Attachment_1_PWS_and_L16.pdf

ATTACHMENT 1

PERFORMANCE WORK STATEMENT FOR OPERATION, MAINTENANCE AND

MODIFICATION OF THE HUMAN STUDIES FACILITY

REVISED IN AMENDMENT 1 ISSUED 5/26/2015

A. GENERAL REQUIREMENTS

1. Background: The Contractor shall provide experienced, appropriately licensed and certified personnel, shop and office facilities, supplies, instrumentation, spare parts, and test equipment to operate, maintain, and modify seven human exposure chambers and their associated support systems, two aerosol particle concentrators and exposure chambers, three non-exposure test rooms, four in-vitro exposure chamber pairs and their support systems, and a climate controlled weigh room to perform this performance work statement. The contractor shall also be responsible for maintenance and modification of the bio-medical equipment in the Medical Station, but not its operation. The support systems include a high capacity clean air supply system, associated computers, pumps, filters, fans, heated and chilled glycol-water supply equipment, a large capacity heat exchange system for generating 450° F oil, electrical distribution equipment and wiring, pollutant generation and control equipment and associated computers, seven computer controlled individual air handling units providing custom conditions to the human exposure chambers, and medical gas and vacuum generation and delivery systems.

All air supply systems are operated by a commercial Andover Building Automation System (BAS) control system. Air pollutants are generated and monitored by the Environmental Exposure System (EES), running custom designed software (called the Pollutant Control System, or PCS) on COMPAC Alpha equipment using the Open VMS operating system. The EES both controls and records the exposure conditions used for each protocol.

2. All the facilities to be operated and maintained are located in the Human Studies Facility (HSF) on the Medical School Campus of the University of North Carolina (UNC) at Chapel Hill, North Carolina, at 104 Mason Farm Road Chapel Hill, NC 27599. Occasional travel may be required to learn about new exposure systems or techniques employed by other organizations, or for training in relevant areas.

3. Contractor staff shall periodically be required to modify and upgrade selected systems to ensure that state of the art capability is maintained at the facility. They shall also be required to design, acquire, install and maintain new equipment and instrumentation.

4. The contractor shall provide preventative maintenance, repairs, operation services, limited overtime services, and support services, such as periodic cleaning of the exposure chambers. All services shall be in accordance with this Performance Work Statement (PWS). Strong emphasis shall be placed on identifying and correcting potential problems before they disrupt research operations.

Some weekend work may be required for equipment repairs or replacement, or to ensure that exposure systems are available for work at the beginning of the week.

5. The contractor shall maintain assigned machinery spaces, storerooms and other work areas in a clean and orderly manner. Following work in any area, contractor staff shall daily remove all debris, clean as appropriate and properly store equipment and material. All facility operations, including disposal of all hazardous materials and wastes, shall be in accordance with applicable UNC and Environmental Protection Agency (EPA) policies.

6. The contractor shall keep records and inventories of government equipment assigned for its use, supplies, parts, maintenance schedules and records of activity, chamber operating conditions, individual exposures, malfunctions and corrective actions taken, other problems, and overall records of their operations and actions, including written operating plans. All contract related records shall be available to the Agency upon request.

7. The contractor shall provide reports of work as specified in Attachment 2. All reports should be in hard copy format, and electronic versions supplied upon request.

B. DEFINITIONS

1. “Operations” include the daily and other periodic starting, stopping, adjusting, inspecting, lubricating, calibrating and troubleshooting of the mechanical, electrical, utility, safety, and biomedical equipment necessary to conduct human and cell exposure studies at the Human Studies Facility. Operations further include generating and monitoring the desired pollutant concentrations specified in each research protocol for each exposure, whether conducted in the exposure chambers or using other exposure equipment. Overall, all contractor efforts shall be directed to supporting exposures of trained test volunteers to carefully monitored levels of pollutants, under conditions approved by designated Institutional Review Boards (IRBs).

Specific responsibilities and expectations are identified in Task 1.

2. “Maintenance” is work required to perform equipment repairs, and includes “preventive maintenance,” the routine inspection and checking of equipment, followed by the actions necessary to correct defects and prevent breakdowns. Repairs include all work required to put an item of equipment or a system back into service after a breakdown or failure. The objective of these activities is to ensure that exposure studies are carried out safely and reliably, without unscheduled disruptions attributable to equipment problems. Specific responsibilities and expectations are identified in Task 1.

3. “Modifications” are the system changes and upgrades necessary to ensure that the best and most modern equipment available is used in conjunction with exposure studies. New techniques, instrumentation and system components shall be incorporated into existing systems and equipment to ensure that Human Studies Facilities reflect the state of the art, and that new or additional equipment is available to address changes in program priorities. Design, acquisition and installation of new equipment and instrumentation may also be required. Specific responsibilities and expectations are identified in Task 5.

C. TASK 1- SYSTEM OPERATION AND MAINTENANCE

This task provides for the operation and maintenance of the systems supporting the human exposure and in vitro chambers, subject test rooms, the Medical Station, and their support systems. A list of all major items of equipment is provided in Attachment 3, Asset/Equipment Inventory, for each of the major subsystems. The Contractor is responsible for providing all basic tools required to perform the contract. The major systems and subsystems to be operated and maintained are listed below.

1. Exposure Air Supply System. The exposure air supply system is made up of three custom configured air handling units (or “skids”) which bring in outside ambient air, and filter and otherwise clean and dehumidify it for use as supply air to the exposure chambers. The three skids each supply up to 5,500 cubic feet per minute of clean, dry air (temperature 10 C, dew point -10 C) to a common plenum. Each skid consists of a supply fan, cooling and heating coils, a desiccant wheel dehumidification unit, air filters and scrubbers. Dust and High Efficiency Particulate Arrestance (HEPA) filters remove particles down to sub-micron sizes. Scrubber filter systems using carbon chemisorbent and a catalytic oxidizer remove gas phase air contaminants.

A gas fired, six million Btu/hr heat exchange unit supplies heated oil (up to 450 °F) for the catalytic units.

The seven individual air handlers for the exposure chambers take their supply air from the common clean air plenum. Each chamber air handler contains a supply fan, steam grid humidifier, cooling and heating coils, and controls. Exhaust fans for each chamber are located in a penthouse on the roof of the research tower building. The HSF has a dedicated steam to steam generator supplying Reverse Osmosis/DeIonization (RO/DI) steam to the chamber humidifiers, and a two-loop glycol chiller system. Both systems are respectively supplied by steam and chilled glycol from UNC plants. All of the above systems and equipment are operated by a central Andover BAS control system.

2. Pollutant Delivery and Control System. The Pollutant Delivery and Control System regulates the concentration of ozone, carbon monoxide, nitrogen dioxide, sulfur dioxide, volatile organic compounds,(VOCs) and other possible pollutant gases injected into the inlet air stream of the human exposure and in vitro chambers. The system delivers the contents of bottled gases, or gases produced on site to the input clean air supply of each chamber. Once delivered, the system continuously monitors concentrations in the chambers using dedicated glass sampling lines and analyzers. The Pollutant Delivery and Control System operates in conjunction with the Exposure Air Supply System (EASS) described above, and is controlled centrally using the analyzers monitoring the chambers. Automated calibration, data logging and alarm features are also incorporated.

3. Aerosol Concentrator Exposure Systems. The facility has two vacuum operated aerosol concentrator exposure systems. The first concentrates coarse particles of from 2.5 to 10 um- MMAD (micrometers in mass median aerodynamic diameter) and is made up of a high volume, size selective inlet (SSI), a two-stage virtual impactor, a diluter/conditioner, a single person human exposure chamber, and inlet and outlet aerosol monitoring equipment. During operation, ambient air from the roof of the chamber wing of the HSF enters the high volume SSI where particles larger than 10 um-MMAD (PM 10.0) are inertially separated from the air stream. The remaining flow with particles of less than 10.0 um-MMAD enters the two-stage, slit type virtual impactor which inertially concentrates particles larger than 2.5 um. Particle concentrations average approximately 30 times ambient levels. The concentrated aerosol stream is then diluted with clean, conditioned air before entering the human exposure chamber on the floor below, where internal atmospheric pressure ranges from negative .5 to negative 1.5 inches of water.

Instrumentation used in this system includes: total filter samplers, Aerosol Particle Sizers, and DataRam particle counters.

The second concentrator system concentrates fine and ultra fine particles of 2.5 um-MMAD and smaller. It consists of a high volume, size selective inlet, steam generation and control equipment compatible with reagent grade water, a refrigeration unit and condenser, a two stage virtual impactor, and a heated particle reshaping unit. Its principles of operation are the same as the coarse concentrator, with the addition of steam moisture followed by cooling in order to grow ultra fine particles to a size which allows for inertial concentration. Particle concentrations average 20 to 40 times ambient levels and atmospheric pressure in the chamber ranges from negative 20 to negative 25 inches of water during exposures to ultra fine particles.

Instrumentation includes Scanning Mobility Particle Sizers, DataRAMS and Tapered Element Oscillating Microbalance. (TEOMs).

4. Particle Generation Systems. The HSF currently has two pollutant generation systems which supply particles for delivery to individual exposure chambers. The first includes a wood stove and smoke pickup, dilution and delivery system. The second includes a 100 kilowatt, diesel generator, with load bank, and an exhaust stream pickup, dilution and delivery system. Both of these systems may be modified or replaced by other systems at a later date.

5. Laboratory and Medical Compressed Air and Vacuum Systems. Laboratory grade compressed air is supplied to both the human exposure chambers and individual laboratories by a 150 hp. 618 cfm compressor and a 75 hp., 292 cfm compressor. Compressed air is processed using two Zeks drying units in a lead/lag configuration. Air is heatless dried, filtered and scrubbed using Nomonox catalyst. Air for laboratory applications is then routed to regulators for distribution throughout the facility. Air for medical grade applications receives further filtration and processing, as well as dew point and hydrocarbon content monitoring to achieve (National Fire Prevention Act) NFPA 99 standards for breathable air.

Laboratory air for instrumentation calibration is processed using an AADCO pure air generator.

Incoming air is dried, filtered and scrubbed using a heated catalyst. The finished air contains less than .001 ppm ozone, sulfur and nitrogen compounds, and less than .005 ppm methane and other carbon compounds.

Vacuum for operating the aerosol concentrator systems is supplied by a 50 hp Quincy oil flooded, rotary screw pump, which produces 682 scfm at atmospheric pressure, 400 scfm at -15 inches mercury. Laboratory and medical vacuum are supplied by two 25 hp Quincy direct drive, rotary screw pumps in a lead/lag configuration, supplying 365 acfm each.

The contractor is also responsible for operation, maintenance and possible modifications to the distribution lines for the laboratory, medical grade and instrumentation air systems, and for the laboratory and medical vacuum lines.

6. In-Vitro Chamber Systems. There are four sets of In-Vitro chambers, consisting of small exposure chamber pairs housed in constant-temperature incubators. One chamber of each pair functions as a cell culture exposure chamber for the same air pollutants used in the whole body chambers. The other chamber functions as a clean air reference. The chambers measure 12 x 12 x 16 inches high. Each is housed in a temperature controlled box which operates at a slightly negative air pressure with respect to the room. Each chamber has one-pass air flow with the air generally moving from top to bottom at the rate of 20 L/min. Pollutants are produced and delivered to the chambers using a computer controlled system of compressed gas cylinders and gas generators. Analyzers modified to operate in a high temperature and humidity environment measure the pollutant concentrations in the chambers and provide information to the computer program that controls pollutant delivery.

7. Medical Systems. This task includes maintenance of biomedical equipment located in two Subject Test Rooms, the Medical Station (including exam and special procedures rooms), and other specified locations throughout the building, as well as equipment associated with the human exposure chambers. The Contractor shall be responsible for calibration, maintenance, emergency repairs, electrical safety and inventory control of this equipment, but not its operation when used with subject volunteers. Examples of the equipment in use include bronchoscopes, a SpaceLabs centralized electrocardiogram (EKG) monitoring system, and various pulmonary function testing equipment, such as spirometers and plethysmographs.

8. Piped Laboratory Gas Supply and Distribution Systems. These systems supply bottled nitrogen (N), oxygen (O2), and carbon dioxide (CO2) to laboratories throughout the building.

Bottles are stored and connected to distribution line connections in gas bottle rooms located in the rear of the building.

9. Reverse Osmosis/DeIonized (RO/DI) Water System. This system supplies highly scrubbed and filtered water for use in laboratories throughout the building. Beginning with city feed water, incoming water is first processed by two carbon scrubbers to remove chlorine and other sanitation additives, followed by carbon media filtration that removes mineral deposits and chlorine. The water then passes through a ultra violet (UV) light to eliminate organics and biologics. In the next phase, feed pump pressure is increased to 240-255 psig in order to force it through the RO membrane and remove more minerals from the water. Additional mineral removal is accomplished in the DI media tank, which uses electronically charged plates to remove more contaminates. The final product is water quality of 13 mega ohms or greater.

With the exception of #7 above, the Medical System, operation and maintenance conducted under this task shall include all of the following seven activities. The Medical System shall receive only preventive maintenance, calibration, and emergency repairs.

1. Preventive Maintenance. Documented preventive maintenance procedures and schedules shall be followed for each item of equipment listed in Attachment 3. The Contractor shall keep a sufficient supply of spare parts and consumables to ensure that all preventive maintenance can be carried out in a timely manner. The Contractor shall employ flexible schedules since all preventive maintenance shall be performed between human studies experiments. The schedules shall incorporate the use of nights, weekends and Government holidays when required to maximize the use of system down time. The Contractor shall maintain records of the preventive maintenance performed during the contract period of performance. At a minimum, the records must include equipment property numbers, the date maintenance was performed, the work performed and who performed it, and any problems noticed. Schedules and procedures shall be reevaluated from time to time and modified as required to minimize facility downtime and maximize effectiveness and safety.

2. Calibration. Selection of calibration tests shall depend on the device being calibrated. The types of calibration required include the following general categories:

a. Static calibration to determine the response of the system to a series of non-varying test signals resulting in a calibration curve, e. g., output voltage vs. magnitude of input signal.

b. Dynamic calibration to determine device phase and frequency response.

c. System integrity checks to ensure that a device operates properly under actual conditions of use.

The Contractor shall calibrate all transducers associated with the systems in accordance with a maintenance schedule agreed upon by EPA staff.

The Contractor shall maintain suitable records of all calibrations made during the contract period of performance. Calibration schedules shall maximize use of system down time and not affect routine research operations. Where possible, all calibration standards should be traceable to the National Institute of Standards and Technology or derived from accepted values of physical or chemical constants. Calibration of medical equipment shall be performed or supervised by appropriately qualified staff.

3. Emergency Repairs. The Contractor shall provide on-site personnel who shall be capable of repairing a human exposure system, training room, medical station, small scale exposure, or in vitro chamber subsystem failure within two hours of notification. Repair procedures may require that Contractor personnel enter the environmental chamber during an exposure experiment when gaseous, VOC, or aerosol pollutants are present (protocol requirements limit pollutant concentrations to levels found in the ambient environment). The Contractor shall maintain records of emergency or unscheduled repairs made during the contract period of performance. At a minimum, the records shall include the property number, the date the repair was performed, the work performed and who performed it. These records shall be reviewed periodically and used to evaluate and possibly change preventive maintenance frequency or modify maintenance procedures.

4. Daily System Inspection. The Contractor shall inspect critical systems each research day to determine that the systems are functioning within specifications. Special emphasis shall be placed on system components which could compromise the safety of operators or subjects.

Documented evidence of these inspections shall be maintained through the use of Daily Check Sheets which are filed after their completion, and maintained for the contract period of performance.

5. Subject Exposure Log. The Contractor shall maintain and file, for the contract period of performance, a Subject Exposure Log. This log shall be used to record all subject chamber exposures. At a minimum, the log shall include the date, times, subject number, protocol ID, desired pollutant levels, signatures of system operators, and notes of any unusual events during exposures.

6. Inventory Control. The Contractor shall provide an inventory control system for all materials provided to the contractor, as well as those acquired under the contract. Reports of inventory shall be available when requested by the EPA Contracting Officer’s Representative (COR) and others designated by the Contracting Officer or COR.

7. Housekeeping. The Contractor shall be responsible for ensuring the overall cleanliness, organization and appearance of all areas and equipment under his purview. This includes trash removal, sweeping, vacuuming, mopping, wet wiping and scouring of floors, walls, windows, plumbing fixtures, equipment, and work surfaces, as needed. The Contractor shall only perform housekeeping for the exposure chambers and related work areas that are used for the performance of this contract and not being serviced by the current EPA custodial contractor.

D. TASK 2 - COMPUTER OPERATIONS AND DATA MANAGEMENT

The Contractor shall be responsible for operating and maintaining the computer systems associated with the systems listed in item 1 below. Systems are understood to include computer hardware and software, data management, and applications software. This task specifically excludes system upgrades which are covered in Task V.

Computer Hardware Operation and Maintenance, The Contractor shall be responsible for the operation, preventive maintenance, backup and repair of computers and their associated peripheral equipment used in the Exposure Air Supply System, the Pollutant Delivery and Control System, the In Vitro Chamber System, the Aerosol Concentrator Exposure Systems, bio medical equipment, and the associated database machines. All equipment is listed in Attachment

3. Maintenance of network hardware necessary for these systems is also included. Other computers and systems may be added as new exposure systems and equipment are developed.

Operation of these systems shall include calibration, set up for data collection, review of collected data, and PI notification of discrepancies.

2. Data Management. The Contractor shall maintain the Exposure Facility database. The technical description of the database is contained in the Human Studies Database Data Dictionary, document number 68D00207--0093DDDBS, Attachment 4. This includes the following records and databases.

Calibration Data: Calibration constants derived from the latest calibration procedures.

Exposure Data: Pollutant concentration profiles.

Data Validation: Data validation is defined as accepting or rejecting data based on criteria defined by the Agency. The Contractor shall be responsible for the validation of all data collected or generated by the Contractor, including the pollutant delivery and control system, calibration and off-line data generated from sources such as small scale systems or filter weighing. A summary of the data validation process is incorporated into the contract in the Quality Assurance Project Plan (QAPP), which can be found at Attachment 5.

Data Reporting: The contractor shall be responsible for running and developing programs that shall provide data reports to EPA describing the performance of the Pollutant Delivery and Control Systems.

3. Software Maintenance. The Contractor shall be responsible for maintaining system software, application software, and support programs. The Contractor shall also procure and maintain appropriate software licenses for systems maintained under this contract. Software shall be kept current and upgrades should be acquired and installed in a timely manner.

E. TASK 3- QUALITY ASSURANCE

The Contractor shall perform the necessary quality assurance (QA) and quality control (QC) activities to meet the quality assurance objectives for the contract’s Performance Work Statement (PWS), as stated in the Quality Assurance Project Plan, Attachment 5. All QA requirements (pre-award and post-award) are included in the Section E clause entitled “Higher-Level Contract Quality Requirement (Government Specification) (Far 52.246-11) (Feb 1999)”

If modification or additional development of the QAPP is required, the Contractor shall prepare the required revision within 30 calendar days of notification and submit it to the COR for approval. Clarifications of the revised QAPP shall be resubmitted within 30 calendar days of notification of the revisions by the COR. Upon EPA approval of the revised QAPP, it shall be implemented by the Contractor. The Contractor shall modify the QAPP throughout the period of performance of this contract to meet new requirements identified by the Contractor or by EPA and shall submit proposed modifications for COR approval. At a minimum, the Contractor shall review the plan annually and submit written certification of that review to the COR.

The Contractor shall submit Quality Assurance Reports as separate sections of its progress reports. In addition, the Contractor shall accommodate and support as needed, EPA-conducted independent assessments of the Contractor's QA/QC program throughout the contract's period of performance.

F. TASK 4 - SAFETY

The contractor shall operate and maintain all the equipment and systems under its purview in a manner which ensures the safety of subjects and system operators. Major aspects of the required safety program are identified below.

1. Test Subject Safety. The Contractor shall ensure the general safety of test personnel, including test subjects, by compliance with the requirements specified in the facility safety manuals identified in Section 2 of this TASK 4. In addition, the applicable Department of Health and Human Services (DHHS) regulations for conducting Biomedical Research on human subjects apply. As applied to EPA, these regulations are spelled out in EPA Order 1000.17, change A1, Policy and Procedures on Protection of Human Research Subjects in EPA Conducted or Supported Research. This document can be found at http://www.epa.gov/oamrtpnc/forms/index.htm. Specific subject safety in exposure facilities shall be ensured by the following provisions:

• Two-way voice communication,

• Direct visual contact, including closed-circuit television, and

• ECG monitoring.

Provision, operation and maintenance of the equipment needed to accomplish these provisions will be the contractor’s responsibility.

Contractor personnel shall be knowledgeable in the use of emergency treatment equipment, which include an on-site defibrillator, crash cart, respirator, etc. In addition, all on-site Contractor personnel should be trained in CPR techniques.

2. Electrical Safety. The Contractor shall implement procedures found in the Operational Electrical Safety Manual for the Clinical Research Branch, relating to all subject related electrical equipment. Procedures include logging of equipment, testing of electrical receptacles, equipment leakage measurements and ECG safety inspections for all subject areas in the facility. These procedures define a clinically and technically effective electrical safety manual which complies with applicable state codes and the most recent versions of the following documents:

• Health Care Facilities, ANSI/NFPA 99

• National Electrical Code, ANSI/NFPA 70

• Electrical Equipment Maintenance, NFPA No. 70B

The Contractor shall continuously monitor the status of changing electrical safety of medical instrumentation by various manufacturers and new regulations, and shall provide a periodic update of this knowledge to the Agency. Revisions to NFPA 99 shall be provided in updates within 120 calendar days of becoming effective. The Contractor shall also perform necessary retrofit maintenance on all systems to ensure conformance to regulations and protection of human test subjects from electrical shock in accordance with manufacturer changes and current federal regulations.

3. Facility Safety. The Contractor shall be responsible for identifying and correcting all instances of non-compliance with Occupational Safety & Health Administration (OSHA) standards.

4. Safety Officer. The Contractor shall designate a single person within its organization as the Safety Officer. Major responsibilities of the Safety Officer shall include:

• Interface with the EPA Safety Officer

• Preparation of incident reports describing specific safety violations

• Conduct twice annual facility inspections to identify possible safety hazards violation

• Oversight of the Contractor’s on-site safety program

5. Gas Pollutant Supply. The Contractor shall supply all gas cylinders required to operate the Gas Control System. If available, United States Pharmacopeia (USP) grade gases shall be used for exposure to human subjects. A vendor-certified post-fill analysis of the contents shall be obtained for other pollutant gases purchased for use in human exposures. At least 99.5% of cylinder components shall be accounted for in the analysis.

6. Chemical Pollutant Supply. All chemicals used as a pollutant source shall be accompanied by a Material Safety Data Sheet. No chemical that is a known hazard (class A toxin) at the intended level of exposure is to be used in any of the Human Exposure Chambers.

G. TASK 5 - UPGRADING OF SYSTEMS

Using space and facilities on-site at the Human Studies Facility, the Contractor shall maintain shop facilities with a sufficient assortment of machine tools for repair or construction of devices associated with this contract. The Contractor shall also maintain sufficient electronic shop facilities for repair and construction of electronic circuits.

The Contractor shall, upon written approval of the COR, correct all deficiencies in contract related systems. As new techniques, instrumentation, and improved components become available, the Contractor shall upgrade the performance of the systems and assemble new systems to ensure that the most up-to-date and appropriate equipment available shall be used in human exposure studies.

The Contractor shall provide and use a tracking system for requesting modifications and reporting progress, including costs, schedules and milestones.

In response to documented EPA directions, the Contractor shall recommend changes in design of equipment, instruments, or systems to correct deficiencies or improve performance of the exposure chambers, biomedical systems, or other human testing facilities. Upon written approval by the COR, the Contractor shall implement the changes, including acquisition of new equipment.

The following are examples of the types of tasks the Contractor shall be expected to perform, and examples of equipment and instruments that may require redesign, modification, or replacement with new acquisitions during the term of this contract. This list is by no means all inclusive.

1. System Development and Maintenance

a. Replace current hardware that is difficult to maintain and increasingly inclined to failure with maintainable, reliable new equipment.

b. Make use of improved products in computer technology to improve systems performance, increase systems reliability, and reduce operating costs.

c. Integrate "off-the-shelf” hardware/software measurement systems into the human exposure chambers and other systems.

d. Employ common design philosophies when upgrading the biomedical, gas, and aerosol systems to improve compatibility and maintainability.

2. Biomedical System.

a. Integrate new medical test equipment into contractors’ preventive maintenance program.

b. Modernize, and otherwise upgrade test subject data collection systems.

c. Develop systems for conducting exposures to different pollutants.

3. Facilities.

In accordance with the changes clause, the Contractor may be required to design, acquire, and install new equipment or instrumentation not originally present in the Facility. These may include items such as filters, ducts, regulators, controllers and physiological, pollutant monitoring or other devices relating to the safe exposure and measurement of test subjects or biological samples.

H. TASK 6 - SYSTEM DOCUMENTATION AND TECHNICAL REPORTS

The contractor shall maintain the system documents, incorporated by reference in Attachments 3,4,and 5, and all manuals delivered under Contractor control relating to the systems installed in the Human Studies Facility. All documents and drawings are currently considered accurate.

The contractor shall prepare new documentation describing system additions and modifications.

The contractor shall identify and replace outdated documentation and drawings when system modifications are made. As new systems are added, the contractor shall prepare new operation manuals, maintenance manuals, and other documentation necessary to operate and maintain the system.

Upon receipt of technical direction from the COR, the Contractor shall prepare the following documents:

l. Technical reports related to work conducted under this contract.

2. Papers to be published in journals. Such papers shall be prepared according to the directions of the specific journal.

These reports shall be published in EPA's Research Reporting Series and shall be prepared in accordance with EPA-600/9-91-004, "Technical Information Policy and Guide of the Office of Research and Development", l991. These or other papers based in whole or in part on work conducted under EPA contract shall be submitted to EPA for approval prior to submission.

Indications of authorship of such reports and articles shall be mutually agreed upon on assignment, but will be at the discretion of the EPA COR.

I. PROPERTY CONSIDERED ACCESSIBLE TO THE CONTRACT

(a) In accordance with Clause G.5, the contractor shall not fabricate or acquire, on behalf of the Government, either directly or indirectly through a subcontract, any item of property which is not considered a repair part, replacement item, or upgrade to existing property accessible to the contract without written approval from the Contracting Officer. For items that are repair parts, replacement items, or upgrades to existing property accessible to the contract, the contractor shall obtain written approval of the Project Officer prior to fabricating or acquiring items in excess of $250.00.

(b) In accordance with paragraph (a) above, for use in the performance of this contract, the Contracting Officer authorizes the contractor to acquire and/or fabricate repair parts, replacement items, or upgrades to existing property accessible to the Contract, which are listed in Attachment 3, Property Considered accessible to the contract, for items valued less than $250.00 and to acquire and/or fabricate repair parts, replacement items, or upgrades to existing property accessible to the contract for items valued at $250.00 or more upon written approval of the Project Officer. Items listed in this attachment are subject to the provisions of the "Government Property" clause only as it relates to recording, tracking, and reporting, and the contractor shall continually update and maintain the list to reflect the current property accessible to the contract.

See the clause entitled "Government Property" for information regarding the recording, tracking and reporting requirements.

(c) The Government will provide the Contractor for use in connection with and under the terms of the contract, all items of property that are considered accessible to the Contract. These items are deemed to be accessible to the contract and typically, the Government is responsible for costs associated with their maintenance, upgrade, and replacement. This property includes but is not limited to the following:

The special purpose exposure chamber, seven (7) human exposure chambers, and their associated support systems, three (3) non-exposure test rooms, four (4) in-vitro exposure chamber pairs and their support systems, a climate controlled weigh room and a Medical Station (with two special procedures rooms) with associated biomedical equipment. The support systems include a high capacity clean air supply system, associated computers, pumps, filters, fans, heated and chilled glycol-water supply equipment, a large capacity heat exchange system for generating 450 F oil, electrical distribution equipment and wiring, pollutant generation and control equipment and associated computers, seven computer controlled individual air handling units providing custom conditions to the human exposure chambers, and medical gas and vacuum generation and delivery systems.

Major subsystems for the laboratories are considered property accessible to the contract and include the air handling and conditioning systems, gas generation and control systems, aerosol generation and control systems, volatile organic generation and control systems, and physiological and environmental data acquisition systems. See Attachment 3 for details.

(d) Additionally, the Government will provide the Contractor access to the facilities that support and house these items of property and permit the contractor to use the facilities for activities associated with the performance of work under this contract. The contractor shall vacate the facilities and return the space back to the Government when performance on the contract ceases.

(e) The Contractor shall provide maintenance parts and services (agreements) for the property accessible to the contract. Before implementation of any service agreement, the Contractor shall obtain Project Officer approval. Maintenance parts and service agreements to be acquired by the

Contractor as described above shall appear as separate Other Direct Cost (ODC) line items on the invoices and shall be charged under Line Items 000_B for the appropriate period

L.16 LOCAL CLAUSE - PROPOSAL INSTRUCTIONS (EPA-L-36-101) (FEB 2014)

In addition to the requirements of FAR 52.215-1 Instructions to Offerors-Competitive Acquisition, offerors shall adhere to the following proposal preparation instructions for this solicitation.

As stated in FAR 52.215-1, the Government intends to evaluate proposals and award a contract without discussions with offerors. Therefore, the offeror’s initial proposal should contain the offeror’s best terms from a cost or price and technical standpoint.

Proposals shall be submitted electronically via FedConnect. See Clause L.14 above for additional information concerning electronic submission of proposals.

The offeror’s proposal shall be valid for no less than 180 calendar days.

(a) Proposal Instructions

(1) The offeror's response is to be submitted in two volumes. The technical proposal is to be separate from the cost proposal.

(2) Offeror’s shall include a cover letter with their proposal. The cover letter shall include, but is not limited to, the following:

(i) The solicitation number;

(ii) The name, address, telephone numbers, facsimile numbers, and electronic addresses of the Offeror;

(iii) Names, titles, telephone numbers, facsimile numbers, and electronic addresses of persons authorized to negotiate with the Government on the Offeror’s behalf in connection with this Solicitation;

(iv) Name, title, and signature of person authorized to sign the proposal. Proposals signed by an agent shall be accompanied by evidence of that agent’s authority;

(v) Name, title, and signature of principals of the firm.

(vi) The name, address, telephone number, facsimile number, and electronic address of the individual in the Offeror’s organization to be contacted, if necessary, during evaluation of the proposal;

(vii) The complete formal name and address of the Offeror’s organization and/or other participants to be used in any resulting contract. Provide Dun and Bradstreet LTD DUNS number for each organization and new entity if one is being created;

(viii) The name, address, telephone numbers, facsimile numbers, and electronic addresses of representatives of the Government agency having administrative cognizance over the Offeror, contractor team arrangement (as defined at FAR 9.601), or parent company, as applicable (such as contract administration within the meaning of FAR 42.3, Audit, and Equal Employment Opportunity); and

(ix) A statement that the Offeror grants to the EPA or its authorized representatives, the right to examine, for purposes of verifying the information submitted, those books, records, documents, and other supporting data that will permit adequate evaluation; and this right may be exercised in connection with any such reviews deemed necessary by the Government.

(3) Notwithstanding any other provision or clause in this solicitation to the contrary, proposals shall be submitted via the FedConnect web portal (www.fedconnect.net). In order to submit proposals, offerors must register in FedConnect at www.fedconnect.net, see main page of FedConnect website for registration instructions. For assistance in registering or for other FedConnect technical questions please call the FedConnect Help Desk at (800) 899-6665 or email at support@fedconnect.net.

(b) Volume-Specific Instructions mailto:support@fedconnect.net

(1) Technical proposal instructions -

(i) The technical proposal shall include the offeror's responses to the criteria/factors listed in Section M of this solicitation. The technical proposal shall be organized in the same order as the evaluation criteria presented in Section M, clause M.3 entitled “Evaluation Factors for Award” of the solicitation and shall comprehensively address each technical evaluation criterion.

(ii) Each section of the proposal shall be titled:

A. Understanding and Technical Approach B. Quality Assurance C. Staffing Plan D. Corporate Experience E. Safety Plan F. Past Performance G. Transition Plan

A. Understanding the Technical Approach. 20 Points

The offeror’s proposal shall demonstrate a full and complete understanding of the technical requirements by providing a detailed technical approach to the tasks and activities described in the Performance Work Statement (Attachment 1). The offeror’s approach must be technically sound, logistically appropriate, and efficient. Specifically, the proposal must reflect a demonstrated:

• Understanding of systems maintenance, upgrade and operations issues;

• Understanding of issues associated with exposure of human subjects under research conditions, and;

• Understanding of air pollution chemistry, sampling and monitoring as applicable to human exposures.

B. Quality Assurance. 10 Points

The offeror shall demonstrate a comprehensive quality assurance (QA) program which addresses the Performance Work Statement. The offeror shall describe their QA system, paying particular attention to the following areas:

• Management of subcontracts including the qualification processes for vendors and subcontractors, especially with regard to clinically recognized certifications of outside testing laboratories and service providers;

• Collection, validation, and confidence of biomedical and subject environmental exposure data;

• Records management and retention; and

• Other areas deemed important by the offeror.

C. Staffing Plan. 25 Points

Offerors shall demonstrate their plans for staffing and managing this effort including the qualifications, abilities, and availability of the proposed staff and the offeror's managerial approach for establishing and maintaining systems to perform, monitor, and control work under the proposed contract. The staffing plan shall identify, by labor category, the occupational title of the individuals proposed and the number of work hours per year proposed for each occupational title.

For each key personnel proposed, the offeror shall include a résumé. This criterion includes any proposed subcontractors or consultants. The key personnel positions are listed in the Section H clause entitled “Key Personnel”. Proposals shall include the qualifications including technical experience, academic and technical education, and specific training of key personnel. Proposals shall indicate whether key personnel are presently employed by the company and what proportion of their time would be available for this contract, as well as the nature and extent of their commitment to other efforts. The flexibility of proposed personnel to work in and across other disciplines shall be addressed as well.

Key Personnel Qualifications:

Personnel and qualifications listed below are provided for information purposed only and are not intended to limit the contractor’s ingenuity in meeting the function requirements found in the Performance Work Statement. For example, it is possible that a single person could fill two or more of the positions listed or that a position may require more than one person to meet contractual requirements. This list is not intended to be all inclusive.

Program Manager: The program manager provides overall management and direction to accomplish the requirements stated in the Performance Work Statement in a timely manner. A program manager may have a bachelor’s degree or equivalent, and both a managerial and a scientific/technical background. He or she may have direct technical experience and/or managerial experience in the following fields; health effects research, physiology, ambient air monitoring, process control, data base management and facility engineering.

Environmental Scientist: The environmental scientist may have a master’s degree or equivalent, be familiar with air pollution monitoring techniques, atmospheric chemistry, aerosol physics, and instrumentation to supervise operation of the gas and aerosol control system. It is thought that a senior level person would be required with at least five years’ experience in the air monitoring field. It would be beneficial if the environmental scientist also had experience with computerized real-time data acquisition techniques, digital logic circuitry, and closed loop control techniques.

Facility Engineer: The facility engineer may have a bachelor’s degree in engineering or at least five years experience directly related to the operations and maintenance of a complex facility. This person should have an excellent knowledge of mechanical systems, HVAC systems, pneumatic control systems and electrical distribution systems. This person should have the capability of quickly identifying problems and effecting repairs such that protocols in progress will be minimally affected. This person should be capable of performing major modifications if systems are found to be deficient.

Biomedical Manager: The biomedical manager assigned to this program should have ‘hands-on” experience in the maintenance, operation and calibration of physiological instrumentation. This person may have a bachelor’s degree or equivalent in biomedical engineering. This person should have demonstrated experience in designing and implementing a comprehensive maintenance and calibration plan (including electrical safety inspection) for a system of physiological instruments. The biomedical manager should have experience with real-time data acquisition from physiological instruments. This person should have the ability to write comprehensive and understandable reports. This person should be a Certified Clinical Engineer.

D. Corporate Experience. 10 Points

The offeror shall demonstrate the corporate experience in similar size and scope as outlined in the RFP.

The offeror shall describe the depth of corporate structure to provide expertise as programmatic needs change as well as the overall project management organization plan.

E. Safety Plan. 15 Points

The offeror shall demonstrate their understanding of the importance of safety throughout all areas of work as specifically defined in this RFP. The offeror must also describe the general and specific approaches that will be taken to assure that the health, safety and welfare of research subjects will be protected.

F. Past Performance. 10 Points

The offeror's past performance will be evaluated on the demonstrated quality of the offeror’s performance of contracts and subcontracts performed during the past three (3) years, which are similar size, scope, and complexity to this requirement. The following items will be considered when evaluating the offeror's past performance: Quality of Product or Service; Cost Control; Timeliness of Performance; Business Relations;

and Customer Satisfaction. The offeror's past performance shall be evaluated based on the information obtained through the Past Performance Questionnaire, and the Government may also consider information obtained from other sources.

Offerors with no past performance history, whose past performance is not relevant, or for whom past performance data is not available, will be given, a neutral rating of adequate (score = 3).

G. Transition Plan. 10 Points

The offeror shall demonstrate a transition plan to be implemented following contract award shall include a time line for staffing and establishing an infrastructure to support this effort. The transition plan should include the specifics of how the plan will be implemented to minimize the down time.

RESPONSIBILITY MATTERS

APPENDIX A – Quality Management Plan (QMP)

In this appendix to the technical proposal the offeror shall include the pre-award documentation required by the Section E Clause entitled “FAR 52.246-11 Higher-Level Contract Quality Requirement (Government Specification)”. Also see the section L provision EPA-L-46-101 INSTRUCTIONS FOR THE PREPARATION OF A QUALITY MANAGEMENT PLAN for additional QMP submission instructions. The offeror’s QMP will be incorporated into any resulting contract.

(2) Cost or pricing proposal instructions- The electronic copy shall be in commercial spreadsheet program format and shall include formulas and factors used in calculating the financial data.

The Price Proposal shall be written to include the following sections:

COVER PAGE / TABLE OF CONTENTS

In this section the offeror shall include a cover page with: the information listed in paragraph (2), Section L, of this provision.

SECTION I - SF 33 AND INCORPORATION OF SOLICITATION AMENDMENTS

In this section the offeror shall include a signed copy of the SF 33 for this…