36C26124Q1058_1.docx

36C26124Q1058

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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.

UEI:

EFT:

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

36C261-24-AP-5024

593-25-1-968-0020 36C26124Q1058 09-11-2024 Alex Hernandez 916-759-6461 09-17-2024 08:00

PDT

00261 Department of Veterans Affairs Network Contracting Office 21 VA Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas

NV

89086 X 325413 1250 Employees N/A X See Delivery Schedule

00261 Department of Veterans Affairs Network Contracting Office 21 Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas

NV

89086

Financial Services Center P.O. Box 149971 Austin

TX

78714-9971 See CONTINUATION Page This RFQ is a Sole Source to Biomerieux Inc for the Brand Name Vitek Microbiology cost per test analysis and supplies in support of VA Southern Nevada Healthcare System.

Please fill in the unit price and complete required information in Section B.2 "Price/Cost Schedule".

Please provide delivery timeframe in terms of number of days after receipt of order in Section B.3 "Delivery Schedule".

Please send information to: Alex.Hernandez@va.gov no later than the date and time indicated in Block 8 above.

Please complete block 17 above and identify UEI number.

See CONTINUATION Page X Alex Hernandez Contracting Officer 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 36C261 Alex Hernandez

Network Contracting Office 21 VA Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086

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.

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

36C26124Q1058

Page 1 of Page 1 of Veterans Affairs Southern Nevada Healthcare System

STATEMENT OF WORK

1. CONTRACT TITLE: Biomerieux

2. REQUIREMENTS/SCOPE: The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in this SOW, perform all the required tests described within this solicitation, 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. SPECIFIC TASKS:

3.1.1. Equipment shall maintain, or preferably reduce the number of workstations and/or overall labor required to accomplish the required testing by each laboratory.

3.1.2. The Contractor shall 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 dates shall be clearly marked on reagents, 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.

3.2. Primary analyzer(s) – Base equipment offered 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 the technical specifications of this solicitation. If a back-up analyzer is required, the back-up analyzer shall meet the technical functionality and the capabilities of the primary analyzer, to include additional analyzer(s) that meet the definition of a primary analyzer.

a. Operational Features - The instrumentation offered shall have the following, at a minimum:

i. The capability of performing analysis on 100% of the test panels listed.

ii. Sufficient capacity and throughput to meet the volume and service demands as defined in list.

iii. Safety features to avoid exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment shall be minimal through the use of sealed consumables.

iv. 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 included and immediately available for implementation to the VA computerized hospital information system.

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

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

v. Equipment shall accept, at a minimum, BCBC characters in specimen identifier that is alpha and/or numeric, depending on the facility.

vi. Minimal daily, monthly, and periodic maintenance.

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

b. Technical Features - The instrumentation shall be approved by the FDA and shall have the following, at a minimum:

i. The capability of accurately and reliably of identifying gram negative and gram positive bacteria, yeast, and anaerobes 90 – 99% of the time.

ii. The capability of reporting susceptibility tests in accordance with FDA/CLSI guidelines. At a minimum, the equipment shall provide Minimum Inhibitory Concentrations (MIC) values for the following antibiotic-organism combinations in B.3.4.d.iii.

iii. A list of current needs include:

iv. The information below shall be updated as new versions of standards are released:

0.45% NACL SALINE BAG/CASE

0.45% SALINE 1000ml Bottle/CASE

2mm x 75mm POLYSTYRENE TUBES

ACCESSORY KIT VITK2 PIP/DIL

KIT DENSICHEK PLUS STANDARDS

GN TEST KIT VTK2

GP TEST KIT VTK2

YST TEST KIT VTK2

NH TEST KIT VTK2

ANC TEST KIT VTK2

AST-GP TEST KIT

AST-ST02 TEST KIT

AST-GN TEST KIT

AST-XN TEST KIT

ii. The capability of detecting emerging antimicrobial resistance.

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

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

iv. Software or equipment modifications, 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) The platform shall be able to increase throughput by connecting the two machines together.

(2) The included middleware shall include, as a standard, the ability for continuous remote notification of critical events, and delayed processing steps.

(3) The included middleware shall be able to manage multiple instruments through a unified interface.

v. Comprehensive array of bacterial antimicrobial susceptibility panels Contractor shall supply a list of available susceptibility panels as well as a list of antibiotic exceptions and limitations for their methodology at time of quote.

vi. Built-in quality control program to continuously monitor system performance.

c. Data Management - The System shall have the following, at a minimum:

i. 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, etc.)

(1) Conditional statements shall also allow for modification of reporting/not reporting selected antimicrobial agents by enabling/disabling suppression rules.

(2) Capability to connect to the Veterans Health Information Systems and Technology Architecture (VISTA) interface.

a. The Contractor shall supply IT personnel support to implement VISTA verification from the supplied equipment middleware interface upon installation of the instrumentation.

ii. Capability to record, store and print the following information:

(1) Manufacturer required quality control and instrument maintenance information

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(2) Patient demographic information and specimen results

(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.

(4) Sufficient memory to store patient information and test results with downloading capability to an encrypted/password protected external hard drive, thumb drive, or equivalent medium for long term storage of patient records and other information.

d. Hardware Features - The instrumentation shall have the following, at a minimum:

i. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

ii. An on-board monitor/screen that is easily readable.

iii. 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).

iv. An uninterruptible power supply with line conditioner for each instrument provided.

e. Support Features –

i. Commercial marketing. The equipment models being quoted shall be in current production as of the date this quote is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being quoted as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Gray market equipment, supplies, reagents are not acceptable.

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

iii. Training. The Contractor shall provide an off-site instrument training program for up to two operators initially that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and equivalent to a training program that the Contractor provides in the commercial market. This shall include, but is not limited to, training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

iv. Service Requirements

(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.

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(2) Equipment repair service shall be provided on site during core business hours between 8 AM and 5 PM within twenty-four (24) hours. If equipment malfunction is deemed to jeopardize the need for continuation of patient care, then the Contractor will provide an emergent on-site repair service to be conducted outside routine business hours within twenty-four (24) hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

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

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

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

a. Date and time notified

b. Date and time of arrival

c. Serial number, type and model number of equipment

d. Time spent for repair, and

e. Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance

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

v. Upgrades. The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system, 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 quoted, 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 includes replacing the original piece of equipment provided under the BPA if the new equipment is deemed superior by the receiving facility and results in significant changes in the hardware operational capability.

vi. Ancillary support equipment. The Contractor shall provide, install and maintain through the life of the BPA, 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.

vii. The Contractor shall be responsible for moving the quoted instrumentation/equipment in the event of facility renovation, or as needed by the VA, for the term of the BPA and subsequent Delivery Orders.

viii. 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.

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ix. 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 make a determination if the waste is a hazardous waste or otherwise regulated.

(1) The determination and description shall address the following:

a. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

b. Waste ignitability (Reference 40 CFR §261.21)

c. Waste corrosivity (Reference 40 CFR §261.22)

d. Waste reactivity (Reference 40 CFR §261.23)

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

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

g. Solid Waste (Reference 40 CFR §261.2)

h. Exclusions (Reference 40 CFR §261.4)

(2) The Contractor shall 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 shall fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

(3) The Contractor shall provide a description of all wastes that 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, corrosiveness, reactivity and toxicity as defined in 40 CFR §261 shall be determined and documented. Any mercury containing reagents shall 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, thimerosol and formaldehyde) shall be developed and SDS sheets shall 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 shall be included with Contractor response:

c. Chromium (Total)

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n. pH

o. Flash point (to higher than 200°F)

p. BOD; biochemical oxygen demand

(4) The documentation the Contractor provides will be used to work with the VAHS 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.

x. Implementation/transition timeframe. The implementation of the services/requirements described in this solicitation shall be completed no later than 30 days after the award of the BPA. 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 30 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

(1) Upon award of a BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through [TBD] days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

(2) Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed [TBD] days for the transition of all services under the awarded BPA 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 BPA for cause under the Termination for Cause clause of the BPA.

(3) At the end of [TBD] days from award of the BPA, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA.

f. 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 BPA] is accepted by the Government. 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 after the installation date, equipment verification, and after the written acceptance by the VA that the equipment can perform the requirements stated within this solicitation. 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 BPA at an effectiveness level of 90% or more.

g. 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 thirty (30) consecutive days.

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ii. If the equipment fails to meet the standard of performance after sixty (60) 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 Part 52.212-4 entitled “Termination for Cause.” (The Contractor shall receive revenue for tests reported during the ninety (90)-day acceptance period.)

iii. 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 Government 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 Government in proper operating condition.

iv. 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 in excess of the minimum of one-hundred (100) hours.

v. The Government shall 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.

vi. During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the POC 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.

4. PERIOD OF PERFORMANCE/SCHEDULE:

The POP for this contract shall be: (1) 1 (1) 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 of a patient reportable 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.

A. Normal daytime working hours will be adhered to. Normal daytime work hours are 0730 to 1600 Monday through Friday. If the contractor wishes to work at nighttime or during other unscheduled times, they must first get permission from the Contracting Officer.

5. PARTICIPATING FACILITY: VA Southern Nevada Healthcare System (VASNHS) Pathology and Laboratory Service located at 6900 North Pecos Road, North Las Vegas, Nevada 89086

6. CONTRACTING OFFICER REPRESENTATIVE:

The Contracting Officer Representative (COR) shall provide general instructions and shall be responsible for administrating the contract and ensuring invoices are certified for payment in a timely manner.

Location

COR:

Phone:

e-mail:

7. CONTRACTOR POINT OF CONTACT:

a. Contractor shall designate one employee as the Point of Contact (POC) responsible for administrative matters in the performance of services under this contract. The POC shall have full authority to act for the Contractor on all matters relating to the daily performance of this contract.

b. The POC shall be available by telephone Monday through Friday, between 7:30 a.m. and 4:00 p.m. excluding national holidays.

c. Contractor shall provide the name and telephone number of the person designated as Point of Contact, Alternate Point of Contact, and the name, location and telephone number of the office where normal and emergency service calls are to be placed:

Alternate Point of Contact (Full Name):

Telephone Number:

E-mail Address:

Emergency Service Contact Information:

Emergency Service Telephone Number:

8. U.S. GOVERNMENT FURNISHED MATERIALS AND SERVICES:

The contractor shall be responsible for the receipt and handling of all equipment and materials. The contractor shall coordinate proposed delivery areas with the Engineer.

9. CONTRACTOR FURNISHED ITEMS AND SERVICES:

The contractor shall furnish all necessary supplies, fuels, lubricants, solvents, parts, materials, equipment, products, tools, and any other items and services to perform all delivery and pick-up operations required by this statement of work.

The contractor shall provide fully qualified on-site personnel who shall be responsible for the performance of the work. The name of the person and all alternates shall be designated in writing to the Contracting Officer. The project manager shall be on-site during normal work hours and for contingencies requiring work beyond normal work hours.

The contractor shall certify in writing that all employees operating equipment are trained and qualified.

10. CONTRACTOR RESPONSIBILITIES:

Contractor Employees. The contractor shall not employ personnel for work on this contract if such employee is identified to the contractor as a potential threat to the health, safety, security, general well-being or operational mission of the installation and its population.

The Contractor shall furnish service manuals and/or test equipment for the performance of this contract. It is the responsibility of the Contractor to bring the appropriate equipment, parts and/or supplies necessary to complete the work as required. The Contractor shall be familiar and follow maintenance guidelines contained in current technical service manuals for all equipment and sub-assemblies listed. Manuals shall include but not be limited to schematics, diagrams, written procedures and parts lists.

All work shall be performed, and equipment shall function in conformance with all VA safety standards, manufacturer’s/industry standards, the latest published edition of NFPA-99, FDA, OSHA, Joint Commission, and other applicable national standards. The COR may facilitate a copy of VA safety standards to the Contractor upon request.

Contractor personnel shall present a neat appearance and be easily recognized as contractor employees. This may be accomplished by wearing distinctive clothing bearing the name of the company or company ID badge. Contractor field service personnel shall be dressed to present a clean, neat appearance at all times when performing under this contract.

Personnel performing maintenance and repair services must be fully qualified, competent, technicians. “Fully qualified and competent” is defined as factory trained and verified by Polar Leasing.

11. SERVICE RESPONSE TIMES:

The following service response times shall be adhered to at all times identified below. Polar Leasing assumes all costs associated with any service or maintenance performed during or after hours or on the weekends. Hours cited below are Pacific Standard Time.

a. Two hour maximum callback for service calls made during normal work hours, Monday through Friday. Normal work hours are between the hours of 7:30AM and 4:00 PM.

b. Two hour maximum callback for service calls made after 4:00PM, Monday through Friday.

c. Two hour telephone callback required for calls made on weekends or national holidays (Friday after 4:00PM through 7:30AM of the next working day).

d. On site response shall be within 12 hours of first call for service, Monday through Friday, including after 4:00PM.

e. On site response for calls received during weekend hours and holidays shall be within 12 hours.

12. RE-PERFORMANCE:

a. If performance does not conform to the contract specifications, the VA Healthcare Center’s COR or the Contracting Officer shall require the Contractor to perform the service again to conform to the contract specifications, at no cost to the Government. When the defects in service cannot be corrected by re-performance, the VA Medical facility may require the Contractor to call in a senior technical engineer from the manufacturer or from a different company. The Contractor shall incur and absorb all expenses for consultation outside the Contractor’s organization.

b. Repeated malfunctions of any system component or subsection more than three (3) times within one (1) quarter is not acceptable. The Contractor is responsible for repairing all faulty equipment and identifying the nature and cause of repeated failures. The Contractor in this situation must either:

1. Make repairs in such a manner that the identified problems are corrected to the extent that repeated failures are eliminated.

2. Prove that the equipment is not faulty and an external cause for the problem exists and provide recommendations for resolution.

3. Provide repair services from the original equipment manufacturer at the Contractor’s expense.

13 CHECK–IN AND OUT ON SERVICE CALLS AT THE VA FACILITIES:

ACCESS: Access to work areas, and performance monitoring, will be provided by VA Energy Plant maintenance personnel. After hours response will be monitored by VA Central Energy Plant operators, 702-791-9000 Extension 16900. In all cases, VA Central Energy Plant operator shall be notified of any changes which may affect the response time of vital equipment.

For repairs or services required on weekends, holidays or after normal working hours, the Contractor’s repairman is required to check-in and check-out upon arrival and departure at Security Service and with COR, if available, or the on-duty Supervisor of the department, prior to effecting repairs. The procedures defined above are mandatory and will be strictly enforced.

14 NATIONAL HOLIDAYS:

The Contractor is not required to provide delivery or pick up services on the following National Holidays.

When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by U.S. Government agencies. When a holiday falls on a Saturday, the preceding Friday shall be observed as a legal holiday by U.S. Government agencies. Also included would be any other day specifically declared by the President of the United States as a National Holiday.

15 OVERTIME AND HOLIDAYS:

Any overtime or holiday pay that may be entitled to Contractor personnel performing under this contract shall be the sole responsibility of the Contractor and shall not be billed to nor reimbursed by the Government.

16 PARKING POLICY:

It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the VA Police. The VA shall not invalidate or make reimbursement for parking violations of Contractor's personnel under any circumstances.

17 SMOKING POLICY:

Contractor personnel may not smoke on VA property.

18 ORDERING ACTIVITY:

Contractor shall not accept any instructions issued by any person other than the CO or COR acting within the limits of his/her authority.

19 CHANGES TO CONTRACT:

Only those services specified herein are authorized. Before performing any service of a non-contractual nature, Contractor shall advise the CO of the reason(s) for the additional work and/or service.

20 COMPLAINTS:

Contractor shall promptly and courteously respond to complaints within 3 working days. Including complaints brought to Contractor’s attention by the CO. Contractor shall maintain a written record of all complaints, both written and oral showing the identity of the individual, the nature of the complaint, and Contractor’s response. Contractor shall permit the Government to inspect such records upon reasonable notice.

21 BADGES:

All Contractor personnel shall be required to wear company ID badges.

22 INVOICE REQUIREMENTS:

a. Payments will be broken out into four quarterly payments and paid in arrears.

b. No advance payments will be authorized.

c. The Government shall pay the Contractor, upon the submission of a properly prepared invoice for prices stipulated in this contract for services and supplies delivered and accepted.

d. Payment of invoices may be delayed if appropriate field service reports are not completed and submitted as specified herein.

e. The invoice shall be itemized to include the following minimum information:

1) Invoice Number and Date.

2) Contract Number.

3) Purchase Order/Obligation Number (to be assigned upon task order award).

4) Date of service.

5) Line item from Schedule of Service associated with each charge.

23 POST-AWARD PERFORMANCE CONFERENCE: The CO may schedule a post-award performance conference with Contractor, if deemed necessary, for contract orientation purposes.

24 SECURITY REQUIRMENTS:

A. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

B. A prohibition on unauthorized disclosure: "Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA." See VA Handbook 6500.6, Appendix C, paragraph 3.a.

C. A requirement for data breach notification: Upon discovery 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, the contractor/subcontractor shall immediately and simultaneously notify the COR, the designated ISO, and Privacy Officer for the contract. 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. See VA Handbook 6500.6, Appendix C, paragraph 6.a.

D. A requirement to pay liquidated damages in the event of a data breach: "In the event of a data breach or privacy incident involving any SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost of providing credit protection services to those individuals." See VA Handbook 6500.6, Appendix C, paragraph 7.a., 7.d.

E. A requirement for annual security/privacy awareness training: "Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall complete on an annual basis either: (i) the VA security/privacy awareness training (contains VA's security/privacy requirements) within 1 week of the initiation of the contract, or (ii) security awareness training provided or arranged by the contractor that conforms to VA's security/privacy requirements as delineated in the hard copy of the VA security awareness training provided to the contractor. If the contractor provides their own training that conforms to VA's requirements, they will provide the COR or CO, a yearly report (due annually on the date of the contract initiation) stating that all applicable employees involved in VA's contract have received their annual security/privacy training that meets VA's requirements and the total number of employees trained. See VA Handbook 6500.6, Appendix C, paragraph 9.

F. A requirement to sign VA's Rules of Behavior: "Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall sign on an annual basis an acknowledgment that they have read, understand, and agree to abide by VA's Contractor Rules of Behavior which is attached to this contract." See VA Handbook 6500.6, Appendix C, paragraph 9, Appendix D. Note: If a medical device vendor anticipates that the services under the contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor's designated representative. The contract must reflect by signing the Rules of Behavior on behalf of the vendor that the designated representative agrees to ensure that all such individuals review and understand the Contractor Rules of Behavior when accessing VA's information and information systems.

G. 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 vendor at the end of lease, for trade-in, or other purposes." See VA Handbook 6500.6, Appendix C, paragraph 5.h., for the specific options.

RECORDS MANAGEMENT LANGUAGE

Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. Chapters. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

In accordance with 36 CFR 1222.32, the contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

The VA Southern Nevada Healthcare System (VASNHS) and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VASNHS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the contractor must report to VASNHS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

The contractor shall immediately notify the appropriate Contracting Officer (CO) upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract documents. The contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VASNHS control or the contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the CO or address prescribed in the contract documents. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

The contractor is required to obtain the CO's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The contractor (and any sub-contractor) is required to abide by Government and VASNHS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

The contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VASNHS policy.

The contractor shall not create or maintain any records containing any non-public VASNHS information that are not specifically tied to or authorized by the contract.

The contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the FOIA.

VASNHS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VASNHS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

Training. All contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training. The contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

Flowdown of requirements to Subcontractors:

The contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this contract document, and require written subcontractor acknowledgment of same.

Violation by a subcontractor of any provision set forth in this clause will be attributed to the contractor.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

0.45% NACL SALINE BAG/CASE

Contract Period: Base POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 417820

LOCAL STOCK NUMBER: 417820

0.45% SALINE 1000ml Bottle/CASE

POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 423718

LOCAL STOCK NUMBER: 423718

2mm x 75mm POLYSTYRENE TUBES/2000 BO

POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 69285

LOCAL STOCK NUMBER: 69285

ACCESSORY KIT VITK2 PIP/DIL

POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical…