S02 - RFQ-36C26223Q0138_ID_AST_MALDI_01-17-2023.docx

36C26223Q0138

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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C262-23-AP-0694

36C26223Q0138

Robert W. Hutchison

36C262 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

X

325413 1,250 Employees

NET 30 Days

N/A X

36C262

VISN 22

See Section B – Paragraph B.2.3

Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

Financial Services Center Submit Invoices Electronically to www.tungsten-network.com/us/en

(877) 752-0900 Option #2

See CONTINUATION Page

VISN 22 – seven (7) sites Microbiology Identification (ID) / Susceptibility (AST)/ Matrix-Assisted Laser Desorption Ionization Time of Flight Mass Spectrometer (MALDI-TOF-MS) Equipment Purchase and Cost-Per-Test (CPT) solution in accordance with the schedule herein.

Base Period of Performance (5 Years): 08/05/2023 – 08/04/2028 OY1 Period of Performance (1 Year): 08/05/2028 – 08/04/2029 OY2 Period of Performance (1 Year): 08/05/2029 – 08/04/2030

See CONTINUATION Page

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

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 36C262 Daniel Ruiz at Daniel.Ruiz@va.gov.

Department of Veterans Affairs (VA) Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

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 Financial Services Center Submit Invoices Electronically to www.tungsten-network.com/us/en

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 DESCRIPTION OF CONTRACT

1. INTENT: (i) This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number 36C26223Q0138 is issued as a Request for Quotation (RFQ). (iii) The provisions and clauses in this document are in effect through the Federal Acquisition Circular 2023-01, December 30th, 2022. (iv) This solicitation intends to award a contract through full and open competition to a business associated with NAICS Code 325413. In the spirit of the Federal Acquisition Streamlining Act and pursuant to Federal Acquisition Regulation (FAR) Part 12 and FAR Part 13, the Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN) 22 Healthcare Centers is establishing this single award Indefinite-Delivery / Indefinite-Quantity (IDIQ) contract for a Microbiology ID / AST / MALDI-TOF-MS Equipment Capital Purchase and CPT Solution as described within this solicitation. The Contractor shall make available for purchase all the necessary products and services commercially available by Contractor to meet VISN 22 Healthcare Center’s needs as outlined within this IDIQ. VISN 22 Healthcare Centers require the following: 1) A complete solution from a single Contractor to avoid problems with equipment interface, warranties, validations, and multiple points of contact for the solution, plus it streamlines workflow and enhances patient care outcomes; 2) Rapid testing is required by the VA to meet its mission for the best patient care to our veteran population; 3) The solution must be FDA approved to reduce the VA manhours for lengthy comprehensive validation processes of lab developed tests, to reduce the high complexity level of VA staff required in the laboratory, and to reduce the need of hiring additional staffing levels required to carry out non-FDA approved systems and testing. In addition, as requirements change, products and services may be added or deleted by supplemental agreement of the Government and the Contractor. Prices in this schedule represent an all-inclusive rate including labor, incidental costs, overhead, processing fee, delivery fee, handling fee, insurance premium payments for applicable insurance coverage, etc. Costs not incorporated into the contractor’s price will not be reimbursed by the Government.

2. TERM OF CONTRACT: This IDIQ shall be for a five (5) year base period, with two (2) one (1)-year option periods, for a total of seven (7) years. The IDIQ will be reviewed annually to ensure the IDIQ terms are met, and to assess current market conditions and determine price reasonableness. Additional discounts maybe requested by VISN 22 sites at any time. If the Contractor fails to perform in a manner satisfactory to the Contracting Officer (CO), this IDIQ may be canceled with thirty (30) days written notice to the Contractor by the CO.

3. PARTICIPATING FACILITIES: The following VISN 22 sites are included in this IDIQ.

3.1 Greater Los Angeles Healthcare System, 11301 Wilshire Blvd, Los Angeles, CA 90073

3.2 Loma Linda Healthcare System, 11201 Benton St., Loma Linda, CA 92357

3.3 San Diego Healthcare System, 3350 La Jolla Village Dr., San Diego, CA 92161

3.4 Long Beach Healthcare System, 5901 E. 7th St., Long Beach, CA 90822

3.5 Tucson Healthcare System, 3601 S. 6th Ave., Tucson, AZ 85723

3.6 Phoenix Healthcare System, 650 E. Indian School Rd., Phoenix, AZ 85012

3.7 Albuquerque Healthcare System, 1501 San Pedro S.E., Albuquerque, NM 87108

4. IDIQ LIMITS: The guaranteed minimum amount for this contract is $1,000.00. The maximum aggregate value / ceiling of the orders that can be placed under this contract is $6,910,000.00. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum amount. This IDIQ contract shall not exceed a total duration of ninety (90) months from the effective date of the IDIQ. Pricing shall be established based on the estimated quantities listed in (Attachment A) – Schedule of Pricing.

5. IDIQ ORDERS: This IDIQ is a pricing agreement and does not obligate any funds. The Government is obligated only to the extent of authorized IDIQ Delivery Orders (DOs) issued under the IDIQ by authorized individuals. DO’s shall be identified by the IDIQ Number TBD and DO Number 36C262(fiscal year)N(sequential four digit number). DO’s may include option years, if it is determined that option years would be in the best interest of the Government. Any DO’s issued during the effective term of this IDIQ shall be completed by the Contractor within the time specified in the DO, including all option years, which may extend beyond the IDIQ term. All products and services ordered under DO’s shall be subject to the terms and conditions of this IDIQ. The Contractor shall accept the price, terms and conditions of an issued DO as long as they do not conflict with the terms set forth in the IDIQ. Single DO’s shall be limited to $3,000,000.00 per order. This amount is subject to change if additional supplies and services are needed to meet VISN 22 sites’ needs.

6. ORDERING METHOD: All orders shall be placed against valid DO’s signed by the CO. The CO shall designate primary facility Points of Contact (POC’s), as necessary, who may coordinate delivery quantities and schedule via Electronic Data Interchange (EDI), telephone, facsimile, email or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

7. IDIQ PROGRAM MANAGER: The Contractor shall provide a primary IDIQ program manager who shall be responsible for the performance of the work under the IDIQ. In addition, the program manager shall act as the main focal point of communication between the CO and the Contractor. The name of this person shall be designated in writing to the CO. The program manager shall have full authority to act on behalf of the Contractor on all contractual/IDIQ matters relating to daily operation of the IDIQ.

8. ORDERING CONTACT: The Contractor shall list in the spaces below the name(s) and address(es) of customer service departments with whom the Government facilities shall place orders:

9. DELIVERY: The Contractor shall deliver all supplies and services identified in the schedule to the locations identified in Section B.2.3, Participating Facilities. The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The primary facility POC shall be required to notify the Contractor when delivery locations have been changed.

All deliveries shall be accompanied by a delivery ticket or sales slip which shall contain Contractor name, date of order, date of delivery, itemized list of products furnished, including product description and quantity shipped. All deliveries shall be made during normal working hours from 8:00a.m. to 5:00p.m, PST unless specified otherwise. The Contractor shall provide an emergency point of contact, if different from the standard points of contacts.

10. PACKAGING: All supplies shall be adequately packaged to prevent damage during shipping, handling and storage. Bags or packages shall be whole, intact, and not otherwise torn or damaged. Upon delivery, the Government shall examine all packages. The Contractor shall be required to replace unacceptable or damaged products at the Contractor’s expense.

11. INVOICING AND PAYMENT INFORMATION: An itemized invoice shall be submitted weekly, bi-weekly, monthly or upon expiration of this IDIQ, whichever occurs first, for all deliveries made during a billing period and for which payment has not been received. These invoices need not be supported by copies of delivery tickets. Invoices shall be submitted to WWW.TUNGSTEN-NETWORK.COM in accordance with FAR Part 52.232-34, Payment by Electronic Funds Transfer and VAAR Part 852.232-72.

The following information shall be listed on all invoices (Failure to comply may result in refusal of an invoice resulting in delayed payment at the fault of the Contractor).

11.1.1 Facility’s Name and address where service was provided

11.1.2 IDIQ Number (For Example: 36C26223D0001)

11.1.3 Delivery Order Number (For Example: 36C26223N0001)

11.1.4 Obligation Number (For Example: 600C20001)

11.1.5 A Line Item break down of usage for example:

11.1.6 Line item 1 GI Scope Lease: 1 MO at $400.00

11.1.7 Line item 4 GI Service Maintenance: 1 MO at $10.00

11.1.8 Include the period of time that is being invoiced for in the invoice.

11.1.9 IDIQ Holder’s Internal Contract number (if applicable)

11.1.10 Include point of contact for concerns and questions. Contractor must name a specific person, phone number and email.

12. IDIQ REVIEW: The Contractor shall conduct a complete IDIQ review with the CO/CS annually and/or as requested by the CO/CS, to ensure the IDIQ terms and conditions are being met, analyze and project item ordering trends, and discuss all other actions that are within the scope of this IDIQ.

B.3 PRICE/COST SCHEDULE

VISN 22 – Base Period Five (5)-Year Pricing - 08/05/2023 - 08/04/2028

VISN 22 – Option Year #1 / One (1)-Year Pricing - 08/05/2028 - 08/04/2029

VISN 22 – Option Year #2 / One (1)-Year Pricing - 08/05/2029 - 08/04/2030

B.4 STATEMENT OF WORK

1. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

1.1. SCOPE OF PROCUREMENT:

1.1.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall be able to simultaneously perform the testing 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).

1.1.2. Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory.

1.1.3. If Contractor offers a family of analyzers, Veterans Integrated Service Network (VISN) 22 technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

1.1.4. Equipment shall be acquired for each of the clinical laboratories located at the VISN 22 facilities: Greater Los Angeles, CA; Long Beach, CA; San Diego, CA; Loma Linda, CA; Tucson, AZ; Phoenix, AZ; and Albuquerque, NM.

1.1.5. The Contractor is required to provide a continuously stocked 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.

1.1.6. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and 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 twenty-four (24) hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Veterans Affairs (VA) site in the most expeditious manner possible without additional cost to the VA, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one (1) week (under normal VA test load volume). If additional requests for emergency supply deliveries are required by the VA, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supply deliveries.

1.2. DEFINITIONS:

1.2.1. 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) 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; 2) All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); 3) All necessary software licensing; and 4) Training for VA personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge.

1.2.2. Business Associate Agreement (BAA)- (When Applicable) A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

1.3. TEST MENU: Refer to (Attachment A) for desired test menu and estimated annual volumes.

1.4. GENERAL REQUIREMENTS:

1.4.1. Primary analyzer(s)– Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer shall be equivalent to a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment.

VISN 22 VA medical centers are in need of a Matrix-Assisted Laser Desorption Ionization Time of Flight Mass Spectrometer (MALDI-TOF-MS) as an additional faster bacterial identification system. The device must analyze material from microbial cultures to provide organism identification within minutes.

1.4.1.1.1. The instrument must include a Food and Drug Administration (FDA)-approved broad library of gram positive, gram negative, anaerobic bacterial organisms as well as yeast and fungi (or equivalent methodology) to limit the amount of work needed on self-validation/verification studies. System and data base library must be FDA- approved.

1.4.1.1.2. The instrument must have bench side accessibility. (Small footprint, set on top of laboratory work bench)

1.4.1.1.3. The instrument must be FDA 21 CFR Part 11 Compliant.

1.4.1.1.4. A preparatory apparatus and equipment must be provided for specimen preparation, and there must be an easy method for securely linking specimen information to each spot on the target slide.

1.4.1.1.5. The instrument must be fully integrated with the antimicrobial susceptibility testing platform in place with automatic linking of organism ID to sensitivity.

1.4.2. The system shall provide self-contained, automated identification and antibiotic susceptibility testing system for minimally aerobic, facultative, fastidious microorganisms, yeast, and anaerobes.

1.4.3. Operational Features- The instrumentation offered shall have the following:

1.4.3.1. The capability of performing analysis on one hundred (100) % of the test panels listed in (Attachment A).

1.4.3.2. Sufficient capacity and throughput to meet the volume and service demands as defined in (Attachment A).

1.4.3.3. 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.

1.4.3.4. A bi-directional, bar-coded computer interface compatible 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.

1.4.3.4.1. The accuracy of the barcode reading must have less than a one (1) % failure rate.

1.4.3.4.2. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

1.4.3.5. Equipment must accept, at a minimum, barcode characters (BCBC) in the specimen identifier that is alpha and/or numeric depending upon site.

1.4.3.6. Minimal daily, monthly, and periodic maintenance.

1.4.3.7. Ability to store and retransmit records twenty-four (24) hours of maximal instrument throughput) in case of interface outage.

1.4.4. Technical Features- The instrumentation must be approved by the FDA and shall have the following:

1.4.4.1. The capability of accurately and reliably identifying both gram-negative and gram-positive bacteria, yeast (or equivalent methodology), and anaerobes.

1.4.4.2. The capability of reporting susceptibility tests in accordance with FDA/CLSI guidelines. At a minimum, the equipment must provide the following antibiotic-organism combinations.

1.4.4.3. The information below must be updated as new versions of standards are released:

1.4.4.3.1. Antibiotics Required on Panels:

Gram Negative Panels

Ampicillin/Sulbactam

Amoxicillin/Clavulanic Acid

Ticarcillin/Clavulanic Acid

Ceftolozane/Tazobactam

Meropenem/ Vaborbactam

Cefazolin

Cafazolin

Cefoxitin

Cefuroxime

Cefpodoxime

Ceftazidime

Ceftriaxone

Cefepime

Imipenem

Meropenem

Gentamicin

Tobramycin

Levofloxacin

Moxifloxacin

Minocycline

Tetracycline

Tigecycline

Nitrofurantoin

Trimethoprim/Sulfamethoxazole

Gram Positive Panels

S. agalactiae

S. agalactiae

Vancomycin Susceptible E. faecalis

S. agalactiae

S. agalactiae

S. aureus, S. epidermidis, S. haemolyticus

Vancomycin Resistant E. faecium, S. agalactiae

S. agalactiae

S. haemolyticus, S. agalactiae, E. casseliflavus

S agalactiae

MSSA-Methicillin-susceptible S. aureus, MRSA-Methicillin-resistant S. aureus, MSSE-Methicillin-susceptible S. epidermidis

Streptococcus pneumoniae Panels

Streptococcus spp Panels

Viridans group Streptococcus

Viridans group Streptococcus, Strep. pneumoniae

Strep. pneumoniae

S. pneumoniae, S. pyogenes

Viridans group Streptococcus

Group C/F, G Beta-hemolytic Streptococcus, Viridans group Streptococcus , S. milleri

S. pyogenes, S. agalactiae, Viridans group Streptococcus

Viridans group Streptococcus

S. agalactiae

Fungal Panels (or equivalent methodology)

C. tropicalis, C. guilliermondii, C. glabrata

C. tropicalis, C. guilliermondii, C. lusitaniae

C. guilliermondii, C. lusitaniae, C. parapsilosis, C. tropicalis

C. tropicalis, C. lusitaniae, C. guilliermondii

1.4.4.4. The capability of detecting emerging antimicrobial resistance.

1.4.4.4.1. MRSA (Methicillin Resistance Staphylococcus aureus, VRE (Vancomycin Resistant Entercoccus, ESBL (Extended Spectrum Beta Lactamase), KPC (Klebsiella pneumonia Carbapenemase), and others as they arise.

1.4.4.5. Comprehensive and extensive data base of bacteria and yeast species that is consistent with FDA/CLSI guidelines.

1.4.4.6. Software or equipment modifications as needed and, when commercially available, to comply with changes in standards for identification or susceptibility testing established by CLSI, Center for Disease Control (CDC) and other governing or authoritative bodies. Allow for manual modification of susceptibility breakpoints to comply with new CLSI guidelines until such time as the Contractor applies necessary software upgrades.

1.4.4.6.1. The platform must be able to increase throughput by connecting the two (2) machines together.

1.4.4.6.2. The included middleware must include, as standard, the ability for continuous remote notification of critical events, and delayed processing steps.

1.4.4.6.3. The included middleware must be able to manage multiple instruments through a unified interface.

1.4.4.6.4. The system must interface with the existing VA systems DI/VISTA.

1.4.4.7. Comprehensive array of bacterial antimicrobial susceptibility panels which each individual facility may select to meet individual needs. Contractor shall supply a list of available susceptibility panels as well as a list of antibiotic exceptions for their methodology at time of proposal.

1.4.4.8. Built-in quality control program to regularly monitor system performance.

1.4.5. Data Management - The System shall have the following:

1.4.5.1. Capability to provide varied options for analysis and reporting/review of cumulative patient data on organisms isolated and antimicrobial profiles, i.e., using conditional statements (if/then statements), that all search and retrieval of specific information (by patient, by organism, by antimicrobial agent, by specimen type, by MIC {when applicable}, etc.)

1.4.5.1.1. Conditional statements shall also allow for modification of reporting/not reporting selected antimicrobial agents by enabling/disabling suppression rules at the specimen, test, and isolated level in a standard way.

1.4.5.1.2. Capability to connect to the DI/VISTA interface using standard protocols such as HL7. Transmission protocol shall meet current VA security standards. Contractor shall provide connectivity specifications as well as instrument connectivity/interface operating procedures.

1.4.5.1.2.1. The contractor will supply information technology (IT) personnel support to implement a DI/VISTA auto-verification script from the supplied equipment middleware interface.

1.4.5.1.2.2. The contractor will supply Information Technology and informatics support for initial interface establishment and on-going LIS connectivity support through-out the established contract maintenance and support period. The instrument operating systems meet current minimum VA Information Technology Operating System requirements and will provide VA required documentation to adhere to VA Handbook 6500.6, Appendix C, security requirements, see (Attachment B). The vendor will provide support for current and arising system security vulnerabilities as identified by qualified VA information security personnel and guidance.

1.4.5.2. Capability to record, store, transmit in standard communication language such as HL7, and print the following information:

1.4.5.2.1. Required quality control and instrument maintenance information.

1.4.5.2.2. Patient demographic information and specimen results.

1.4.5.2.3. Capability of manipulating/sorting the patient demographic information and patient microbiology test results to generate epidemiological reports, i.e. antibiograms (with the option of first-isolate antibiograms), organism trending report, phenotype occurrence report, etc.

1.4.5.2.4. Sufficient memory to store patient information and test results with downloading capability to an external medium for long term storage of patient records and other information. A daily backup shall be performed at a specified time.

1.4.6. Hardware Features- The instrumentation shall have the following:

A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. An on-board monitor/screen that is easily readable (A computer integrated with instrument system). A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID) if unable to utilize network printing. An uninterruptible power supply with line conditioner for each instrument provided. Database/storage solution must be specified in Contractor’s response and include funded line items for use by the VA. Examples include on-site hardware, VA provided/Vendor funded virtual machine, applicable cloud-based solutions, etc.

1.4.7. Support Features-

1.4.7.1. Commercial marketing. 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 equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

1.4.7.2. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories, and any other items needed and/or required to establish instruments for operation for performance of acceptance testing.

1.4.7.3. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally two (2) operators per facility per year at the discretion of the VA for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. All training must be on-site at the VA

1.4.7.4. Service Requirements-

1.4.7.4.1 A technical assistance center shall be available by telephone twenty-four (24) hours per day, seven (7) days per week with a maximum call back response time of one (1) hour.

1.4.7.4.2 Equipment repair service shall be provided on site within twenty-four (24) hours during core business hours of 8:00am – 5:00pm, seven days a week. If equipment malfunction is deemed to jeopardize the need for continuation of patient care, then the vendor will provide an emergent on-site repair service to be conducted outside core business hours within twenty-four (24) hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

1.4.7.4.3 Equipment repair response time shall be no more than two (2) hours.

1.4.7.4.4 Preventative maintenance shall be performed on all primary and back-up instrumentation and any incremental support equipment as frequently as published in the manufacturer’s operator’s manual and within two (2) weeks of the scheduled due date.

1.4.7.4.5 A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

1.4.7.4.5.1 date and time notified

1.4.7.4.5.2 date and time of arrival

1.4.7.4.5.3 serial number, type, and model number of equipment

1.4.7.4.5.4 time spent for repair, and

1.4.7.4.5.5 proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

1.4.7.4.5.6 Each notification for an emergency repair service call shall be treated as a separate and new service call.

1.4.7.4.5.7 Contractor shall have and maintain a current Memorandum of Understanding/Information Security Agreement (MOU/ISA) with the VA to provide remote support assistance, diagnostics and systems monitoring capabilities. Vendors not having a current agreement shall agree to completing an MOU/ISA for this purpose at the vendor’s expense.

7. 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 VA. 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, expanded database, 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 and include replacing the original piece of equipment provided under the Indefinite Delivery / Indefinite Quantity (IDIQ) contract; however, it does refer to if the new equipment is deemed superior by the receiving facility and results in significant changes in the hardware operational capability.

1.4.7.6 Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the IDIQ contract, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

1.4.7.7 Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CSLI format or an on-line procedure manual in the instrument software.

1.4.7.8 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 in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. 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 determine if the waste is a hazardous waste or otherwise regulated.

1.4.7.8.1 The determination and description shall address the following:

1.4.7.8.1.1 Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

1.4.7.8.1.2 Waste ignitability (Reference 40 CFR §261.21)

1.4.7.8.1.3 Waste corrosivity (Reference 40 CFR §261.22)

1.4.7.8.1.4 Waste reactivity (Reference 40 CFR §261.23)

1.4.7.8.1.5 Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)

1.4.7.8.1.6 Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)

1.4.7.8.1.7 Solid Waste (Reference 40 CFR §261.2)

1.4.7.8.1.8 Exclusions (Reference 40 CFR §261.4)

1.4.7.8.2 The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

1.4.7.8.3 Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosal and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response:

1.4.7.8.3.16 BOD; biochemical oxygen demand

1.4.7.8.4 The documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system.

1.4.7.9 Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after the award of the IDIQ contract, but no later than 8/5/2023. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 120 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the VA.

1.4.7.9.1 Upon award of a IDIQ contract, the transition period for the awarded IDIQ contract to have all equipment and peripherals installed and operational shall be within 120 days, but no later than 8/5/2023. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

1.4.7.9.2 Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 120 days, but no later than 8/5/2023, for the transition of all equipment/services under the awarded IDIQ contract including installation and training of personnel, transition of all testing materials, reagents, and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate IDIQ contract for cause under the Termination for Cause clause of the IDIQ contract.

1.4.7.9.3 At the end of 120 days, but no later than 8/5/2023, the awarded Contractor shall have full and sole responsibility for CPT services under the awarded IDIQ contract.

1.4.8 Standard and Quality of Performance - This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or IDIQ contract] is accepted by the VA. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of thirty (30) consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any IDIQ contract at an effectiveness level of ninety (90) % or more.

1.4.8.1 In the event that equipment does not meet the standard of performance during the initial thirty (30) consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

1.4.8.2 If the equipment fails to meet the standard of performance after ninety (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 clause 52.212-4 entitled “Termination for Cause.” (The Contractor shall receive revenue for tests reported during the ninety (90)-day acceptance period.)

1.4.8.3 Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period-of-time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the VA makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the VA in proper operating condition.

1.4.8.4 During the performance period for a system, a minimum of one hundred (100) hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when more than the minimum of one hundred (100) hours.

1.4.8.5 The VA will maintain daily records to satisfy the requirements of this paragraph and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

1.4.8.6 During the term of the IDIQ contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of ten (10) % or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of ninety (90) % in each month of the term of the agreement for equipment.

1.4.9 VA’s Responsibility - The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions.