Solicitation HT940624R0006 SAM.docx

HT940624R0006

INSTRUCTIONS TO OFFERORS

INSTRUCTIONS TO OFFERORS

**Addendum to FAR 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services (Mar 2023)**

1. GENERAL INSTRUCTIONS AND NOTICES

This requirement is being solicited in accordance with FAR Part 12 and FAR Part 13.5. In addition to FAR 52.212-1, this section specifies the format and content that Offerors shall use in responding to this Request for Proposal (RFP). The intent is to ensure a certain degree of uniformity in the format in the response for evaluation purposes. The proposal should be legible and comprehensive enough to provide the rating standards for a sound evaluation by the Government. Information provided should be precise, factual, and complete. Legibility, clarity, completeness, and responsiveness are of the utmost importance. If the proposal does not provide, at a minimum, that which is required in this solicitation it may be determined to be substantially incomplete and not warrant any further consideration. The offer shall also be compliant with all requirements as stated in the Performance Work Statement (PWS).

The Offeror’s initial proposal should contain the Offeror’s best terms from a cost or price and technical standpoint.

All offer information is subject to verification by the Government. Falsification of any offer submission, documents, or statements may subject the Offeror to civil or criminal prosecution under Section 1001 of Title 18 of the United States Code.

The Offeror shall comply with FAR 52.204-7, System for Award Management (SAM). In complying with this clause, the Offeror shall ensure that all representations and certifications contained in this solicitation are completed and uploaded to its SAM record at http://www.sam.gov by the date specified for receipt of the proposal. If the Offeror does not have an active SAM record or has a record that does not include all representations and certifications required in this solicitation, they may be considered ineligible for award.

Any data previously submitted in response to another solicitation to DHA SEM-CD or another agency shall be assumed to be unavailable during this proposal evaluation and source selection process. The Government will not reimburse the Offeror for costs incurred as a result of preparation and submission of an offer in response to this solicitation.

SUBMISSION OF PROPOSALS: A proposal shall be submitted and received no later than 02 January 2024 by 1000 Eastern Time. The proposal shall be submitted electronically, via e-mail, to Mr. Joshua Grim, Contract Specialist at joshua.m.grim.civ@health.mil.

QUESTIONS: All questions shall be addressed in writing and submitted electronically to Mr. Joshua Grim, Contract Specialist at joshua.m.grim.civ@health.mil. Questions shall be submitted no later than 15 December 2023 by 1000 Eastern Time.

The Offeror’s proposal shall consist of four separate volumes. Each volume shall be separate and complete, so that the evaluation of each one may be accomplished independently and concurrently with evaluation of the others. Each Volume shall be an independent document, labeled accordingly. The volumes are:

Volume 1 – Past Performance Volume 2 – Price Volume 3 – Technical Approach Volume 4 - Business

*No pricing information shall be included in Volume 1 – Past Performance, Volume 3 – Technical Approach, or Volume 4 – Business.

Files shall not contain classified data. The use of hyperlinks in proposals is prohibited.

ELECTRONIC SUBMISSION: Proposals shall be electronically submitted to the POC above. Your submission shall include four (4) separate parts: (1) Past Performance, (2) Price (3) Technical Approach and (4) Business. Volume 1 – Past Performance shall be submitted in MS Word 2000 or searchable PDF format. Volume 2 - Price shall be submitted in MS Excel 2000 or higher, but not greater than MS Excel 2007 format. Volume 3 – Technical Approach may include items such as brochures or pictures. Volume 4 - Business may be submitted in MS Word 2000 or searchable PDF format. The firewall utilized by the Government contracting office does not authorize or accept zip files.

2. PROPOSAL FORMATTING & PACKAGING GUIDELINES

a. Format. The submission shall be clearly indexed and logically assembled. Each volume shall be clearly identified and shall begin at the top of a page. All pages of each volume shall be appropriately numbered and identified by the complete company name, date and solicitation number in the header and/or footer. The proposal shall be clear and legible. Attachments shall conform to the following guidelines:

- Type Font: 12-point, 10-pitch (Times New Roman)

- Spacing: Single-spacing between lines of text

- Margins: 1.0 inches on all sides

- Acronyms: Spell out all acronyms the first time when they are used. One page, following the proposal body, is allocated to spell out acronyms, abbreviations and symbols and will be excluded from the total page limits.

- Language: English

- Format: Microsoft Office Applications (i.e. MS Word, Excel) or Searchable PDF format

- Graphics & Tables: 10-point, 10-pitch (Times New Roman).

In addition, each paragraph should be separated by at least one blank line. A standard, Times New Roman, 12-point minimum font size applies. Tables and illustrations may use a reduced font size not less than 8-point and may be landscape.

b. File Packaging. None of the proposal files shall be compressed (zipped). Zipped files cannot be opened by the Contracting Office.

c. Page Limitations. Volume 3 – Technical is limited to 5 pages single sided. Pages shall be numbered consecutively throughout the document and not by sections. For Volume 3, pages exceeding the specified limit will be removed and not forwarded for evaluation. The page limitation does not include a title page, table of contents or Acronym/Abbreviations/Symbols page.

3. VOLUME CONTENT

a. Volume 1 – Past Performance

Offerors shall submit a Project Summary Sheet (PSS), Attachment 1, as part of Volume I. The PSS requires the offeror to identify contract/task orders that will be evaluated in accordance with the evaluation criteria identified herein. References cited shall be for work performed with the Federal Government and/or commercial customers that demonstrate recent and relevant past performance.

Volume I must contain a PSS, Attachment 1. If a PSS is not included, the offeror may not be considered for award. Ideally, the Government will receive not more than three (3) PPQs or CPARS reports that correspond to the contract/task orders identified on the PSS; however, the Government understands that offerors may ask customers to complete more than three (3) PPQs to ensure that three (3) are received by the response time. If the Government receives more than three (3) PPQs or the Offeror includes more than three PPQs or CPARS reports in its proposal, the Government will only consider the first three (3) contract/task orders identified on the PSS (considered the order of preference). The PSS is set-up to allow three (3) contract/task orders to be cited, but it can be edited by the offeror to identify more task orders. The PSS shall identify no more than one Point of Contact (POC) and if more than one POC is provided, only the first POC will be considered. The Government may contact the POCs listed on the PSS. POCs must be either Government personnel (civil service or military) or employees of private sector clients for whom you have provided services. Information provided by or for POCs who work directly for your company, or indirectly (i.e., in a prime/subcontractor or mentor/protégé relationship, etc.), will be determined not relevant.

If a task order is identified on the PSS and a corresponding PPQ or CPARS report is not received, the Government will not make an attempt to evaluate the task order; however, the Government may use information already in its possession to evaluate the task order. In this situation, because performance is limited to no more than three (3) relevant task orders, the Government will only consider the first three (3) task orders identified on the PSS. If a PPQ or CPARS report is received for a task order not identified on the PSS, it may not be further considered.

Recent is defined as within the last three (3) years. Contracts/Task Orders cited must be current or have ended not more than three (3) years prior to the closing date of the solicitation. If the contract performance ended more than three (3) years prior to the closing date of the solicitation it will be determined to not be recent and not evaluated further. Relevant is defined as work similar to complexity and magnitude of the work described in the Performance Work Statement related to this solicitation.

A Past Performance Questionnaire (PPQ), Attachment 2, shall be submitted for each contract/task order identified on the PSS, Attachment 1. Contracts/task orders cited shall be for the prime, i.e., subcontractor performance shall not be submitted. The offeror shall complete the sections noted as “to be completed by the Offeror” prior to sending the PPQ to Government agencies requesting past performance information on applicable contract/task orders. PPQs cannot be completed by current or previous teaming partners. PPQs may be submitted by the offeror as part of the Volume I submission or submitted directly to the Government by the POC identified on the PPQ. If the PPQ is received from the offeror, the PPQ must contain an electronic signature (either a verified electronic signature or a scanned copy of the original signature) from the POC that completed the PPQ. Contract Performance Assessment Reporting System (CPARS) reports may also be submitted in lieu of PPQs as long as they were completed no more than three years prior to the closing date of this solicitation. For the purposes of this solicitation, the completion date of the CPARS report will be the date the Assessing Official signs the report. If a completed PPQ or CPARS report does not contain enough information to make a relevancy determination, the past performance reference cited may be determined to be not relevant and not evaluated.

NOTE: It is the responsibility of the offeror to track and ensure the completion/submission of the PPQs by the proposal due date. The Government may not accept incomplete or late PPQs. If available, an electronic copy of the completed PPQ(s) shall be submitted with the Volume I submission (Do not refer Government personnel to a previous PPQ without enclosing a copy).

The Government may also consider information obtained through other sources. Past performance information will be utilized to determine the quality of the offeror’s past performance as it relates to the probability of success of the required effort.

If the offeror does not possess relevant past performance, the offeror shall submit a statement affirming that it does not possess relevant Past Performance.

b. Volume 2 – Price

Pricing shall be submitted in the Excel workbook provided with the solicitation (Attachment 3). Offerors shall enter pricing in the highlighted cells only. The offeror shall complete all pricing required in the electronic workbook.

The completed file shall be submitted in the proposal as Volume 2. Please note that any reformatting of the pricing workbook may cause the offeror's proposal to no longer be considered. The price quote shall remain valid for a minimum of 90 days from the date of submission.

c. Volume 3 – Technical Approach. Offerors shall submit a written technical approach which effectively demonstrates the Offeror’s clear understanding of all the tasks (including the approach to staffing) and how the approach is likely to yield the required results.

The Offeror’s proposal response shall demonstrate the Offeror's understanding of tasks to be performed, as well as the basic functional approach and methodology that will be utilized in accomplishing any resultant award.

The Government does not have a requirement for Offeror’s equipment to capture, store, and/or transmit DoD PII, PHI or CUI or connect to the MTF’s network at all. If Offeror’s equipment provides such capability the Offeror shall ensure the equipment is accredited in accordance with DoDI 8510.01, Risk Management Framework (RMF) for DoD IT and comply with annual Federal Information Security Modernization Act (FISMA) security control testing; or shall ensure the capability to capture, store, and/or transmit DoD PII, PHI or CUI is disabled when in use.

d. Volume 4 – Business. The Offeror’s Business Volume shall be a separate volume from the Past Performance and Price Volumes, and shall include the following:

1. Acknowledgement of all solicitation amendments (if applicable). An Acrobat PDF file shall be created to capture the signatures for submission. It is the offeror’s sole responsibility to periodically check the website for amendments and to ensure that all amendments issued prior to the closing date are acknowledged in accordance with instructions in Block 11 of the SF 30. If an offeror fails to acknowledge a material amendment, the offeror’s proposal will be determined incomplete and will result in rejection of the offeror’s entire proposal.

2. Offeror Representations and Certifications. The Offeror shall complete and submit only paragraph (b) of FAR 52.212-3 if annual representations and certifications has been completed electronically through the System for Award Management (SAM) at https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall compete and submit only paragraphs (c) through (u) of FAR 52.212-3. The Offeror shall also complete and return FAR 52.204-24, FAR 52.229-11, DFARS 252.204-7016 and DFARS 252.204-7017.

3. System for Award Management (SAM) Registration. The offeror must be registered in SAM, in accordance with FAR 52.204-7. The offeror shall verify its SAM record is current, accurate, complete, and applicable to this solicitation as of the date of the offer and is incorporated in the offer by reference.

EVALUATION CRITERIA

EVALUATION CRITERIA

**Addendum to FAR 52.212-2, Evaluation—Commercial Products and Commercial Services (Nov 2021)**

The Government will award one contract resulting from this solicitation to the offeror whose proposal, conforming to the solicitation, offers the best value to the Government, price and past performance considered. Past performance is more important than price. The Contracting Officer has broad discretion in determining which awardee shall receive a contract and reserves the right to pay a premium for past performance benefiting the Government.

1. Past Performance Evaluation Methodology. Past performance will be based on the PPQs or CPARS reports. Remaining offerors will be assigned an overall Performance Confidence Assessment (PCA), see below, which is based on an integrated assessment of the offeror’s relevant past performance. The resulting PCA represents an overall evaluation of offeror performance. Offerors without a record of relevant past performance or for whom information on past performance is so sparse that no meaningful confidence assessment rating can be reasonably assigned will not be evaluated favorably or unfavorably on past performance and, as a result, will receive a "Neutral Confidence" rating for the Past Performance factor.

*The Government reserves the right to use information from the PPQs and CPARS, as well as information obtained from other sources available to the Government, to include, but not limited to, Federal Awardee Performance and Integrity Information System (FAPIIS), or other databases; interviews with Program Managers, Contracting Officers, and commercial sources and/or non-Government sources.

Relevancy Assessment: An assessment of the past performance information will be made to determine if it is relevant. To be relevant, the contract/task order must be for Autotransfusion services and must be non-personal services and not inherently governmental or closely associated inherently governmental. Services performed by offeror personnel that supplement existing Government personnel and completed no more than three years prior to the closing date of this solicitation are considered relevant. Clinical (direct patient care), advisory and assistance, information technology, housekeeping or facility management services are not considered relevant. Examples of services considered not relevant include hands on, direct patient care services performed in a clinical setting. Task orders that are determined to be not relevant will not be further evaluated.

Performance Confidence Assessment (PCA): The Government will consider the performance quality of relevant efforts and assign an overall PCA. Offerors with experience providing Autotransfusion services in a higher number of FTEs may be rated more favorably. The confidence ratings noted in the table below will be used. For each relevant contract/task order reviewed, the performance quality of the work performed will be assessed using the PPQ, CPARS report and/or contact with the POC listed on the PPQ to obtain information regarding past performance as it relates to providing the services required under this solicitation, including but not limited to recruiting and retaining qualified contract employees. The Government is not restricted from evaluating and considering other relevant past performance information in its possession. Past performance information may be obtained from any other source available to the Government.

PERFORMANCE CONFIDENCE ASSESSMENTS

2. Price Evaluation Methodology. The factors to be considered in evaluating proposed prices will include:

A. Completeness. The Government will evaluate if Attachment 2 is complete, and all required pricing has been submitted. This includes all required pricing for the base period and all option periods. In the event that any of the pricing is incomplete, the Contracting Officer may exclude the offeror’s proposal from further evaluation.

B. Reasonableness. The degree to which the proposed prices (base period and option periods) compare to the prices a reasonably prudent person would expect to incur for the same or similar services.

An offeror with pricing that is determined to be questionable for reasonableness (for any period of performance) may not be further considered for award.

ATTACHMENTS

EXHIBIT/ATTACHMENT TABLE OF CONTENTS

Attachment 1 – Project Summary Sheet Project Summary Sheet Provide the following information for each past performance reference submitted in response to this solicitation. Offerors are allowed to edit this sheet to identify more than three (3) task orders by copying one of the blank tables included below.

PPQ #1:

Offeror Name:

Contract Number:

Task Order Number:

PPQ #2:

Offeror Name:

Contract Number:

Task Order Number:

PPQ #3:

Offeror Name:

Contract Number:

Task Order Number:

Attachment 2 – Past Performance Questionnaire Past Performance Questionnaire

The Defense Health Agency (DHA) Southeastern Contracting Division (SEM-CD) is conducting an acquisition for the services noted below. The offeror has identified you as a reference to validate past performance.

Solicitation HT940624R0006 is for non-personal services; Autotransfusion Services at the Naval Medical Center Portsmouth located in Portsmouth, VA.

Please complete the following questionnaire to assist our evaluation of the offeror’s past performance and return via email no later than 10:00 am Eastern Time on Tuesday, 2 January 2023 via email to joshua.m.grim.civ@health.mil. Please reference “Solicitation HT940624R0006” in the subject of the email.

RESPONDENT INFORMATION (to be completed by the Offeror):

Contracting Activity/Customer:

Point of Contact (POC):

Title of POC:

Telephone:

Email:

CONTRACT INFORMATION (to be completed by the Offeror):

Contract Number:

Task Order Number (if applicable):

Performance Period: (Base plus any options):

Description of Services (included position description(s)):

REQUIREMENT DESCRIPTION

Number of FTEs/description of required schedule:

Facility Type Services performed for (i.e., Hospital/Clinic):

All information from here down shall be completed by the Reference POC. The Reference POC shall also verify the information completed by the Offeror and make any necessary corrections before signing this form.

Please refer to the following assessment definitions to assess the Offeror’s performance in each of the areas listed in this questionnaire:

(E) Exceptional - The Offeror’s performance meets contractual requirements and exceeds many (requirements) to the Government’s benefit. The contractual performance was accomplished with few minor problems for which corrective actions taken by the Offeror were highly effective.

(V) Very Good - The Offeror’s performance meets contractual requirements and exceeds some (requirements) to the Government’s benefit. The contractual performance was accomplished with some minor problems for which corrective actions taken by the Offeror were effective.

(S) Satisfactory - The Offeror’s performance meets contractual requirements. The contractual performance contained some minor problems for which corrective actions taken by the Offeror appear or were resolved satisfactorily.

(M) Marginal - Performance does not meet some contractual requirements. The contractual performance reflects a serious problem for which the Offeror has not yet identified corrective actions or the Offeror’s proposed actions appear only marginally effective or were not fully implemented.

(U) Unsatisfactory - Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The contractual performance contains serious problem(s) for which the Offeror’s corrective actions appear or were ineffective.

(N) Not Applicable – Unable to assess the area.

Overall Fill Rate (CPARS “Quality of Service” Rating Area)

Provided qualified contract personnel IAW the terms and conditions of the contract.

Ensured that qualified contract personnel remained filled IAW the terms and conditions of the contract.

Recruited, placed and retained qualified contract personnel with minimal disruption for hard-to-fill (specialty) positions or at remote locations.

If other than “Satisfactory,” explain how the performance exceeds or does not meet contractual requirements:

On-Time Fill Percentage (CPARS “Schedule” Rating Area)

Provided qualified contract personnel on time IAW the terms and conditions of the contract.

Provided complete, current and accurate qualifying package for each contract personnel IAW the terms and conditions of the contract.

If other than “Satisfactory,” explain how the performance exceeds or does not meet contractual requirements:

Turnover Rate (CPARS “Management” Rating area)

Retained qualified contract personnel without frequent turnover and minimal operations disruption IAW the terms of the contract.

If other than “Satisfactory,” explain how the performance exceeds or does not meet contractual requirements:

Replenishment Rate (CPARS “Management” Rating area)

Planned for and provided replacement candidates during the life of the contract to, include pre-planned/unplanned absences and extended leave of absence to avoid disruption of services and/or work schedule IAW the terms of the contract.

If other than “Satisfactory,” explain how the performance exceeds or does not meet contractual requirements:

Would you award this firm another contract:

If you answered “No” provide an explanation:

Was the contract terminated for default or cause:

If you answered “Yes” provide an explanation:

Additional Comments:

Signature: _________________________________________ Date: __________________

Print Name: ________________________________________

Title: ______________________________________________

Telephone: _________________________________________

Thank you for your participation in providing a detailed and accurate history of past performance for this offeror.

PERFORMANCE WORK STATEMENT

Department of Defense Defense Health Agency Performance Work Statement

Autotransfusion Services

Main Operating Room (MOR), Directorate of Surgical Services in support of Naval Medical Center Portsmouth, VA

Solicitation Number: HT940624R0006

GOVID: 20230623-021964

Start Date: 02/01/2024

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide Autotransfusion services for the Main Operating Room (MOR) and same day operating areas, Directorate of Surgical Services, located at the Naval Medical Center Portsmouth, VA (hereafter referred to as “NMCP” and/or “MTF”).

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform Autotransfusion services 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: Autotransfusion is the process of recycling the patients’ blood and returning it to the patient through a contained, sterile system. The advantages are: the risk of transmission of infectious diseases (hepatitis, malaria, lues, AIDS etc.) is eliminated; there is no danger of isosensitization; autologous blood ensures a better oxygen transfer and higher activity of coagulation factors; pretransfusion examinations are eliminated; there is no need to postpone the operation for shortage of blood; the consumption of homologous blood is reduced; economy; religious objections against transfusion of homologous blood are eliminated.

1.4 Objectives: To provide Autotransfusion services for surgical cases requiring patient’s own blood salvaged and transfused while in the operating room/areas. This Contract is a non-personal health care services contract, under which the Contractor is an independent contractor.

1.5 Scope: Adult autotransfusions and pediatric orthopedic autotransfusion services. Services include Intraoperative Autotransfusion Services as requested for nonemergent and emergency procedures. The contractor shall provide service in operating rooms (OR)/areas and in same day-operating areas. Work shall be performed in a medical setting. Long periods of standing may be required.

1.5.1 The Contracting Officer will designate and authorize an individual to act as the Contracting Officer's Representative (COR). Any such representative appointed will be specifically designated by letter from the Contracting Officer. The COR exclusively represents the Contracting Officer in all technical phases of the work, but is not authorized to issue Change Orders, Supplemental Agreements, or direct any contract performance requiring contractual modification or adjustment. Changes in the scope of work can only be made by modification properly executed by the Contracting Officer. All observations made by persons other than the Contracting Officer, or the COR are strictly advisory and shall not influence the Contractor's operations except for administrative requirements and responsibilities specified herein.

1.6 Period of Performance (PoP):

Base Period: 01 February 2024 through 31 January 2025 Option Period 1: 01 February 2025 through 31 January 2026 Option Period 2: 01 February 2026 through 31 January 2027 Option Period 3: 01 February 2027 through 31 January 2028 Option Period 4: 01 February 2028 through 31 January 2029

1.6.1 Transition: Transition-in/transition-out period

1.6.1.1 Transition-in period: Full performance start date is, 02/01/2024. Transition-in performance is defined as, once the contract is awarded, the process should commence to implement the contract with minimal issues or disruptions to the agency, including extended delay to scheduling upcoming surgeries. During the transition-in period, the contractor shall prepare to meet all contract requirements and ensure incoming personnel are functionally trained and qualified on the full performance start date except cybersecurity requirements, which must be fully adhered during transition and full performance periods. The remaining incoming personnel shall be trained and qualified within seven days.

1.6.1.1.1 The contractor shall comply with transition-in requirements of the DHA, as listed in paragraph 1.11.1, for contractors needing to be issued Common Access Card (CAC) identification, including Department of Defense (DoD) and DHA-directed training and forms submission, prior to network access.

1.6.1.2 Transition-out period: The transition-out shall facilitate the accomplishment of a seamless transition from the incumbent to an incoming contractor/Government personnel at the expiration of the contract. See Part 7, Technical Exhibit 1.

1.6.1.2.1 The contractor shall comply with transition-out requirements of the DHA for contractors who have been issued a CAC or who generate “records”, as defined by DoD (records manual), including DoD-directed disposition of records, and others displayed on the In/Out (I/O) Processing Portal.

1.7 Administrative specifications

1.7.1 Place of performance: The work shall be performed at the Main Operating Room (MOR), Directorate of Surgical Services in support of Naval Medical Center Portsmouth, VA

1.7.2 Recognized Federal holidays: Services may be required for emergency procedures on federally recognized holidays.

1.7.3 Hours of operation: The contractor is responsible for conducting nonemergent procedures Monday thru Friday 0700 through 1830 hours, except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. All closings for severe weather or other emergency will be at the sole discretion of the government. The Contractor shall maintain the required service schedule unless the COR notifies the Contractor that weather conditions or an emergency authorizes a closing. The Contractor will receive guidance from the COR of the MTF protocol for 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.

1.7.4 Emergency Services: Services for emergency procedures shall be provided at any time Monday through Sunday, including after hours, weekends and Federal holidays. See section 5.1.4

1.8 Contractor travel: N/A

1.9 Other Direct Costs (ODC): There will be no authorized ODC

1.10 Quality

1.10.1 Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS and is consistent with the MTF Quality Control Program. The Contractor shall also actively participate in the established medical Quality Improvement (QI) Plan of the MTF. Current copies of this Contract, the Contractor’s QCP, and the MTF’s QI plan shall be maintained on-site for ready reference by the Contractor during the term of this Contract. Contract employees shall read, be familiar with, and implement this Contract, including the Contractor’s technical response, QCP, medical QI Plan, and any revisions. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is the means by which the work complies with stated requirements. After contract award, but not later than commencement of services, the Contractor shall submit a Quality Control Plan to the COR and the Contracting Officer for review. The Contractor’s QCP shall be consistent with Joint Commission standards and the MTF Quality Control Program. The QCP shall, at a minimum, include (a) a plan for providing services by appropriately qualified personnel that includes a specific methodology for doing so; (b) a plan to ensure maintenance and enforcement of Standards of Conduct for Contractor personnel as specified in Section 11.2; and (c) a plan for a patient relations program that is compliant with the MTF's patient relations protocols and which includes a notification process for all patient compliments and complaints. After acceptance of the Quality Control Plan (QCP) the contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system. See Part 7, Technical Exhibit 1 - CDRL A001.

1.10.1.1 Upon receipt of the Contractor's QCP, the MTF will review and provide comments to the Contractor. If the MTF finds deficiencies in any portion of the proposed QCP, the Contractor shall have five (5) business days to correct the deficiencies. The MTF COR will provide final approval of the QCP.

1.10.2 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).

1.10.3 This is a nonpersonal services Contract that supports the NMCP mission to oversee and coordinate the delivery of economical and effective medical, dental and other health care services. The autotransfusion services required by this Contract support the provision of patient care in the medical treatment facilities within the Area of Responsibility (AOR) and ensure services are available to beneficiaries. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

1.10.4 The services provided by the Contractor are provided in the capacity of an independent contractor. The government will evaluate the quality of services for purposes of contract inspection and acceptance. The Contractor shall be solely responsible for any and all liability caused by the acts or omissions of its agents or employees. The Contractor shall not in any manner represent or infer that it is an instrumentality or agent of the United States Government. The Contractor shall recognize that the Commanding Officer maintains administrative and operational responsibility for all activities within the Command and may take such actions as necessary to preserve and maintain the integrity of the Command, subject to the limitations prescribed by law and Defense Health Agency Regulations

1.10.5 The Contractor shall comply with applicable provisions of the law, rules and regulations of all governmental authorities, including but not limited to, the regulations and standards of the MTF. The Contractor shall adhere to and comply with all Defense Health Agency (DHA) and MTF Instructions and notices which may be in effect during the term of this Contract.

1.11 Contractor personnel

1.11.1 CAC requirements: For all contractors who will work in Government facilities, the Facilities Security Officer (FSO)/Company's Security point of contact (POC) will provide the Government all the required information per the DHA CAC request process current version 2.1, January 2018, or more recent when updated. See process attached at Part 7 Section 7.1.1 of the PWS. A CAC is the standard identification for eligible DoD contractor personnel.

1.11.1.1 The contractor shall return all CACs to the COR upon the departure of the contractor(s). The Contractor and all Contractor personnel shall comply with all MTF checkout processes. These processes include returning government property, i.e., identification badges, pagers, cellular phones, etc., to the MTF upon Contractor personnel’s last day of service. Failure to do so promptly may result in delay of payment to the Contractor.

1.11.2 Contractor onboarding and training. The contractor shall complete all requirements, training, and forms as prescribed in the following requirements:

1.11.2.1 The Contractor Appointed Personnel shall report to the COR on the first day of contract performance. The COR will provide direction for a proper check-in and any additional documentation or instructions that may be necessary for contract performance. The DHA’s “Onboarding Checklist for Contractor Employees” is located at the DHA Onboarding and Offboarding Portal at https://info.health.mil/cos/admin/hr/IO/SitePages/Home.aspx

1.11.2.2 The DHA’s contractor training instructions embedded at Part 7 Section 7.1.2.

1.11.2.3 The contractor shall comply with onboarding requirements of the DHA for contractors needing to be issued CAC identification, including DoD- and DHA-directed training and forms submission, prior to network access, as displayed in the In/Out-Processing Portal at: https://info.health.mil/cos/admin/hr/IO/SitePages/home.aspx (note: Public Key Infrastructure (PKI)-restricted, printed versions available).

1.11.3 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

1.11.4 Key control: RESERVED

1.11.5 Lock combinations: RESERVED

1.12 Key personnel (Contractor): The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the CO. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 0800 to 1700, Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons. Qualifications for all key personnel are listed below:

1.12.1Contract Manager and Alternate. The Contract Manager and Alternate must have the required schooling/training and certifications allowing them to operate the autotransfusion equipment during scheduled or emergent surgeries.

1.13 Data rights: RESERVED

1.14 Reporting

1.14.1 Contractor Manpower Reporting (CMR): RESERVED.

1.14.2 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 the 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.

1.14.3 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, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

1.15 Contractor Identification

1.15.1 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.

1.15.2 Contractor personnel shall 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.

1.15.3 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.

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

1.16.1 FSO/Company's Security POC shall notify the DHA Personnel Security Office after being awarded a contract that requires access to a DoD system. 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.

1.16.2 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.

1.17 Personnel Security

1.17.1 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 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:

1.17.1.1 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.

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

1.17.1.3 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:

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. The government employee responsible for negotiating changes in terms, conditions, or amounts cited in this Contract.

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. The government employee responsible for assuring the Contractor’s performance through audit, documentation, and liaison with the Contracting Officer. The COR is appointed in writing by the Contracting Officer. The COR has no authority to resolve disputes or obligate funds.

2.1.5 Non-personal 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.

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.

2.1.7 Additional Definitions:

ACTIVE-DUTY MEMBER: Full-time duty in uniformed service of the United States, including the United States Navy. This includes full-time training duty, annual training duty and attendance while in the active service at a school designated as a service school by law or by the Secretary of the Military Department concerned. It does not include full-time National Guard duty.

COMMANDER/COMMANDING OFFICER: The individual naval officer who has responsibility for the operation of the medical treatment facility (MTF) for which the contract services are provided.

CONTRACT EMPLOYEE: For the purpose of this Contract, “contract employee” means an individual employed by the prime or subcontractor.

CONTRACTOR: That entity or its representative responsible for the delivery of the services or materials specified in this contract, as designated by contract award.

DOCUMENT (verb): To completely, accurately and legibly record information, using prescribed forms or a computer terminal, as appropriate.

EQUIPMENT: A moveable object, such as a typewriter which is used to perform a procedure(s) that results in a work product.

JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS (JOINT

COMMISSION): A national organization dedicated to improving the care, safety, and treatment of patients in healthcare facilities; publishers of the Joint Commission Accreditation Manual for Hospitals and the Ambulatory Healthcare Standards Manual.

KEY PERSON: A skilled and experienced professional and/or technical person who is essential for successful accomplishment of the work to be performed under this Contract.

MAINTENANCE: The upkeep of buildings, fixtures, furniture, and/or equipment that is required to keep these items fully functional and/or to produce an acceptable level of performance or quality of operation.

MEDICAL TREATMENT FACILITY (MTF): Unless otherwise specified, "the MTF" refers to the Naval MTF at which services are being performed under this Contract. The MTF includes all activities providing outpatient and/or inpatient health services for eligible beneficiaries.

PERFORMANCE IMPROVEMENT (PI): An ongoing program designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems.

PROTOCOLS: Written procedures…