure immediate turn-in of badges and parking passes upon termination of employment (voluntary or other) and immediately report any occurrences of lost or duplicated badges to the CPD Laboratory security point of contact. The Contractor shall place FOUO and coded data/log sheets into a burn bag for proper disposal.

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:

1.6.7.2.1 In the event keys, other than master keys, are lost or duplicated, the Contractor shall, upon direction of the Contracting Officer, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from the monthly payment due the Contractor. In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the monthly payment due the Contractor.

1.6.7.2.2 The Contractor shall prohibit the use of Government issued keys/key cards by any persons other than the Contractor’s employees. The Contractor shall prohibit the opening of locked areas by Contractor employees to permit entrance of persons other than Contractor employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the Contracting Officer.

1.6.7.3 Lock Combinations: The Contractor shall establish and implement methods of ensuring that all lock combinations are not revealed to unauthorized persons. The Contractor shall ensure that lock combinations are changed when personnel having access to the combinations no longer have a need to know such combinations.

These procedures shall be included in the Contractor’s Quality Control Plan.

1.6.8 Special Qualifications: The contractor shall ensure that employees are fully trained and aware of biological safety procedures such as aseptic technique, handling blood-borne pathogens as well as the handling, packaging and transport of bio-hazardous materials and infectious substances.

1.6.9 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.

1.6.10 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 with regard to 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.

1.6.11 Key Personnel: The personnel listed below are considered essential to the work being performed hereunder.

Prior to substituting, removing, replacing, or diverting any of the specified individuals, the Contractor shall notify the Contracting Officer 15 working days in advance and shall submit a written request and justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on this Contract. The proposed substitution of personnel must meet or exceed the education, experience, and other technical requirements of the personnel being replaced. No change in personnel shall be made by the Contractor without the prior written consent of the Contracting Officer. In the event the proposed substitution of key personnel does not meet or exceed the education, experience, and other technical requirements of the personnel being replaced, the Government reserves the right to require continued performance of previously approved key personnel or to require substitution of acceptable replacements for the individuals specified below. The key personnel listed below may, with the consent of the contracting parties, be amended from time to time during the course of the Contract to either add or delete personnel as appropriate.

Key personnel titles and qualifications are listed below:

1.6.11.1 Senior Scientist/Lab Program Manager: The Contractor shall provide a Philosophical Doctorate (PhD)-level scientist with strong background in scientific inquiry, investigation, molecular microbiology, and demonstrated familiarity with PCR and immunoassay procedures, test design, and validation procedures. Functions as the highest-level technical scientist and plays key roles as needed to scientifically develop and guide projects for the Special Studies CLIN. This individual shall be responsible for compliance with this PWS. The Program Manager shall be designated in writing to the Contracting Officer. The Program Manager shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. Identified persons shall have at least two (2) years of experience either managing a Government contract of this magnitude or four (4) years of overall Government contract project management experience.

1.6.11.2 Laboratory Manager: The Contractor shall provide a scientist with a Master of Science (MS) degree in Microbiology, Molecular Biology or equivalent, having at least two (2) years of experience in scientific investigation, aseptic technique, contamination control and laboratory management. This individual shall operate on-site in the laboratory as an operational supervisor.

1.6.11.3 Scientists Level I: The Contractor shall provide a sufficient number of scientists with successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in biology, chemistry, or basic medical science that includes at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics and college algebra, or their equivalent. This level has less than two (2) years of experience and performs testing under supervision, reporting to shift leads. These individuals shall operate on-site in the laboratory.

1.6.11.4 Scientists Level II: The Contractor shall provide a sufficient number of scientists with successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in biology, chemistry, or basic medical science that includes at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics and college algebra, or their equivalent. This level has at least two (2) years relevant experience and performs testing under supervision, reporting to shift leads.

These individuals shall operate on-site in the laboratory.

1.6.11.5 Shift Leads: The Contractor shall provide a sufficient number of higher level scientists to cover all shifts, with a minimum two (2) years hands-on experience in applicable analytical methods and demonstrated decision making skills along with successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in biology, chemistry, or basic medical science that includes at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics and college algebra, or their equivalent. These individuals shall operate on-site in the laboratory.

1.6.11.6 Database Manager: The Contractor shall provide an individual with at least three (3) years of experience in database administration to include activities such as installing, updating, patching and troubleshooting Microsoft Access-based databases. The Database Manager must also be proficient with SQL server installation, operation and maintenance and have a basic understanding of common IT. The database manager must be able to train other personnel in the operation, maintenance and querying of the database. The Database Manager must understand SMS systems and be able to assist in connecting SMS into LIMS.

1.6.11.7 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 4:30p.m., Monday thru Friday and be available by phone and email after hours, on Federal holidays or when the government facility is closed for administrative reasons.

1.6.12 Additional Personnel:

1.6.12.1. Quality Assurance Manager: The Contractor shall provide an individual with a minimum Bachelor of Science (BS) degree in a scientific field with skills in interpreting, explaining, and applying technical requirements and specifications to quality problems encountered in such activities as procedure evaluation, process audits, or investigations of aberrant results. Identified person shall have at least two (2) years of experience in overseeing and managing a quality assurance plan for a laboratory. Quality Assurance Manager cannot be the same individual as any on-site personnel or Senior Scientist/Lab Program Manager.

1.6.12.2. Lab Safety Manager: The Contractor shall provide an individual with a minimum BS degree in biology, chemistry or basic science, who has experience in oversight of a safety and occupational health program that addresses instruction of employees and supervisors in the techniques of performing duties free of mishaps. Position requires ability to address issues associated with potential biological hazards through recommendations of protective equipment, isolation techniques and aseptic technique.

1.6.13 Identification of Contractor Employees: 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. Contractor personnel are required to wear badging to identify themselves throughout the contract.

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: To minimize any decreases in productivity and to prevent possible negative impacts on additional services, the Contractor shall have personnel on board, during the first sixty (60) days phase-in / phase-out periods. During the phase-in period, the Contractor shall become familiar with performance requirements in order to commence full performance of services on the contract start date. Please refer to PWS Section 5.9, Requirements for Transition, for more details.

PART 2

DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1 DEFINITIONS:

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

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

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

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

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

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

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

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

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

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

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

2.1.12 WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

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

2.2. ACRONYMS:

ACOR Alternate Contracting Officer's Representative AR Army Regulation CFR Code of Federal Regulations CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative

COTS Commercial-Off-the-Shelf DD254 Department of Defense Contract Security Requirement List DFARS Defense Federal Acquisition Regulation Supplement DMDC Defense Manpower Data Center DOD Department of Defense FAR Federal Acquisition Regulation HIPAA Health Insurance Portability and Accountability Act of 1996 KO Contracting Officer OCI Organizational Conflict of Interest ODC Other Direct Costs PIPO Phase In/Phase Out POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program TE Technical Exhibit

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

3.1. GFE for On-Site Laboratory: The Government shall provide the facilities, equipment, materials, and services identified below:

- A fully equipped laboratory facility on site at the Pentagon Reservation designed and built to BSL 3 standards.

- The Government shall furnish the necessary desk space, telephones, computers and other items necessary to maintain an office environment.

- Building management and facility maintenance of the lab facility.

- Shower/locker room facilities, restrooms and a lunch area.

- All existing laboratory instruments/equipment needed to perform the two methods of analysis, such as:

o Three (3) ABI HT 7900 Fastblock PCR instruments o Three (3) Luminex MagPIX analyzers o Sufficient biological safety cabinets (BSC) (ten) to maintain proper work flow and contamination containment.

o Sufficient refrigerators and freezers to permit separation of clean items from dirty items.

- Standard lab equipment such as centrifuges, rotors, pipettes, thermometers, thermomixers, vortexes, bead beaters, vacuum pumps, etc.

- Autoclave

- Sample Management System (SMS) software compatible with the LIMS system to facilitate sample receipt.

- DoD approved assays and reference material for use by the Contractor specific for the PCR and IMMUNOASSAY assays.

- Access privileges/passes, parking placards and other authorized forms of required identification.

- Training such as the use of security equipment, building assessment system (BAS), and building utilities.

3.2 GFE for Off-site Laboratory: The Government shall provide the following items/equipment:

- All existing instrumentation to perform the PCR and IMMUNOASSAY assays (transferred from the incumbent’s laboratory).

o Two (2) ABI HT 7900 Fastblock PCR instruments o Three (3) Luminex MagPIX analyzers o Automated Biological Agent Testing System (ABATS) o As required, PFPA approved assays and reference material for use by the Contractor specific for the PCR and IMMUNOASSAY assays.

3.3 GFE for Database and SMS Management Services: The Government shall provide the following items/equipment:

- All existing hardware, transferred from the incumbent, necessary for operation of the LIMS and SMS information management systems.

- Any new hardware and software necessary for operation of the LIMS and SMS information management systems, to include desktop computers, printers, barcode scanners, and barcode label printers

- Items for special studies, as required to test, validate and implement LIMS and SMS hardware and software.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General : The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract that are not listed under Section 3 of this PWS.

4.2 Secret Facility Clearance: The contractor shall possess and maintain a SECRET facility clearance from the Defense Security Service. The Contractor’s employees, performing work in support of this contract shall have been granted a SECRET security clearance from the Defense Industrial Security Clearance Office. The DD 254 is provided as Attachment 1.

4.3. Materials. The Contractor shall provide all supplies, consumables and reagents required to execute the full spectrum of testing performed by PFPA CBRN Laboratory. The Contractor shall maintain, at minimum, a three month inventory of all supplies, reagents and consumables at the on-site PFPA government facility and a one month inventory at the off-site Contractor’s alternate laboratory facility. The Contractor shall regularly rotate inventory from facilities and storage locations to ensure that no expired supplies, reagents or consumables are ever used in testing PFPA samples.

4.4. Equipment: The Contractor shall provide equipment maintenance agreements, service contracts, warranties and equipment repair for all PFPA CBRN Laboratory instruments and equipment, ensuring no interruption of laboratory processes due to instrument/equipment failure. The Contractor shall provide equipment maintenance agreements, service contracts, warranties and equipment repair for all PFPA CBRN Laboratory equipment and instruments maintained at the alternate laboratory support facility, ensuring no interruption of laboratory processes at the Alternate Laboratory support facility due to instrument/equipment failure.

PART 5

SPECIFIC TASKS

5. Specific Tasks:

5.1 Basic Services: The contractor shall provide services for laboratory analysis and collection.

5.2 On-Site Laboratory Analysis: The contractor shall provide trained technical and supervisory personnel for an existing, government owned laboratory located on-site at the Pentagon in Arlington VA. The contractor staff shall receive and analyze environmental samples 24 hours per day, seven (7) days per week, including Federal Holidays.

Sample types shall include wet and dry filters from air collection devices, swabs, and any other PFPA approved means of sample collection. Samples analyzed at this site will come from PFPA designated locations, as well as from other clients potentially interested in utilizing the CBRNE laboratory for analysis. Personnel shall be responsible for all normally required laboratory functions such as processing samples for testing, sample analysis, quality assurance/safety activities, equipment maintenance, and quality control. Personnel shall abide by the Standards of Conduct of the Pentagon Reservation at all times.

5.2.1 Schedule for Samples: The Contractor shall accept delivery and perform analysis of approximately 35-40 field samples Monday thru Friday, approximately15 on Saturday, Sunday, and holidays, with a surge capacity to 100.

Currently, the samples are delivered in the evening, up until approximately 9:00 PM so that the work is primarily performed in evening and overnight hours, with results expected within 12 hours of the receipt of samples. The Contractor shall also be prepared to accept and analyze any special samples requiring immediate analysis anytime throughout the day within established turnaround times as directed by PFPA according to PFPA CBRN Laboratory CONOPS. The frequency of receipt and the number of samples is subject to change per PFPA direction.

5.2.2 Testing Protocols: The contractor shall utilize protocols developed by the United States Army Medical Research Institute for Infectious Diseases (USAMRIID) or other CPD approved procedures, shall follow current CPD SOPs, and shall utilize specified reagents as directed by PFPA to perform all analyses. Testing shall be performed by PCR based gene amplification for a minimum of four (4) agents with two (2) or more targets per agent, plus inhibition and Luminex MAGPIX Immunoassay, or equivalent, based immunological assays for a minimum of two agents. The PCR shall be run on purified DNA that has been extracted from the sample, unless otherwise directed by PFPA.

5.2.3 Tier 1 and Tier 2 Testing: Contractor shall follow CPD approved Concept of Operations (CONOPS) by testing all samples detected by Tier 1 protocols through to Tier 2 protocols for confirmation. Description of Tier 1 and Tier 2 protocols shall be made available to offerors in a classified document environment. History shows that approximately 0.05% of the samples require Tier 2 testing which includes reanalysis along with an orthogonal method of detection to confirm potential positive results obtained from Tier 1 testing.

5.2.4 Tier 2 Protocol: Contractor shall provide immediate verbal notification to CPD Laboratory personnel of any sample considered a presumptive positive as detected by current CONOPs. Upon CPD request, all samples detected by Tier 2 protocols shall be appropriately packaged and transported by the contractor to a PFPA designated laboratory for confirmation. Proper International Air Travel Agency (IATA) certification for transport of biological samples shall be required.

5.2.5 Tracking Samples: Contractor shall utilize a PFPA-directed Laboratory Information Management System (LIMS) as listed in Appendix A that is compatible with the sample management system used for environmental sample collection, providing complete tracking of samples from receipt in the laboratory to result generation (chain of custody requirements).

5.2.6 Testing Storage and Disposal: The Contractor shall store non-detected environmental samples and Quality Assurance/Proficiency Testing samples for at least 60 days at 4 degrees Celsius. An existing large capacity refrigerator already exists for storage capability. After 60 days, samples may be disposed of by THE CONTRACTOR USING PFPA-APPROVED METHODS., e.g. autoclaving. Detected samples shall be kept by the Contractor for a time period directed by PFPA. The Contractor personnel shall be trained in accordance with IATA for the packaging, shipping and transport of potentially biohazardous samples (containing up to Centers for Disease Control and Prevention Category A biological agents). The Contractor shall prepare laboratory biological waste for disposal and collection.

5.2.7 Waste removal: The contractor shall also provide for a biomedical waste removal service to come to the PFPA CBRN Laboratory no less than every other week to collect and haul waste to an authorized incinerator for disposal.

In a typical two week period, the laboratory generates an average of 16 boxes (23x18x18) for pickup. The service shall include provisions for transportation, treatment, disposal, boxes, red bag liners, labels and tape. Contractor shall provide documentation of recorded pickups and tracking of medical waste. The contracted service shall abide by applicable state and local regulations - issued by VA Department of Environmental Quality (VDEQ) and Maryland Department of the Environment (MDE) regarding the transport of medical waste.

5.2.8 Additional duties: Laboratory personnel shall be available to assist with routine functions such as supply inventory, stocking, and laboratory access/visitor control. Laboratory personnel shall, at the request of the government, during expected business hours, attend meetings with government representatives to provide input into CONOPS, process improvements, SOP revisions, etc. Lab personnel shall also complete DoD/PFPA required training, within expected time frame, as directed by the COR. The contractor shall monitor and immediately report to the Government conditions/broken equipment that impacts the operational environment of the laboratory. Assist the government with initiation and follow-through with facility related issues to include maintenance, work orders, coordination of authorized personnel access.

5.2.9 Personnel Qualifications: The laboratory staff shall be fully qualified in all laboratory methods prior to reporting any laboratory results, as per applicable lab SOPs. By the first day of contract performance, the contractor shall possess ISO 17025 accreditation, be capable of performing work at the level that will assure continued successful accreditation. ALL personnel must maintain at a minimum, an interim SECRET clearance. Contractor shall also have demonstrated experience in the performance of PCR and immunoassay methods, along with demonstrated ability to perform routine laboratory practices, sample receipt and sample management.

5.3 Alternate Laboratory Capabilities: The Contractor will be responsible for providing, operating, and maintaining a warm-based off-site laboratory to be used as an alternate in the event of a loss of operations at the primary facility, if sample numbers exceed the capacity of the on-site laboratory, or if the numbers change due to an increase in scope resulting from changes in threat conditions or CONOPs. The Contractor shall also provide trained and qualified personnel to perform laboratory support services such as quality assurance, biological safety and database management that are required both onsite and at the off-site alternate laboratory facility.

5.3.1 Lab duties: The Contractor shall provide trained technical and supervisory personnel, reagents, testing, supplies and calibrated/maintained equipment and instruments, and certification for its off-site laboratory to ensure the laboratory would be able to operate in a moment’s notice and provide testing capability similar to the operations at the on-site primary facility. This off-site lab shall serve as the location for Continuity of Operations (COOP) plans, allowing at least four (4) Government personnel to work from the facility. The laboratory shall perform, at a minimum, analysis of QA samples and PT samples to maintain its level of competency and demonstrate ability to assume operations under any given circumstances. The lab shall follow similar CONOPs that utilize a tiered approach so that Tier 1 positive samples would be taken to Tier 2 for further confirmation. In the event of a loss of operations from the on-site facility, Contractor personnel shall assist in the transport of specimens for analysis to off-site location as needed.

5.3.2 Lab qualifications: The laboratory must be within 35 miles of the Pentagon AND within 70 miles of Raven Rock Mountain Complex to allow for timely delivery of specimens. The facility shall be a fully functional, outfitted and certified BSL-3 capable facility and be able to provide operations on a 24/7 basis. The laboratory must be accredited to ISO 17025. The lab shall be structured to provide similar technology for lab analysis for the CPD lab.

The off-site lab shall participate in inter-laboratory Proficiency Testing (PT) that allows peer review of data and identifies protocol/testing problems inherent to the procedures. The facility shall have the capability of performing microbiological culturing for live agents, the ability to provide positive control materials and the ability to prepare liquid media and reagents. The contractor shall ensure that all available personnel have, at a minimum, an interim SECRET clearance.

5.3.3 Database Management Services: The contractor shall provide personnel, to support the management of the Laboratory Information Management System, the Sample Management System (SMS) and future replacement platforms for each. The effort consists of installing system patches and updates, troubleshooting, installing and replacing Government-furnished hardware, performing system backups, installing new operating systems and corresponding new versions of LIMS and SMS software and training for the operation and maintenance of LIMS and SMS.

5.3.4 SMS tracking system: Contractor shall utilize a PFPA-provided SMS that is compatible with the Laboratory Information Management System LIMS) used at the laboratories, providing complete tracking of samples from sample collection to receipt in the laboratory, to laboratory result generation (chain of custody requirements). The SMS shall be used to track the disposition of a DFU filter sample during the collection (replacement) / transport /analysis process. The contractor shall label all samples with a CPD specified unique bar code/label and record for sample tracking purposes. In the event the SMS method does not perform as designed, a CPD Division provided back-up manual labeling system shall be used to account for the disposition of DFU filter samples. Contractor employees must be trained / proficient in using the SMS and manual back-up methods. All information technology (IT)/communications purchases for systems that shall be integrated into the PFPA Network shall be approved by the PFPA CPD Laboratory Branch and PFPA IT Division prior to purchase. The contractor shall be required to coordinate/cooperate with the SMS manufacturer/developer and others as designated for improvements/up-keep of the SMS system. Contractor shall provide a monthly SMS data back-up disc to the COR

5.3.5 QA sample preparation and support: The contractor shall create an annual spiking plan for 260 QA samples that provides for the spiking of agents of interest onto relevant matrices and statistical analysis of testing results for purposes of routine QA assessment of the Laboratory’s ability to detect specific target organisms using relevant analytical platforms. The plan shall ensure that all agents, targets, matrices, and methods currently tested by CPD Laboratory are equivalently represented. The contractor shall follow applicable ISO/IEC 17025 International Standard, General requirements for the competence of testing and calibration laboratories. The number of samples may be modified per request of PFPA with advanced notice. The contractor shall receive PFPA procured spiking materials and qualify using PFPA approved qualification criteria for spiking materials. The contractor shall perform biweekly spiking and QC testing of matrices according to the PFPA-approved spiking plan. The contractor shall ship biweekly a two week inventory of spiked matrices to the PFPA laboratory totaling five (5) QA samples per week.

Each shipment is to include a certificate of analysis describing performance of the materials used in preparation of the samples and of the prepared QA samples.

The Contractor shall ensure that personnel involved in the preparation of spiking schemes and QA samples work independently of daily sample analysis activities in which QA samples are tested. The Contractor shall ensure that personnel involved in the preparation of spiking schemes and QA samples are free of undue pressure and/or conflicts of interest presented by the management structure or work environment. The contractor shall ensure that activities involving the preparation of spiking schemes and QA samples are separated from activities involving the testing of daily environmental and/or QA samples by time and/or space.

5.3.6 Quarterly report: The contractor shall provide quarterly reports to the PFPA Contracting Officer’s Representative (COR) that include statistical statements describing laboratory performance. Cumulative performance metrics shall be reported for the previous 24 month period, when possible. PFPA will approve the quarterly report format, content and any modifications thereafter. The Contractor shall provide LIMS capabilities to include tracking of laboratory results and other data for internal quality control samples, QA samples and field samples.

5.4 Sample Increases (Surge)

5.4.1 The CPD Laboratory anticipates testing approximately 35-40 samples per day. Sample numbers could increase or decrease based upon threat conditions, budget constraints, surges for special events, and acquisition of new clients. If the government were to attain additional workload, the contractor must be able to perform analysis of these additional samples within the same turnaround time constraints as currently exist. The government will provide at least 30 days advance notice to allow contractor to hire/train additional staff as needed to accommodate any additional workload. The possibility exists that an additional 40+ samples could be delivered mid-day, 7 days per week, requiring immediate processing for results to be available within 8 hours.

5.4.2 As directed by the Contracting Officer, the contractor shall provide surge project support for additional work within the overall scope of this task order. Such direction will be made via issuance of bilateral firm-fixed-price or fixed-price-level-of-effort modification(s) to the task order against the Government specified not-to-exceed amount.

This CLIN may be exercised more than once by the Government as needed throughout the performance of this task order.

5.5 Lab Analysis Reports and Contractor Availability

5.5.1 Daily Reports: The Contractor shall prepare and distribute electronically a daily sample analysis report(s), in PFPA approved format, detailing sample testing conducted during the previous 24 hours for samples processed at the on-site location. The report shall include, at minimum, preliminary results for samples received during the past 24 hours, a complete sample inventory from the past 24 hours and complete Tier 2 results, as indicated, for samples received over 24 hours. Pending results shall be clearly indicated. Preliminary results shall be updated daily until the final disposition can be made. Currently, the report shall be submitted by 0900 each day, but this may be adjusted to conform to changes in CPD’s operational requirements. Separate reports may be required based upon customer or sample type. The recipients of these reports will be specified by CPD.

5.5.2 Monthly Reports: The Contractor shall provide monthly reports (electronic), which include the tally of the samples analyzed and a complete breakdown of hours completed by Full-Time Equivalents (FTEs). They will be broken down into CLINs and subCLINs as directed by the Government, which will support the billing information for the monthly invoice. All invoiced costs must be provided with a breakdown of cost by sample location to separate sample location and or client as directed by PFPA. The monthly status report shall be in PDF format and emailed to the COR or designee. Reports are required no later than the 10th day of the following month.

5.5.3 Additional Reports: Upon request, the Contractor shall email raw data files in file types including, but not limited to, Microsoft Word, Excel, Access and portable document format (PDF) to specified email accounts. The Contractor shall generate and maintain testing data that can be utilized for real-time trending analysis and other reports as defined by CPD. Items of interest include, but are not limited to, the following: detection rates by location/ by agent, Tier 1 and Tier 2 occurrences, quality control trending, reagent lot-to-lot variability and false positive/negative rates for spiked QA samples.

5.5.4 Contractor Availability: The Contractor shall be available to discuss issues related to requirements and performance during the regular business day,…