36C24720Q0003-001.docx

36C24720Q0003

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C24720Q0003 09-09-2019 Donald L. Battle 404-321-6111 ext. 205129 10-11-2019 12:00pm EST Department of Veterans Affairs VISN 7 Network Contracting Office LaVista Business Park - Bldg A 2008 Weems Road Tucker

GA

30084 X 334516 1000 Employees N/A X Atlanta VA Medical Center Microbiology Laboratory, Room 2B184 1670 Clairmont Rd.

Decatur

GA

30033 Department of Veterans Affairs VISN 7 Network Contracting Office LaVista Business Park - Bldg A 2008 Weems Road Tucker

GA

30084

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin

TX

78714-9971 1-877-489-6135 See CONTINUATION Page Molecular Diagnostics Reagents and Analyzer Cost-Per-Test Period of Performance Base Year: November 1, 2019 – October 31, 2020 Option Year 1: November 1, 2020 – October 31, 2021 Option Year 2: November 1, 2021 – October 31, 2022 Option Year 3: November 1, 2022 – October 31, 2023 Option Year 4: November 1, 2023 – October 31, 2024 Firm-Fixed-Price Contract See CONTINUATION Page X X X X X Sheryl Harris Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

N/A

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C247 Sheryl Harris Department of Veterans Affairs VISN 7 Network Contracting Office LaVista Business Park - Bldg A 2008 Weems Road Tucker GA 30084

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PERFORMANCE WORK STATEMENT (PWS)

A. GENERAL

1. Contract Title

Microbiology Molecular Diagnostics reagents and analyzer cost per lab test (to include the following components: one analyzer capable of running FDA-approved real-time polymerase chain reaction (PCR) tests: a) qualitative Chlamydia trachomatis / Neisseria gonorrhoeae (CT/NG) on male urine specimens, female urine specimens, and female vaginal swabs, and b) quantitative viral load for human immunodeficiency virus type 1 (HIV-1) on human plasma (Plasma Preparation Tube [PPT] and Ethylene-Diamine-Tetra-Acetic acid [EDTA] anticoagulated blood specimens).

2. Background

a. This effort is required in order to continue provision of microbiology testing thru the Pathology & Laboratory Medicine Service Line to Atlanta VAMC patients. (Testing of patient specimens is currently performed by the in-house microbiology laboratory at the Atlanta VAMC.) This procurement will continue work from prior years as provided by prior contracts A list of the most recent contracts awarded:

· V797P-7037A, VA247-15-F-1197; 508C75564, 508C85157 & 508C95039

· 7-month extension on 3/2/2018, 508-17-2-2043-0010

b. By providing base + 4-year period of performance After Notice of Action. Award will contain several upgrades in clinical microbiology scientific technologies, intended to save technologist time and maintenance, while improving patient care.

B. DESCRIPTION OF SERVICES

1. Period of Performance: Base year with the possibility of (4) one-year option periods.

Place of Performance: Atlanta VA Medical Center, Microbiology Laboratory, Room 2B184, 1670 Clairmont Rd., Decatur, GA 30033

2. Description of Maintenance and Repair Services / Scope of WORK.

a. The Microbiology Department of the Pathology & Laboratory Medicine Service (P&LMS) Line requests to enter into a cost per test agreement for a new base + 4-year period of performance award for a single analyzer capable of running FDA-approved real-time polymerase chain reaction (PCR) tests: a) qualitative Chlamydia trachomatis / Neisseria gonorrhoeae (CT/NG) on male urine specimens, female urine specimens, and female vaginal swabs; and b) quantitative viral load for human immunodeficiency virus type 1 (HIV-1) on human plasma (Plasma Preparation Tube [PPT] and Ethylene-Diamine-Tetra-Acetic acid [EDTA] anticoagulated blood specimens). All component(s) are to be managed thru one platform middleware (touching the Laboratory Information System (LIS) intermediary hardware/software linking with VistA ) before patient results are transmitted thru the intermediary hardware/software across an interface to VISTA. This request is for use of/replacement of existing components, several of which are aged and nearing the end of their performance lifespan. In addition, the Microbiology Department has begun to exceed the workload that the current system instrumentation can accept. In recent years, newer technology has emerged which is more technologically advanced and provides faster and safer molecular testing on a single FDA-approved platform.

b. Vendor will be responsible for delivery and set up of analyzer components, as well as for performing periodic maintenance and required repairs on-site throughout the life of the agreement. Vendor will also be responsible for training the Microbiology technologists on-site at the Atlanta VAMC Microbiology Laboratory.

c. Microbiology Molecular Diagnostics reagents and associated analyzer for the testing and reporting of HIV-1 viral loads in patient blood specimens and identification of CT/NG (Chlamydia trachomatis and Neisseria gonorrhoeae) are required in order to perform moderate and high-complexity laboratory testing on patient specimens obtained across the Atlanta VAMC enterprise (including CBOCs), but performed specifically on-site at the P&LMS clinical MICROBIOLOGY laboratory at the main Atlanta VAMC Healthcare System hospital in Decatur, GA (30033). These diagnostic clinical laboratory tests are required for managing anti-viral treatment of already-positive HIV patients, and for identifying sexually transmitted diseases among our VAMC patient population in a timely manner. Method of testing on the analyzer: in vitro nucleic acid amplification tests utilize the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) deoxyribonucleic acid (DNA) to aid in the diagnosis of chlamydial and gonococcal disease; in-vitro nucleic acid amplification test utilizes PCR for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma. The human immunodeficiency virus (HIV-1) is the etiologic agent of acquired immunodeficiency syndrome (AIDS).

3. Instrument System Operation Overview:

a. Labeled and inoculated PPT/EDTA blood specimens for HIV PCR viral load testing and/or CT/NG urine/vaginal swab specimen transport tubes are received into the microbiology laboratory. These tubes are then scanned via a barcode and placed into the molecular analyzer(s) by a laboratory technologist/technician. The specimen tubes are then continuously monitored in a controlled environment (inside the instrument) during the complex, highly sensitive PCR (polymerase chain reaction) test procedure. Reagents on-board the analyzer(s) are auto-pipetted into the reaction vessels (containing specimen) in pre-determined FDA-approved procedure methodologies. After processing and subsequent placement (manually or by analyzer) onto the 96-well reaction microwell plates, incubation and monitoring of the reactions take place (by the analyzer).

b. HIV resulting of viral load is detected by the instrument’s detection method and the instrument reports to the end user in viral copies/log, quantitative results. CT/NG resulting is detected by the instrument’s detection method and the instrument reports to the end user in terms of DETECTED (POSITIVE) or NOT DETECTED (NEGATIVE) qualitative results. If anything malfunctions or specimens are rejected during the processing of the run(s), the analyzer notified the user via computer screen alerts and warning lights. All results (quality control and patient specimen results) are reviewed by the technologist and then manually entered or uploaded electronically thru an interface into the laboratory information system (LIS) by a laboratory technologist. Of note: Newer technology has emerged which is more technologically advanced and provides faster testing and analysis, as well as safer testing protocols for the technologists performing the lab tests (i.e. ability to place specimen tubes directly on board the analyzer without having to perform manual pipetting steps). Delays in reporting cost the medical center money due to delayed treatments for HIV therapy, or delays in reporting sexually transmitted diseases (STDs) to the providers and Health Departments.

3.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the PWS. The instrument shall have continuous loading capability and batching ability and be able to simultaneously perform the complete profiles as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

3.2. A total equipment footprint that when installed in the laboratory by the vendor shall not impact the functionality/operations of that laboratory. Equipment must maintain or, preferably, reduce the number of work stations or overall labor required to accomplish the required testing.

3.3. If Contractor offers a family of analyzers (system), the technical evaluation panel (laboratory technical specialist, pathologists, technologists) will determine if proposed instrumentation components in the system meets needs of the ATL VAMC.

3.4. The Contractor is required to provide a continuously available inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts, should be forwarded to the designated individuals determined at contract award.

3.5. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective or unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the regularly scheduled standing order/routine supplies delivery.

4. Specific Contractor Tasks Include:

4.1 LANGUAGE

4.1.1. INTENT: It is the intent of the Department of Veterans Affairs to establish an Indefinite Delivery/Indefinite Quantity (IDIQ) contract for Fully Automated Microbiology Molecular Diagnostics reagents and analyzer cost per lab test (to include the following components: one analyzer capable of running FDA-approved PCR testing for HIV-1 quantitative viral load on human plasma (PPT and/or EDTA specimens) and CT/NG qualitative PCR on human specimens (female swabs or urine, and male urine). The IDIQ shall be Cost per Test (CPT) and Clinical Laboratory Analyzer(s). The Government will award a CPT IDIQ to a single Contractor for Automated Molecular Diagnostics Instrumentation. Contractor agrees to the following terms of the IDIQ exclusively with the Atlanta VA Medical Center and awarded in the final IDIQ. Additional tests/reagents/instrumentation may be added to the IDIQ as new technology becomes available on the market and IDIQ.

4.1.2. PRICES AND TERMS: Atlanta VAMC will provide an estimated volume by test and test menu as reflected in Attachment A. Pricing is based on the annual test volume per reagents/analyzer system. The Government estimates the volumes as listed in Attachment A, but does not guarantee volumes as listed; they are estimates ONLY (average increase may be 5% per year, 20% over 5-year term).

4.1.3. TERM OF AGREEMENT: This will be a single award, firm-fixed price IDIQ with one base year, and four one-year options. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time there is a need to be a change in the contract. Please price a six months extension after the end of the base and option years in case one is needed. If the Contractor fails to perform in a manner satisfactory to the CO, this IDIQ may be canceled with thirty days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This IDIQ shall be reviewed annually.

4.1.4. ORDERING METHOD: The Atlanta VAMC may order products via Electronic Email, telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions (to include Purchase Order number).

4.2. DEFINITIONS:

NOTE: For the purposes of this PWS document, this PWS requirement refers to one Microbiology Molecular Diagnostics analyzer with reagents and consumables, containing the following components: one analyzer capable of running FDA-approved PCR testing for HIV-1 quantitative viral load on human plasma (PPT /EDTA specimens) and CT/NG qualitative PCR on human specimens (female swabs or urine, and male urine), as well as ability to be managed and linked (touching) the Laboratory Information System (LIS) intermediary hardware/software linking with VistA before patient results are transmitted thru the intermediary hardware/software across an interface to VA’s VISTA.

4.2.1. Cost per Patient Reportable Result (CPRR) - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) five year equipment system use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation of a patient reportable result. The cost per patient reportable result price shall also encompass all costs associated with repeat and confirmatory testing required to produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI); (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge.

4.2.2. Cost per Test (CPT) - Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) five year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result; (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors are required to provide delivery, installation, decontamination, and removal of equipment at no additional charge.

4.2.3. Primary Processing Station – Any pre-analytical processing equipment offered that will allow preparation of the pre-analytical specimen set-up and processing functions, as indicated in the general requirements section.

4.2.4. Reagents/Analyzers (components) in the system – Individual processing components to include molecular diagnostics reagents and analyzer capable of running FDA-approved PCR testing for HIV-1 quantitative viral load on human plasma (PPT /EDTA specimens) and CT/NG qualitative PCR on human specimens (female swabs or urine, and male urine).

4.2.5. Contractor Middleware Management Component - For the purposes of this solicitation, this is a separate component or module that electronically connects all the testing instrumentation components in the entire system to manage raw specimen data, computed results, and workflow of two or more pieces of instrumentation at any given time. This may or may not be required, depending on the analyzer system. (Not to be confused with intermediary software for interfacing equipment with the hospital/laboratory information system).

4.3. Test Menu – Refer to Attachment A for desired test menu and estimated annual volumes.

4.4. GENERAL REQUIREMENTS

In general, the instrumentation and reagents required are: Microbiology molecular diagnostics reagents and analyzer cost per lab test (to include the following components: one analyzer capable of running FDA-approved PCR testing for HIV-1 quantitative viral load on human plasma (PPT /EDTA specimens), and CT/NG qualitative PCR on human specimens (female swabs or urine, and male urine), and any middleware software capable of interfacing with the VAMC VISTA LIS system (thru LIS intermediary hardware/software).

4.4.1. Primary analyzer – Base equipment consisting of a single analyzer that shall fully support the scope of operations (minimal requirements).

4.4.2. Microbiology Molecular Diagnostics analyzer platform shall be linked thru onboard middleware that will interface seamlessly with LIS intermediary hardware/software.

4.4.3. The instrumentation and reagent test kits offered shall be approved by the Food and Drug Administration (FDA) for use in the United States at time of solicitation.

4.4.4. Requirement for HIV-1 blood specimen viral load quantitative testing targets: At minimum, Dual target gag and LTR targets/regions with internal controls are required.

4.4.5. HIV-1 Viral load quantitative results must be linear and reportable with a linear range from 20 copies to 10 million viral copies.4.4.6. On-board automated dilution testing must be readily available for quantitative tests.

4.4.7. Specimen collection containers and test methods must be FDA-approved for testing of blood plasma (HIV-1) and testing of male or female urine/female vaginal swabs (CT/NG).

4.4.8. Minimal requirement for CT/NG PCR qualitative testing targets to include internal controls: Dual targets, CT/NG dual DR9(A) and DR9(B) for GC targets and CT101 and 103 primers (or equivalent) to include CT cryptic plasmid and omp /MOMP gene targets.

4.4.9. HIV-1 test method must be approved for use with PPT and/or EDTA type blood tubes.

4.4.10. The analyzer must be able to accept continuous loading of samples, reagents, and consumable, in addition to batch loading.

4.4.11. Molecular Diagnostics instrument analyzer must have the ability to run three (3) or more independent assays on same sample simultaneously.

4.4.12. Molecular Diagnostics instrument analyzer must have throughput capability of at least 200 samples per 8 hour shift. (Large batch testing must be accommodated.)

4.4.13. On-board Quality Control (QC) data management system must be present. Analyzer must have the ability to capture, store and electronically transfer and print out QC data.

4.4.14. The system must detect processing errors and provide error notification.

4.4.15. Visibly bloody vaginal specimens and urine specimens should be able to be run on the analyzer and resulted without rejection due to a product limitation.

4.4.16. Safety features to avoid unnecessary exposure to biohazardous and chemical material: Sample preparation must be limited; sample must be able to be placed directly onto the analyzer with no manipulation after initial processing). Extraction processing must be confined to reduce aerosolization.

4.4.17. Analyzer primary automated processing includes: Preparation area where specimens are placed for processing by the analyzer using the primary specimen collection transport tubes.

4.4.18. Analyzer primary automated processing includes: barcode scanning area(s) where samples are prepared for loading onto the analyzer.

4.4.19. Instrumentation shall include sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A (test volumes).

4.4.20. All instrumentation shall include a specimen/data management system to manage and track sample progress and position, as well as retrieve archived results.

4.4.21. The system must detect processing errors and provide error notification.

4.4.22. System downtime and complaints must be minimal, as measured by CPARS past vendor performance.

4.4.23. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

4.4.24. Technical support must be available 24 hours a day, 7 days a week.

4.4.25. All PMS (scheduled routine maintenance) included; any calibrators to be included per protocol.

4.4.26. All repairs (scheduled and unscheduled) included; accompanied by detailed and legible field service report which will include a detailed description of the preventive maintenance inspection or emergency repair services performed, including replaced parts and estimated prices required for the service call.

4.4.27. On-site training provided for microbiology technologists as needed throughout the term.

4.4.28. During the warranty period, a service call should include replacement or repair of all vendor-provided ancillary equipment (i.e. printers, monitors, UPS).

4.4.29. A bi-directional computer interface compatible of interfacing with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system - thru vendor middleware to LIS intermediary hardware/software which links to VISTA.

4.4.30. Contractor shall collaborate with the lab to write/develop protocols to establish customer configurable rules and reports to enhance workflow management and productivity.

4.4.31. An uninterruptible power supply (UPS) with line conditioner for instrumentation.

4.4.32. Equipment relocation and possible reinstallation should the equipment need to be moved due to construction or laboratory redesign at no additional cost.

4.4.33. Method Performance/Validation Requirements: Method performance/comparison shall be at the expense of the Contractor, shall include all materials and reagents, and be consistent with current the Clinical and Laboratory Standards Institute (CLSI) guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. All studies performed will be appropriate for the test menu of the respective laboratory to include EDTA and PPT plasma tubes, urine, and vaginal/cervix specimens. These validation requirements are applicable to all new testing analyzers. Correlation studies for each single and multiplex test analyte. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall meet current standards defined by Clinical and Laboratory Standards Institute (CLSI) and CAP microbiology laboratories.

4.4.33.1. Precision (reproducibility) study using normal and abnormal control material. This shall include, at a minimum, within and between run precision studies.

4.4.33.2. Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied.

4.4.33.3. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects to include interfering substances.

4.4.33.4. Carryover Studies. Successful carryover studies shall be completed by the contractor on all analyzers of the system during installation (as applicable). These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to the laboratory at no charge.

4.4.33.5. Reference Range- If applicable, a reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested.

4.4.34. Characterization of Waste – The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges (if applicable) in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

4.4.35. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the IDIQ. This timeline is based on a reasonable attempt of the Contractor to complete all necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 90-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

4.4.36. A technical support specialist from the instrument manufacturer will assist in equipment installation/set-up, providing all manpower, procedures, and reagents/supplies to perform validation and correlation studies [evaluation/comparison data sufficient to satisfy College of American Pathologists (CAP) standards].

4.4.37. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled “Termination for cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

4.4.38. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new (or current existing at the ATL VAMC laboratory) equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

4.4.39. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the IDIQ; however, it does refer to significant changes in the hardware operational capability.

4.4.40. The vendor/distributor and/or the manufacturer must provide all necessary procedure manuals, troubleshooting manuals and operator manuals to the microbiology laboratory department. Paper (hardcopy) manuals must be provided.

4.4.41. Start-Up Reagents - The Contractor shall provide all reagents, calibrators (if applicable), controls, consumable/disposable items, parts, accessories and any other item included on the contract and required to establish instruments for operation for performance of acceptance testing. This applies to all equipment as well as additional or replacement equipment placed under the terms and conditions of this contract. The Contractor shall perform/assist, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government; to include new tests added to the test menu (contract modification), and the event of a reagent upgrade (new generation). The Contractor shall perform all of the statistical analysis as stated in the Method Performance/Validation section above and provide a hard-copy of data in an organized, clearly comprehensible format. The contractor will perform all the validation studies that are required, as determined by the laboratory director or designee.

4.4.42. All items quoted must be F.O.B. destination. All items shall be shipped to the following location: Atlanta VAMC, Microbiology Laboratory (Room 2B184), 1670 Clairmont Road, Decatur, GA 30033

4.4.43. Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall decontaminate and remove the equipment. The Contractor shall disconnect the analyzer and shall be responsible for all packing and shipping required to remove the analyzer.

4.4.44. The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

4.4.45. Prior to termination or completion of this IDIQ, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this IDIQ without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the IDIQ.

4.4.46. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the IDIQ or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be retained by the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the IDIQ or disposal or return of the IT equipment, whichever is earlier.

4.4.47. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

· Contractor must accept the system without the drive;

· VA’s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or

· VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

· Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

· Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order.

· A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

ATTACHMENT A

Fully Automated Microbiology MOLECULAR DIAGNOSTICS analyzer ESTIMATED ANNUAL VOLUME (5% ANNUAL INCREASE each year over base year) in terms of TEST MENU:

Approximate NUMBER of reportable PATIENT TESTS for past 12 months:

5. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

5.1. All contractor employees who require access to the Department of Veterans Affairs’ computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to subcontractor personnel requiring the same access.

5.1.1. Position Sensitivity – The position sensitivity has been designated as Low Risk.

5.1.2. Background Investigation – The level of background investigation commensurate with the required level of access is minimum background investigation.

5.2. Contractor Responsibilities

5.2.1. The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship, and are able to read, write, speak and understand the English language.

5.2.2. The contractor shall submit or have their employees submit the required forms (SF 86 or SF 85P, SF 85P-S, FD 258, Contractor Fingerprint Chart, VA Form 0710, Authority for Release of Information Form, and Optional Forms 306 and 612) to the VA Office of Security and Law Enforcement within 30 days of receipt.

5.2.3. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the affected employee from working under the contract.

5.2.4. Failure to comply with contractor personnel security requirements may result in termination of the contract for default.

5.3. Government Responsibilities:

5.3.1. The VA Office of Security and Law Enforcement will provide the necessary forms to the contractor, or to the contractor’s employees, after receiving a list of names and addresses.

5.3.2. Upon receipt, the VA Office of Security and Law Enforcement will review completed forms for accuracy and forward the forms to the office of Personnel Management (OPM) to conduct background investigations.

5.3.3. The VA Office of Security and Law Enforcement will notify the CO, and contractor, of adjudication results received from OMB.

5.4. Training

5.4.1. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

5.4.1.1. Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

5.4.1.2. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

5.4.1.3. Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

5.4.1.4. Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document - e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

5.4.1.5. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

5.4.1.6. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

6.1 Enterprise Management Controls.

Deliverables: Contract Management Plan Quarterly Status Report

(SEE QASP)

List of deliverables

Deliverables: All reagents and consumables are NOT TO BE SHIPPED ALL AT ONCE, rather, microbiology laboratory department representative /supervisor/or COR will place orders as needed against the annual Purchase Order number assigned by contracting. Invoicing will be electronic and may occur as soon as the reagents and consumable supplies have been shipped.

7. Performance Monitoring / Measures: (SEE QASP and COR QUARTERLY CONTRACTOR EVALUATION REPORT)

The COR will monitor performance via:

a. Routine inspections of hardware

b. Routine evaluation of any quality management/lab occurrence reports related to reagents or software

c. Routine inspection of each product delivery prior to certifier approval of invoices

Requirement

Method

All consumables and reagents, and other supplies necessary for the proper operation of the system are provided in a timely manner. Includes maintenance, repairs, and training.

Not more than 1 observed instances of a failure to maintain established work schedules and standards

SATISFACTORY

Not more than 2-3 observed instances of a failure to maintain established work schedules and standards

UNSATISFACTORY

Not more than 4 observed instances of a failure to maintain established work schedules and standards A positive or negative performance will be documented in past performance reports (CPARS), or contract termination.

Not more than 1 instances (annually) of a failure to submit invoices within 30 days of services being completed.

SATISFACTORY

Not more than 2-3 instances (annually) of a failure to submit invoices within 30 days of services being completed.

UNSATISFACTORY

Not more than 4 instances annually of a failure to submit invoices within 30 days of services being completed.

A positive or negative performance will be documented in past performance reports (CPARS), or contract termination.

Laboratory occurrence reports and provider complaints will be reviewed on a monthly basis to assess for any quality items related to the reagents/supplies provided by vendor (and used in the lab testing of patient specimens).

Not more than 1 instances (annually) replacement items not being received in a “Timely” manner (based on the Vendor’s standard SLA) after contacting the Technical Services Hotline.

SATISFACTORY

Not more than 2-3 instances (annually) replacement items not being received in a “Timely” manner (based on the Vendor’s standard SLA) after contacting the Technical Services Hotline.

UNSATISFACTORY

Not more than 4 instances (annually) replacement items not being received in a “Timely” manner (based on the Vendor’s standard SLA) after contacting the Technical Services Hotline.

A positive or negative performance will be documented in past performance reports (CPARS), or contract termination.

8. Security Requirements

ISO required FORM 6500.6 is required.

9. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

No GFE/ GFI required.

10. Other Pertinent Information or Special Considerations.

a. Identification of Possible Follow-on Work.

None identified at the time of this PWS.

b. Identification of Potential Conflicts of Interest (COI).

c. No organizational COI exists.

d. Identification of Non-Disclosure Requirements.

Contractor will not have access to proprietary information. Contractor will not have access to sensitive patient information.

d. Packaging, Packing and Shipping Instructions.

Shipment of system components to be scheduled with ATL VAMC WAREHOUSE and LOGISTICS; Warehouse to deliver reagents to Room 2B184 Microbiology Laboratory; vendor to coordinate delivery of analyzer instrumentation with WAREHOUSE/LOGISTICS and Microbiology Lab Rm 2B184.

e. Inspection and Acceptance Criteria.

The COR will be responsible for inspection and acceptance of system, consumables, and reagents.The COR will contact vendor if any shipment is not acceptable and the reason why will be provided (expired reagents, damaged consumables, etc.)

11. Risk Control

Risk assessment for microbiology laboratory and Safety Office (Industrial Hygienist) to include assessment of safety (PCR technology) and waste as acceptable by the SAFETY / CHEMICAL HYGIENE OFFICE risk assessment. Items to be included in Laboratory Chemical Hygiene Plan. (No requirement for risk assessment for patient safety; not applicable.)

12. Place of Performance.

Work will be performed at the government site: Microbiology Laboratory, Atlanta VAMC, Decatur, GA 30033 (Room 2B184).

13. Period of Performance.

Base plus 4 years. Period to begin 11/1/2019.

14. Delivery Schedule.

throughout term

*…