Amendment No 0002.pdf

W40M USA HCA

MEDICAL READINESS CONTR OFFICE WEST

POC: TAMMI R. LAMBERT

3160 MCINDOE, BLDG 1103

FORT SAM HOUSTON TX 78234

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to provide a revised Statement of Work, dated 8 November 2023. The request for quote deadline is now 15 November 2023. POC: Tammi Lambert, tammi.r.lambert.civ@health.mil

1. CONTRACT ID CODE PAGE OF PAGES

J 1 34

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 08-Nov-2023

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street , County, State and Zip Code) X W81K0024Q0001

X 9B. DATED (SEE ITEM 11)

20-Oct-2023

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

08-Nov-2023

CODE

W40M USA HCA

MEDICAL READINESS CONTR OFFICE WEST

3160 MCINDOE BLDG 1103

JBSA FT SAM HOUSTON TX 78234-4504

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

W81K0024Q0001

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

ADDENDUM TO 52.212-1

Offerors shall submit quotes in electronic form via email no later than 3:00PM, Central Standard Time, 15 November 2023. The point of contact for this solicitation is the Contract Specialist Tammi R. Lambert, tammi.r.lambert.civ@health.mil and the Contracting Officer J. Chris Finkenstadt, john.c.finkenstadt2.civ@health.mil.

Offers shall be submitted via e-mail only. Quotes received after 3:00 P.M., CT on 15 November 2023 will be late and will not be considered for award. Failure to submit the required documentation as specified in the following paragraphs will make the Offeror non-compliant and ineligible for award. It is vital that Offerors follow instructions provided and adhere to page limits specified.

Questions shall be submitted in electronic form via email no later than 2:00PM, Central Standard Time, 27 October 2023. No questions will be entertained after this date. Do not submit multiple emails for questions. The point of contact for this solicitation is the Contract Specialist Tammi R. Lambert, tammi.r.lambert.civ@health.mil and the Contracting Officer J. Chris Finkenstadt, john.c.finkenstadt2.civ@health.mil. Answers to the vendors questions will be posted to SAM.GOV.

(a) To assure timely and equitable evaluation of quotations, quoters must follow the instructions contained herein.

Quoters are required to meet all solicitation requirements, including terms and conditions, representations and certifications, and technical requirements, in addition to those identified as evaluation factors. Failure to meet a requirement may result in an offer being ineligible for award. Quoters must clearly identify any exceptions to the solicitation terms and conditions and provide complete accompanying rationale.

(b) Submission of quotes. Submit quotes, to include all fill-in clauses to the office specified in this solicitation at or before the exact time specified in this solicitation.

(c) Address any questions, clarifications or concerns you may have via email to: Ms. Tammi Lambert at tammi.r.lambert.civ@health.mil and J. Chris Finkenstadt at john.c.finkenstadt2.civ@health.mil .

(d) Exceptions taken to terms and conditions of the RFQ, to any of its attachments, or to other parts of the RFQ shall be identified. Provide rational in support of the exception and fully explain its impact, if any, on the performance, schedule, cost and specific requirements of the RFQ. Failure to comply with the terms and conditions of the RFQ may result in the quoter being removed from consideration for award.

Quoter(s) is(are) required to include a completed copy of the provisions at 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services, with their quote. A quoter shall complete only paragraph (b) of this provision if the contractor has completed the annual representations and certifications electronically via http://www.sam.gov. If a quoter has not completed the annual representations and certifications electronically at the SAM website, the contractor shall complete only paragraphs (c) through (o) of this provision.

The Government will award a single contract resulting from this RFQ to the responsible quoter whose supplies are technically acceptable and quotes the lowest overall price.

The clause at 52.212-4, Contract Terms and Conditions – Commercial Products and Commercial Services, applies to this acquisition and also Addendum to FAR 52.212-4.

The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Deviation), all FAR clauses cited in the clause are applicable to the acquisition.

Offerors shall submit their quotes in separate volumes consisting of Volumes I - IV. Volume I –Administrative, Volume II – Technical Capability, Volume III –Price and Volume IV – Subcontracting Plan. No pricing data shall be included in Volume I, II. and IV. Each subfactor under Volume II shall be separately tabbed and addressed in sufficient detail so that the government may evaluate each subfactor independently. Instructions to complete each volume are provided below. Page limitations are as follows:

VOLUME TITLE NUMBER OF DIGITAL &

ELECTRONIC COPIES

PAGE

I ADMINISTRATIVE 1 EACH – MS WORD OR PDF N/A

II TECHNICAL CAPABILITY 1 EACH – MS WORD OR PDF (Includes subfactors)

III PRICE 1 EACH – MS WORD, EXCEL or PDF N/A

IV SUBCONTRACTING PLAN 1 EACH – MS WORD or PDF 10

The quote shall not exceed the limits stated at the table above. If the page limits are exceeded, the pages in excess of the limit shall be removed and unread. The Government will not accept any changes to the offeror’s Quote after the closing date of the solicitation.

Page limit includes all appendices, charts, graphs, diagrams, tables, photographs, or drawings. Page limit does not include covers for volumes, tables of contents, glossary of abbreviations and acronyms, indices, title pages, cross reference indices, and section dividers/tables if they are inserted solely to provide ease to the reading in locating parts/sections. Pages will be counted if they contain any other information, i.e., diagrams or extraneous data. Pages marked “this page intentionally left blank” will not be counts.

What counts as a Page. A page shall be an 8 ½ x 11 sheet of paper. Letter size and spacing requirements for illustrations and tables can be at the discretion of the offeror but must be easily readable. Margins shall be at least 1 inch on the top and bottom and ¾ inch on the side. The offeror shall number each page in order to eliminate any confusion. In the event an offeror creates an ambiguity in their numbering of pages, the Government may exercise its own discretion in counting pages.

Volume I - Administrative

Administrative: Within the Administrative volume, offerors shall ensure that the original solicitation SF 1449, Blocks 12, 17A (with offeror's name, address, and telephone number), and 30A – C, are completed in their entirety.

Offerors shall also acknowledge each amendment by completing each SF 30, Blocks 8 and 15A - C, if any are issued. The Quote shall also have a title page identifying the Offeror; offeror's CAGE code and Unique Entity Identifier (UEI) number; the full address, and phone numbers of the Offeror; points of contact (POCs) authorized to negotiate with the Government on the offeror's behalf; the solicitation number; a statement confirming the Offeror is willing to hold its prices firm for at least 120 days from the date specified for receipt of offers; and the Quote contents (which may be included on a second page, if necessary).

Registrations and Certifications: Offeror shall be registered in the System for Award Management (SAM) with the appropriate NAICS Code and shall not have any Active Exclusions listed within SAM. If the Offeror is currently registered in SAM with completed representations and certifications, an affirmation on the title page (or second page) that these representations and certificates are current, complete, and accurate as of the date Quotes are due shall suffice. Otherwise, the Offeror shall include one (1) copy of the following provisions located within this solicitation shall be completed and included with the Quote: FAR Provision 52.212-3 (Dev), Offeror Representations and Certifications (DEC 2022) Deviation 2023-O0002; (2) FAR Provision 52.209-7, Information Regarding Responsibility Matters (JUL 2013); and any other applicable provisions herein.

Quote Submission: Quote must be received by the date and time listed on page 1, block 8 of this solicitation. Quote received after this time will be considered late and shall not be evaluated.

Volume II - Technical Capability

Factor 1 - Technical Capability:

The technical quote shall address each of the subfactors in sufficient written detail for the Government to determine if the Offeror understands the technical aspects of the Government’s requirement. Offerors shall demonstrate how their proposed items comply with the Government’s Statement of Work via the submission of a written capability statement, product literature, or other materials.

Subfactor 1A: Statement of Work Salient Characteristics (SOW Ref Attachment 1).

Subfactor 1B: Performance Requirement Summary (SOW Ref 11.1, Table 5).

Volume III – Price

Factor 2 – Price:

Offerors shall submit proposed pricing for all contract line-item numbers identified in the Solicitation Schedule, unless otherwise noted. Include the price per unit of measure, and total extended price for each contract line-item number. Offerors shall also complete the pricing matrix contained at Attachment 1 - Pricing Worksheet in Excel format and shall provide a price for each CLIN in the pricing worksheet, not to exceed the hundredths decimal point.

Ordering Period. The Government will evaluate offers for award purposes by adding the total price for each ordering period to the total price for the basic requirement. The Government may determine that an offer is Unacceptable if the ordering periods are significantly unbalanced.

Volume IV – Subcontracting Plan

Factor 3 - Subcontracting Plan:

The offeror shall submit a Subcontracting Plan with their quote. If the offeror already has a current Commercial Subcontracting Plan approved by a Government Contracting Officer, that plan (along with corresponding approval) is sufficient for submission. If the offeror does not believe any subcontracting opportunities exist, an explanation with supporting documentation shall be submitted.

(End of Addendum to 52.212-1)

STATEMENT OF WORK

Statement of Work (SOW) - Chemistry and Immunoassay Testing Revised 8 November 2023

Statement of Work - Chemistry and Immunoassay Testing

1. General Requirements:

1.1 Description of Work: The contractor shall provide two (2) Leased Automated Chemistry and Immunoassay Integrated Analyzer Systems, and all required chemical and immunological reagents for testing of various diseases. The Contractor shall provide Chemistry /Immunoassay Testing under a Cost Per Reportable Result (CPRR) agreement to include equipment, reagents, tools, materials, training, and water purification system (if applicable), Uninterruptable Power Supply (UPS) and services necessary to meet the Chemistry and Immunochemistry testing and analysis requirements for Bayne Jones Army Community Hospital (BJACH), at Fort Johnson, Louisiana. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays as well as any application or software licenses necessary to run the testing/analyzer. Initial Method Validations per CLIA/NCCLS/DPALS QM guidelines, to include method correlation, linearity verification to maximum dilution, precision, carry-over, normal reference range validation, serum/plasma and blood collection tube validation, initially and with each new assay and/or conversion and for trouble-shooting purposes. Validation Study criteria to be established by Director. Vendor to provide review to Director for acceptability and approval of all assays prior to proceeding with Clinical Testing. To include analyzer decontamination when necessary and removal of all instruments at the termination of the contract. The analyzer systems shall provide users with rapid, reliable test results that are critical for patient care. The Contractor shall be responsible for maintenance service, on-site repair and parts as required in order to maintain a minimum 98% uptime for all instrumentation. All testing materials to include reagents, equipment, etc., must be FDA approved platforms. All costs will be calculated on a cost per reportable result based on estimated patient volume and test type listed in Attachment 1.

Period of Performance duration will be from 01 April 2024 to 31 March 2029 plus four option years.

Base Year: 01 April 2024 thru 31 March 2025 Option Year 1: 01 April 2025 thru 31 March 2026 Option Year 2: 01 April 2026 thru 31 March 2027 Option Year 3: 01 April 2027 thru 31 March 2028 Option Year 4: 01 April 2028 thru 31 March 2029

1.2 Chemistry and Immunochemistry Analyzer Equipment – The contractor shall provide a Chemistry and Immunochemistry System that is fully automated capable of linear integration and have discrete random-access capabilities for chemistry, immunometric, potentiometric, and colorimetric assays within the same instrument. The system shall be capable of performing all the required tests and assays listed in Attachment 1. The system shall provide dual redundancy (to ensure continuous operations), training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment. Contractor will provide all printers associated with the chemistry analyzer. All equipment displays and supporting literature shall be in the English language. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial Method Validations per CLIA/NCCLS/DPALS QM guidelines and analyzer removal at the termination of the contract.

1.3 For the purposes of these performance requirements, the Chemistry analyzer system includes at a minimum:

- Peripherals (e.g., instrument specific computer terminals and CPUs, printers, toner etc.)

- Uninterruptable Power Sources (UPS)

- Bidirectional Track

- Water purification system (not required for the analyzers using dry technology)

1.4 The two analyzers shall be determined by the minimum throughput, available menu requirements, patient acuity, ability to continually operate for 12-hrs without having to stop to load reagents or consumables and must fit within existing space of 600(ft2)-Main Core Lab allowing for existing benches, half-wall(s), offices, and minimal to no renovations. Single-day Site evaluation to be provided which allows vendor to check the current layout, size, space, and infrastructure of the lab in person.

1.5 Minimum actual through-put shall be: 600 tests per hour for immunometric assays, 1600 tests per hour for enzymatic/rate and colorimetric/photometric assays and 2000 tests per hour for ISE assays.

1.6 Each analyzer shall be a random access, discrete analyzer system with STAT interrupt capability and a primary tube sampling system capable of handling 100mm x 16mm, 100mm x 13mm, 75mm x 13mm, 64mm x 10.25 and 46mm x 10mm (microtainer) test tubes with standard or Hemogard caps and screw caps. The analyzer will be capable of accommodating both Becton- Dickinson and Greiner tubes.

1.7 These analyzer systems shall be capable of performing in low, medium, and high-volume work periods to produce results that are accurate and precise.

1.8 Analyzer throughput shall be measured as a function of number of STAT panels (see Table 1) fully completed in 30-minutes.

1.9 The test types and annual estimated volumes for each area are illustrated in the Tables 1 through 4 and Attachment 1

1.10 An explanation and illustration for Contractor Performance Requirements Summary is in table 5; Performance/Quality Standards for the chemistry/immunoassay analytes is in table 6.

1.11 The 30-min STAT panel includes the assays listed in Table 1. These assays shall be analyzed from the same specimen with a maximum turn-around-time (automated pre-analytical processing to certification) of 30 minutes.

Table 1 – Assays that must be completed from the same specimen within 30 minutes as a STAT panel Acetaminophen Alanine Amino Transferase (ALT) Albumin

Creatinine Kinase, Total (CK) Glucose Alkaline Phosphatase

Ammonia (NH3) Amylase Aspartate Amino Transferase (AST) Bilirubin (Direct/Conjugated) Bilirubin (Total) NTproBNP or BNP

Chorionic Gonadotropin (hCG) Methotrexate Myoglobin Potassium Protein, Total Salicylate

Calcium (Total) Sodium

Carbon Dioxide (CO2) Theophylline Chloride Troponin-T or high sensitive Troponin Creatinine, enzymatic Digoxin

Parathyroid Hormone Phenytoin Phenobarbital Phosphorous Procalcitonin

Urea Nitrogen Magnesium Lactate Lipase Thyroid Stimulating Hormone Vancomycin C-reactive Protein Ethanol

2. Reagents and Inventory Management

2.1 The analyzer shall have the on-board ability to maintain reagents at the proper storage temperatures for the assays listed in Performance Requirements. On-board stability for chemistry and immunochemistry assays should provide for minimal reagent changes. On-board stability to be evaluated per assay. All assays shall be FDA approved.

2.2 The analyzer shall be capable of maintaining calibration curves for all the assays listed in Performance Requirements simultaneously. Assays must have a minimum calibration stability of greater than 10 days for Chemistry and Immuno-chemistries. Calibration stability to be evaluated per assay.

2.3 The assays listed in Table 2 below shall be approved by the FDA for plasma as well as serum samples. In addition, the Contractor shall clearly demonstrate an acceptable correlation between plasma and serum values during the initial set up and validation studies. Whole blood HbA1c without pretreatment must be available for random access testing. Serum indices required for all testing.

2.4 The contractor shall provide minimum specimen volume requirements. Minimum specimen volume requirements to be evaluated per assay and panel, with and without dead-space requirements.

2.5 The contractor shall sequester the required calibrator, quality control material, and reagents to ensure no more than (4) lot changes per contract year.

2.6 The analyzers provided shall have the capability to add/change out reagents/reagent packs with only a minimal operational interruption/minimal calibration requirements/minimal quality control requirements (i.e., shall allow the user to calibrate any assay, remove the assay reagents/reagent packs for a period of undetermined time, and then reload the reagents/reagent packs during operation to run the assay without the need for recalibration. The analyzer must allow for loading of reagent packs during operation, intermittently and unscheduled.

2.6.1 The analyzer systems shall provide open channels to accommodate third party assays, e.g., Glucose-6-phosphate Dehydrogenase (G6PD). The Contractor shall provide consumables, reagent containers, etc. in sufficient quantities and quality to perform these assays. Volume listed in Table 3 Reference Lab.

2.6.2 The contractor shall deliver reagents no later than one (1) week following request for products/supplies. Standing Order schedules for routine delivery of supplies to be defined by Laboratory with no additional charges for revisions.

2.6.3 The contractor shall provide Inventory Program or System for continuous monitoring and management of all reagents, consumables and necessary supplies and their utilization.

Table 2 - Assays That Must be Approved for Use with Plasma and Serum Samples Acetaminophen Alanine Amino Transferase (SGPT) Albumin Alcohol (Ethanol) Alkaline Phosphatase Ammonia Amylase Anti HCV Aspartate Amino Transferase (SGOT) Bilirubin (Direct) Bilirubin (Total) B12 Calcium (Total) Carbamazepine Carbon Dioxide (CO2) Chloride Cholesterol Cortisol, Total C-Reactive Protein (CRP) C-Reactive Protein, High Sensitivity (HS-CRP) Creatinine Creatinine Kinase (CK) Total Creatinine Kinase MB Fraction (CK-MB) Digoxin

DLDL

Estradiol Ferritin Folate

FSH

fT4 Gentamicin Glucose Glutamyl transferase, Gamma (GGT) Gonadotropin, Chorionic (hCG) BhCG and Intact

HAVAB-M

HBsAg HBcAb High Density Lipoprotein (HDL) Homocysteine

Iron Lactate (Lactic Acid) Lactate (Dehydrogenase) (LDH)

LH

Lipase Lithium Magnesium Methotrexate Myoglobin NT proBNP or BNP Phosphorus Inorganic (Phosphate) Potassium Procalcitonin Progesterone Prolactin Protein, Total PTH (must be validated for Intra-operative use) Salicylate Sodium Theophylline Thyroid Specific Hormone (TSH) Transferrin Triglycerides Troponin I or T; High Sensitivity Troponin I or T Urea Nitrogen Uric Acid Vancomycin Vit D 25OH

The assays listed in Table 3 shall be approved by the FDA for urine samples.

Table 3 – Listing of Assays That Must be Approved for Use with Urine Samples Amylase Calcium (Total)

Potassium Protein, Total

Chloride Creatinine

Phosphorus Inorganic (Phosphate)

Glucose Magnesium Microalbumin (Quantitative)

Sodium Urea Nitrogen Uric acid

The assays listed in Table 4 shall be approved by the FDA for CSF and Body Fluid samples.

Table 4 – Listing of Assays That Must be Approved for Use with CSF and Body Fluid Samples

Glucose Protein Lactate

2.7 Mid-Low Patient Testing Volume Analytical Systems

2.7.1 Chemistry System should have ability to perform >= 300 tests per hour depending on method mix. Provide STAT testing capabilities. Allow for multiple tube sizes on same rack without use of adaptors. Provide clot, liquid level detection. Low specimen carryover with minimal requirements for reagents, calibrations and quality control.

2.7.2 Immunoassay System shall perform 60-100 tests per hour, allow loading of 20-40 patient samples with STAT capabilities.

2.7.3 Immunoassay System shall allow liquid ready to use reagents – that do not require pretreatment. Provide large menu for Immunoassay reagents to be tested.

2.7.4 Reagent assays must have valid biotin tolerance threshold of 30 nanograms per ml or higher.

3. Maintenance and Service

3.1 ANCILLARY MAINTENANCE. The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the systems at all locations at a 98% uptime guaranteed. The Contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot and remedy the reasons for the analyzer failure or malfunction at no additional cost.

3.2 The Contractor shall provide direct customer service and support, 24 hours/7 days a week, to include hotline telephone service (provided in English) and on-call emergency repair service support, to assist operators in correcting equipment operation and IT issues.

3.3 The Contractor shall provide repair service response within 1 hour and technician arrives within 12 hours after notification for routine/ and 4 hours after emergency failures. The Contractor’s qualified service technician shall be on site to provide routine services; service requiring immediate repair; and scheduled services for preventive maintenance, as specified in the Contractor’s instrument maintenance manual and as determined by Laboratory Director.

Performance of Safety checks and calibration included as required by this statement of work.

The equipment shall be repaired and operational within 24 hours after initial response by the Contractor.

3.4 Contractor shall provide two (2) paper and two (2) electronic (CD) copies of the Operator’s and Maintenance manuals and a statement of the warranty terms in the English language per location. The level of detail required of appropriate instrument maintenance manuals extends only to routine maintenance procedures performed by the user. All instrumentation specified is non-Government owned equipment that is provided, serviced, and maintained by the Contractor.

3.5 Contractor shall provide adequate service support for the following areas:

decontamination, relocation, installation management, Lab Process consultants for pre and post workflow analysis, IT Project management for IT implementations and on-going initiatives.

3.6 Periodic Advanced Operator Training/Education must be offered for all levels of staffing (i.e., Manager/Supervisor, Operations-Technical, and Information Systems). The contractor shall provide PACE accredited continuing education to all personnel on relevant Laboratory related topics at minimum bi-annually on-site or via online courses.

3.7 Contractor must provide access to dedicated Sales Specialist for support with establishing standing order schedules for routine delivery of supplies and for managing stat orders.

4. Training

4.1 The Contractor shall provide training for two (2) primary operators per analyzer at the Contractor’s training site, prior to delivery and installation of the analyzer and annually thereafter with each option year. The Contractor shall provide initial on-site operator training to all technicians assigned to the Government site (i.e., BJACH Department of Pathology Laboratory Staff) prior to initiation of use of the analyzer for patient testing. On-site analyzer training shall be provided for up to 8 technicians annually at no additional cost to the Government or individual trainee.

4.2 Contractor shall provide Information Technology type training (e.g. Rules Writing) for two (2) operators per year starting with Base Year and annually thereafter with each option year.

4.3 Periodic Advanced Operator Training/Education must be offered for all levels of staffing (i.e. Manager/Supervisor, Operations-Technical, and Information Systems).

5. Information Technology Management Requirements

5.1 The analyzer system shall be capable of interfacing with the military hospital computer system, i.e., the Military Health System Genesis. The Contractor shall have a driver compatible for interfacing the analyzer with MHS Genesis. The interface between MHS Genesis and the analyzer shall be bi-directional. The contractor shall identify the contractor specific equipment or third-party vendor’s equipment that is able to connect via driver to IT (Middleware) interface;

vendor to include two (2) third party licenses for additional connectivity.

5.2 The analyzer system shall include a data management system for control of the operation of the analyzer system, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer for the production of hard copy patient reports and other reports generated via the analyzer system’s data management system. The Data Management system shall have a comprehensive, fully integrated Quality Control (QC) software module that stores and evaluates quality control results. Results can be viewed in a variety of formats including Levy-Jennings charts, moving patient averages, CAP connectivity, EP Evaluator, and statistical summaries. The application shall validate QC results by checking them against user selected rules and automatically alert the operator when a rule violation has occurred.

5.3 Data Management system shall have a user friendly " 64bit Microsoft Windows interface or a web browser-based interface. The interface shall include a data management system for operational control of the analyzer system, management of the QC program, on-instrument useful life of the reagents/reagent packs, and management of patient results.

5.4 The software shall provide a single operator interface for workload management, data management, and instrument operational status monitoring. The software controls the operations of the analyzer, monitors the lot number expiration date of on-board reagents and control materials. The software shall have the capabilities to warn the operators or cease testing if the on-board reagents and control materials are expired. This shall be accomplished via communication connections between the analyzers and hospital Laboratory Information System

(LIS).

5.5 Remote diagnostics and troubleshooting shall be available using a maintenance application program that allows technical and service specialists at the Contractors technical support center or a field representative to remotely access the instruments to diagnose a problem.

When remote diagnostics not available, vendor shall provide quarterly onsite support and as needed. Quarterly onsite support to consist of 2 days/6 shift minimum or until current IT issue resolved.

5.6 TELECOMMUNICATION - Systems that provide the ability to control instrument software from remote locations are preferred. All Contractor systems that communicate with Department of Defense (DoD) systems shall interconnect through the established Military Healthcare System (MHS) Virtual Private Network (VPN) Business to Business (B2B) gateway.

For all Web applications, Contractors shall connect to a Defense Information Systems Agency (DISA)-established Web Demilitarize Zone (DMZ). All software must be able to pass MITC testing and review and be awarded a Certificate of Net worthiness (CoN) before contract is awarded.

5.6.1 The Contractor shall follow Army Regulation 25-1, “Army Knowledge Management and Information Technology, AR 25-2, “Information Assurance (IA)”, and DoD 6025.18-R, DoD Health Information Privacy Regulation.

5.6.2 In accordance with contract requirements, Contractors shall connect to the B2B gateway via a Contractor procured Internet Service Provider (ISP) connection. The Contractor shall assume all responsibility for establishing and maintaining their connectivity to the B2B gateway.

This shall include acquiring and maintaining the circuit to the B2B gateway and acquiring a Virtual Private Network (VPN) device compatible with the MHS VPN device.

5.6.3 All costs for VPN hardware and software shall be incurred by the Contractor.

5.6.4 The Contractor shall initiate, maintain, and document personnel security investigations appropriate to the Business Associate Representative’s responsibilities and required access to MEDCOM Sensitive Information (SI) as determined by the site Chief Information Officer.

5.6.5 The Contractor shall validate that systems authenticate users through the use of the Common Access Card (CAC) or CAC alternative as a part of a two-factor authentication mechanism on the business partner side of the VPN. The Contractor shall also identify the exact location from which remote operational control will take place from, the encryption that will be used, and how the vendor's technical users will maintain secure logon.

5.7 DEPARTMENT OF DEFENSE INFORMATION ASSURANCE CERTIFICATION

AND ACCREDITATION PROCESS (DIACAP) IMPLEMENTATION PLAN

5.7 1 The Contractor shall provide all required information to support and initiate the DIACAP Implementation Plan. This shall include the required information for the System Identification profile.

5.7 2 The Contractor shall provide information for the Risk Assessment Analysis to the Government for all networking IT applicability.

5.8 SECURITY CLEARANCES

5.8.1 Personnel to be assigned to an Automated Data Processing (ADP)/IT position shall undergo a successful security screening before being provided access to DoD information technology resources. Prior to an employee being granted interim access to DoD sensitive information, BJACH shall receive notification that the Office of Personnel Management (OPM) has scheduled the employee's investigation. This requirement shall be met by Contractors, subcontractors and other who have access to information systems containing information protected by the Privacy Act of 1974 and protected health information under HIPPA.

Background checks are required for all ADP/IT personnel who receive, store, display, or transit sensitive information. Employees shall have at a minimum an ADP Sensitivity Designation of Level II to access the DoD Network.

5.8.2 All Contractors that use the DoD gateways to access Government systems shall submit a DISA Form 41 or equivalent in accordance with COR guidance. In addition, Form 41s are required for each system administrator responsible for each host-to-host interface. Contractors shall complete and submit to TMA one Form 41 for their organization, attached to which shall be a listing of those individuals for whom background checks have been completed, submitted to the OPM, and acknowledgements have been received from OPM that the applications are complete and are pending action by OPM. The request shall clearly delineate the ports and protocols used for each Internet Protocol (IP) address. The Contractor shall complete the form and submit to the Government for final processing.

5.8.3 All costs for the Contractors employee background investigations are the responsibility of the Contractor, unless the investigation is completed by the Government, which would be at no cost to the Contractor.

5.8.4 The terms and conditions of this clause shall be completed no later than three (3) months post award.

6. BUSINESS TO BUSINESS (B2B) PARTNERS AND 3rd PARTY VENDORS

6.1 General Security Requirements. The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data, to ensure the confidentiality, integrity, and availability of Government data. As a minimum, this shall include provisions for personnel security, electronic security and physical security as listed in the sections that follow. Vendors must ensure ability to conform to all standards set forth by Department of Defense Risk Management Framework.

6.1.2 PERSONNEL SECURITY.

6.1.2.1 The Contractor shall comply with the following:

• DoD Directive 8500.1, “Information Assurance (IA)”

• DoD Instruction 8500.2, “Information Assurance (IA) Implementation”

• DoD Directive 5400.11, “DoD Privacy Program”

• DoD 6025.18-R, “DoD Health Information Privacy Regulation”

• DoD 5200.2-R, “Personnel Security Program Requirements”

• Local regulations as deemed appropriate by the Information Assurance Officer

• AR 25-1, “Army Knowledge Management and Information Technology”

• AR 25-2 “Information Assurance”

• AR 525-13 Antiterrorism

• AR 530-1 Operations Security (OPSEC)

6.1.2.2 Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements:

6.1.2.2.1 Follow the DoD guidelines for submittal of Automated Data Processor/Information Technology (ADP/IT) background investigations and ensure all Contractor personnel are designated as ADP/IT-I, ADP/IT-II, or ADP/IT- III where their duties meet the criteria of the position sensitivity designations outlined in AR25-2.

6.1.2.2.2 Initiate, maintain, and document personnel security investigations appropriate to the individual’s responsibilities and required access to Information Systems within the logical boundaries of the facility local area network (LAN).

6.1.2.2.3 Immediately report to the MTFs Security Office and deny access to any automated information system (AIS), network, or information if a contractor employee filling a sensitive position receives an unfavorable adjudication, if information that would result in an unfavorable adjudication becomes available, or if directed to do so by the appropriate Government representative for any reason.

6.1.2.2.4 Ensure that all Contractor personnel receive information assurance (IA) training before being granted access to DoD AISs/networks and information.

6.1.2.3 AT Level 1 Training. All contractor employees, to include subcontractor employees, requiring access Army installations, facilities, and controlled access areas shall complete AT Level 1 training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR, or to the Contracting Officer, if a COR is not assigned, within 10 days after completion of training by all employees and subcontractor personnel. AT Level 1 Awareness Training is available at the following website: https://atlevel1.dtic.mil/at.

6.1.2.4 Access and General Protection/Security Policy and Procedures. Contractor and all associated sub- contractor employees shall comply with applicable installation, facility, and area commander installation/facility access and local security policies and procedures (provided by Government representative). The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshall Office, Director of Emergency Services or Security Office. Contractor workforce shall comply with all personal identity verification requirements as direct by DOD, HQDA, and or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

6.1.2.5 OPSEC Training. Per AR 530-1, Operations Security, new contractor employees shall complete Level 1 OPSEC training within 30 calendar days of their reporting for duty. All contractor employees shall complete annual OPSEC awareness training.

6.2. ELECTRONIC SECURITY

6.2.1 Contractor Information Systems (IS)/networks that are involved in the operation of systems in support of BJACH shall operate in accordance with controlling laws, regulations, DoD, and local policy.

6.2.2 Certification & Accreditation (C&A) requirements apply to all DoD and Contractor’s IS/networks that receive, process, display, store or transmit DoD information. The Contractor shall comply with the C&A process for safeguarding IS. Certification is the determination of the appropriate level of protection required for IS/networks. Certification also includes a comprehensive evaluation of the technical and non-technical security features and countermeasures required for each system/network.

6.2.3 Accreditation is the formal approval by the Government to operate the Contractor’s IS/networks in a particular security mode using a prescribed set of safeguards at an acceptable level of risk. In addition, accreditation allows IS/networks to operate within the given operational environment with stated interconnections, and with appropriate level of protection for the specified period.

6.2.4 The contractor shall comply with C&A requirements, as specified by the Army that meet appropriate Army Information Assurance requirements. The C&A requirements shall be met before the contractor's system is authorized to access Army data or interconnect with any Army IS/network that receives, processes, stores, displays or transmits Army data. The contractor shall initiate the C&A process by providing the Contracting Officer Representative, within 60 days following contract award, the required documentation necessary to receive an Approval to Operate (ATO). The contractor shall make their IS/networks available for the testing, and initiate the C&A testing four months (120 days) in advance of accessing Army data or interconnecting with Army IS/networks. The contractor shall ensure the proper contractor support staff is available to participate in all phases of the C&A process. They include, but are not limited to:

• Attending and supporting C&A meetings with the Government

• Supporting/conducting the vulnerability mitigation process

• Supporting the C&A Team during system security testing

6.2.5 Contractors shall confirm that their networks are locked down prior to initiating testing.

6.2.5.1 Conformation of system lock down shall be agreed upon during the definition of the C&A boundary and be signed and documented as part of the System Security Authorization Agreement (SSAA).

6.2.5.2 Locking down the system means that there shall be no changes made to the configuration of the system (within the C&A boundary) during the C&A process.

6.2.6 Any re-configuration or change in the system during the C&A testing process shall require a re-base lining of the system and documentation of system changes. Some changes will necessitate a pause in work depending on the severity and impact of change and determined by the COR in conjunction with the IA representative. Vulnerabilities that have been identified by the Army as “must fix” issues during C&A process must be mitigated according to the timeline identified by the Army Representative. C&A checklists are provided for complying Army C&A requirements. A request for a waiver to the C&A requirements may be submitted for temporary testing and other unusual circumstances. A waiver request must be submitted, in writing, to the Designated Approving Authority. The request must include mitigation strategies that ensure adequate protection measures and security controls are in place.

6.2.7 Disposing of Electronic Media. Contractor shall follow the DoD standards, procedures, and use approved products to dispose of unclassified hard drives and other electronic media, as appropriate, in accordance Army Regulation 25-2, “Information Assurance” and Army Best Business Practices (BBP), “Reuse of Computer Hard Drives.”

6.2.8 Information Assurance Vulnerability Management (IAVM). The Contractor shall implement an information assurance vulnerability management program. The Army IAVM program provides electronic security protections against known threats and vulnerabilities. The IAVM program requires the registration of AIS system assets, which then allows for the timely dissemination of critical vulnerability information. It also assists in the documentation and tracking of compliance, providing increased electronic security to MEDCOM systems. As part of the program, the contractor shall provide a primary and secondary point of contact for IAVM compliance reporting. The contractor shall thoroughly test all mitigations for the vulnerability, and upon applying the mitigation to the system, report compliance to the MEDCOM IA Operations point of contact. Receipt and compliance messages to MEDCOM shall occur within the stipulated window, as stated in the vulnerability message. Guidance regarding the requirement for IAVM is contained in the Army Regulation 25-2, “Information Assurance” and Army Regulation 25-1, “Army Knowledge Management and Information Technology.” An asset is defined as any hardware devise, such as a router, firewall, server, or an operating system image accessed by more than one user. The MEDCOM IASO list servicer is the primary means to disseminate IAVAs, Information Assurance Vulnerability Bulletins (IAVBs), and Information Assurance Technical Advisories down to the System Administrator (SA) and applicable personnel throughout the chain of command. Requests to be added to the IASO list server should be sent to medcom.ia@amedd.army.mil.

6.2.8.1 The contractor shall maintain any development environments in accordance with MEDCOM Information Assurance (IA) best practices and operational requirements. During product development for the Army, the contractor shall ensure that all IA mitigation strategies have been applied to the development environment prior to any Army data being loaded onto any assets or software for testing or delivery. IA mitigation strategies include security updates, service packs, and changes to operating procedures as physical and cyber vulnerabilities are detected. Operating system, routers, servers, development platforms and the application being delivered to the Army shall be in compliance with all known applicable Army Computer Emergency Response Team (ACERT) Alert, Bulletin, and Technical Advisory Notices published during the past 36 months.

6.2.8.2 Ports Protocols and Services. Contractors shall follow all current Army standards and requirements for acceptable Ports, Protocols, and Services. Any requests for exception to using the current Army Ports, Protocols, and Services standards requires a request for exception sent through the Program Manager at the DAA.

6.2.8.3 Public Key Infrastructure and Encryption. Contractors shall follow the Army standards, policies, and procedures related to the use of the Public Key Infrastructure (PKI) certificates and biometrics for positive authentication. Where interoperable PKI is required for the exchange of unclassified information between the Army and its contractors and contractors, industry partners shall obtain all necessary certificates. Contractors must turn over to the Army all encryption keys for deployed systems, backdoor algorithms, and procedures for their use in remote support. The Contractor must provide a written report detailing all of the above, prior to task order expiration regardless of modifications or extensions.

6.3 INFORMATION SYSTEMS (IS)/NETWORKS PHYSICAL SECURITY.

6.3.1 The Contractor shall employ physical security safeguards for IS/Networks involved in processing or storage of Government Data to prevent the unauthorized access, disclosure, modification, destruction, use, etc., and to otherwise protect the confidentiality and ensure use conforms with DoD regulations. In addition, the Contractor shall support a Physical Security Audit performed by the Government of the Contractor's internal information management infrastructure.

6.3.2 The MHS Physical Security Audit Matrix is available at:

http://www.tricare.osd.mil/tmis_new/Policy/PSA_Matrix_%20012304%200930%20clean%20ve rsion.xls.

6.3.3 The Contractor shall correct any deficiencies identified by the Government of the Contractor's physical security posture. New Army policies will be posted to the following website: http://www.apd.army.mil.

6.4 SPECIAL REQUIREMENTS FOR PROTECTED HEALTH INFORMATION.

6.4.1 The contractor shall ensure that data which contains PHI is continuously protected from unauthorized access, use, modification, or disclosure. The contractor shall comply with all previously stated requirements for HIPAA, Personnel Security, Electronic Security, and Physical Security.

6.4.2 Notify the MTF HIPAA Security Manager.

6.4.3 Follow all DUA and DoD requirements for secure disposal, destruction, and/or sanitization of all equipment that contained PHI.

7. PROGRAM MANAGEMENT

7.1 GENERAL. The Contractor shall provide comprehensive Program/Project Management services.

7.2 Program Manager (PM). The Contractor shall provide a dedicated PM, who shall be responsible for the initial instrument implementation, instrument upgrades, implementation of new methods or procedures and optimization of workflow processes and procedures.

7.2.1 The PM, and an alternate who shall act for the Contractor when the PM is absent, shall be designated in writing to the Contracting Officer and Contracting Officer Representative (COR) within 10 days of contract award.

7.2.2 The PM and alternate PM shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract.

7.2.3 The PM and/or alternate shall be actively engaged in all aspects of this SOW.

7.2.4 The Contractor shall provide an Information Technology Project Manager for implementation of the instrument interface and middleware.

7.2.4.1 The IT PM shall have demonstrated working knowledge of Information Security…