Attachment 1 Performance Work Statement.doc

CBRNE Laboratory Analysis and Collection Performance Work Statement

All changes are underlined and in bold print Amendment 0001: Revises sections 2.1.1, 2.3, 6.1, and 12.1.

Amendment 0003: Revises sections 12.0 and 12.1.

PERFORMANCE WORK STATEMENT

FOR

LABORATORY ANALYSIS AND COLLECTION

PENTAGON FORCE PROTECTION AGENCY

(PFPA)

CHEMICAL BIOLOGICAL RADIOLOGICAL

NUCLEAR AND EXPLOSIVES DIRECTORATE

(CBRNE)

TABLE OF CONTENTS

1.0 General Information 2.0 Requirements for Lab Analysis Services 3.0 Requirements for Collection Services 4.0 Requirements for Maintenance Services 5.0 Requirements for Supplies 6.0 Requirements for Special Studies 7.0 Requirements for Transition

8.0 Requirements for Quality Assurance 9.0 Requirements for Safety

10.0 Requirements for Security

11.0 Government Furnished Equipment

12.0 Requirements for Personnel

13.0 Appendix A: Applicable Documents

14.0 Appendix B: Transition Acceptance Criteria for Lab Analysis Services

15.0 Appendix C: Transition Acceptance Criteria for Collection Services 16.0 Appendix D: Laboratory Equipment and Instrument Service Agreements 17.0 Appendix E: Consumables/Supplies/Equipment 18.0 Appendix F: Instructions for Routine DFU Collection 19.0 Appendix G: Deliverables

20.0 Appendix H: Quality Assurance Surveillance Plan (QASP) 21.0 Appendix I: Past Performance Incentives

1.0 GENERAL INFORMATION

1.1

BACKGROUND

The Chemical, Biological, Radiological, Nuclear, and Explosives (CBRNE) 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 CBRNE Directorate is responsible for testing environmental samples for biological agents. Polymerase Chain Reaction (PCR) and Electrochemiluminescense (ECL) are proven methods and have been utilized since 2001 to test for the presence of a number of biowarfare/biothreat agents in environmental samples. The CBRNE Directorate utilizes these methods to have samples analyzed at its on-site lab located on the Pentagon Reservation.

1.2

OBJECTIVES

This contract shall provide for accurate and timely analysis and collection services in addition to equipment maintenance and the supplies necessary to support 24/7 CBRNE sample analysis operations.

1.3

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 four (4) separate groups, as follows:

1.3.1 Analysis Services: The contractor shall provide personnel capable of performing PCR and ECL, 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 reach back capabilities and other duties.

1.3.2 Collection services: The contractor shall provide personnel, supplies, and vehicles to support the Environmental Sampling Unit (ESU) effort. The effort consists of routine collection and transport of environmental samples taken from designated locations as defined in this Performance Work Statement. An environmental sample refers to a dry filter collected from a Dry Filter Unit (DFU) or similar device and then placed into a container suitable for maintaining sample integrity during transport. The collection schedule ensures timely laboratory analysis in keeping with the Detect-to-Treat mission assigned to the Pentagon Force Protection Agency.

1.3.3 Equipment Maintenance: The contractor shall provide equipment and instrument service maintenance agreements and/or calibration services to ensure that all laboratory instruments, equipment, and devices utilized in the testing procedures are covered by a service contract which meets ISO 17025 Standards. Service contracts on instruments must align with the manufacturer’s guidelines so as to ensure quality and/or warranty requirements.

1.3.4 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. Inventory shall be sufficient to meet a minimum of four month supply and the contractor shall ensure delivery of the items to the laboratory located on the Pentagon Reservation.

2.0

REQUIREMENTS FOR LAB ANALYSIS SERVICES

2.1

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.

2.1.1 Schedule for Samples: The contractor shall accept delivery and perform analysis of approximately 38-42 field samples Monday thru Friday, 25-27 on Saturday, Sunday, and holidays, with a surge capacity to 100. Currently, the samples are delivered in the evening, up until 8:00 PM so that the bulk of the work is performed in the overnight hours, with results expected within 12 hours. An additional small subset of (4) samples is received mid-day twice per week with results expected within eight (8) hours of receipt. The contractor shall also be prepared to accept and analyze any special samples requiring immediate analysis anytime throughout the day within proven turnaround times as directed by PFPA. The frequency of receipt and the number of samples is subject to change per PFPA direction.

2.1.2 Testing Protocols: The contractor shall utilize protocols developed by the United States Army Medical Research Institute for Infectious Diseases (USAMRIID) or other CBRNE approved procedures, shall follow current CBRNE 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 ECL, 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.

2.1.3 Tier 1 and Tier 2 testing: Contractor shall follow CBRNE 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 offorors 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.

2.1.4 Tier 2 protocol: Contractor shall provide immediate verbal notification to CBRNE Laboratory personnel of any sample considered a presumptive positive as detected by current CONOPs. Upon CBRNE 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 IATA certification for transport of biological samples shall be required.

2.1.5 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).

2.1.6 Testing storage and disposal: The contractor shall store negative environmental samples and QA/PT samples for at least 60 days at 4 degrees C. An existing large capacity refrigerator already exists for storage capability. After 60 days, samples may be disposed of by PFPA approved method, i.e. autoclaving. Detected samples shall be kept for a time period directed by PFPA. The contractor shall prepare laboratory biological waste for disposal and collection.

2.1.7.

Waste removal: The contractor shall also provide for a biomedical waste removal service to come to the on-site 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 Dept Environmental Quality (VDEQ) and Maryland Department of the Environment (MDE) regarding the transport of medical waste.

2.1.8 Additional duties: Laboratory personnel shall be available to assist with routine functions such as supply inventory, stockage, 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.

2.1.9 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.

2.2

REACH BACK CAPABILITIES

The contractor will be responsible for providing, operating, and maintaining a warm-based off-site laboratory to be used as reach back 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.

2.2.1 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 stand up 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 COOP plans, allowing at least four (4) Government personnel to work from the facility. The laboratory shall perform, at a minimum, analysis of Quality Assurance samples and Proficiency Test 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.

2.2.2 Lab qualifications: The laboratory must be within 35 miles of the Pentagon 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 CBRNE lab. The off-site lab shall participate in interlaboratory 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.

2.2.3 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 CBRNE 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.

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 for internal quality control samples, QA samples and field 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.

2.3

SAMPLE INCREASES (SURGE)

2.3.1 The CBRNE Laboratory anticipates testing approximately 38-42 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.

2.3.2 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.

2.4

LAB ANALYSIS REPORTS & CONTRACTOR AVAILABILITY

2.4.1 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 CBRNE’s operational requirements. Separate reports may be required based upon customer or sample type. The recipients of these reports will be specified by CBRNE.

2.4.2 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 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.

2.4.3 Additional reports: Upon request, the contractor shall email raw data files in 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 CBRNE. 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.

2.4.4 Contractor availability: The contractor shall be available to discuss issues related to requirements and performance during the regular business day, Monday through Friday (except Federal holidays), 0800 until 1630 hours. Contractor shall attend and participate in two Program Reviews per year with the Government and other program participants as part of the JPEO program. Most meetings shall be held at the Government or contractor’s facility. The contractor shall provide quarterly review meetings summarizing all activities performed within the reporting quarter, such as schedules, any operational problems/trends, quality issues, updates on any special studies in progress, etc. The contractor shall prepare and submit meeting minutes for each quarterly review within 10 days of the completion of the meeting.

3.0

REQUIREMENTS FOR COLLECTION SERVICES

The contractor shall provide vehicles, adequately trained technical and supervisory personnel and sample collection supplies. Contractor is responsible for ensuring all equipment is functioning properly. Samples collected will come from PFPA designated locations. A sample is composed of (1) the buffer extracted DFU filter collected from a DFU (filter in 50ml conical tube containing app. 10 ml buffer) and (2) the remaining DFU filter collected from the DFU. The contractor shall collect samples from three (3) designated DFU units from a single location; however, operations shall be scalable, to rapidly accommodate changes in mission (increases or decreases in the number of samples), both short term (surges) and long term. The Government may modify procedures based on air sampling device or continuous system improvement. Currently, up to as many as 10 buildings are equipped with DFU(s) with the potential for collection needs. Also, the potential exists for the contractor to expand services to include the Pentagon Reservation. The contractor shall provide its own base of operation. Precise locations and numbers of DFUs per building is controlled information, and will be made available to offerors with SECRET clearances in a “Reading Room.” Contractor shall collect samples using a PFPA/CBRNE or client approved SOP. For a list of procedures, see Appendix F.

3.1 Collection schedule: The CBRNE Directorate will indicate collection frequency and times for each location. Collection frequencies may be subject to change based upon CBRNE mission requirements, and frequency and time of collection may vary by location. Routine collection of DFU filter samples at time of award will one location, once (1x) per day, seven (7) days per week and DFU filter collection will typically occur after midday, or as specified by PFPA. The contractor shall be able to adjust to: (1) an increase or decrease in the number of DFUs and/or locations from which samples are collected, subject to continuous threat assessment updates conducted by the government, and (2) surge requirements based on increase in Force Protection Condition (FPCON) level. The Government shall notify the contractor at least fourteen days prior to initiating collection from new DFU locations. The contractor shall identify what levels of increase they could accommodate without prior notice, and at what level of increase (threshold) they would need to receive prior notification (e.g., to allow for increasing of staffing). The Government shall provide the collection locations with updated approved personnel access rosters to facilities and coordinate security issues.

3.2 Collection personnel: The contractor shall provide trained technical and supervisory staff for collection of samples at PFPA designated locations. Personnel shall be responsible for all normally required sample collection functions such as security (to include facility, operational security), collection, quality assurance/safety activities, routine equipment maintenance and quality control. Collection personnel shall be available to assist with routine functions such as supply inventory, stockage, and collection site access. The contractor shall ensure that all personnel have, at a minimum, an interim SECRET clearance and maintain a valid driver’s license. Personnel shall abide by the Standards of Conduct of the Pentagon Reservation at all times. Collection personnel shall have at least a high school diploma or equivalent and strong spoken communication skills.

3.3 Collection personnel training: The contractor, in coordination with the CBRNE Directorate Laboratory Division staff, shall provide the necessary personnel, materials, and technical services to assess the training requirements for individuals collecting samples as well as design a training plan to meet those requirements, implement that plan and maintain documentation. All personnel who collect samples must be trained at a minimum in the following areas: sample collection procedures, general workplace safety (IAW OSHA 1910.21 through 1910.30), and general first aid, operation of the SMS and its hardware, and an orientation to biological agents. ESU member competency/proficiency shall be monitored via the quality program. The contractor shall, in collaboration with the Government, maintain and, as required, update the standard operating procedures (SOPs) for all procedures within this PWS. The contractor shall write SOPs in CBRNE Directorate provided format.

3.4 Collection vehicles: Contractor shall provide all necessary transportation to accomplish the terms of the contract and shall provide the government with vehicle tag information and update as necessary. The contractor shall ensure drivers have requisite driving insurance and vehicles are inspected for threats, to include Improvised Explosive Devices (IED) per TSWG document (see Sec 2.0, Applicable Documents). The contractor shall document inspections using a CBRNE Directorate provided format. ESU members must be trained in IED inspection of vehicles (provide training certificate) and receive yearly refresher training. Selection of vehicle shall meet basic operational security requirements (e.g. inconspicuous / generic).

3.5 DFU maintenance: The contractor will perform all recommended daily, monthly and yearly operational checks on DFUs during collection in accordance with (IAW) “Dry Filter Unit Operator’s and Unit Maintenance Technical Manual”: ARMY TM 3-6665-348-12&P recommendations. Any deficiency that actively impedes DFU operation will require DFU replacement. ESU personnel will replace the malfunctioning unit within four (4) hours of identifying the malfunction. ESU will notify the CBRNE COTR or designee that the DFU has malfunctioned, whether they were able to collect a sample, and that replacement of the unit is being pursued. ESU will perform semi-annual airflow checks on DFUs, including spares, using a contractor provided anemometer and provide the DFU Program Manager with documentation of the airflow check readings. Units performing below the acceptable level will need to be replaced. If the contractor expands into collection in support of other programs, all applicable SOPs shall be followed. As the government identifies locations for additional DFUs, or DFUs are relocated, the contractor may assist in the installation of the DFUs, as part of familiarization with the new locations. For added DFUs the contractor shall be notified two weeks (14 days) prior to initiating collection from new DFU locations. All access requirements shall be coordinated with the CBRNE Directorate Security Program Manager.

3.6 SMS tracking system: Contractor shall utilize a PFPA-provided Sample Management System (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 unique bar code and record for sample tracking purposes. In the event the SMS method does not perform as designed, a CBRNE Directorate 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 CBRNE Directorate Laboratory Division and PFPA IT Directorate prior to purchase. The contractor shall be required to coordinate/cooperate with the SMS management contractor for improvements/up-keep of the SMS system.

3.7 Supplies & consumables: Other than the GFE mentioned in 11.0 and below, the contractor shall provide personal protective equipment (PPE) for its employees and all necessary consumable supplies needed for sample collection. The contractor shall maintain accountability of all equipment and track inventory of consumables at contractor owned facility. The contractor shall maintain an inventory of no less than four months of consumable supplies on hand at all times. Consumables include, but are not limited to: gloves, transfer pipettes, plastic bags (self sealing), parafilm, labels and courier forms. The contractor shall maintain accountability of all government furnished equipment/consumables: DFU (1000 or executive models), filters and filter extraction buffer-in-a-tube. The contractor shall have the following government provided operational DFUs, by model, on hand for replacement per instructions listed in DFU maintenance: one DFU-1000 and one DFU-executive.

3.8

COLLECTION REPORTS

3.8.1 Daily reports: The contractor shall generate and disseminate two reports with each sample delivery to the lab(s):

· Report one: Sample transfer documents. The sample transfer documents provide the sample tracking information generated via the Government provided Sample Management System (SMS). Documents shall be distributed via e-mail to the receiving lab and to designated CBRNE Directorate personnel and saved on removable computer media (i.e., 3.5” floppy disk), and transported with the samples to the receiving lab.

· Report two: A unit summary report showing the sample ID, location and collection time transmitted via e-mail to the designated CBRNE Directorate personnel (addresses), within one hour after commencing delivery of the samples.

3.8.2 Monthly reports: the contractor shall provide monthly reports (electronic) which include the tally of the samples collected, broken down into CLINs and subCLINs as directed by the government and which will support the billing information for the monthly invoice. The report shall also include inventories of contractor supplied and government supplied consumables, and government supplied equipment, ESU personnel roster, and reports of any issues associated with access, security, parking, safety or equipment. 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.

3.8.3 Contractor availability: The contractor shall be available to discuss issues related to requirements and performance during the regular business day, Monday through Friday (except Federal holidays), 0800 until 1630 hours. The contractor shall provide quarterly review meetings summarizing all activities performed within the reporting quarter, such as any operational problems, and access, quality or safety issues. Contractor shall provide a monthly SMS data back-up disc to the COR. DFU operational maintenance reports shall be available for review upon request, and semi-annual air flow data reported in the applicable monthly report.

4.0

REQUIREMENTS FOR MAINTENANCE SERVICES

Laboratories are equipped with a number of analytical instruments as well as supportive and safety equipment which are used throughout the testing procedure (See Appendix C: Laboratory Equipment and Instrument Service Agreements, below.) To ensure the accuracy and quality of test results, each of these items requires periodic, regularly scheduled maintenance and calibration checks to guarantee all equipment complies with the required specifications.

4.1 Service maintenance agreements: The contractor shall establish and provide for service maintenance agreements on new and existing government furnished equipment (GFE) or software to ensure minimal downtime, optimal performance and testing accuracy. Instrument service agreements must be at a level that includes technical support availability for troubleshooting during normal business hours, as well as a requirement for 24 hour turnaround time for unscheduled repair visits when instrument downtime impacts mission success. Parts and labor shall be provided under the agreements. Technicians must be specialized in their specific instrument. Repair or replacement parts must be per manufacturer’s specifications so as not to nullify any warranties. The contractor shall ensure that service maintenance agreements and certifications are performed by certified agencies that are ISO 17025 accredited, when applicable.

4.2 Instructions for on-site service personnel: Technicians and service representatives utilized for any services must be U.S citizens and be able to pass an NCIC check in order to be able to service or calibrate the equipment on site at the Pentagon.

4.3 Purchase of additional equipment: If needed to accommodate increased workload, the Government shall purchase additional equipment, and the contractor shall add those items to service maintenance agreements as well.

5.0

REQUIREMENTS FOR SUPPLIES

The contractor shall provide the laboratory with the supplies necessary for the lab to perform its daily operations. The laboratory must also have a reliable purchasing method that ensures sufficient quantities are on hand and orders are readily filled so as to have no impact on test turnaround times. Those items that affect the quality of laboratory output shall have been evaluated by the laboratory to ensure they conform to rigorous ISO 17025 Standards. To that end, the PFPA Laboratory may define specific vendors/manufacturers that meet those requirements. The contractor shall offer a prime vendor procurement system to provide a single, flexible procurement system for all laboratory supplies as well as equipment.

5.1 Additional Supplies: The government shall be able to add supplies to this list as the need arises, so that new items may be ordered and received within a two week period. The contractor shall, when requested by the government, assist in ensuring that potential suppliers of goods to CBRNE Lab complete and return the CBRNE Lab’s Supplier Evaluation form.

5.2 Delivery and Stocking: The contractor shall make available the ability for the lab to receive these supplies within an expected delivery time of fourteen (14) days of order. There should be a means for emergency orders which may require faster turnaround time. Supplies shall be delivered to the lab in a manner that maintains temperature controlled conditions, as needed. Items which were mishandled during shipment shall be reported to the contractor for replacement. Delivery orders shall be received with a document which shows the quantities ordered, the quantities received and any backorders noted. The contractor shall arrange for temperature controlled storage of all supplies, rotation of stock to ensure minimum of 12 month shelf life, and a minimum of four months inventory on hand.

6.0

REQUIREMENTS FOR SPECIAL STUDIES

6.1 Laboratory Special Studies: The PFPA CBRNE Directorate may need to evaluate new processes, equipment or assays aimed at improving the performance and operations of the laboratory. The Contractor may be asked to provide labor and supplies to support the evaluation of new equipment and new protocols aimed at improving the performance and operations of the laboratory. Areas of interest may include but are not limited to development of assays for additional biowarfare agents, protocols to increase the throughput of the laboratory or improve the sensitivity of the assays, protocols/strategies to decrease the sample testing time, preparation of spiked samples to be used to assist in sensitivity and specificity studies for new assays or platforms conduct analyses on samples used for new method validation or design of new protocols or facilities, provide technical and analytical assistance in de-commissioning of facilities, participate in special studies as developed by the Pentagon Science and Technology Office, in which additional, non routine samples may need to be analyzed. If conducted, these studies will have minimal impact on the contractor’s ability to complete their routine analysis.

6.2 Collection Special studies: The Contractor shall provide labor, equipment, and supplies to support special studies such as the evaluation of new equipment, computer hardware/software and new protocols aimed at improving performance and operations. Areas of interest may include development of protocols to increase the operational efficiency, and other areas as requested by the government. Areas of interest may include but are not limited to occupational risk assessments, analyses of protective equipment performance, recommendations for improving protective equipment programs and assessment of efficacy of any new collection devices of interest to the government. If conducted, these studies will have minimal impact on the contractor’s ability to complete their routine collection mission.

Note: There is no guarantee that the PFPA CBRNE Directorate will need to conduct special studies. Therefore, a separate CLIN identified as “Special Studies” will be incorporated under the base year and for each option year of the contract. If a study is required, the Government will provide sufficient details and sample numbers to the contractor to request a firm-fixed price quotation which will be evaluated and negotiated to establish a final not-to-exceed price for the study.

7.0

REQUIREMENTS FOR TRANSITION

7.1 Lab analysis transition: The successful contractor shall work alongside the incumbent for 30 days to ensure a smooth transition of all operations at the on-site facility without interruption of ongoing 24/7 operations. The contractor will maintain the current methodologies and practices for the duration of the transition period. The Government will assess contractor competency in the following areas: accuracy of test results, CONOPS, Laboratory Information Management System (LIMS) utilization, data review, specimen in-processing and contamination control (See also Appendix A, Transition Acceptance Criteria). After a maximum of 30 days, the contractor shall assume full, independent operations, to include both facilities. Once the transition is complete, the incumbent will no longer have contractual obligations toward this effort.

7.2 Collection transition: The contractor shall implement a coordinated training plan proposed by the incumbent and have a facility available to host the trainer (incumbent) for the 14-day transition period. The government will assess contractor competency in the following areas: proper use of personal protective equipment (PPE), sample collection procedures, Sample Management System (SMS) Information Management System (IMS) use, back-up manual procedures, data review and quality assurance, specimen in-processing and contamination control (see Appendix A). Transition training will be documented by both the incoming and outgoing contractors to verify integrity of the transition. After a maximum of 14 calendar days, the contractor shall assume full, independent operations. The incumbent will no longer have contractual obligations toward this effort after the 14-day period.

7.3 Transfer of Government Furnished Equipment: During this 30 day transition period, the contractor shall transfer government owned equipment from the incumbent’s off-site lab to the contractor’s laboratory, inventory, install and verify equipment validation and qualification through Installation Qualification (IQ) and Operational Qualification (OP) principles as defined by the vendor.

7.4 Conclusion of contract performance: The successful contractor for this award will, in turn, provide technical and supervisory personnel, labor, GFE equipment and training to meet the requirement of transitioning these operations to the next incoming performer before the end of the final option year of this contract under terms similar to above requirements. The contractor shall ensure all documents, data, etc., is turned over to the government.

8.0 REQUIREMENTS FOR QUALITY ASSURANCE

8.1 Quality Assurance Program: The lab analysis contractor shall develop and maintain an effective Quality Program that adheres to all the requirements as stated in the ANSI/ISO/IEC 17025-2005, or current version. As part of this, the contractor shall provide personnel for and assistance with internal audits, SOP development and review, trend analysis for QC controls and QA sample results, CAPA investigations, etc. As directed by the Government, the contractor shall participate both on-site and off-site in the Joint Program Executive Office (JPEO) sponsored quality program. This could include participation in scheduled teleconferences and program meetings with other program members. Identified procedural problems or preventive measures shall be addressed by the Contractor via a government established Corrective Action/Preventive Action (CAPA) procedure. The contractor shall perform analysis of approximately five (5) Quality Assurance (QA) samples per week and up to 20 proficiency testing (PT) samples three times per year as directed by the Lab’s Quality Assurance Plan.

8.1.1 QA Specialist: The contractor shall provide a Quality Assurance specialist to ensure compliance with ISO 17025 at the off-site facility and to assist CBRNE’s QA Manager with QA activities as directed by the government. (See Key Personnel)

8.1.2 Training Program: The contractor shall take full responsibility and oversight for a comprehensive training program which clearly documents the competency of trainers and trainees to perform their respective procedures. The documents must be current, reviewed annually and housed on site to be available to any auditors.

8.2 Collection Quality Assurance: The contractor shall develop and maintain an effective Quality Program that adheres to all the requirements as stated in this SOO. As part of this, the contractor shall provide personnel for and assistance with internal audits, SOP development and review and corrective action investigation and remediation. This QA plan shall be reviewed and accepted by the COR. After acceptance, any proposed change(s) to the plan shall receive the COR’s approval in writing. The contractor will conduct a quality review of all daily collections prior to delivery to the laboratories. Identified procedural problems shall be addressed by the Contractor who shall develop and implement procedures to prevent and ensure non-recurrence of errors.

9.0

SAFETY

The contractor shall perform the follow safety activities:

1. Develop, oversee and implement personnel Safety Plan for PFPA approval and ensure that it meets all applicable OSHA regulations. Safety program shall be active prior to the contractor assuming lab analysis and sample collection operations.

2. Provide a Safety Specialist to perform all occupational risk assessments, safety training, hazards information, spill response, develop site specific health and safety plans, recommend appropriate safety control procedures and take part in identification and implementation of regulatory compliance measures. In coordination with the CBRNE Directorate Safety Officer, conduct semi-annual review/audit of the safety program. (see Key Personnel)

3. Submit a medical surveillance plan which must be submitted with the Contract Proposal. Update/changes to the Medical Surveillance plan must be presented to Government for review and approval prior to implementation.

4. Comply with all requirements as detailed in Section 13.0, Applicable Documents.

5. Ensure that the contents of relevant material safety data sheets (MSDS) are current and understood by their personnel.

6. Comply with the requirements contained in the CBRNE SOP for hazardous materials utilized in the laboratory in accordance with DoD Safety Office.

10.0

SECURITY

The contractor shall be responsible for safeguarding all Government-owned property provided for contractor use. At the end of each shift, all appropriate security forms shall be completed. All employees must be US nationals and able to obtain a SECRET level clearance. The contractor shall submit current DD254. The contractor shall immediately report any situation that may influence the security clearance of any employee involved in laboratory testing operations.

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 CBRNE Laboratory security POC. The contractor shall place FOUO and coded data/log sheets into a burn bag for proper disposal.

11.0

GOVERNMENT FURNISHED EQUIPMENT (GFE)/ GOVERNMENT FURNISHED ITEMS (GFI)

11.1 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:

· Three (3) ABI HT 7900 Fastblock PCR instruments

· Three (3) Roche M1M ECL analyzers

· Sufficient biological safety cabinets (BSC) (ten) to maintain proper work flow and contamination containment.

· 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 ECL 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.

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

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

· Two (2) ABI HT 7900 Fastblock PCR instruments

· Three (3) Roche M1M ECL analyzers

· Automated Biological Agent Testing System (ABATS)

· As required, PFPA approved assays and reference material for use by the contractor specific for the PCR and ECL assays.

11.3 GFE for Collection Services: The Government shall provide the following items/equipment:

· The government shall provide DFU filter packs, and “Buffer-in-Tubes” (approximately 10ml of appropriate buffer in 50ml capped, conical tubes).

· The government shall provide DFUs.

· The government shall provide building passes and parking placards.

· Government shall furnish all existing hardware, transferred from the incumbent, necessary for operation of the SMS information management system.

· The government shall purchase any new hardware necessary for operation of the SMS information management system, to include desktop computers, printers, barcode scanners, and barcode label printers

· The government shall purchase items for special studies, as required.

12.0

REQUIREMENTS FOR PERSONNEL

In the event that an onsite Full Time Equivalent (FTE) will not be available for onsite duties for more than five (5) calendar days, the contractor shall notify the COR and provide a temporary replacement (meeting the qualifications for the labor category listed in the PWS) until the subject FTE can return to his/her onsite duties. The Government reserves the right to verify actual hours worked. In the event the contractor does not supply a replacement within the required five (5) days, the contractor shall only invoice the Government for the total number of actual days completed per FTE.

12.1 Key Personnel: All contractor 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. Contract employees working under this contract shall be paid only for days actually worked at the rates established in the contract. The following positions will require the submission of resumes for review:

12.1.1 Senior Scientist/Lab Program Manager-Contractor shall provide a 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 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.