HT940624R0001 Combined Synopsis Amendment 2.docx

HT940624R0001

Amendment 2- Revised PWS

COMBINED SYNOPSIS/SOLICITATION HT940623R0014

Coagulation Hemostasis Analyzer DCSS/Laboratory Naval Medical Center Portsmouth Readiness and Training Center

This is a combined synopsis/solicitation for commercial services prepared in accordance with FAR 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice and FAR 13, Simplified Acquisition Procedures. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is HT940624R0001. The solicitation is issued as a Request for Proposal (RFP). Provisions and clauses in effect through Federal Acquisition Circular 2024-01 are incorporated. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at: https://www.acquisition.gov/.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334516, with a small business size standard of 1,000 employees. This requirement is being procured via full and open competition.

The Naval Medical Center Portsmouth, VA (NMCP) has a requirement for a firm fixed price contract the Lease of two (2)-Coagulation/Hemostasis Systems, Cost-Per-Reportable Agreement, Consumables (reagents) and Maintenance Support Services. The solicitation will result in one (1) firm fixed price contract.

The estimated period of performance is outlined below:

Base Period: 01 April 2024 to 31 March 2025

Option Period 5: 01 April 2029 to 30 September 2029

The scope of the requirement is listed in the Performance Work Statement (PWS). Naval Medical Center Portsmouth, VA (NMCP) requests responses from qualified sources capable of providing services outlined in the Performance Work Statement (PWS).

ADMINISTRATIVE INFORMATION

Contracting Officer: Lorri J. Loveland, lorri.j.loveland.civ@health.mil Contract Specialist: Peggy Suever, margaret.a.suever.civ@health.mil The closing date of the solicitation can be found in ADDENDUM to 52.212-1 – INSTRUCTIONS TO OFFERORS – COMMERCIAL ITEMS

The evaluation criteria can be found in ADDENDUM to 52.212-2 – EVALUATION – COMMERCIAL ITEMS

Attachment I: Addendum to 52.212-1

INSTRUCTIONS TO OFFERORS

1. SPECIFIC REQUIREMENTS. This requirement is for commercial, non-personal services and will result in a Firm Fixed-Price type contract. Performance requirements are provided in the Performance Work Statement (PWS) of this solicitation which also includes the Quality Assurance Surveillance Plan (QASP) that indicates how the Contractor will be assessed throughout contract performance by the Government.

2. PERIOD OF PERFORMANCE:

Base Period: 01 April 2024 to 31 March 2025

Option Period 5: 01 April 2029 to 30 September 2029

3. PROPOSAL SUBMISSION INSTRUCTIONS:

a) POINT OF CONTACT (POC):

Proposal shall be sent via e-mail to the POC for this requirement, POC: Peggy Suever, Contract Specialist E-MAIL: margaret.a.suever.civ@health.mil

The Offeror is responsible for ensuring receipt by the POC.

b) QUESTION AND ANSWERS: All questions shall be addressed in writing and submitted electronically to Mrs. Peggy Suever at margaret.a.suever.civ@health.mil and Mrs. Lorri Loveland at lorri.j.loveland.civ@health.mil. Questions shall be submitted no later than 10:00 am Eastern Standard Time; 03 January 2024.

c) PROPOSAL DUE DATE: No Later Than 10:00 am Eastern Standard Time; 15 January 2024.

d) ELECTRONIC SUBMISSIONS: Proposal information shall be electronically submitted to the POC listed above. Proposal content shall be no smaller than Times New Roman font 12 pitch; Exhibits, graphics, charts, captions, etc., shall be no smaller than Times New Roman font 10 pitch. Your submission as a minimum, shall show –

1. Coversheet (Solicitation # HT940624R0001)

1. Table of Contents

1. Signatory official/contractor POCs

1. Technical Capability - maximum three (3) page limit

1. Past Performance Project Summary Sheet (Exhibit 1)

1. Past Performance Questionnaire (Exhibit 2)

1. Pricing Sheet (Exhibit 3)

1. Price and any discount terms (if applicable)

1. Fill out and submit the following:

8. FAR 52.209-11

8. FAR 52.204-24

8. FAR 52.204-26

8. FAR 52.212-3 Alt I

8. FAR 52.219-28

1. A technical description of the items/services being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary.

NOTE: Offeror’s proposal must include a statement that the pricing shall remain valid for a minimum of 90 calendar days from the date of submission.

Factor 1: Technical Capability

The Offeror MUST provide a written proposal that clearly reflects the technical capability to perform the services and their understanding of the requirements set forth in the performance work statement (PWS). Proposal MUST be clear, coherent, and prepared in sufficient detail for effective evaluation of the Offeror’s proposal against the evaluation criteria. The Government will evaluate only one (1) proposal from the prime Offeror and maximum page limit for Technical Capability is three (3) pages.

The Government will not accept alternative proposals. Pages MUST be numbered consecutively throughout the document and not by sections.

Factor 2: Past Performance

The Offeror shall submit a Project Summary Sheet (PSS), Exhibit 1. The PSS requires the contractor to identify contracts or task orders that will be evaluated in accordance with the evaluation criteria identified in the Addendum to FAR 52.212-2 EVALUATION CRITERIA.

Factor 3: Price

The Offeror’s proposed price will be evaluated/analyzed separately from Technical Capability. Offeror MUST propose pricing for all CLINs 0001 – 5001 via Exhibit 3, Pricing Sheet. Offeror’s Proposal must include a statement that the pricing shall remain valid for a minimum of ninety (90) calendar days from the date of submission.

Price will be evaluated in accordance with FAR 12.209 and 13.106-3 for fair and reasonableness in terms of:

- Pricing is proposed based on level of effort within the solicitation

- Pricing is proposed for all CLINs

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful Offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

Other instructions:

Offeror MUST fill out and submit all applicable FAR and DFARS clauses and provisions.

Attachment II: Addendum to 52.212-2

EVALUATION CRITERIA

(a) The Government will award a contract resulting from this solicitation to the Offeror conforming to the solicitation when technical capability, past performance, and price are considered. The following factors will be used to evaluate the offer:

Order of Importance:

(i) Technical Capability

(ii) Past Performance

(iii) Price

b) Complete and return Exhibit 3, and include a breakdown of the cost, including lease of equipment, maintenance of equipment, reagents, shipping, and handling, for the pricing proposal to be considered complete.

Basis for Award: Award of this requirement will be made on a best value basis, technical capability, past performance, and price considered. The Government intends to award without discussions. The Government reserves the right to hold discussions if deemed necessary. The Offeror MUST provide their best complete proposal upon initial submission.

The Government evaluator(s) will not assume that the Offerors possess any capability or knowledge unless it is specified in the proposal. If Technical Capability received an individual rating of “unacceptable” the collective overall rating will also be “unacceptable.” Only a proposal receiving an overall rating of “acceptable” will be further considered for award.

Factor 1: Technical Capability Technical Capability will be evaluated to the degree to which Offeror demonstrates overall ability to perform the services and their understanding of the requirements set forth in the performance work statement (PWS).

Factor 2: Past Performance Past Performance evaluation considers each offeror’s demonstrated recent and relevant record of performance in supplying services that meet this contract’s requirements. There are three aspects to the past performance evaluation: recency, relevancy and quality (including general trends in contractor performance and source of information).

Recency: The first aspect to be evaluated is recency. To be considered recent, the offeror’s past performance references must have been completed not more than 3 years prior to the posting of this combined synopses/solicitation. Past performance will be assigned a value of Recent or Not Recent. If an offeror’s past performance reference has been assigned a value of Not Recent, it will not be further evaluated.

Relevancy: The second aspect to be evaluated is relevancy. To be considered relevant, the offeror’s past performance references must be for Coagulation/Hemostasis Systems, Cost-Per-Reportable agreement to include Consumables and Maintenance Support Services. Past performance will be assigned a value of Relevant or Not Relevant. If an offeror’s past performance reference has been assigned a value of Not Relevant, it will not be further evaluated.

Quality of Performance: The third aspect to be evaluated is the overall quality of the offeror’s past performance. During this evaluation, information will be collected regarding the level of performance provided for each past performance reference. The Government reserves the right to use information obtained from any sources available to the Government, to include, but not limited to, CPARS, 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.

Based on the offeror’s recent/relevant past performance record, the Government will assign an overall Performance Confidence Assessment rating as described in the below table.

PERFORMANCE CONFIDENCE ASSESSMENTS

In the case of offerors for which there is no information on past contract performance or where past contract performance information is not available, the offeror may not be evaluated favorably or unfavorably on the factor of past contract performance. In this case, the offeror’s past performance is unknown and assigned a performance confidence rating of “Neutral.”

Factor 3: Price Price will be evaluated/analyzed separately from Technical Capability. Price will be evaluated in accordance with FAR 12.209 and 13.106-3 for fair and reasonableness in terms of:

- pricing is proposed based on level of effort within the solicitation

- pricing is proposed for all CLINs

(b) Price will be evaluated for:

Exhibit 1 - 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:

Exhibit 2 – 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 HT940624R0001 is for non-personal services; Lease of two (2)-Coagulation/Hemostasis Systems, Cost-Per-Reportable Agreement, Consumables (reagents) and Maintenance Support Services in support of 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 Monday, 15 January 2024 via email to margaret.a.suever.civ@health.mil. Please reference “Solicitation HT940624R0001” 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 Requirement

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.

CPARS “Quality of Service” Rating Area

Assess the achieved product performance relative to performance parameters required by the contract/order(ie., Assess compliance with all terms and conditions in the contract/order relating to quality)

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

CPARS “Schedule” Rating Area

Assess compliance with all terms and conditions in the contract/order relating to schedule

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

CPARS “Management” Rating area

Assess the integration and coordination of all activity needed to execute the contract/order, specifically timeliness, completeness and quality of problem identification, corrective action plans, customer satisfaction

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

CPARS “Regulatory Compliance” Rating area

Assess compliance with all terms and conditions in the contract/order relating to applicable regulations and codes. (ie., AQL requirements as outlined in the QASP)

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.

Department of Defense Defense Health Agency Performance Work Statement

Coagulation Hemostasis Analyzer DCSS/Laboratory Naval Medical Center Portsmouth Readiness and Training Center

Solicitation Number: HT940624R0001 Version: 1 Date:

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide the Lease of two (2)-Coagulation/Hemostasis Systems, Cost-Per-Reportable Agreement, Consumables (reagents) and Maintenance Support Services for Naval Medical Center Portsmouth.

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 [for Lease of two (2)-Coagulation/Hemostasis Systems, Cost-Per-Reportable Agreement, Consumables (reagents) and Maintenance Support 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: The Laboratory performs Hemostatic testing. These tests help identify patients with hemostatic defects that could cause excessive bleeding. Screening tests are available for each of the three phases of hemostasis: coagulation (fibrin clot formation), platelet plug formation, and fibrinolysis.

CPU Monitor

CPU

CPU Keyboard CPU Symbol Barcode Scanner CPU Brother Printer

1.3.1.3 Analyzer #2

CPU Monitor

CPU

CPU Keyboard CPU Symbol Barcode Scanner CPU Brother Printer

1.3.1.4 The analyzers will be for daily routine test (PT/PTT/Fibrinogen/Thrombin Time/D-Dimer) and special testing(remaining assays) 2-3 days per week.

1.3.1.5 Supplied equipment shall be for the use of the Naval Medical Center Portsmouth (NMCP) Main Laboratory

1.4 Objectives: Contractor to provide lease of two (2)-Coagulation/Hemostasis Systems, Cost-Per-Reportable agreement to include Consumables and Maintenance Support Services for Naval Medical Center Portsmouth- Coagulation Laboratory Department for an estimated test volume to be defined as PT test of 23,064 and PTT test of 16,044.

1.5 Scope: lease of two (2)-Coagulation/Hemostasis Systems, Cost-Per-Reportable agreement to include Consumables and Maintenance Support Services. The contractor shall provide lease of two (2)-Coagulation/Hemostasis Systems, Cost-Per-Reportable agreement to include Consumables and Maintenance Support Services for Naval Medical Center Portsmouth- Coagulation Laboratory Department for an estimated test volume to be defined as PT test of 23,064 and PTT test of 16,044.

The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform delivery, install, analytical validation and technical support as defined in this Performance Work Statement (PWS).

Contactor to warrant that all supplied items are free of manufacturer defects. Contractor shall repair / replace any unsatisfactory items at Contractor’s expense.

Contractor price shall be inclusive of all cost including lease of equipment, maintenance of equipment, reagents, shipping and handling.

1.6 Period of Performance (PoP):

Base Period: 01 April 2024 to 31 March 2025

Option Period 5: 01 April 2029 to 30 September 2029

1.6.1 Transition: Transition-in/transition-out period

1.6.1.1 Transition-in period: Full performance start date is 01 April 2024. Transition-in begins once the contract is awarded, when the awardee shall commence to implement the contract with minimal issues or disruptions to the agency, including extended delay to scheduling services. 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 7 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. N/A

1.6.1.2 Transition-out period: The transition-out plan shall facilitate the accomplishment of a seamless transition from the incumbent to an incoming contractor/Government personnel at the expiration of the contract.

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

Naval Medical Center Portsmouth Attn: Hematology Laboratory Department 54 Lewis Minor Street

BLDG. 250

Portsmouth, VA 23708-2297

1.7. Recognized Federal holidays: The Contractor is not required to perform services on the day of observance of Federal Holidays.

1.7.3 Hours of operation: The contractor is responsible for conducting business 0700 -1700 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. 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. The Laboratory is open 24 hours, 7 days a week.

1.7.4 Emergency Services: On occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours. In this instance, NMCP contracting officer shall be engaged to determine if an emergency Purchase Order is required before services are requested or not provided by Contractor.

1.8 Contractor travel: None

1.9 Other Direct Costs (ODC): N/A

1.10 Quality

1.10.1 Quality Control (QC): N/A

1.10.2 Quality assurance (QA): N/A

1.11 Contractor personnel

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 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. N/A

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). N/A

1.11.2.4 DHA’s new employee handbook at Part 7 Section 7.1.4

N/A

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: The contractor shall establish and implement methods of making sure all keys/key cards issued to the contractor by the Government are not lost or misplaced and are not used by unauthorized persons. NOTE: All references to keys include key cards. No keys issued to the contractor by the Government shall be duplicated. The contractor shall develop procedures covering key control that shall be included in the Quality Control Plan (QCP). Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas. The contractor shall immediately report any occurrences of lost or duplicate keys/key cards to the CO.

1.11.4.1 In the event keys, other than master keys, are lost or duplicated, the contractor shall, upon direction of the Contracting Officer (CO), re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from the monthly payment due the contractor. In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the monthly payment due the contractor.

1.11.4.2 The contractor shall prohibit the use of Government issued keys/key cards by any persons other than the contractor’s employees. The contractor shall prohibit the opening of locked areas by contractor employees to permit entrance of persons other than contractor employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the CO.

1.11.5 Lock combinations: The contractor shall establish and implement methods of ensuring that all lock combinations are not revealed to unauthorized persons. The contractor shall ensure that lock combinations are changed when personnel having access to the combinations no longer have a need to know such combinations. These procedures shall be included in the contractor’s QCP.

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 8:00 a.m. to 4:30 p.m. Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons. Qualifications for all key personnel are listed below:

N/A

1.13 Data rights: N/A

1.14 Reporting: N/A

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 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.

1.14.4 Post award conference/periodic progress meetings: The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The CO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the CO will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

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 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.

1.15.3 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.

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

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

2.1.2 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.

2.1.3 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.

2.1.4 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:

2.3 Applicable Publications, DHA Administrative

2.3 Applicable Publications, DHA Administrative Instructions (AI), etc. N/A

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:

Not Applicable

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: The Contractor:

Will not provide Contractor Furnished Services in support of this contract/task order. As a result, this paragraph is N/A.

PART 5

5.0 SPECIFIC TASKS

System Support:

5.1 The Contractor shall provide system installation, validation, and correlation.

5.2 The Contractor shall provide validation of the equipment following installation with assays that the vendor has proved the efficiency of the assays they are marketing and using for validation purposes and that they have met the approval of FDA to provide means to identify errors or “defects” and reduce variability in reporting results.

5.3 Contractor shall provide overlap equivalent to a (3) month timeframe to allow validation either in comparison equipment due to upgrades and or new Contractor.

5.4 Contractor shall provide at no cost to Government the moving and/or relocation of equipment due to renovation and upgrades to the laboratory department.

5.5 The Coagulation system shall be currently authorized (Authority to Operate) as capable with Military Health System (MHS) Genesis.

5.6 The contractor shall provide on-site operator training for Government personnel upon initial implementation for the base year and for each option year exercised. The training shall include initial system user training for all staff members, and user training for a minimum of two (2) staff members for each additional option year.

5.7 The contractor shall provide yearly off-site training for key operator staff excluding travel, lodging, meals, expenses, and incidentals.

5.8 On-site assistance during system validation shall be provided.

Maintenance:

5.9 The Contractor Field Service Engineers shall be original equipment manufacturer (OEM) trained, experienced, and English-speaking personnel. The Contractor shall provide all labor, tools, diagnostic equipment, software, material, supplies, transportation, parts and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST), and corrective maintenance (CM).

5.10 The Contractor shall provide telephonic communications to discuss technical matters relating to the performance of this contract. An English-speaking systems operator shall be made available to answer technical questions regarding system operations and applications.

5.11 Equipment listed in this contract shall be maintained to meet and retain the OEM’s specifications and/or equipment certification.

Preventive Maintenance and Corrective Maintenance Services:

5.12 Normal Business Hour Maintenance Coverage will be Monday through Friday, between 8:00 A.M. to 5:00 P.M. EST. Contractor shall provide full-service preventive maintenance.

5.13 Preventive maintenance shall be performed in accordance with Original Equipment Manufacturer recommendations.

shall be in compliance with The Joint Commission (JC), OEM, the College of American Pathologist’s (CAP), and Food and Drug Administration (FDA), and National Institute for Standards and Technology (NIST) standards.

5.16 Contractor shall provide on-site corrective maintenance between the hours of 8:00 A.M. and 5:00 P.M. EST, Monday-Friday, to include unlimited service calls. Telephonic support shall be available 24 hours per day, 7 days per week, 365 days a year, excluding Federal Government holidays, which are identified online at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay.

5.17 A Contractor service technician shall respond via telephone within two (2) hours after receipt of trouble call and provide on-site service within twenty-four (24) hours. Equipment shall be operational within forty-eight (48) hours of the initial trouble call. Government request for corrective maintenance will be placed by NMC Portsmouth Biomedical Engineering Division (BIOMED) personnel, to the Contractor. Corrective maintenance shall be completed during the hours specified in the contract. The Contractor’s response to requests for service may include telephone consultation with the equipment user/operator and a Contractor Field Service Engineer (FSE). Telephone consultation 1) shall provide instruction in determining operator error; 2) shall determine the most likely cause of the problem; 3) shall determine if resolution of the problem requires the dispatch of a Field Service Engineer (FSE); and 4) should identify replacement parts likely to be required to return the equipment to 100% operational condition as specified by the OEM.

The Contractor's pricing shall be inclusive to include all parts, consumables, labor, travel, and shipping associated with performing corrective maintenance on the system as well as any other costs associated with performing corrective maintenance on equipment that utilizes water and or sewage, including the cost of water utilized by Contractor during corrective maintenance and any drainage costs associated with that water.

The Contractor FSE shall have his/her own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation and repair of all equipment included in this contract.

Uptime:

5.18 Equipment shall be returned to operational condition within 48 hours after telephone notification from BIOMED. The Contractor shall maintain an overall uptime rate of 95% or better for all equipment.