36C25725Q0273.pdf

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. 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

36C25725Q0273 02-10-2025

Kathryn Prose (kathryn.prose@va.gov) (254) 217-2835 03-06-2025

3:00 PM CST

36C257

Department Of Veterans Affairs

Network Contracting Office (NCO) 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

X

325413

1250 Employees

N/A

X

36C756

Department of Veterans Affairs

El Paso Veterans Health Care System

Pathology & Laboratory Medicine Services

5001 North Piedras Street

El Paso TX 79930-4210

36C257

Department Of Veterans Affairs

Network Contracting Office (NCO) 17

This is accomplished through the

Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

This solicitation is for the procurement of Urine Chemistry and Microscopic Analyzers using a Cost-Per-Reportable-

Result (CPRR) invoicing method for the El Paso Veterans

Health Care System.

Technical questions regarding this solicitation are to be submitted in writing to Kathryn Prose, at kathryn.prose@va.gov, no later than 02/18/2025 at

3:00 PM CST.

See B.2 for the Statement of Work (SOW)

See B.3 for Price/Cost Schedule

See E.3 Addendum to FAR 52.212-1 for Instructions to Offerors See E.6 for FAR 52.212-2 for evaluation criteria

See CONTINUATION Page

X X

X 1

36C25725Q0273

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK (SOW)

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025)

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.9 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.11 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ..37

C.12 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.13 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.2 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.3 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)

E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.5 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.6 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

E.8 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.9 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.10 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE

RESOLUTION (OCT 2018)

E.11 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.12 VAAR 852.273-70 LATE OFFERS (NOV 2021)

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: POC Name: _____________________________

Address: _______________________________

City/State/Zip: ___________________________

POC Phone: ____________________________

POC Email: _____________________________

b. GOVERNMENT: Contracting Officer 36C257

Department Of Veterans Affairs

Network Contracting Office (NCO) 17

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

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. This is accomplished through the Tungsten Network, located at: http://www.fsc.va.gov/einvoice.asp. This is mandatory and the sole method for submitting invoices.

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

AMENDMENT NO DATE

http://www.fsc.va.gov/einvoice.asp

B.2 STATEMENT OF WORK (SOW)

1. Scope. The contractor shall provide Automated Clinical Laboratory Urinalysis Testing for urine dipstick chemistries and urine microscopic analysis using a Cost-Per-Reportable-

Results (CPRR) invoicing method for the El Paso Veterans Health Care System (EPVHCS), Pathology & Laboratory Medicine Service (P&LMS), located at 5001 North Piedras Street, El

Paso, Texas 79930. The CPRR pricing shall include all equipment, comprehensive maintenance, software and hardware upgrades, workstations, servers, training, a quality control program, reagents, calibrators, controls, supplies, consumables, disposable items, parts, accessories, printers, uninterruptable power supply (UPS), and any other item required for the proper operation of its' contractor-owned automated urinalysis testing instruments and peripherals necessary for the generation of accurate automated urinalysis results. The Contractor retains the title of the equipment.

Estimated Quantities. The estimated annual Chemistry and Microscopic Testing is shown in the table below. The estimates are based on yearly counts over the previous 3 years. Historically, counts have remained consistent; however, counts may increase by 1 to 3 percent over the next five years.

Line Item Item Description

Annual Estimate

X001 Chemistry Testing

CPRR

44,000

X002

Microscopic Testing

CPRR 44,000

2. Definitions.

a. Cost Per Reportable Result (CPRR): Contractors must provide a price for each patient test that can be performed on its equipment. The per reportable patient test price shall include costs covering (a) equipment use, (b) all reagents, calibrators, controls, supplies, consumable/disposable items, parts, accessories, UPS, printers, workstations, servers, and any other item required for the proper operation of the contractor's equipment and necessary for the generation and reporting of a patient test result, (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (d) training for Government personnel.

Contractors are required to provide delivery, installation, and removal of equipment at no additional charge. All hard drives are to be removed and handed over to the facilities for destruction when equipment is removed.

b. Clinical Laboratory Urinalysis Analyzer: An automated system for robotic specimen handling, accurate analysis, data review, and reporting of human urinalysis test results. The analyzer provided by the contractor shall fully support the estimated annual site volume listed on the schedule. Routine urinalysis includes macroscopic examination, chemical analysis, and microscopic urine sediment examination.

c. Consumables and Reagents Definition: The Contractor must provide all supplies, reagents, and consumables required for the installation/validation of the analyzer system. This requirement includes all reagents, calibrators, and controls for the analyzer(s). This requirement includes consumable hardware such as needles, probes, syringe tips, automated pipette tips, and supplies. This requirement includes printer ribbons for specialty printers, buffers, diluents, and cleaners. This requirement includes supplies for ancillary equipment such as water system filters, membranes and polishers, air filters, light bulbs, and specialty barcode labels.

d. Chemistry (Macroscopic Urinalysis): The first part of urinalysis involves direct visual observation of color and appearance (i.e., clarity). This portion of urinalysis also includes chemical analysis of the urine, including Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocyte Esterase, and Specific

Gravity, along with Color and Appearance.

e. Microscopic Urinalysis: Microscopic evaluation of urine sediment from a urine sample. Analysis should be able to identify and/or quantitate the following: red blood cells, white blood cells, bacteria, renal epithelial cells, squamous epithelial cells, oval fat bodies, urine crystals (i.e., amorphous, uric acid, calcium oxalate, triple phosphate, calcium phosphate, calcium carbonate, cystine, tyrosine, leucine, and unclassified), urine casts (i.e., hyaline, white blood cells, red blood cells, coarse granular, waxy, and unclassified), yeast (budding and hyphae), sperm, mucus, and trichomonas.

f. Business Associate Agreement (BAA): A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of Protected Health Information (PHI), or that provides certain services involving the disclosure of PHI. VHA is covered under the HIPAA

Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receive, use, or disclose VHA PHI to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that are required of VHA under the Privacy Rule

3. Instrumentation / Equipment Requirement.

a. Fully Automated Urinalysis Solution: Modules shall be fully integrated and walk-away automation with a single load/unload point and a consolidated workstation will be used to manage the instrument, QC, and results review. Base equipment provided that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall be considered primary instrumentation and meet all the technical specifications of this Scope of Work.

b. The Microscopic analyzer shall be integrated with the macroscopic analyzer for true

“walk-away” capabilities.

c. The contractor must provide a backup biochemistry instrument along with the main instrument. The back-up biochemistry instrument must contain a semi-automated strip reader to allow for continuous testing if the main instrument goes down. The test strip reader must share the same methodology as the main instrument to avoid manual reading of the test strips.

d. The total equipment footprint, when installed, must not negatively impact the functionality/operations of the Pathology & Laboratory Service nor will it require significant and/or costly infrastructure changes. The instrument and backup method must fit on a 90 in (W) and 34 in (D) benchtop.

e. Specifications of component equipment as outlined in this section are minimum specifications, unless otherwise stated, and shall not be construed as limiting the overall quality, quantity, or performance characteristics of items furnished in the system. The

Contractor's Furnished Equipment (CFE) shall meet or exceed the minimum requirements and shall be held responsible for the supply, performance, and overall quality of the contractor’s furnished equipment.

f. The desired instrumentation shall be capable of performing or reporting the clinical parameters as defined herein for all urinalysis-related testing. The instrument shall be capable of reflex testing from macroscopic to microscopic evaluations.

g. All equipment to be supplied under this specification shall be the newest and the most current model of a standard product of a manufacturer of record. A manufacturer of record shall be defined as a company whose main occupation is the manufacture for sale of the items of equipment and which:

1) Maintains a factory production line.

2) Maintains a stock of replacement parts for the item.

3) Maintains engineering drawings, specifications, operating manuals, and maintenance manuals.

4) Has published and distributed descriptive literature and equipment specifications on the equipment.

h. All equipment must be new. Remanufactured and discontinued models will not be accepted, and discontinued models will only be made available as remanufactured equipment is not acceptable.

i. The Contractor must provide upgrades to the equipment hardware and software 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 enhance the model of equipment, i.e., a new version of the software, correction of a hardware defect, upgrades to commercial customers at no additional charge, upgrade to replace the model of equipment no longer Contractor supported, etc. This does not refer to replacing the original equipment provided under the contract but to significant changes in the hardware's operational capability.

j. Operational Features- The instrumentation provided shall have the following:

1) Equipment must be fully automated with the ability to load patient samples continuously.

2) Sample throughput for urine microscopy must be up to 80 samples per hour.

3) Sample throughput for urine chemistry must be up to 210 samples per hour.

4) Ability to detect when manual review of automated microscopic is required.

5) Must be able to perform assays without manual confirmation with at least >98% of the samples.

6) The ability to auto-classify and sub-classify particles, reducing manual microscopic review rates.

7) The analyzer must bypass microscopic testing when the urine strip is negative or as defined/ programmed by the user.

8) 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.

9) A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (hardware and software) shall be immediately available for implementation in the VA computerized hospital information system.

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

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

12) Equipment must accept at least 15 characters in alphanumeric specimen identifier.

13) Ability to prioritize STAT testing without compromising existing programmed testing.

14) Minimal daily, monthly, and periodic maintenance.

15) Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

16) Onboard reagent stability sufficient to accommodate both high- and low-volume use. The contractor must provide reagents with expiration dates of at least 6 months.

17) Can analyze small sample volumes (less than 3 ml).

18) Capability to detect out-of-range quality control.

19) Ability to accept various types of sample containers.

20) Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

21) Ability to select numeric or semi-quantitative result format (i.e., mg/dL or large/4+).

22) Ability to set facility-developed flags for reflex to automated microscopic testing.

k. Technical Features

1) The contractor will provide each facility with a Food and Drug Administration

(FDA)- approved analyzer/equipment, reagents, controls, calibration materials, disposables, and any consumable parts necessary for analyzing/testing.

2) Equipment shall be able to monitor reagent usage accurately.

3) The contractor shall provide/install any routine and special items required to operate/maintain the equipment/analyzer in optimal condition, including, but not limited to, printers, an Uninterruptible Power Supply (UPS), interface boxes, and surge suppressors.

4) Shall meet performance and characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

5) Instrument Logistics Information system (LIS) physical connection and translation (drivers). Must be compatible with Dawning Technologies system, Vista, and Cerner Information Systems.

6) The analyzer shall have an editable digital display for visualizing casts and crystals.

7) Any additional hardware and software needed to interface the analyzer and technical assistance with interfacing the analyzer.

8) A Printer capable of printing a chartable patient report with the complete patient results on a single sheet.

9) Automated sampling system. All analyzers must have primary tube sampling capability and be able to sample directly from aliquot containers and specimen tubes of various sizes without necessary sample preparation.

10) The analyzer shall be able to dilute, with the analyzer calculating the final result.

11) The system shall accept urine and other body fluids.

12) The system shall have positive sample identification to reduce possible sources of error/delay and to improve laboratory efficiency.

13) The system shall be designed to eliminate the possibility of reagent or sample carryover or, at the very least, have a mechanism that notifies the technician of the possible carryover.

14) Remote monitoring, maintenance, and/or troubleshooting software that electronically transmits critical operational and administrative information will not be granted.

15) The specimens must be processed through all steps so that the specimen does not have to be carried by human hands between the components of the analyzer.

16) The analyzers must have a comprehensive QC Program for all tests, which include, at a minimum, the following options:

a) QC files with automatic calculations of the mean and standard deviation of individual lots with data storage.

b) The ability to view and print daily and monthly QC results.

c) The ability to view and print Levy Jennings graphs.

d) On-line documentation of out-of-range QC.

e) QC acceptance criteria built in.

17) Equipment shall be able to store and retransmit records (at least 24 hours of maximal instrument throughput) in case of interface downtime. Must have the ability to backup and store patient data on external media.

18) Ability to comment on QC points to document troubleshooting and QC review.

19) Ability to automatically program the performance of QC testing.

20) Analyzer utilizes Windows operating software.

21) The ability to perform dilutions and dilution calculations is preferable.

22) Capable of accepting both conical (i.e., KOVA and various style tubes) and round-bottom sample tubes (including varying sizes of evacuated tubes). The requirement can be met by using different carriers or inserts supplied by the

Contractor at no additional charge.

23) The printer accommodates both single-patient results (for STATS) or batch print options.

24) Ability to track/inventory reagents and consumables (i.e., lot numbers, expiration dates) using bar code technology or other technology, eliminating the need to manually enter reagent/consumable information.

4. Consumables, Reagents, and Inventory.

a. The Contractor must provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials required to properly perform tests on the equipment so that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, and specificity and tested to assure precision and accuracy. The expiration date must be marked on the reagents, standards, and control containers. Unexpected changes in methodology/technology shall be at the

Contractor's expense. Alert/Notification of any shipment delays and technical advisory/recalls/alerts, before or simultaneously with field alerts, should be forwarded to the designated individuals determined at contract award.

b. If the consumables 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 shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the

Government activity. If either circumstance has occurred, the contractor shall deliver to the VA facility in the most expeditious manner possible, without additional cost to the

Government, the necessary consumables in sufficient quantity as required to allow the operation of the contractor's equipment for one week (under normal Government test load volume). If the Government needs additional requests for emergency supply delivery, they shall be honored by the contractor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory may result in default.

c. Contractor shall list the reagents and calibrators that require additional preparation before use, such as warming/mixing/reconstitution.

d. The Contractor shall list the reagents/waste receptacles that require treatment before disposal and all reagents/waste considered above normal toxicity and/or hazard.

e. These items shall be of the highest quality, ensuring sensitivity and specificity, and tested to assure precision and accuracy. The quality of the products shall be high enough to satisfy the proficiency testing standards of the College of American

Pathologists (CAP) and The Joint Commission (TJC).

5. Installation / Implementation / Transition Period

a. Implementation/transition timeframe: Complete installation and go live of their system within 60 days from the effective date of the contract. This timeline is based on the Contractor's reasonable attempt to complete all the necessary implementation requirements within the stated timeframe. The contractor shall not be penalized for implementation timelines that extend beyond the 60-day timeframe if the extension is through no fault of the Contractor and is a result of delays due to the Government.

b. During this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

c. Upon completion of the validation process, the contractor shall move instruments, free of charge, to the final testing location. All proposed equipment must fit the existing space at each VA P&LMS site without renovation work. Small-scale furniture rearrangement is acceptable. Fitting existing space shall include conforming to the current structural parameters of each lab in each facility regarding delivery, installation, and lab space (i.e., equipment size, weight, packaged size for delivery, electrical/voltage).

d. The contractor shall provide the facility with all cross-over supplies and reagents needed during installation and staff training. Test counts for billing will begin after review/approval of all correlation/linearity studies performed at installation.

e. Contractor shall provide with its quotation an implementation plan for installation of new equipment. The contractor’s submitted plan shall not exceed 60 days for the transition of all requirements under the awarded contract, including installation and training of personnel, the transition of all testing materials, reagents, supplies, etc., and the performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered sufficient cause to terminate the contract for cause under the Termination for Cause clause.

6. Method Performance / Validation.

a. The contractor will arrange for validation 30 days before the go-live date.

b. Method performance/comparison shall be at the expense of the Contractor. It shall include linearity material and reagents as required or recommended guidelines and related documents, College of American Pathologists (CAP) standards, and Federal regulations. The Method Validation will include the following:

1) Correlation studies for each analyte. The present and proposed methods shall run at least 20 samples spanning the reportable range. The contractor shall analyze the results and provide statistical data to support the new method's acceptance. Statistics shall meet current standards defined by CLSI.

2) 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.

3) Carryover studies shall be performed, as applicable, as part of the initial evaluation of the instrument. The contractor shall provide an interpretation of the raw data of the instrument installed. The contractor shall also provide documented evidence confirming that the system design removes the possibility of any reagent or sample carryover. The system must have documented evidence of no reagent carryover interference with other onboard assays. These studies shall be performed using either contractor-developed program(s) or program(s) developed by a third party (CAP/CLSI, formerly NCCLS). The program(s) shall be provided to the laboratory at no charge.

4) Reference Range: A reference range must be determined for each test following

CLSI guidelines. Samples used for the reference range study must represent the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used:

a) 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 should be obtained to provide statistically valid verification.

b) A reference range shall be established if the suggested manufacturer’s range is inappropriate for the patient population. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to establish a reference range. The reference interval should be determined using the nonparametric method.

c) 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 unacceptable, one of the items above must be performed.

c. Throughout the agreement's life, the contractor shall assist the user with setting up, maintaining, and troubleshooting user-defined assays as additional tests are identified and utilized.

7. Training

a. The Contractor shall train two key operator(s) per instrument. Additional training shall be available to remaining users on all tours, and competency assessments shall be performed and documented. The Contractor shall arrange key operator training with the VA representative and include all costs associated with the Contractor's off-site training expenses, including transportation (air and ground), room and board, etc.

b. In addition, the vendor shall provide handouts and training materials in enough quantity for each participant. These are off-the-shelf courses. The vendor shall offer or conduct instructional course(s) and provide lesson plans, course material, and media (DVDs, CDs, videos, etc., if required) for each procedure at no additional cost.

c. The Contractor shall provide/install/train users on any data management system through either off-site or in-house training.

d. The contractor shall provide all necessary procedure manuals, troubleshooting manuals, and operator manuals (also available in computer disk format). Procedures shall be in the Clinical and Laboratory Standards Institute (CLSI) format.

8. Service and Maintenance

a. Instrument support service shall assist with troubleshooting and repairing the analyzers. On-site service shall be available Monday through Friday during regular business hours (7:00 a.m.—4:30 p.m.). The support service shall follow up on all downtime calls within one hour.

b. If the malfunction is reported to the vendor no later than 4:30 pm hours, the failure elimination shall be started immediately on the same day.

c. c. The contractor shall provide a twenty-four-hour/seven-day service hotline with technical support, with a maximum call-back response time of one hour.

d. The contractor shall provide a preventative maintenance schedule to include timely scheduled contractor preventative maintenance visits as required.

e. The contractor shall supply engineering controls, if necessary, for any heat, humidity, or noise issues resulting from the proposed system's use.

f. Contractor shall provide standard and routine software and hardware upgrades to the equipment hardware and operating systems without additional charge to the

Government (e.g., upgrades that correct or improve the mechanical operations or software of the system and would keep the instrument performing optimally).

g. Contractor shall define daily, weekly, monthly, and as-needed maintenance and the time required to perform each maintenance task. The contractor shall indicate which tasks are user-level and which are service-level.

h. For reagents with hazardous constituents, the contractor shall provide a mechanism for the Laboratory to meet local discharge requirements and supply information regarding any hazardous chemicals.

i. 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 proposed model of equipment, e.g., starter kits, tables/stands, etc.

9. Interface Requirements.

a. The Contractor shall provide all necessary software support to ensure successful interfacing. The specific requirements for communicating the data streams will be unique to the instrument system involved and dictated by the manufacturer itself.

b. The proposed solution for the contractor's hardware and software meets all VA information security, hardware, software, and network requirements (VA 6500). Any wireless equipment must be FIPS 140-2 compliant with a certificate of compliance.

c. The Contractor supplies responses to required documents to add systems to the VA network, including but not limited to the VA Form 6550, Ports Protocols Services, MSD2, network Topological diagram, and Equipment Inventory hardware/software list.

d. The analyzer must be able to interface with VISTA/CPRS LIM and Data Innovations

Instrument Manager systems to minimize transcription error, tech time, and accurate record keeping. Data is transferred from VISTA to a Data Innovations Middleware (DI) device, which is then sent to the instrument using the appropriate format. Once testing is complete, the instrument sends the result back to the DI, which then sends the result back to VISTA in the appropriate format.

e. Transfer of data is bidirectional and will occur in the following manner:

f. The following data fields will be collected:

Prime ID Specimen ID Patient ID Priority

Action Code Sample Type Collect Date Collect Time

Creation Date Creation Time Last Name First Name

Middle Name Sex Birthday Location

Analyzer Station Test Name

g. If the instrument undergoes software upgrades during its lifetime, the Contractor is responsible for ensuring that the interface can accommodate any changes in the data stream going to the VA Laboratory Interface Middleware.

h. If the Operating System (OS) and/or Firmware is updated or the OS reaches the end of life during the contract period, the Contractor shall update the OS and/or Firmware at no additional cost. Additionally, if the hardware requires an update or replacement to support the OS/Firmware, the Contractor shall update/provide the needed hardware at no additional cost.

i. Sufficient memory to store patient information and test records with downloading capability to an external medium for long-term storage of patient records and other information.

1) Data onboard storage must be up to 10,000 patient results.

2) Data Storage of patient sample results and the ability to export results to external storage media for acceptable review by regulatory agencies.

j. Patient status display for technologist review and workflow management for all integrated (linked) testing instrumentation.

k. Ability to retransmit patient records to universal interface system in case of interface outage.

l. Technology will automatically repeat testing based on customer configurable testing criteria (repeat testing).

m. Technology to automatically direct additional specimen testing based on customer-configurable testing criteria (reflex technology).

n. Technology must interface with the VA-licensed Data Innovations Instrument Manager, sending all appropriate information to complete auto verification rules processing within the VA-licensed IM. It is preferred, but not required, that no additional middleware be necessary to connect instruments beyond the VA-licensed DI IM.

o. The contractor shall collaborate with each lab to write/develop protocols to establish configurable customer rules to enhance workflow management and productivity.

p. The contractor shall assist the customer with optimizing the operation and utilization of the data management system to integrate the desired testing instrumentation fully, enhancing productivity and workflow management. This shall include sending personnel back on-site to optimize the analyzer, automation, and data management workflows six months and twelve months after the system has gone live.

q. The contractor must have an existing VA MOU/ISA or agree to establish an MOU/ISA upon award to provide remote monitoring and support to meet all VA security requirements. The contractor should use remote monitoring to prevent instrument or testing issues as much as possible, in addition to troubleshooting and providing support.

10. Reports. The Contractor shall provide the Contracting Officer and other individuals

(designated post-award) a copy of a quarterly sales report by the ordering facility within 30 calendar days after each quarter’s business closes. Reports are to reflect, at a minimum, total net sales amounts before the discount, discount amounts by the ordering facility, and the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized. They shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge shall not be accepted. No additional charges for any reports will be required as part of the contract.

11. Standard of Performance. This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the contract is accepted by the

Government. This also includes replacement, substitute machines, and machines added, or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date and 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 at an effectiveness level of 90% or more.

a. If the 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.

b. 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 and but not until the completion of a new vendor's equipment installation has completed cross-over studies.)

c. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is used. System failure downtime is the period of time when any machine in the system is inoperable due to equipment failure.

Downtime for each incident shall start when 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.

d. 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 the 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.

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

f. 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, the COR shall decide to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with the 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.

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

h. 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 shall remove the equipment upon expiration of order(s) at termination and/or replacement of 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.

i. The contractor will identify if removable media is required to perform their duties. The

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

j. Prior to termination or completion of this contract, the contractor/sub-contractor must not destroy information received from the 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 the VA by a contractor/sub-contractor 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 an order.

k. 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/sub-contractor or any person acting on behalf of the Contractor/sub-contractor, whichever is earlier. Media (hard drives, optical disks, CDs, backup tapes, etc.) used by the Contractors/sub-contractors 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.

l. 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 the lease for trade-in or other purposes. The options are:

1) The contractor must accept the system without the drive.

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

3) VA must reimburse the company for media at a reasonable open market replacement cost at purchase.

m. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if the VA can't retain the hard drive, then;

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

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 to the 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 contract.

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.

n. Requests for instrumentation upgrades or replacement due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls shall be evaluated as needed/annually by the laboratory, with communication to the contractor to modify the order. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with other analyzer (s) that can produce the required criteria satisfactorily to the user.

o. The contractor shall reimburse the facility for any costs/supplies related to tests sent to a referral laboratory when testing is unavailable through the facility's fault due to reagent problems, other product issues, or other contractor-related factors. The assessed damages shall be applied to the invoice as a credit or deduction.

p. If any consumable, reagent, or other necessary item is 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 shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery from the facility. If either circumstance has occurred, the contractor shall deliver to the facility, in the most expeditious manner possible, without additional cost, the necessary consumables in sufficient quantity so testing is not delayed.

q. This order should assist the Department of Veterans Affairs in pursuing the goal of being a good steward in our community by eliminating, minimizing, or mitigating adverse environmental impacts.

r. The following chemicals have been targeted by the EPA specifically for reductions and feasible elimination. Please list any reagents (and in what concentration) that contain the following chemicals:

Benzene Carbon tetrachloride Chloroform

Dichloromethane Methyl ethyl ketone Toluene

Methyl isobutyl ketone Xylenes Tetrachloro-ethylene

Cadmium 1,1,1-Trichloro-ethane Chromium

Trichloro-ethylene Cyanide Lead

Mercury Nickel

12. Compliance with the General Safety Regulations

a. All contractors and subcontractors performing services for the government shall comply with all Occupational Safety and Health Administration (OSHA), state, county, and municipal safety, and occupational health standards, as well as any other applicable rules and regulations. Also, all Contractors and Subcontractors shall be held responsible for the safety of their employees and any unsafe acts or conditions that may cause injury or damage to any persons or property within and around the work site area under this contract.

b. All ladders, scaffolding, tools, equipment, personal protective equipment, etc., shall be OSHA-approved for the work to be performed. The contractor shall use caution signs as required by OSHA Regulations. Caution signs shall be on-site on commencement of the Contract.

c. The Contractor shall purchase and issue all chemicals in their original containers.

Materials that require precautionary warnings shall have affixed to all containers such labels or markings as are prescribed by law, regulatory agencies, or this Contract.

Any violation of OSHA may be subject to default action.

d. Contractor shall furnish to the COR two (2) copies of Safety Data Sheets (SDS) for all products proposed for use a minimum of seven (7) days prior to beginning service for approval. The contractor must update copies of the SDS on an annual basis. In addition, each time a new chemical product is proposed to be introduced into the facility, a copy of that product's SDS must be provided to the COR for approval prior to the product being used at the facility.

13. Identification, Parking, Smoking, and VA Regulations

a. The Contractor's FSEs shall always wear visible identification while on the premises of the

EPVHCS. It is the responsibility of the contractor to obtain and pay for parking. The

EPVHCS does not provide any parking. The EPVHCS will not invalidate or make reimbursement for parking…