36C24720Q0004-001.docx

36C24720Q0004

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 ATTA

CHED

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. SIGNAT

URE 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

36C24720Q0004 10-18-2019 Donald L. Battle 404-321-6111 ext. 205129 11-18-2019 12:00 pm 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 Pathology & Laboratory Medicine Service Microbiology Laboratory 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 See CONTINUATION Page Microbiology Reagents Analyzer Cost-Per-Test Period of Performance (POP):

Base: December 3, 2019 – December 2, 2020 Option 1: December 3, 2020 – December 2, 2021 Option 2: December 3, 2021 – December 2, 2022 Option 3: December 3, 2022 – December 2, 2023 Option 4: December 3, 2023 – December 2, 2024 See CONTINUATION Page 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 Contract Specialist 36C247 Donald L. Battle

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

I. DESCRIPTION OF SERVICES

a. Location: Atlanta VA Medical Center Pathology & Laboratory Medicine Service Line Microbiology Laboratory 1670 Clairmont Rd.

Decatur, GA 30033

b. Period of Performance: Base Year: December 3, 2019 – December 2, 2020 Option 1: December 3, 2020 – December 2, 2021 Option 2: December 3, 2021 – December 2, 2022 Option 3: December 3, 2022 – December 2, 2023 Option 4: December 3, 2023 – December 2, 2024

c. Type of Contract: Firm-Fixed-Price

1. Contract Overview.

For the purposes of this PWS document, this PWS requirement refers to a Microbiology Reagents/Analyzers System, containing multiple components. The Atlanta VA Microbiology Laboratory is seeking to procure a Microbiology Reagents/analyzers System (cost-per-test). 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) lease of 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 VA Microbiology Laboratory personnel. Contractors are required to provide delivery, installation, decontamination, and removal of equipment at no additional charge. to include leased equipment, reagents/supplies, and ongoing services described below:

· Blood Culture System. This component includes lease of Blood Culture testing site system equipment and the following:

· Anaerobic Blood Culture Bottles

· Aerobic Blood Culture Bottles

· Installation

· Calibration Testing

· Validation and Correlation Studies

· Decontamination

· Removal

· Maintenance and Repairs

· Training of VA Technologist

· Microbiology analyzer which performs organism identification and susceptibility testing on patient microbiology specimen isolates (bacteria and yeast). Site system to include maintenance, repairs, and training of technologists:

· Gram positive antibiotic susceptibility tests (AST)

· Yeast Identification (ID) tests

· Gram positive identification (GPI) tests

· Gram Negative Identification (GNI) tests

· Gram negative antibiotic susceptibility tests (AST)

· Installation

· Calibration Testing

· Validation and Correlation Studies

· Decontamination

· Removal

· Maintenance and Repairs

· Training of VA Technologist

· Mass Spectrometry Microbial Identification System with MALDI-TOF (Microbiology Laser: Matrix-assisted laser desorption/ionization time-of-flight). Automated mass spectrometry microbial identification system that uses the MALDI-TOF technology, as well as a comprehensive marked database to rapidly identify bacteria, yeast, (to include Nocardia and other Actinomycetes). This obligation includes test lease contract, as well as maintenance, repairs, calibrations, and training of technologists.

· Target slides (disposable)

· Reagent Kit MALDI-TOF test system used for rapid laser guided identification of bacteria and yeast

· Installation

· Calibration Testing

· Validation and Correlation Studies

· Decontamination

· Removal

· Maintenance and Repairs

· Training of VA Technologist

· Middleware: Lease of an Integrated and automated middleware system that connects Blood Culture analyzer instrument to MALDI-TOF and Microbiology ID/susceptibility analyzer. This middleware shall interface all components with the VA Laboratory Information System (LIS) intermediary hardware/software linking with VistA.

1.1.1. INTENT: It is the intent of the Department of Veterans Affairs to establish a contract for the lease and maintenance of a Clinical Laboratory Microbiology Reagents/analyzers System. The Government will award a Firm Fixed Price contract to a single Contractor for a Microbiology Reagents/analyzers System.

1.1.2. 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 of 5% per year, 20% over 5-year term).

1.1.3. TERM OF AGREEMENT: This will be a single award, firm-fixed price contract with one base year, and four one-year options.

1.1.4. ORDERING METHOD: The COR assigned at 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). Special handling for emergency orders of supplies: In the event that the regular delivery of supplies are found to be defective or unsuitable, and it is the fault of the contractor, 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).

2. Background Instrument System Operation Overview.

2.1. 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.)

2.2 Labeled and inoculated blood and/or body fluid culture bottles are scanned via a barcode and placed into the blood culture instrument by a laboratory technologist/technician. The culture bottles are continuously monitored for five days in a controlled environment (inside the instrument) at 37oC. After five days of incubation if no growth is detected by the instrument’s detection method the instrument reports to the end user that the culture bottle was negative for microorganism growth. Alternatively, if a blood culture specimen contains a bacterial or yeast microorganism, the instrument alarms and alerts the end user that one of the culture bottles in the instrument is positive. The medical technologist removes the positive culture bottle, inoculates a portion of the liquid contents (broth media) to solid growth media and prepares a Gram stain to determine what type of microorganism growth is present in the culture bottle. Once the Gram stain result is determined, the patient’s provider is notified of the Gram stain result so that proper care can be administered to the patient. (Of note: Newer technology has emerged which is more technologically advanced, providing automated loading and unloading of inoculated blood culture bottles, shortened time-to-detection of positive bottles, as well as automated monitoring and recording of proper fill volume inside the bottles. Proper fill monitoring is a College of American Pathologists (CAP) requirement for all accredited laboratories.) After an additional 18-24 hour from the time of initial positivity of blood cultures (and/or cultures from other body sites), organism growth is achieved on solid culture media and organism identification and antimicrobial susceptibility testing (if clinically indicated) is then performed using the bacteriology identification/susceptibility instrumentation provided with the reagents/analyzer system. The organism (bacteria or yeast) is inoculated into reagents and consumables that are proprietary and vendor-specific. The resulting card/tray is loaded onto the analyzer(s) in the system and results are obtained within 24 hours or less. 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 isolate identification by Matrix-assisted laser desorption/ionization [MALDI] - a soft ionization technique used in mass spectrometry. This component of the system can produce identification results within minutes, as opposed to 4-24 hours. Because not all organisms are capable of being identified by MALDI, a back-up identification component is required in the system. The rapid identification is helpful to providers who treat veterans for life-threatening bacterial infections.) Delays in reporting correct organism identifications cost the medical center money due to delayed treatments, or treatments with incorrect antimicrobial therapies.

2.3. Other patient specimens (urine, stool, sputum, tissue, wound, bronchial, throat, genital, etc.) are routinely submitted for culture to the microbiology laboratory. These specimens are plated directly to nonselective and selective media agars and incubated overnight. Resulting growth is inoculated as described above (to the MALDI and/or identification/susceptibility analyzers) for the positive isolates, and the process continues until organism identification and susceptibilities have been reported to the patient chart(s) via the vendor middleware, thru the Laboratory Information System’s intermediary software linking results to VistA and the patient electronic record.

3. Scope of Work.

3.1. The Veterans Administration (VA) seeks a Microbiology Reagents/Analyzers System containing multiple compatible components for bacteria and yeast identification, bacteria susceptibility, and blood culture analysis. All components are to be managed thru one 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 requirement is for the 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 identification of bacteria/yeasts than the current system, incorporating Matrix-assisted laser desorption/ionization (MALDI) - a soft ionization technique used in mass spectrometry. Newer model blood culture instruments have the ability to automatically monitor blood culture bottles for proper fill volume, as well as provides time-saving steps (decreasing technologist hands-on time). Addition of the all-important middleware will decrease numbers of corrected reports currently experienced because of inability of current interface to provide proper CLIA / CLSI susceptibility breakpoints in final reports, as well as manage data from the individual components of the entire system. (At present, technologists must manually discriminate and correctly enter the proper interpretations into VistA).

3.2. Microbiology reagents/analyzer system for identification of bacteria and yeasts, and bacteria susceptibility, as well as for blood culture analysis are required in order to perform CLIA-approved 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 hospital in Decatur, GA (30033).

4. Requirements:

4.1. MICROBIOLOGY Reagents/analyzers System (cost per test) to include leased equipment, reagents/supplies, and ongoing services, and to include the following related components: Blood Culture System; Microbiology analyzer which performs bacteria and yeast identification and bacteria susceptibility testing; MALDI-TOF; and Middleware.

4.1.1 Pertaining to the entire Reagents/analyzers System:

4.1.1.1. Base equipment offered that shall fully support the scope of operations as outlined in section 4.1. thru 4.9. One analyzer or multiple analyzers connected as a system shall include sufficient capacity and throughput to meet the volume and service demands as defined in Attachments A (volumes) and B (antibiotics).

4.1.1.2. All equipment shall be fully compatible and linked thru integrated database(s) with a single compatible middleware that will interface seamlessly with LIS intermediary hardware/software. A bi-directional computer interface compatible with the current VA laboratory information system (LIS): 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.

4.1.1.3. All instrumentation and reagent test kits offered shall be approved by the Food and Drug Administration (FDA) at time of solicitation.

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

4.1.1.5. The system must detect processing errors and provide error notification by means of an audible and/or visual alarm.

4.1.1.6. Product limitations (found in manufacturer package inserts) must meet or exceed operational requirements, as outlined in section 4 Requirements, that apply specifically to the ATL VAMC Microbiology Laboratory’s antibiotic/reporting formulary menu.

4.1.1.7. Contingency protocols to reduce, prevent and/or provide remedy to address system downtime expected to exceed 24 hours.

4.1.1.8. Documented safety features that provide protection against unnecessary exposure to biohazardous and chemical material

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

4.1.1.10. All PMs (scheduled routine performance maintenance) shall be included; any calibrators to be included per FDA-approved protocol.

4.1.1.11. All repairs (scheduled and unscheduled) shall be include a detailed and legible field service report which will include a detailed description of the preventive maintenance and inspections. Emergencies and unscheduled repair services performed, including replaced parts, shall also include detailed and legible field service report; which will include estimated prices for service calls outside the established contract parameters.

4.1.1.12. Availability of contractor to provide On-site training, as needed, throughout the term of contract.

4.1.1.13. All system components must have barcoding capability that links the specimen isolates to the system and middleware.

4.1.1.14. Vendor must provide training and assistance in collaborating with the lab to write/develop protocols to establish customer configurable rules (i.e. MIC reporting rules, CLSI reporting rules) to enhance workflow management and productivity.

4.1.1.15. An uninterruptible power supply (UPS) with line conditioner shall be provided for each instrument.

4.1.1.16. The technology to print results in real time or on demand for entire system, as well as an option to print exception reports held in the middleware for auto-verification purposes (example: reporting negative blood cultures).

4.1.1.17. The ability to produce antibiogram reports for the VA Microbiology Laboratory.

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

4.1.1.20. Quality Control material (ATCC strains) is not required to be included in this contract; however, the Cost-Per-Test price shall include control products for lot changes and troubleshooting purposes.

4.1.1.21. Method performance/comparison shall be at the expense of the Vendor, 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 nasal swabs, stool, urine, blood, and other microbiology specimens, as applicable. These validation requirements are applicable to all new testing analyzers. Precision (within- and between-run), Sensitivity, Carryover, Specificity, Reference Range, and Correlation studies for each analyte shall be included. Contractor shall assist VA microbiology technologists in analyzing results and providing statistical data to support acceptance of the new method for above studies. (Patient testing will not go “live” until acceptance of the data by the VA Chief Pathologist.) Statistics shall meet current standards defined by Clinical and Laboratory Standards Institute (CLSI) and CAP microbiology laboratories.

4.1.2. Pertaining to the Blood Culture Component: Blood Culture testing site system to include:

· Anaerobic Blood Culture Bottles

· Aerobic Blood Culture Bottles

· Installation

· Calibration Testing

· Validation and Correlation Studies

· Decontamination

· Removal

· Maintenance and Repairs

· Training of VA Technologist

4.1.2.1. The ability to sort and retrieve data for infection control regarding blood culture contamination.

4.1.2.2. Blood culture instrumentation bottles must be FDA-approved for testing of blood, as well as for testing of sterile body site fluids.

4.1.2.3. Blood culture instrumentation shall have the capability to directly measure blood volume in both the aerobic and anaerobic bottles obtained from adult patients at the time of loading; if bottle blood volume is not within specifications, the instrument shall then notify the technologist immediately using an audible and/or visual alert.

4.1.2.4. The blood culture instrument component should have the capability to automatically load and unload bottles.

4.1.2.5. Capability to add a visual or audible remote alarm system for positive blood cultures shall exist, where technologists in other areas of the laboratory may be alerted.

4.1.3. Pertaining to the Microbiology Analyzer which performs organism identification and susceptibility testing on patient microbiology specimen isolates (bacteria and yeast). Site system to include:

· Gram positive antibiotic susceptibility tests (AST)

· Yeast Identification (ID) tests

· Gram positive identification (GPI) tests

· Gram Negative Identification (GNI) tests

· Gram negative antibiotic susceptibility tests (AST)

· Installation

· Calibration Testing

· Validation and Correlation Studies

· Decontamination

· Removal

· Maintenance and Repairs

· Training of VA Technologist

4.1.3.1. Specimen preparation for Microbiology ID/AST Instrumentation shall include the fewest types of inoculum products (quantitate).

4.1.3.2. Specimen preparation for Microbiology ID/AST Instrumentation shall include automated dilution with no manual pipetting steps between ID and AST tubes.

4.1.3.3. Specimen preparation for Microbiology ID/AST Instrumentation shall include automated pour-off or aspiration of inoculated tubes to trays/cards at or before time of insertion into analyzer.

4.1.3.4. At least 80% percent of ID/AST results / reports should be available within 18 hours or less.

4.1.3.5. Bacteria and yeast ID must be able to be set up and analyzed separately from the MIC susceptibility on the ID/AST analyzer (i.e. no combination panels).

4.1.4. Pertaining to the Mass Spectrometry Microbial Identification System with MALDI-TOF (Microbiology Laser: Matrix-assisted laser desorption/ionization time-of-flight). Automated mass spectrometry microbial identification system that uses the MALDI-TOF technology, as well as a comprehensive marked database to rapidly identify bacteria, yeast (to include Nocardia and other Actinomycetes). This obligation includes test lease contract, as well as maintenance, repairs, calibrations, and training of technologists:

· Target slides (disposable)

· Reagent Kit MALDI-TOF test system used for rapid laser guided identification of bacteria and yeast

· Installation

· Calibration Testing

· Validation and Correlation Studies

· Decontamination

· Removal

· Maintenance and Repairs

· Training of VA Technologist

4.1.4.1. Bacteria (aerobic and anaerobic) and yeast ID (to include Nocardia and other Actinomycetes) must be able to be performed using FDA-approved matrix-assisted laser desorption/ionization (MALDI) - a soft ionization technique used in mass spectrometry.

4.1.4.2. Use of MALDI shall incorporate disposable target slides.

4.1.4.3. MALDI capability of identification of Salmonella to the species level must be present, as part of the FDA-cleared clinical database available to the VAMC microbiology medical technologist operator.

4.1.4.4. Any remote calibrations or function tests and any remote access must be pre-approved by Atlanta VA Information Security Officer (ISO). In the absence of ISO approval or remote ability, vendor must provide onsite calibrations and function tests at regular, pre-defined intervals. (Ex. For MALDI-TOF)

4.1.5. Pertaining to the Middleware: Integrated and automated middleware system that connects all components: This middleware shall interface all components with the VA Laboratory Information System (LIS) intermediary hardware/software linking with VistA

4.2. Test Menu – Refer to Attachment A for desired test menu and estimated annual volumes. Refer to Attachment B for desired antibiotic formulary testing requirements.

4.3. 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. Implementation/transition timeframe - The implementation of the installation services/requirements described in this solicitation shall be completed no later than 90 days after the award of the contract.

4.4.1. A technical support specialist from the contractor will provide 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.

4.4.2. 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.

4.4.3. 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.

4.4.4. 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 contract; however, it does refer to significant changes in the hardware operational capability.

4.4.5. 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.

4.4.6. 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 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.

4.4.7. 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

4.5. Ownership of Equipment - Title to the equipment shall remain with the Contractor.

All accessories (unused consumables, etc.) furnished and paid for 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. The removal of any contractor equipment or system components from the VA shall be done in accordance with all applicable federal laws and regulations and VA policies.

4.6. 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.

4.7. Prior to termination or completion of this contract, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this contract 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 contract.

4.8. 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 contract 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 contract or disposal or return of the IT equipment, whichever is earlier.

4.9. 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

· 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 Blood Culture and Bacteria/Yeast Identification and Susceptibility Instrumentation 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:

Test menu:

ATTACHMENT B

SUSCEPTIBILITY TESTING ANTIBIOTICS required for formulary at ATL VAMC Microbiology Laboratory:

ESBL

optional

Ertapenem optional

DAPTOMYCIN

X

Bet-lactamase optional

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;

Requirement

Method

Rating Incentive

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.

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. GENERAL ENTERPRISE MANAGEMENT CONTROL

Contract Management Plan. Quarterly Status Report (SEE QASP)

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

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).

No organizational COI exists.

c. 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.

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 addition of MALDI technology to SAFETY / CHEMICAL HYGIENE OFFICE risk assessment. Items to be included in Laboratory Chemical Hygiene Plan. (No additional requirement for risk assessment for patient safety.) MALDI contains an internal laser under vacuum.

12. Place of Performance

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

13. General Overview of Delivery the Equipment / Services

No more than 90 Days

No more than 90 Days

No more than 90 Days

throughout term

No more than 90 Days

14. Personnel

14.1. Emergency Health Services: The VA will render emergency health services for an incapacitating injury or otherwise serious illness occurring while on duty. All services, to include wages earned during the period of initial medical evaluation provided by the VA, shall be reimbursed by the contractor. The contractor shall furnish the VA with the necessary injury/illness form(s) for reporting purposes. The VA for statistical and/or billing purposes will retain a copy of the complete form(s).

14.2. Infection Control Requirements: In general, all contract personnel must comply with OSHA requirements for healthcare facilities. VA will notify the contractor of any significant communicable disease exposures as appropriate. The contractor’s occupational health provider shall adhere to current CDC/HICPAC Guideline for “infection control” in health care personnel (AJIC 1998; 26:289-354) for disease control. The contracting agency shall provide follow up documentation of employee’s clearance to return to the workplace prior to their return.

14.3. Identification, Parking, Smoking and VA Regulations

14.3.1. Contract personnel shall maintain a neat personal appearance and maintain a professional decorum. Contract personnel shall wear protective clothing as required.

14.3.2. Contract personnel shall wear visible identification badges while on Government property.

14.3.3. It is the responsibility of contract personnel to park in designated parking areas only. Parking information and applicable parking decals and stickers will be available from the VA Police. The Government will not invalidate or make reimbursement for parking violations of the contract personnel.

14.3.4. Intoxication, debilitation resulting from drug use, insubordination, theft, patient abuse, dereliction or negligence in performing directed tasks and possession of weapons is prohibited and grounds for immediate removal from VA facility. Enclosed containers, of any nature, are subject to search.

14.3.5. Violations of VA regulations may result in a citation answerable in the U.S. Federal District Court, not a local district, state or municipal court.

15. Security Incident Investigation

15.1 The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

15.2 To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets…