36C24920Q0162-001.docx

36C24920Q0162

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

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

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA

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

ARE

ARE NOT ATTACHED.

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

ARE

ARE NOT ATTACHED

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

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

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

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

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

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

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C24920Q0162 04-08-2020 LaShanda Harrington 615-225-6974 04-21-2020 9:00 a.m.

90C Department of Veterans Affairs Network Contracting Office 9 1639 Medical Center Parkway Suite 400 Murfreesboro TN 37129 X X Y 334516 1000 Employees N/A X Department of Veterans Affairs VA TN Valley HCS Nashville Campus VA Murfreesboro Alvin C York Campus VA Lexington Cooper Drive Campus

90C Department of Veterans Affairs Network Contracting Office - 9 1639 Medical Center Parkway Suite 400 Murfreesboro TN 37129

90C FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

Setup 1-877-489-6135 See CONTINUATION Page This is a Indefinite-quantity contract for furnishing Automated Glychohemoglobin Instrumentation, A1C Testing Supplies and CPRR with TVHS (Nashville & Murfreesboro) & Lexington VAMC. All items shall be priced separately based on equipment, supplies, testing and CPRR.

The period of performance is one-base period with four (4) 12 months option periods as provide in the price schedule.

Orders for scheduled deliveries may be placed against this contract in accordance with SOW and price schedule.

See CONTINUATION Page X x 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 36C249 LaShanda Harrington Department of Veterans Affairs Network Contracting Office 9 1639 Medical Center Parkway Suite 400 Murfreesboro TN 37129

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.

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

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

B.2 Statement of Work

1.1 INTENT: It is the intent of the Department of Veterans Affairs, Tennessee Valley Healthcare System (TVHS) and Lexington VA Healthcare System to establish a contract for Automated Glycohemoglobin Instrumentation. The Government will award a Cost per Reportable Result (CPRR) contract to a single Contractor for Automated Glycohemoglobin Instrumentation. Contractor agrees to the following terms exclusively with TVHS and Lexington. Additional tests/reagents/instrumentation may be added to the contract as new technology becomes available on the market.

1.2 PRICES AND TERMS TVHS and Lexington will provide an estimated volume by test but does not guarantee volumes as listed; they are estimates ONLY. TVHS and Lexington pricing will be based on the Cost per reportable result (CPRR). TVHS and Lexington will fax or email their reportables (obtained from the Laboratory Information System) by the 10th of the following month to the awarded contractor. The estimated tests per year for Nashville is 45,000, Murfreesboro 50,000 and Lexington 27,000.

1.4 TERM OF AGREEMENT: This will be a single award, firm-fixed price indefinite-requirement contract with one base with four (4) one-year options. The period of performance estimated October 1, 2020 through September 30, 2025.

1.5 IDENTIFICATION: Delivery Orders will be issued against base contract award with purchase order.

1.6 ORDERING METHOD: TVHS and Lexington may order products via telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

2.0 DESCRIPTION/ SPECIFICATIONS/ STATEMENT OF WORK

2.1 SCOPE OF PROCUREMENT

2.1.1 The desired instrumentation shall have the capability of performing and reporting the clinical parameters as defined in the statement of work. The instrument shall be able to simultaneously perform the complete profile 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).

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

2.1.3 If Contractor offers a family of analyzers, TVHS and Lexington will determine if instrumentation proposed meets needs of using facility.

2.1.4 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 dates 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.

2.1.5 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 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

2.2 DEFINITIONS

2.2.1 Cost per Patient Reportable Result (CPRR)- Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (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. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge.

2.3 TEST MENU: Glycohemoglobin A1c by HPLC (High Performance Liquid Chromatography) or Capillary Electrophoresis detection method.

2.4 GENERAL REQUIREMENTS

2.4.1 Primary analyzer – 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 is required to meet the productivity specifications defined herein.

2.4.2 Parameter Definitions

2.4.2.1 The system must be certified by the National Glycohemoglobin Standardization Program and approved for use as a diagnostic assay for diabetes testing.

2.4.2.2 The system’s A1c performance shall be calibrated and traceable to the method used in the Diabetes Control and Complications Trail (DCCT). This data will show evaluation against NGSP reference method targets with an acceptable limit equal to +6% of the accuracy-based target value. This is same information used to evaluate each lab/method by CAP (College of American Pathologists) for the Hemoglobin A1c (GH5) and Hemoglobin A1c Accuracy Calibration Verification/Linearity (LN15) surveys.

2.4.2.3 The analyzer must have a tolerance for wide hemoglobin concentrations (tests unaffected by sedimentation while sample is waiting to be sampled).

2.4.2.4 The analyzer must have minimal interference from hemoglobin variants, and must identify common variants: Hgn S, Hgn C, Hgn D, Hgn E. Analyzer must be unaffected by the presence of HbD, HbAS, HbAC, HbF (from 0-10% of total hemoglobin), carbamylated Hb (from 0-2.5% of total hemoglobin) and acetylated Hb (from 0-2.5% of total hemoglobin). Contractor must provide listing of all known interferences and at what Total Hemoglobin % the accuracy of the HbA1c may be affected.

2.4.2.5 The analyzer must have the ability to detect the presence of major hemoglobinopathies that can affect HPLC or capillary electrophoresis.

2.4.2.6 The system must have a high level of precision specifically the Coefficient of Variation (CV) must be less than 2.5%.

2.4.3 Operational Features – The instrumentation offered shall have the following:

2.4.3.1 The capacity of performing analysis on tests with complete (100%) separation of the HbA1c peak from hemoglobin variant peaks on the chromatogram.

2.4.3.2 Must have autoload and walk-away capability with sufficient capacity and throughput to meet the volume and service demands with one analyzer. Vendor must specify autoload capabilities and test throughput capabilities.

2.4.3.3 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.

2.4.3.4 The ability to analyze patient specimens up to 96 hours after collection.

2.4.3.5 A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system or any other future laboratory interfaced systems. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

2.4.3.5.1 Equipment should be able to support multiple barcode formats (e.g. Code 39, Code 128) that may be enabled concurrently. Analyzer must be interfaced with Data Innovations. Vendor must provide proof of this interface capability and drivers must exist for Data Innovations.

2.4.3.5.2 Equipment should accept, at a minimum, 10 characters in the specimen identifier that is alphanumeric.

2.4.3.6 Middleware is included in CPRR and any future updates (software and hardware).

2.4.3.7 Ability to prioritize STAT testing without compromising existing programmed testing.

2.4.3.8 Minimal daily, monthly, and periodic maintenance; no more than one time per day required. Routine maintenance should be required no more than once per day with ability to test 200 samples minimum without added maintenance. The vendor shall take into account that multiple runs of patient samples are performed daily (instead of batching patient samples) due to the demand from the providers for a quicker turnaround time for patient results.

2.4.3.9 Ability to store and retransmit at least 2,000 records in case of interface outage.

2.4.3.10 On board reagent stability sufficient to accommodate high volume use; 500 tests per day. Contractor to provide expiration dates of at least three (3) months for reagents.

2.4.3.11 No requirements for sample pre-treatment.

2.4.3.12 Primary specimen container(s) loaded into a storage area, e.g. tray, rack, wheel, etc. for automated processing; ability to hold 80 samples.

2.4.3.12.1 Diluting and injecting of the specimen is handled with minimal operator intervention.

2.4.3.12.2 Ability to accept various types of sample containers.

2.4.3.13 Minimal reagent preparation.

2.4.3.14 Capability to store at least 10,000 patient results in database for immediate recall.

2.4.4 Technical Features - The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following:

2.4.4.1 Ability to monitor instrument performance.

2.4.4.2 On board reagent inventory system.

2.4.4.3 Minimal carryover.

2.4.4.4 Long calibration stability.

2.4.4.5 Internal ability to assess column and detector functionality over time. A method for the determination of column and detector integrity must be provided.

2.4.4.6 Complete separation of the glycated hemoglobin A1c.

2.4.5 Hardware Features – the Instrumentation shall have the following:

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

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

2.4.5.3 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).

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

2.4.5.5 An auto sampling system that includes cap piercing closed tube aspiration, auto-loader, and auto-mixing.

2.4.5.6 Primary tube sampling.

2.4.6 Specific Equipment Requirements:

2.4.6.1 Controls for primary use (assayed) will be provided.

2.4.6.2 Capability to detect out of range quality control.

2.4.6.3 On-board QC data management system with a minimum storage capacity of monthly QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data.

2.4.7 Capable of directly measuring A1c Hemoglobin by High Performance Liquid Chromatography (HPLC) or capillary electrophoresis.

2.4.8 Method Performance/Validation Requirements- Method performance/comparison shall be performed at the expense of the Contractor, which shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations.

2.4.8.1 Correlation studies for each analyte. A minimum of 20 samples spanning the reportable range shall be run by the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI.

2.4.8.2 Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire AMR range shall be performed as a minimum.

2.4.8.3 Precision study using normal and abnormal control material. This shall consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control.

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

2.4.8.5 Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances.

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

2.4.9 Reference Range- A reference range must be determined or verified for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used.

2.4.9.1 A verification of the manufacturer’s suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used to verify the manufacturer’s range. Any apparent outliers should be discarded, and new specimens obtained to provide a statistically valid verification.

2.4.9.2 If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference range must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.

2.4.9.3 If a laboratory is currently using the proposed instrument/reagent system, the “in-use” reference range can be transferred to the “new” system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed.

2.4.10 Reports- The Contractor shall provide to the Contracting Officer and the TVHS and Lexington P&LMS COR a copy of a quarterly report of sales, by ordering facility, within 20 calendar days after the close of each quarter’s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment, reporting the savings realized. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge shall not be accepted. There will be no additional charges for any reports required as part of the contract.

2.4.11 Support Features:

2.4.11.1 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.

2.4.11.2 Start-Up Reagents - The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies and required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, 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, carryover, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format.

2.4.11.3 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. The in-depth initial training shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant. Thereafter, the Contractor shall provide training minimally for two operators per facility per year during the Option Years 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. Additional on-site technical training must be provided as required per facility for new employee training and/or refresher training for existing employees. In addition, the Contractor shall provide supplemental operating training to above Government personnel, without additional charge to the Government, upon installation of the upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished.

2.4.11.4 Equipment Preventative Maintenance/Repair Service - The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary instrumentation and any support equipment, e.g. water system, offered according to the following terms:

2.4.11.4.1 Service Requirements

2.4.11.4.1.1 A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 1 hour.

2.4.11.4.1.2 Equipment repair service shall be provided by the field service representative during core business hours (Monday through Friday 8:00am to 4:30pm). Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

2.4.11.4.1.3 Equipment repair response time shall be no more than 24 hours.

2.4.11.4.1.4 Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

2.4.11.4.1.5 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:

Date and time notified, date and time of arrival, serial number, type and model number of equipment, and time spent for repair. Proof of instrument repair includes documentation of a sample run of quality control verifying acceptable performance. Each notification for an emergency repair service call shall be treated as a separate and new service call.

2.4.11.5 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.

2.4.11.5.1. All current software and upgrades that pertain to the operation, analysis of data or interface to the Laboratory Information System will be provided at no additional cost to the government.

2.4.11.6 Ancillary Support Equipment- The Contractor shall provide, install and maintain through the life of the 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.

2.4.11.7 Interface Requirements:

2.4.11.7.1 The contractor shall provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself.

2.4.11.7.2 If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any fees required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

2.4.11.7.3 If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system.

2.4.11.7.4 If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

2.4.11.8 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 Microsoft Word procedure manual in CLSI format or an on-line procedure manual in the instrument software.

2.4.11.9 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.

2.4.11.9.1 The determination and description shall address the following:

Waste toxicity, waste ignitability, waste corrosivity, waste reactivity, hazardous waste from non-specific sources (F-listed), discarded commercial products (acutely toxic or P-listed and toxic or U-listed), and solid Waste.

2.4.11.9.2 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.

2.4.11.9.3 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, thimerosol 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.

Barium (Total), Cadmium (Total), Chromium (Total), Copper (Total), Cyanide (Total), Lead (Total), Mercury (Total), Nickel (Total), Silver (Total), Zinc (Total), Arsenic (Total), Selenium (Total), Tin (Total), pH, Flash point (to higher than 200 F), and biochemical oxygen demand.

2.4.11.9.4 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 the waste from each device can legally be disposed of via the sewerage system.

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

2.4.11.10.1 Upon award of a contract, the transition period to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

2.4.11.10.2 Contractor shall provide with its quotation and implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 90 days for the transition of all services 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 for cause under the Termination for Cause clause of the contract.

2.4.11.10.3 At the end of 90 days from award of the contract, the awarded Contractor shall have full and sole responsibility for services under the awarded contract.

2.4.12 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 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 on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any contract at an effectiveness level of 90% or more.

2.4.12.1 In the event that equipment does not meet the standard of performance during the initial 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.

2.4.12.2 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 in accordance with the provisions of FAR 52.212-4 entitled “Termination for cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period).

2.4.12.3 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 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.

2.4.12.4 During the performance period for a system, a minimum of 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 100 hours.

2.4.12.5 The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section 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.

2.4.12.6 During the term of the contract, 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 COR/CO 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 90% in each month of the term of the agreement for equipment.

2.4.13 Government’s Responsibility - The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

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

2.4.15 The Contractor will identify if removable media is required to perform their duties. The Biomedical 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.

2.4.16 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.

2.4.17 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 returned to 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.

2.4.18 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:

2.4.18.1 Contractor must accept the system without the drive;

2.4.18.2 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

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

2.4.19 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:

2.4.19.1 The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

2.4.19.2 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.

2.4.19.3 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.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Nashville - (1) Cost per Patient Reportable Result (CPRR)- Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (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. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel.

Contract Period: Base POP Begin: 10-01-2020 POP End: 09-30-2021

Murfreesboro - (1) Cost per Patient Reportable Result (CPRR)- Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (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. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel.

Lexington - (1) Cost per Patient Reportable Result (CPRR)- Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (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. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel.

Nashville - (1) Cost per Patient Reportable Result (CPRR)- Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (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. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel.

Contract Period: Option 1 POP Begin: 10-01-2021 POP End: 09-30-2022

Murfreesboro - (1) Cost per Patient Reportable Result (CPRR)- Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (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. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI).