PWS - Neo-TPN Methemoglobin.pdf

DHA PWS Template V13 November 16, 2021

Department of Defense Defense Health Agency

Performance Work Statement

Blank Purchase Agreement for Neonatal TPN and Methemoglobin Testing

Directorate of Clinical Support Services / Neonatal Stabilization Unit

Solicitation Number:

Version:

Date:

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide neonatal Total Parenteral Nutrition (neo-TPN) and Methemoglobin Testing.

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, laboratory specimen tubes, facilities, tools, materials, supervision, and other items and non-personal services necessary to perform neo-TPN compounding and Methemoglobin Testing as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this PWS.

1.3 Background:

Neonatal Total Parenteral Nutrition (neo-TPN): Neonatal TPN (Total Parenteral Nutrition) is a medical treatment that provides essential nutrients to newborns, especially preterm or critically ill infants, who cannot feed through the gastrointestinal tract. It directly delivers nutrients such as proteins, fats, carbohydrates, vitamins, and minerals into the bloodstream via an intravenous (IV) line.

Methemoglogbin Testing: Methemoglobinemia is a condition in which a newborn has elevated levels of methemoglobin in the blood. Methemoglobin is a form of hemoglobin that cannot effectively bind and transport oxygen. As a result, high levels of methemoglobin reduce the oxygen delivery to tissues, potentially leading to cyanosis (a bluish discoloration of the skin), respiratory distress, and other serious health issues.

November 16, 2021

The neo-TPN and methemoglobin testing services are required to support the establishment of a new 3-bed Neonatal Stabilization Unit that will provide 24/7 care of critical neonates for up to 10 days at Naval Hospital Guam.

1.4 Objectives:

1. Neonatal Total Parenteral Nutrition (neo-TPN):

• Guam Regional Medical City (GRMC) will provide standard and custom neonatal TPN formulations.

• The beyond-use date for each compounded neo-TPN at GRMC is designated to expire 24 hours after compounding.

• A copy of GRMC’s ingredients typically used for neonatal TPN formulations.

• NH Guam will request neo-TPN using GRMC’s Neonatal Parenteral Nutrition Physician

Order form.

• Neo-TPN orders may be placed 7 days a week and must be received by GMRC no later than 1500 ChST.

• NHG is responsible for initiating the neo-TPN order request and coordinating logistics for the requested services.

2. Methemoglobin Testing:

• NHG is responsible for collecting, handling, and coordinating the transportation of the methemoglobin specimen to the laboratory department at GRMC, as well as establishing the appropriate mode of communication to receive the laboratory results.

• GRMC laboratory services are able to process methemoglobin samples 24 hours a day, 7 days a week.

1.5 Scope: Neonatal Total Parenteral Nutrition and Methemoglobin testing. Services include providing neonatal TPN (standard and custom), and Methemoglobin testing. The contractor shall accomplish compounding neonatal TPN per pharmacy standards, and processing methemoglobin samples per laboratory standards upon request from NHG.

1.6 Administrative specifications

1.6.1 Place of performance: The work shall be permanently performed at Guam Regional Medical City, Dededo, Guam.

1.6.2 Recognized Federal holidays: GRMC is required to perform services on holidays.

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

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1.6.3 Hours of operation: The contractor is responsible for conducting business Sunday thru Saturday or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.6.4 Emergency Services: On occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours.

1.7 Other Direct Costs (ODC): N/A

1.8 Quality

1.8.1 Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.11 Reporting

1.11.1 Contractor Manpower Reporting (CMR): RESERVED.

1.11.2 Non-Disclosure Agreement (NDA): All contractor personnel who will obtain access to proprietary, classified, or confidential information or any information release of which is protected or governed by law or regulation associated with DHA acquisitions shall be required to complete and sign a DHA contractor NDA (DHA Form 49) prior to beginning work on the subject contract. The contractor shall execute an NDA on behalf of the company and shall ensure that all staff assigned to, including all subcontractors and consultants, or other personnel performing on contract/Task order execute an NDA protecting the procurement sensitive information of the Government and the proprietary information of other contractors. The NDA shall be executed not later than first day of employment and to be renewed upon exercising a contract option period. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the contractor. The contractor shall maintain originally signed NDAs of individual employees and provide copy to the COR.

1.11.3 Government’s COR: The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the CO and contractor of any deficiencies; coordinate availability of government furnished property; and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, November 16, 2021 estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

1.12 Contractor Identification

1.12.1 Contractor personnel performing services in a contractor capacity in a Government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. All contractor personnel shall identify themselves as contractor support personnel in all forms of communication with all entities with whom DHA/Deputy Assistant Director for Acquisition (DAD-A)/Head of the Contracting Activity (HCA) has business dealings. The contractor shall: Answer all telephone calls and have a personalized voice message with an introductory statement that includes the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the DAD-A understands that the person is contractor support personnel.

Include a title block in all emails that states the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting DHA/DAD-A/HCA understands that the person is contractor support personnel.

1.12.2 Contractor personnel will be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order.

Contractor personnel shall make their contractor status known during introductions.

1.12.3 Contractor personnel, while performing in a contractor capacity, are prohibited from using their retired or reserve component military rank or title in any written or verbal communications associated with the contracts in which they provide services.

1.14 Contractor Access to Health Affairs (HA)/DHA Network(s)

1.14.1 FSO/Company's Security POC shall notify the DHA Personnel Security Office after being awarded a contract that requires access to a DoD system (If applicable, if not delete 1.16.1 and 1.16.2 and replace to 1.16 Reserved). Contractor personnel requiring access to the HA/DHA networks for performance of their tasks require a background investigation and the security awareness training. The contractor shall be prepared for this process as it could take two (2) or more weeks. The FSO/Security POC shall submit a Standard Form (SF) 85/86 to DHA's Personnel Security Office for a background investigation.

1.14.2 Company's FSO/Security POC must notify the Personnel Security Office when the contractor has submitted the SF-85/86. The FSO/Security POC, or the COR must notify the DHA Personnel Security Office in writing of a contractor's termination from the contract, including the termination date.

1.15 Personnel Security

1.15.1 The contractor shall comply with DoD 8570.01-M, “Information Assurance Workforce Improvement Program, CH4” November 10, 2015 as amended; 8500.01, “Cybersecurity”, dated March 14, 2014; DoD Manual (DoDM) 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs” dated March 3, 2019, Department of Defense Instruction (DoDI) 6025.18 “HIPAA

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Privacy Rule Compliance in DoD Health Care Programs”, dated March 13, 2019; and DoDM

5200.02 “Procedures for the DoD Personnel Security Program (PSP),” incorporation change 3, effective September 24, 2020. Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements:

1.15.1.1 Follow the DHA Personnel Security Office guidelines for submittal of security clearances. Contact the DHA Personnel Security Office for guidance on the appropriate background investigation required for personnel on the contract. The DHA Personnel Security Office can be reached at (703) 275-6038.

1.15.1.2 Initiate, maintain, and document personnel security investigations appropriate to the individual’s responsibilities and required access to Controlled Unclassified Information (CUI).

1.15.1.3 DHA Personnel Security Office does not deny any access to any automated information system (AIS), network, or Controlled Unclassified Information (CUI). If a contractor receives an unfavorable background investigation, the request for access will be sent back to the FSO for further action. Any unfavorable adjudication will result in DHA Personnel Security Office not signing off on any access request.

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE

PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

• Neo-TPN: Neonatal Total Parenteral Nutrition.

• PN: Parenteral Nutrition

2.1.1 Category D: Information Technology (IT) and Telecommunications Services (called D- Services)

2.1.2 Category R: Support (Professional/Administrative/Management) Services (called R- Services)

2.1.3 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.4 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.5 Nonpersonal services contract: a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

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2.1.6 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

2.2 Acronyms:

AIS Automated Information System AQL Acceptable Quality Level CDRL Contract Data Requirement List CMR Contractor Manpower Reporting CO Contracting Officer(s) COR Contracting Officer Representative COTR Contracting Officer's Technical Representative CUI Controlled Unclassified Information DAD-A Deputy Assistant Director for Acquisition DFARS Defense Federal Acquisition Regulation Supplement DHA Defense Health Agency DoD Department of Defense DoDI Department of Defense Instruction DoDM Department of Defense Manual EVM Earned Value Management FAR Federal Acquisition Regulation FCI Federal contract information FRCS Facility Related Control Systems FSO Facilities Security Officer HA Health Affairs HIPAA Health Insurance Portability and Accountability Act HCA Head of the Contracting Activity IGCE Independent Government Cost Estimate IA Information Assurance IO Initial Outfitting IS Information System IT Information Technology ODC Other Direct Costs POC Point of Contact PRS Performance Requirements Summary PSP Personnel Security Program PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Plan SP Special Publication US United States

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services and determined:

3.1 Services: The Government:

☐ Will NOT provide Government Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Government Furnished Services required in support of this contract/task orders. These Services are described below: transportation of neo-TPN from GRMC to NHG and transportation of methemoglobin sample from NHG to GRMC.

3.2 Facilities: The Government:

☒ Will NOT provide Facilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Facilities in support of this contract/task orders. The Government provided Facilities are described below: n/a.

3.3 Utilities: The Government:

☒ Will NOT provide Utilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Utilities in support of this contract/task orders. The Government provided Utilities are described below: n/a.

3.4 Equipment: The Government:

☒ Will NOT provide Equipment in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Equipment in support of this contract/task orders. The Government provided Equipment is described below: n/a.

3.4.1 Procurement Integrated Enterprise (PIEE), GFP Module Application

The contractor shall be responsible for obtaining and maintaining access, training and successful operation of the PIEE/GFP Module application for the entirety of the contract/task order PoP.

The PIEE GFP Module application is located at the following website: https://wawf.eb.mil/piee-landing/. Access to PIEE/GFP Module application training materials and in-depth information https://wawf.eb.mil/piee-landing/ https://wawf.eb.mil/piee-landing/ Dada, Oyekade PO1 USN DHA GUAM MARKET (USA) Contracting Team

November 16, 2021 applicable to the contractor’s responsibilities regarding GFP can be found at the following website: https://dodprocurementtoolbox.com/.

Contracting Office Responsibilities:

The Contracting Office shall ensure close coordination and validation of the GFP items with the COR and DHA Accountable Property Officer prior to uploading the GFP Attachment into the PIEE/GFP Module. At the time GFP is anticipated and identified, the Government will upload the GFP Attachment into the PIEE/GFP Module. It is the Contracting Office’s responsibility to prepare, upload and maintain the GFP Attachment in the PIEE/GFP Module in accordance with the GFP Attachment instructions provided at the DoD Procurement Toolbox. The CO and COR shall manage and keep an inventory of any GFP associated with contract/task orders awarded through DHA, in accordance with applicable FAR Part 45, DoD FAR Supplement (DFARS) 245 with respective clauses, DHA AI 095 and PD 45-01 following the change in disposition of items listed on that PIEE/GFP Module Attachment.

The contracting office will also review, acknowledge, reject and/or approve shipment orders provided by the contractor as appropriate. Functional roles can be determined within the Contracting Office, and requested within the PIEE/GFP Module system.

Contractor Responsibilities:

A key contractor responsibility is to work with the CO and COR to ensure the PIEE/GFP Module data, to include the PIEE/GFP Attachment, provides a timely, complete and accurate accounting of the GFP applicable to the contract/task order. Contractors are required to report the receipt of any GFP shipped to them, regardless of whether it is listed on the GFP Attachment for their contract. Similarly, contractors are required to utilize the GFP Module application in conjunction with the shipment of GFP to the Government, or in reporting Property Loss of GFP issued (such as destruction or loss). Discrepancies or disputes regarding property shipped to or shipped from the contractor must be reported via the GFP Module application, with the CO having authority over final designation of status.

The contractor shall report semi-annually 100% inventories, reconciliations, and final disposition of GFP provided by the government. Final invoices will not be paid pending GFP reconciliation.

Contractors shall be aware of and ensure compliance with applicable FAR Part 45, DFARS 245 and 252.245, Defense Pricing and Contracting Policies, Procurement Integrated Enterprise Environment Standards, DHA Administrative Instruction 094 and DHA Guidance.

3.5 Materials: The Government:

☒ Will NOT provide Materials in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ IS providing Materials in support of this contract/task orders. The Government-provided Materials are described below: n/a.

https://dodprocurementtoolbox.com/

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: GRMC

☐ Will NOT provide Contractor Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Contractor Furnished Services required in support of this contract/task orders.

These Services are described below: outlined in part 5.

4.2 General: contractor shall furnish all supplies including laboratory specimen tubes, equipment, facilities and services required to perform work listed under Section 5 of this PWS.

4.3 Materials: The contractor shall provide all materials and supplies including laboratory specimen tubes necessary to meet the requirements under this PWS.

4.4 Equipment: The contractor shall provide the equipment to meet the requirements under this

PWS.

4.5 Facilities: The contractor shall perform services requirements under this PWS at their facility.

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PART 5

5.0 SPECIFIC TASKS

Scope of Services:

The Guam Regional Medical City (GRMC) will provide two (2) services to Naval Hospital Guam: Neonatal Total Parenteral Nutrition (neo-TPN) and Methemoglobin testing.

5.1 Neonatal Total Parenteral Nutrition:

5.1.1 The contractor shall provide:

• Standard and custom neonatal TPN formulations available 7 days a week if request is received before 1500 local Guam time.

• A compounded neo-TPN product that is designated to expire 24 hours after compounding.

• A copy of GRMC’s ingredients typically used for neonatal TPN formulations.

5.2 Methemoglobin Testing:

5.2.1 The contractor shall:

• Receive, assession, and result laboratory specimen samples for methemoglobin 24 hours, 7 days a week.

5.3. Requested Services: Neonatal Total Parenteral Nutrition (neo-TPN) and Methemoglobin

5.3.1. Neonatal Total Parenteral Nutrition:

5.3.1.1. Standard TPN with ELCYS 22mg/1gm Amino Acid

Order Volume (mL): 250 Compound Volume (mL): 250

Standard TPN 250 mL Components:

Dextrose…………………………………………….….. 10% Trophamine (protein)…………………………………… 3.75% Calcium Gluconate……………………………………… 0.63 mEq/dL Heparin PF……………………………………………… 1 units/mL ELCYS (cysteine)………………………………………. 0.08%

5.3.1.2. Custom TPN: The custom TPN will be compounded according to the provider’s need for the patient based on the GRMC Neonate Parenteral Nutrition (PN ) Guidelines and Physician Orders.

GRMC PN

Guidelines & Physici

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PART 6

7.0 ATTACHMENTS/TECHNICAL EXHIBIT LISTING

7.1 The following forms are to be completed by the FSO/Security POC, or COR once the contractor is granted the proper background investigation.

7.1.2 DHA’s contractor training instructions.

Adobe Acrobat

Document DHA FY22 Annual

Training List_Oct 2021

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PART 7

7.2 Other Attachments

Attachment 2, Deliverable Schedule Table (Paragraph 6.5.2.1.1)

Attachment 2-Deliverable Schedul

Attachment 3, Cybersecurity Regulations and Guidance (Paragraph 6.7.2.3)

Attachment 3-Cybersecurity Regu

Attachment 4, FRCS Responsibility Matrix (Paragraph 6.7.5.3)

Attachment 4-FRCS Responsibility Matrix.p

Attachment 5, Risk Assessment Timeframes (Paragraph 6.7.7)

Attachment 5-Risk Assessment Timefram

PART 7