A07-Attach_1_PWS_18Q0181.docx

PERFORMANCE WORK STATEMENT (PWS)

Title: Air Emission Sample Analysis Contract

Requiring Activity Name: U.S. Army Public Health Center (APHC)

1. INTRODUCTION

The U.S. Army Public Health Center (APHC) is part of the U.S. Army Medical Command (MEDCOM) and focuses on epidemiology, laboratory sciences, occupational health sciences, public health information and toxicology to enhance Army readiness and assure the quality and effectiveness of Army’s Public Health Enterprise.

2. PURPOSE AND BACKGROUND

As part of the APHC mission, the Lab Sciences Directorate requires the analysis of Air Emissions samples in support of the Army operating environments and military bases to ensure the safety and security of all who work there. The LS does not currently have the analytical capability to perform air emission analyses required including analyses from various worldwide locations and from natural or man-made disaster locations.

3. SCOPE

The contractor shall perform analytical services for the analysis of source emission testing samples for dioxins/furans, metals, semivolatile organics (SVOC), and halides/halogens

The data obtained under this contract shall be used by the Department of the Army to comply with Federal and State laws and regulations such as the Clean Air Act.

4. PERIOD OF PERFORMANCE

This contract is for one (1) twelve (12) months Base Period and four (4) twelve (12) month option periods.

The periods of performance for this contract are as follows:

5. WORK SCHEDULE AND LOCATION

The work location is at the Contractor’s or Sub-Contractor’s laboratory facility.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

To provide Air Emissions sample analysis for the parameters identified in the PWS.

6.2. Specific Tasks / Requirements

6.2.1. Objective 1 – The Contractor shall perform analysis on Air Emissions samples provided by the Government. The contractor shall follow Chain-Of-Custody (COC) procedures as defined in the contractor’s COC Standard Operating Procedure

6.2.1.1. Key Task 1 – Receipt and Storage of Samples prior to analysis. Each container contains specific parameters for which the sample must be analyzed. The contractor is responsible for storing and handling the samples in accordance with the analytical method specifications.

Samples will be provided to the Contractor either through a contractor provided courier, shipment from APHC, shipment directly from the field, meeting of APHC field personnel with contractor courier or APHC field staff drop-off at the Contractor location.

6.2.1.1.1 Sample Pickup Protocol from the APHC lab. If applicable, the contractor’s courier shall be responsible for pickup (from APHC), packaging and delivery of samples. Samples shall be picked up by the contractor’s courier within 24 hours of notification by the COR or a designated representative. The contractor-provided courier is responsible for packaging and transporting the samples under conditions dictated in the applicable methodology. At the time of sample pickup by the contractor (if applicable), the samples and required tests will be identified by the APHC COR on an Outsource Document. This document shall be signed and dated by the APHC COR or designee to document the date and time of sample transfer to the contract lab. The contractor courier shall date and sign the Outsource Document to document the transfer of possession of the sample(s). A contractor representative/project manager shall document the transfer of possession from the courier to the contract lab facility including sample receipt temperature. The contractor shall immediately report in writing to the COR all samples lost or broken in transit.

6.2.1.1.2 Sample Shipment Protocol from the APHC lab. If applicable, APHC shall pay the shipping costs for transportation of the samples. Contractor and APHC shall store and/or ship samples in accordance with the preservation guidelines as noted in the analytical method until samples are analyzed, and thereafter until results are approved by the COR. The contractor shall immediately report all samples lost or broken in shipment, with as much detail as possible, to the COR. In addition, the sample receipt temperature must be reported to the COR if applicable, within 24 hours of sample receipt.

6.2.1.1.3 Direct shipment of samples from the field to the contractor. If holding times are of concern, there may be a necessity to ship the samples to the contract lab directly from the field following collection. The APHC sample submitter will ship the samples and a corresponding field Chain-of-Custody (COC) document to the contract lab.

When the contract lab receives the samples and corresponding field COC forms, the contractor’s project manager shall sign the COC forms documenting receipt of samples and immediately (within the same business day of receipt) forward the field COC to the COR for review, accountability and LIMS login at the APHC. The contractor’s project manager will also report to the COR the condition of the samples upon receipt (to include receipt temperature) in the contractor lab. The APHC COR shall use project planning information and the information on the COC form to generate an Outsource Document containing all applicable information (i.e. APHC lab ID, APHC field ID, analyses requested, matrix, points-of-contact, etc.). The generated Outsource Document will be forwarded electronically to the contract laboratory. The contractor shall then begin sample analysis. The contract laboratory project manager shall assure that the contract laboratory analyzes the sample within holding times specified in applicable methodology. If paperwork from the COR is pending, the contract lab should obtain guidance from the COR to proceed with analysis to meet holding times.

6.2.1.1.4 Contractor-provided Courier meets a sampling POC at a Pre-Determined location –In the event that it is deemed necessary to determine a mutual meeting location to transfer the samples between the field sampling personnel and the laboratory to minimize cost or travel requirements and to meet project requirements, this shall be coordinated by the COR. These situations will be coordinated on a project by project basis. The Contractor-provided courier would be responsible for properly transporting the samples from the pick-up location to the laboratory under applicable laws and sample storage criteria as dictated by the analytical method. This coordination will occur between the COR and the contract laboratory.

6.2.1.1.5 APHC field crews Drop off samples at Contract Laboratory – The Contractor may also receive samples dropped off by the Government directly at the laboratory facility. This will be communicated to and coordinated with the contract laboratory on a project to project basis.

6.2.1.2 Key Task 2 – Perform Sample Analysis & Media Preparation (Deliverable 4) within the stated Turnaround Time (TAT). The samples will designate as either “STANDARD” or “HIGH PRIORITY”. Turnaround times are calculated from the date of contractor receipt of samples to the date of receipt of technically acceptable analysis results acceptance by the Government.

For each sample designation, the contractor shall provide the following per priority type as follows:

STANDARD:

MEDIA – 14 Calendar days from date of request RESULTS – 21 Calendar days from the date of sample receipt FINAL Level IV REPORT and EDD – 23 Calendar days from date of sample receipt

HIGH:

MEDIA – To Be Negotiated - Calendar days from date of request RESULTS – 10 Calendar days from the date of sample receipt FINAL Level IV REPORT and EDD – 12 Calendar days from date of sample receipt

Turnaround time is defined as the intervening time period between the date of sample receipt (considered day zero) in the contractor’s laboratory to the date of receipt of a complete and technically acceptable data package (Final PDF copy + Electronic Data Deliverable (EDD)) by the APHC laboratory. Technical acceptability will be determined by a thorough review by qualified APHC technical Subject Matter Experts (SMEs) and communicated to the COR for any required actions with the Contractor.. Holidays and weekends are considered ‘calendar’ days.

6.2.1.3 Key Task 3 – Provide Quality sample Analysis on Air Emission Samples for various parameters as identified in this PWS in accordance with the documented methodology.

6.2.1.3.1 Use industry standard, state-of-the-art instrumentation, technologies and methodologies to analyze samples for any of the parameters listed in the Chemical Parameters, Methodologies and Quantitation Limits document (Attachment 3). Any special analyses or additional testing requirements will be stated on the sample. It is anticipated that the contractor will receive between 350 and 750 fractions per year. Natural disasters or military mobilization may alter these estimates.

When the contract laboratory is performing sample analyses using the methodologies specified in Attachment 3 the contract laboratory shall follow quality control guidelines specified in that particular method and applicable accreditation requirements.

6.2.1.3.2 Analyze quality control data and, where the results are found to be outside pre-defined criteria, planned actions shall be taken to correct the problem and to prevent incorrect results from being reported. If additional quality assurance/quality control protocol is designated in the methodologies, these guidelines shall also be strictly followed.

6.2.1.3.3 Analyze samples within the maximum holding times specified in the method, even if these times are less than the allotted TAT for reporting as defined in the PWS section 6.2.1.2.

The Contractor is required to ensure the method defined holding times are met whenever possible. If the Contractor does not process the sample within the specified holding time per method, the sample will be considered “lost”, unable to be analyzed and required to be recollection by the APHC project officer. The contractor shall not bill the government for tests performed on samples beyond their holding times and be assessed liquidated damages in accordance with the “Liquidated Damages” clause incorporated into this contract. If the Contractor receives the samples on the final day of the hold time, the COR shall waive the penalty if the contract lab makes reasonable attempts to meet the hold times. Extenuating circumstances can be negotiated on a case by case basis with the COR. (Examples – Weekends/Holidays, late arrivals, unannounced arrivals.)

6.2.1.3.4 Provide the required analytical expertise and instrumentation to obtain reporting/quantitation limits equal to or lower than 95% of those specified in Attachment 3 not to exceed a factor of 5 above the requested reporting/quantitation limits for any individual compound.

6.2.1.4 Key Task 4—Disposal of unused sample volumes and return of Government shipping containers.

Unless otherwise instructed by the COR, the Contractor shall be required to dispose of unused sample volume and used sample bottles/containers no earlier than 60 calendar days following submission of analytical data. Sample disposal and disposal of unused sample bottles/containers is the responsibility of the Contractor and should be done in accordance with all applicable laws and regulations governing disposal of such material.

All Government shipping containers, unless otherwise specified, shall be returned to the COR within three business days of receipt.

6.2.1.5 Key Task 5 – Sampling Media Request for Support

The APHC may request the contractor to supply sampling media (XAD). The media/cartridges and filters shall be cleaned by the contract lab upon request. The Contractor shall check the media for cleanliness if requested (according to the analytical reference methods or other procedures agreed to with PHC), with the proof data provided to APHC before sampling. This will be requested on a case by case basis as required by the government. The Contractor shall pack the cartridges with the media, spiked as appropriate, and shipped for sampling. The Contractor shall also provide filters for metals sampling upon request.

6.2.1.6 Key Task 6 – Liquidated Damages assessment for late or deficient reporting.

The Contractor shall submit Final and Preliminary reports as well as electronic data as discussed in Attachment 5. If the contractor does not submit data packages on time and/or submits incomplete/technically deficient data packages, the contractor may be required to pay liquidated damages to the Government as follows:

- 5% per day late to a maximum of 100%

Extensions for matrix issues and sample analysis anomalies may be negotiated with the COR on a case by case basis. However, these issues must be made known to the COR when they occur and when the lab believes a delay is possible, not after the data package is overdue.

6.3 Laboratory Qualifications and Capabilities

Laboratory Instrumentation/Technology Requirements. The contractor must have the following instrumentation/technologies to ensure the contractors ability to process sample analyses within a timely manner based on the anticipated volume:

6.3.1 Instrumentation/Technology (minimum requirements to perform the required testing methods)

6.3.1.1 Ion Chromatography (IC)

6.3.1.2 Inductively Coupled Plasma-Optical Emission Spectrometry (ICP)

6.3.1.3 Flow Injection Mercury System (FIMS) or other mercury analysis instrumentation capable of performing cold vapor atomic absorption (CVAA)

6.3.1.4 Low Resolution GC/MS

6.3.1.5 High Resolution GC/MS (dioxins/furans)

6.3.1.6 Other glassware/instruments for cleanup/extraction/digestion

6.3.2 Laboratory Facilities (minimum requirements):

6.3.2.1 Minimum of 5000 sq. ft. of laboratory space

6.3.2.2 Adequate electrical service

6.3.2.3 Reagent water to meet ASTM Type II classification

6.3.2.4 Class A volumetric glassware for all analyses

6.3.2.5 Adequate fume hood system to provide safe handling of hazardous materials

6.3.3 Laboratory Certifications and Qualifications for Air Emissions Sample Analyses

The Contractor shall be accredited through the National Environmental Laboratory Accreditation Program (NELAP), and/or by another (ISO 17025) accrediting body (that must be an ILAC signatory). All method-matrix-analyte combinations covered under this contract must be on the laboratory’s accreditation scope. Contractor must be certified/approved to perform testing of stack emissions samples by the state of Utah. The COR must be notified, in writing, within 30 days of any loss of certification for any methods covered under this PWS. If accreditation is lost after contract bid is placed and prior to contract award, the KO must be notified within 48 hours. Loss of accreditation may result in a technically unacceptable evaluation of a potential contract laboratory.

6.3.4 Loss of Accreditations during Contract Performance

The contractor is required to notify the COR within 48 hours of losing any of the required laboratory certifications (to include loss of accreditation in individual methods or analytes). The contractor shall cease performance of any sample analysis until accreditation is restored. If accreditation is not restored within 30 days from notification, the contract may be terminated for default.

6.3.5 Standing Operating Procedures (SOPs): At a minimum, the contract laboratory shall have in place the following Standing Operating Procedures (SOPs):

6.3.5.1 Sample receipt, handling, storage and control.

6.3.5.2 Security, chain of custody and document control.

6.3.5.3 Hazardous waste/sample disposal.

6.3.5.4 Sample analysis (to include types of analyses required, sample preparation, modifications to established methods, peculiarities of instrumentation, etc.)

6.3.5.5 Calibration of standards, traceability (show traceability of standards to National Measurement Systems (e.g. National Institute of Standards and Technology)

6.3.5.6 Ongoing or routine laboratory operations (including maintenance of instrumentation, procurement of supplies, scheduling of calibration for balances, thermometers, etc.)

6.3.5.7 Laboratory Safety and Chemical Hygiene (should address wearing of coats, gloves, goggles, handling of hazardous materials, eye lavaging, storage of hazardous materials, safety showers, fire safety, etc.).

6.3.5.8 Lab QA/QC (to include procedures for conducting in house audits; procedures for allowing technicians and chemists to have an independent means of checking the quality of their results; procedures for the development and implementation of contingency plans; and procedures for the initiation of corrective action.

6.3.5.9 Data production, reduction, transcription, verification, review, distribution and in house storage

6.3.5.10 Determination of Reporting Limits. (Contractor must document the criteria under which the reporting limits are established/re-established for each analytical process. Must also include acceptance criteria for such reporting limit evaluation)

6.3.6 Analytical Training Records (Deliverable 6)

All Contractor personnel performing sample handling/processing/analysis in support of this Government contract shall have records demonstrating proficiency in performing methodologies detailed in Attachment 3.

6.4 Contractor Manpower Reporting

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the US Army Institute of Surgical Research via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: https://www.ecmra.mil/Default.aspx. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2017. Contractors may direct questions to the help desk at help desk at DoD.MRA.Support.Desk@mail.mil.

6.5 On-Site Laboratory Inspections. The Government reserves the right to conduct on-site inspections of the contractor’s and subcontractor’s laboratories to ensure that appropriate processes and quality assurance procedures are being followed in order to ensure that samples are being analyzed in accordance with the standards listed in PWS section 3.0, the requirements found in the published methods, as well as the requirements in the applicable Accreditations and corresponding checklist(s).

6.6 Subcontracting.

6.6.1 The Contractor shall be responsible for any subcontract management necessary to integrate work performed on this contract and shall be responsible and accountable for subcontractor performance. The prime Contractor will manage work distribution to ensure there are no OCI considerations. A notification must be sent to the KO and COR within 30 days of the agreement between the prime and the subcontractor.

6.6.2 Due to the need to maintain the integrity of the sampling and the laboratory certifications, the contractor may subcontract with no more than one other laboratory. The subcontractor laboratory and personnel shall hold the same qualifications and certifications as required by the prime. The prime contractor shall not subcontract more than half of the methods listed in Attachment 3.

6.6.3 Subcontracting of the analytical portion of this contract is NOT permitted for the following tests:

Dioxins/Furans - EPA RM 23 or 0023A/8290 Metals - EPA RM 29/6020A HCl/Chorine - EPA RM26A Semi-volatiles - EPA 0010/3542/8270 C or D

6.6.4 All other analytical tests as listed in Attachment 3 may be sub-contracted to no more than one (1) other contract lab facility. All requirements in this PWS must also be followed by the subcontract laboratory as well. The location of the lab performing the analysis must be clearly identified in the submission package by the contract lab. All applicable documents from that subcontracting facility must also be submitted for evaluation.

6.6.5 The Government reserves the right to conduct on-site inspections of the contractor’s and subcontractor’s laboratory to ensure that appropriate processes and quality assurance procedures are being followed in order to ensure that samples are being analyzed in accordance with the standards listed in PWS section 3.0, the requirements found in the published method, as well as the requirements in the NELAP and/or by another (ISO 17025) accrediting body Accreditation and corresponding checklist(s). The lab(s) used for subcontracting must first be audited to the same standards as the prime and approved by APHC prior to submitting samples. No exceptions to this requirement will be accepted.

6.6.6 Sending samples to any location for analysis other than the physical location that is placing the bid is considered sub-contracting even if it is within the same corporation.

6.6.7 The Subcontractor shall adhere to the same quality requirements as the oversight contractor, to include all applicable sections of the PWS. It should be noted that every time the term “contractor” is used throughout this performance work statement, the term “sub-contractor” is also applicable.

6.7. Management Reports and Plans

6.7.1 Monthly Financial Tracking Report (Deliverable 1). The contractor shall provide a spreadsheet with detail of real time expenditure levels of every contract line item number (CLIN). The initial report is due 30 days after contract award and by the first of each month thereafter.

6.7.2 Quality Control Plan (Deliverable 2). The contractor shall provide a draft Quality Control Plan (QCP) no later than 30 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction.

6.7.3 Contract Manpower Reporting Application (CMRA) (Deliverable 3). This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help desk at:

http://www.ecmra.mil/.

The contractor shall register under the "All Other Defense Components" module. The APHC Unit Identification Code (UIC) is W23MWP.

7. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to the performance objectives (Attachment 2). The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

8. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

DELIVERABLES TABLE

By October 31 or on the last day of contract performance – whichever is first.

7.1. Reports and Documents

Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable FAR clause 52.227-14, Rights in Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

7.2. Contractor Performance Assessment Reporting System (CPARS). The Contractor CPARS is the DoD mandatory system to electronically capture assessment data and manage the evaluation process. CPARS is used to assesses a Contractor’s performance and provide a record, both positive and negative, on a given contract during a specific period of time. The CPARS process is designed with a series of checks and balances to facilitate the objective and consistent evaluation of Contractor performance. Both Government and Contractor program management perspectives are captured on the CPAR form and together make a complete CPAR. Once the Assessing Official completes the proposed assessment for the period of performance, the CPARS is released to the appropriate Government Contractor Representative for their review and comments. User ID and password will be provided to the designated Government Contractor Representative upon issuance of a task order. The Contractor has 30 days after the Government's evaluation is completed to comment on the evaluation. The Government Contractor Representative must either concur or non-concur to each CPAR. If the Contractor concurs with the proposed assessment and the Reviewing Official does not wish to see the CPAR, the Assessing Official may close out the CPAR. Otherwise, they must forward the CPAR to the Reviewing Official for them to review, enter comments if appropriate, and close out. The Reviewing Official may at their option direct the Assessing Official to forward every CPAR to them for review.

7.3 Inspection and Acceptance

The COR delegated oversight of specific technical, functional and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.

7.4 Contracting Officer’s Representative (COR): TBD following contract award

8. KEY PERSONNEL

Positions considered to be Key Personnel are listed in the table below. Substitutions of proposed Key Personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement Key Personnel shall have the necessary experience and knowledge required to perform the duties defined herein. For temporary and/or permanent replacement of Key Personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of Key Personnel. Contractor personnel must submit necessary information to be issued a clearance prior to reporting for performance. Substitution or replacement personnel shall be replaced with 30 days.

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

KEY PERSONNEL TABLE

b) TM must be an employee of the laboratory

c) TM must be present onsite at least 20 hours per week or 50% of the laboratory operating hours (whichever is less) to address technical issues for the lab staff and customers.

d) TM must ensure that adequate supervision is provided for all lab technical personnel.

e) Regulations outlining requirements: ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories.

b) The Quality Manager must be an employee of the laboratory

c) Regulations outlining requirements: ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories.

b) PM must be an employee of the laboratory

c) PM must be proactive and able to meet short suspense dates and stringent QA/QC requirements.

Although not listed as Key Personnel, laboratory personnel shall meet the qualification requirements as defined in ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories, 2005.

9. GOVERNMENT FURNISHED PROPERTY-There is no Government Furnished Property with this requirement.

10. Contract Management

10.1. Government Management

The COR for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. Only the KO has the authority to enact changes to this award.

10.2. Contractor Management

The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.

10.3. Contractor Organization

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement.

10.4. Subcontract management

10.4.1. The contractor is responsible for any subcontract management necessary to integrate services performed on this contract.

10.4.2. The contractor is responsible and accountable for subcontractor performance on this contract

10.4.3. The contractor is responsible to manage task distribution to ensure there are no OCI considerations

10.4.4. Contractor my add subcontractors to their team after notification and written approval from the KO.

10.4.5. Privy of contract is with the contractor and the subcontractor.

11. COMPLIANCE DOCUMENTS

11.1. General Compliance

11.1.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Command (MEDCOM) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46. The International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/rodorphrpo.asp.

12. OTHER TERMS, CONDITIONS, AND PROVISIONS

12.1. Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contractor Officer (KO) immediately.

12.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

12.3. Inherently Governmental Functions

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

12.4. Acquisition Functions Closely Associated with Inherently Governmental Functions

There are no functions closely associated with inherently Governmental in this requirement.

12.5. Organizational Conflict of Interest

The APHC has categorized all service procurements into one of the following three categories as defined below, for the purpose of identifying, avoiding, or mitigating Organizational Conflicts of Interest (OCI) in accordance with (IAW) Federal Acquisition Regulation (FAR) Subpart 9.5. These categories are defined as follows:

Category 1: Command Wide Internal Support: Services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating. Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts with subordinate directorates/Commands.

Category 2: Program Management Support: Services which assist APHC in planning and managing an organization’s activities and programs. These include, for example: requirements analysis, acquisition support, budget planning and management, business process reengineering, program planning and execution support, and independent technical management support. Services would be characterized as having access to only Directorate or Subordinate Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/ Subordinate Commands.

Category 3: Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs. These include, for example: concept exploration and development, system design, system development and integration, COTS procurement and integration, internal development testing, deployment, installation, operations, and maintenance. Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

OCI Certification. APHC OCI Category 3 is applicable for this acquisition. The Contractor shall perform a thorough comparative analysis of the potential new work against all current and previous works performed in support of the APHC organization and ascertain whether they have a possible conflict of interest. If there is a conflict of interest or the appearance of a conflict of interest, the Contractor shall provide a comprehensive OCI Mitigation Plan. The Contractor shall complete the OCI Certification at time of proposal submission.

12.6. Invoices

The contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice.

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

13. Acronyms

14. ATTACHMENTS

Attachment 2 – Quality Assurance Surveillance Plan Attachment 3 – Chemical Parameters, Methodologies and Quantitation Limits Attachment 4 – General Quality Control Requirements Attachment 5 – Reporting Requirements and Deliverables Attachment 6 - Organizationall Conflict of Interest