B01 Draft PWS - Performance Work Statement Sysmex.docx

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Notice of Intent to Sole Source for Hematology Analyzer Maintenance Services
Solicitation number
PANMRA-24-P-0000_004305
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About this file

This document is a Performance Work Statement (PWS) for maintenance services on a Sysmex XN1000V Hematology Analyzer for the Defense Centers for Public Health - Aberdeen (DCPH-A). The key requirements include performing preventive maintenance, unlimited emergency repair visits, providing replacement parts, updating software and equipment, integrating new equipment, and providing 24/7 telephone technical support. The government intends to use a Quality Assurance Surveillance Plan to monitor the contractor's performance. The contract has a base period with two option periods. The contractor must be factory-trained and have a minimum of two years' experience on the equipment. The PWS also details compliance requirements, information assurance, and contractor identification.

The related federal contract opportunity is a notice of intent to award a sole source contract to Sysmex America, Inc. for maintenance services on the Sysmex XN1000V Hematology Analyzer used by DCPH-A. The contract is necessary to ensure the analyzer remains operational and calibrated. The North American Industry Classification System code is 811210 - Electronic and Precision Equipment Repair and Maintenance. The government will consider capability statements from interested parties, but this is not a request for competitive proposals. The anticipated contract award date is 12 July 2024.

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PERFORMANCE WORK STATEMENT (PWS)

Title: Sysmex XN1000V Hematology Analyzer Maintenance

Requiring Activity Name: Defense Centers for Public Health – Aberdeen (DCPH-A)

1. INTRODUCTION

The Defense Centers for Public Health – Aberdeen (DCPH-A) is part of the Defense Health Agency (DHA) and focuses on epidemiology, laboratory sciences, occupational health sciences, public health information and toxicology to enhance readiness and assure the quality and effectiveness of the Public Health Enterprise.

2. PURPOSE AND BACKGROUND

The mission of the DCPH-A is to “support our Nation by improving health and building readiness – making extraordinary experiences ordinary and exceptional outcomes routine.” The Toxicology Directorate, DCPH-A, requires a maintenance contract for the Sysmex XN1000V Hematology Analyzer to support the mission of conducting toxicity studies in support of human health evaluations of new items of Army material. The instrument must be maintained in calibrated and operational status to support the requirements for Good Laboratory Practice compliance.

3. SCOPE

The DCPH-A requires the contractor to perform the following services for a Sysmex XN1000V Hematology Analyzer: Preventive Maintenance, Emergency Maintenance, Replacement Parts, Operational and Safety Improvements, Instrument Integration, Peripherals, Telephone support, and Estimates between the hours of 8:00am – 4:30pm, Monday through Friday except Federal holidays or when the government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows:

Base period

Option period 1

Option period 2

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

Defense Centers for Public Health – Aberdeen (DCPH-A) ATTN: Toxicology, Building E2100 8988 Willoughby Rd Aberdeen Proving Ground, MD 21010

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

Objective 1 - Preventive Maintenance. (Deliverable 1) The Contractor shall provide one preventive maintenance visit to DCPH-A per year in order to perform alignments and verify the Sysmex XN1000V Hematology Analyzer meets operations specifications of the manufacturer. Contracted services are to be performed on a date mutually agreed by DCPH-A and the contractor. This service must take place during normal duty hours (Monday through Friday 8:00am-4:30pm).

Objective 2 - Emergency Maintenance. (Deliverable 2 and 4) The Contractor shall provide unlimited emergency visits to DCPH-A to support the Sysmex XN1000V Hematology Analyzer. Contractor is required to respond within 48 hours during normal duty hours.

a. The Contractor shall report in person or telephonically notify the Contracting Officer’s Representative (COR) prior to commencing services during normal duty hours (8:00 am until 4:30 pm). The Contractor shall not report or attempt service during non-duty hours.

b. After performing Calibration/Verification/Certification services, the Contractor shall affix and/or update DD Form 2163 (Medical Equipment Verification/ Certification). The Contractor shall complete DD Form 2163, in accordance with the instructions provided in TB 38-750-2, or by the maintenance activity’s internal standard operating procedure (SOP).

Objective 3 – Replacement Parts. The Contractor shall furnish non-consumable replacement parts for the Sysmex XN1000V Hematology Analyzer, including those discovered during the Preventive Maintenance visit that fail due to fair wear and tear.

Objective 4 - Operational and Safety Improvements. The Contractor shall provide updates of software and/or equipment upgrades including Technical Updates recommended by the manufacturer.

Objective 5 - Instrument Integration. The Contractor shall provide Calibration and verification of any newly installed items of equipment.

Objective 6 - Peripherals. The Contractor shall update or replace peripheral equipment, to include but not limited to printers, monitors and keyboards.

Objective 7 - Telephone support. The Contractor shall provide unlimited live telephone technical support, 24 hours/day, 7 days/week.

Objective 8 - Estimates. The Contractor shall provide, to the COR, an estimate prior to initiation of repairs, and the repair may not exceed 50 percent of the value of the equipment.

6.2. Specific Tasks / Requirements

Objective 1: Key Task 1 – Contractor shall return the unit to factory specifications and provide warranty on all electrical and mechanical part (non-consumables).

Objective 2: Key Task 1 – Contract shall enter building E2100 via the main entrance in front of building E2100 and sign in at the receptionist area prior to beginning any work. The Contractor/Technician will be checked into the building by the COR or designee before beginning work in the building.

Objective 2: Key Task 2 - Contractor shall have a Government escort while in the building.

Objective 2: Key Task 3 – Contractor shall comply with the Office of Safety and Health Administration lockout/tag-out standards while performing maintenance on equipment.

Objective 2: Key Task 4 – Contractor shall be factory trained and have a minimum of two years of experience working on the contracted equipment.

Objective 2: Key Task 5 - Contractor shall use only new or Original Equipment Manufacturer (OEM) refurbished repair parts.

Objective 2 Key Task 6 – Contractor shall return to the COR to provide an out brief prior to signing out upon completion of the work for the day.

Objective 2: Key Task 7 – (Deliverable 3) Contractor shall provide a field service report detailing the work performed and any recommendations, upon completion of the repair.

6.3. Equipment Table

Sysmex XN1000V Hematology Analyzer
ECN: 111660
Serial Number (SN): 40749

7. 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

PWS Ref.
Number
Title/Description
Due
6.1
1
Preventive Maintenance (PM) Service
Within 12 months of the

previous preventive maintenance service date.

6.2
2
Onsite Repair Service
When repair is required

and reported by DCPH-A to the Contractor.

6.2
3
Field Service Report - detailing all work related to the provided support. The report shall include a

detailed list of all hours worked, and workload accomplished, to include but not limited to, a list of equipment serviced and writing assignments in support of all tasks.

Due to the COR within 5 business days of work completion.

6.1
4
Emergency Repairs/Replacement Parts
When repair is required

and reported by DCPH-A to the Contractor.

7.1. Reports and Documents

Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical 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. 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 IAW the performance standards contained in the PWS and all terms and conditions of this order, including all modifications.

8. 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 performance objectives. 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.

The Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

PERFORMANCE REQUIREMENTS SUMMARY MATRIX

#
PWS Ref.
Performance Objective
Performance Standard
Acceptable Quality Level
Performance Measurement
Incentive
1
6.1
The contractor shall perform one preventive maintenance visit to DCPH-A per year in order to perform alignments and verify equipment meets operations specifications of the manufacturer.
Within 12 months

of the previous preventive maintenance service date.

>90%
COR receipt of

service report and inspection checklist.

Current performance and future award.

2
6.1
Contractor shall

perform unlimited emergency visits to DCPH-A.

Contractor is required to respond within 48 hours during normal duty hours.

>90%
Equipment operator

will maintain records of telephone calls and/or emails to the contractor with regard to nature of service/maintenance calls for this.

Current performance and future award.

3
6.2
Contractor shall

provide a field service report detailing the work performed and any recommendations, upon completion of the repair.

Due to the COR within 5 business days of work completion.

100%
Direct observation

by COR and installation security.

Current performance and future award.

4
9.0
Installation

Access - Contractor shall follow installation access procedures.

Sum of all incidents in which contractor personnel did not follow installation access procedures.

100%
Direct observation

by COR and installation security.

Current performance and future award.

5
9.0
Information Assurance – Contractor information assurance

Workforce personnel are trained in accordance with DoD and Army policy.

Number of calendar days after contract award in which the contractor submits training certifications for all personnel requirement information assurance training.

< 30 calendar days
COR receipt of all

certifications.

Current performance and future award.

8. Contract Management

8.1. 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.

8.2. Contractor Management

The contractor shall designate a single point of contact (POC) for communication with the COR. 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.

8.3. Contractor Organization

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

8.4. Subcontract management

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

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

8.4.3. The contractor is responsible to manage task distribution to ensure there are no Organizational Conflict of Interest (OCI) considerations.

8.4.4. Contractor may add subcontractors to their team after notification and written approval from the KO.

9. COMPLIANCE DOCUMENTS

9.1. General Compliance

9.1.1. 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.

9.1.2. Occupational Safety and Health Administration

The contractor shall comply with Occupational Safety and Health Administration Standard Number 1904.32.

9.1.3. DoD Compliance Documents

A complete list of DoD compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html .

a) DoD Privacy, Civil Liberties, and Freedom of Information https://dpcld.defense.gov/privacy/authorities-and-guidance/

b) DoD Information Assurance and Cyber Security https://dodcio.defense.gov/library/

c) Title 21, CFR Part 11 Electronic Records: Electronic Signature. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

9.2. Medical and Laboratory Compliance

9.2.1. Department of Defense Federal Privacy Rule, Title 32 CFR Part 310 Compliance information regarding the DoD Privacy Rule may be found at: https://www.ecfr.gov/current/title-32/subtitle-A/chapter-I/subchapter-O/part-310

10. OTHER TERMS, CONDITIONS, AND PROVISIONS

10.1. Non-Personal Services

This PWS identifies services that are strictly nonpersonal 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 KO immediately.

10.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

10.3. Inherently Governmental Functions

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

10.4. Organizational Conflict of Interest

DCPH-A has categorized all service procurements into one of the following three categories as defined below, for the purpose of identifying, avoiding, or mitigating OCI IAW 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 DCPH-A 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, Commercial Off the Shelf (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.

10.5. Invoices

The Contractor shall submit invoices 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 contractor shall attach back up information to receiving reports for Other Direct Costs (ODCs). Backup information for ODCs shall list all elements of costs, such as travel breakout backup, including itinerary, dates of travel, quantity of employees traveling, plus per diem costs shall accompany the receiving report. Equipment purchases are not authorized under this contract. The WAWF application is the required method of invoice submission.

Where applicable, the Contractor shall include additional ODC invoice details as required per protocol for any volunteer payments in support of this PWS.

10.6. Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this contract or contained in the reports to be furnished pursuant to this contract without prior written approval of the COR or the KO.

10.7. Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts. Contractors may not use or allude to former or current military rank during the performance of this work.

10.8. Attendance at Meetings

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract or assistance agreement representatives to meet the requirements of this contract. Contractor personnel shall make their contractor status known during introductions.

10.9. Data Rights

All data received, processed, evaluated, loaded, and created as a result of this contract shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract, unless the KO grants a specific exception.

10.10. Anti-Terrorism (AT) and Operational Security (OPSEC)

10.10.1. AT Level I Training.

All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable.

The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR or to the KO if a COR is not assigned, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website: http://jko.jten.mil.

10.10.2. Access and General Protection/Security Policy and Procedures.

Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office.

In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

For contractors that do not require CAC but require access to a DoD facility or installation. Contractor and all associated subcontractor employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (Army Directive 2014-05/AR 190-13); applicable installation, facility and area commander installation and facility access and local security policies and procedures (provided by Government representative); or, at Outside Continental United States (OCONUS) locations, in accordance with status-of-forces agreements and other theater regulations.

iWATCH Training. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility, or area. The contractor and all associated subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 15 calendar days of new employees commencing performance, with the results reported to the COR no later than 30 calendar days after contract award.

10.10.3. For Contracts That Require OPSEC Training.

Per AR 530-1, Operations Security, the contractor personnel must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

10.11. Sexual Harassment / Assault Response and Prevention (SHARP) The contractor shall comply with Office of the Surgeon General (OTSG)/U.S. Army Medical Command (MEDCOM) Policy Memo 16-033, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP). The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

The contractor shall require all contractor personnel with knowledge of an incident of sexual assault or sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the Government's COR or Contracting Officer. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

The contractor shall ensure all service providers receive SHARP training not later than 60 calendar days after contractor personnel begin performance under this contract and annually thereafter. Training can be self study using the attached slides, obtained online for contractor personnel with an Army Knowledge On-line (AKO) account or in person. If the employee has an AKO account, they can access training online at Army AKO https://www.us.army.mil/. Once in AKO:

Under the "Self Service" tab, click on "My Training"; once that page comes up, in the center of the page, click on the ALMS logo or the "Access the ALMS" option. On the left hand side of the page that launches, click on “Search”, and enter “SHARP Standing Strong” in the Search option (in about the middle of the page that opens). Sexual Harassment/Assault Response and Prevention Standing Strong Training (Version: FY15) will appear as one of your options. Under that option, click on the “Begin Registration” option.

10.12. Compliance with Relevant DoD, Service, and Institutional Policy Regulations.

The Contractor shall comply with Health Insurance Portability and Accountability Act (HIPAA) and all relevant DoD/US Government regulations for collection, storage, and transfer of sensitive data and Protected Health Information (PHI). In addition, the Contractor will comply with all requirements for communication of findings and publication in the scientific peer reviewed literature (e.g. Public Affairs clearance and Operational Security clearance for dissemination).

10.13. Personally Identifiable Information (PII) and Protected Health Information (PHI) The contractor shall comply with the Defense Health Agency Procedures, and Information (PGI) 224 – Protection of Privacy and Freedom of Information. The contractor may access PII in the course of task response to the requirements of this contract, as such the contractor shall comply with the document entitled “Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements”.

The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with Defense Federal Acquisition Regulation Supplement (DFARS) Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoD Instruction (DoDI) 5400.11, “DoD Privacy and Civil Liberties Programs,” DoD 5400.11-R, “DoD Privacy Program,”, and DoD Manual (DoDM) 5400.11, “DoD Privacy and Civil Liberties Programs: Breach Preparedness and Response Plan.” The contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 CFR Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoDM 6025.18, "HIPAA Privacy Rule in DoD Health Care Programs," and DoDI 8580.02, “Security of Individually Identifiable Health Information in DoD Health Care Programs.”

Information technology (IT) services that collect, maintain, use, or disseminate personally identifiable information must be managed in a manner that protects privacy, in accordance with section 552a of Title 5, U.S.C., DoDI 5400.11, and DoD 5400.11-R. DoDI 5400.16 established the guidance for development, review, and approval of Privacy Impact Assessments, in accordance with chapter 36 of Title 44, U.S.C..

11. ATTACHMENTS

Attachment 1 – Acronyms List Attachment 2 – Organizational Conflict of Interest

ATTACHMENT 1 – ACRONYMS LIST

Acronym
Definition
AKO
Army Knowledge Online
AT OPSEC
Antiterrorism and Operational Security
CAC
Common Access Card
CFR
Code of Federal Regulations
CONUS
Continental United States
COR
Contracting Officer Representative
COTS
Commercial Off The Shelf
DCPH-A
Defense Centers for Public Health - Aberdeen
DFARS
Defense Federal Acquisition Regulation Supplement
DoD
Department of Defense
FAR
Federal Acquisition Regulation
FPCON
Force Protection Condition
GFE
Government Furnished Equipment
GFI
Government Furnished Information
HIPAA
Health Insurance Portability and Accountability Act
HQDA
Headquarters United States Department of the Army
OCI
Organizational Conflict of Interest
OCONUS
Outside Continental United States
OEM
Original Equipment Manufacturer
OPSEC
Operational Security
PWS
Performance Work Statement
QASP
Quality Assurance and Surveillance Plan
SHARP
Sexual Assault Prevention and Response Program
SOP
Standing Operating Procedure
UIC
Unit Identification Code
US
United States
USG
United States Government
USAMRAA
United States Army Medical Research Acquisition Activity
WAWF
Wide Area Work Flow

ATTACHMENT 2: ORGANIZATIONAL CONFLICT OF INTEREST

The Defense Centers for Public Health – Aberdeen (DCPH-A) has categorized all service procurements into one of the following three categories as defined below, for the purpose of identifying, avoiding or mitigating against Organizational Conflicts of Interests (OCI), 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 DCPH-A 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, Commercial Off the Shelf 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.

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information. Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that DCPH-A presumes that award of a contract or order in the subject category will give rise to real or apparent OCIs with respect to requirements in the other two categories; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in DCPH-A requirements and in identifying and, where possible, avoiding or mitigating against OCIs; and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all United States Army Medical Research and Development Command (USAMRMC) requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying, avoiding and/or mitigating against OCIs, DCPH-A will examine all its non-purchased care requirements and acquisitions regardless of the cognizant contracting activity (e.g., USAMRAA, Government Services Administration, and other agency Multiple Award Schedules, etc.) or the type of contract vehicle used (e.g., Federal Supply Schedule order, Fair Opportunity competitive order under Multiple Award Indefinite Delivery/Indefinite Quantity Contracts, competitively negotiated awards under FAR Part 15, etc.).

Each DCPH-A non-purchased care solicitation will therefore be designated as falling within one of the three above defined categories. The work called for under this contract / order has been determined by DCPH-A to fall within the following non-purchased care OCI category:

Category 2: Program Management Support

DCPH-A will administer this clause for purposes of award eligibility for each solicitation as follows:

An Offeror that has never provided support to DCPH-A in any of the categories is eligible for award in any category without any further action required under this clause.

An Offeror that provides or has provided support to DCPH-A in only one category of work and has never supported DCPH-A in any other category (a single-category Contractor) is eligible for award for any future requirement in that single category without further action under this clause.

A single-category Offeror/Contractor wishing to submit an offer in a different category, or any Offeror/Contractor which now provides or previously has provided support in more than one category, must include the following as part of its offer:

• Perform a comparative analysis of the potential new work against all current and previous work performed in support of DCPH-A in any category other than that of the new work being offered. The comparative analysis must be included in the proposal for the new work and must include a statement certifying whether the Contractor believes that its performance of the proposed new work would create a real or apparent OCI. If the Contractor believes that no real or perceived OCI will result from an award of the proposed work, no additional action by the Contractor is required.

• If the Offeror/Contractor believes that a real or apparent OCI may exist as a result of an award, the Contractor shall also submit an OCI Avoidance or Mitigation Plan with its proposal.

Inclusion of the comparative analysis and OCI Avoidance or Mitigation Plan will not be counted against any offer page limitations otherwise stated in the solicitation.

The Contracting Officer (and when applicable the appropriate program office, acquisition manager, and legal counsel) will review the comparative analysis and, if provided, the Avoidance or Mitigation Plan, in accordance with the requirements of FAR Subpart 9.5 (Organizational Conflict of Interest) to determine whether award to that Offeror would be consistent with those requirements. If it is unilaterally determined by the Contracting Officer that no OCI would arise or that the OCI Avoidance or Mitigation Plan adequately protects the interests of the government in the event of award to that Offeror, the Offeror will be determined, for purposes of this clause, to be eligible for award. If the Contracting Officer reasonably determines that a Contractor has not provided either a comparative analysis or avoidance/mitigation plan, or both, or that the analyses or plan provided is inadequate, sanctions including elimination from the award process, or termination of the related contract effort already awarded, as well as other appropriate sanctions will be considered.

If the Offeror/Contractor knows of no OCI in accepting work under this contract, it shall certify its OCI status and submit the certification at the end of this clause with its proposal and any later award, if awarded the contract. The Contractor shall also obtain a similar certification of OCI status from all subcontractors, teaming partners or consultants prior to tasking any such party under this contract. The Contractor shall appropriately modify and include this clause, including this paragraph, in all consulting agreements and subcontracts of any tier to preserve the rights of the Government.

For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

Prior to a contract modification involving a change to the Statement of Work, or an increase in the level of effort or extension of the term of the contract, the Contractor shall submit any applicable organizational conflict of interest disclosure or an update of the previously submitted disclosure or representation.

The Offeror/Contractor should review the considerations below in determining whether or not a conflict of interest exists.

• Does the Offeror or any intended subcontractors, teaming partners, proposed employees, or affiliates have Unequal Access to Information? Would award to the Offeror result in the Offeror having the opportunity to access nonpublic information that may give the Offeror a competitive advantage in a later competition for a government contract? Specifically, will the Offeror/Contractor have access to any of the following information:

oBudget(s), or Budget Information?
oAcquisition Sensitive Information related to the procurement process to include, but not limited to Acquisition Plans, Requirements, Statements of Work, or Evaluation Criteria?

• Does the Offeror or any intended subcontractors, teaming partners, proposed employees, or affiliates have “impaired objectivity” because the Offeror’s ability to render impartial judgments may be compromised because of its conflicting role(s) on this effort and other government contracts?

• Do “biased ground rules” exist? Most commonly, this would include a situation where the Offeror has, as a government Contractor, written specifications or a statement of work for this effort, which could skew competition in favor of itself?

• Is the Offeror aware of any other information relating to this proposed contract/order, which could reasonably be construed as creating an OCI?

The Offeror/Contractor hereby certifies to the best of its knowledge its OCI status below:

(Offeror: Choose one of the following two statements. Indicate which one applies by placing an X in the box to the left of the statement.)

No real or perceived OCI, as defined in FAR 2.1 and discussed in FAR 9.5, will result from an award of the proposed work (there are no ‘Yes’ responses to the questions above).

A real or apparent OCI may exist as a result of an award and therefore an appropriate OCI Avoidance or Mitigation Plan is attached (Offeror shall include an appropriate OCI Avoidance or Mitigation Plan, as required by this clause, with its quote to the Contracting Officer).

Upon award the Contractor agrees that it will provide timely OCI training to all employees and subcontractor employees working on this effort, which will include emphasis on how work performed by Contractor employees (either prime Contractor, subcontractor, or other teaming partners) under one DCPH-A OCI category can exclude the Contractor as well as its teaming partners from performing related tasks under a different OCI category of work.

____________________________ (Signature) ____________________ (Date)

____________________________ (Printed Name) ____________________ (Title)

File details come from the government source that posted it. Updated .