RFQ 36C25724Q0560.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

36C25724Q0560 04-23-2024

Kathryn Prose (kathryn.prose@va.gov) (210) 617-5300 Ext. 50242 05-22-2024

12:00 PM CDT

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

36C519

Department of Veterans Affairs West Texas VA Healthcare System Pathology & Laboratory Medicine Service 300 Veterans Blvd.

Big Spring TX 79720-5566

36C257

Department Of Veterans Affairs Network Contracting Office (NCO) 17 5441 Babcock Road Ste. 302

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

This solicitation is for the procurement of urinalysis CPRR testing for the West Texas VA Health Care System.

Technical questions regarding this solicitation shall be submitted in writing to Kathryn Prose, at kathryn.prose@va.gov, no later than 05/08/24 at 12:00 PM CDT.

X X

X 1

36C25724Q0560

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

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 (FEB 2024)

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) ..35

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 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (FEB 2024)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.8 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.9 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.10 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 5441 Babcock Road, Ste. 302

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

B.2 STATEMENT OF WORK

1. Scope. The contractor shall provide Automated Clinical Laboratory Urinalysis Testing for urine dipstick chemistries, urine microscopic analysis, and body fluid analysis (as applicable) to produce Cost Per Reportable Results (CPRR) for the West Texas VA Healthcare System (WTVAHCS), Pathology & Laboratory Medicine Service (P&LMS) department, located at 300 Veterans Blvd., Big Spring, TX 79720-5566. 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.

Estimated Quantities. The estimated annual Macroscopic and Microscopic Testing for CPRR 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 1 to 3 percent over the next five years.

Line Item Item Description

Annual Estimate

X001 Macroscopic Testing

CPRR

16,700

X002

Microscopic Testing

CPRR 8,900

2. Definitions.

a. Cost Per Reportable Result (CPRR): Contractors are required to 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: Automated system for the robotic specimen handling and 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 consists of macroscopic examination, chemical analysis, and microscopic urine sediment examination.

c. Consumables and Reagents Definition: Contractor shall provide all supplies, reagents, consumables required for the installation/validation of the analyzer system. This requirement includes all reagents, calibrators, 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, specialty barcode labels.

d. Macroscopic Urinalysis: The first part of urinalysis being a direct visual observation of color and appearance (i.e., clarity). This portion of urinalysis will also include the chemical analysis of the urine to include specific gravity, pH, glucose, bilirubin, urobilirubin, ketones, occult blood, protein, nitrite, and leukocyte esterase.

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 a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule

3. Instrumentation / Equipment Requirement.

a. Primary analyzer(s) (one analyzer for West Texas VAHCS): 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, likewise, be considered primary instrumentation and shall meet all the technical specifications of this Scope of Work. Those additional analyzer(s) provided meeting the definition of a primary analyzer shall be equivalent to a back-up analyzer and shall replace the requirement for that category of equipment.

b. Specifications of component equipment as set forth 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 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.

c. 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.

d. All equipment shall be new equipment. Remanufactured and discontinued models will not be accepted. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

e. The Contractor shall provide upgrades to both 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., new version of software, correction of hardware defect, upgrades 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.

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

1) Sufficient capacity and throughput to meet the volume and service demands as defined in this Statement of Work.

2) 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.

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

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

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

6) Equipment must accept, at a minimum, 15 characters in specimen identifier that is alphanumeric.

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

8) Minimal daily, monthly, and periodic maintenance.

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

10) On board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least 6 months for reagents.

11) Capable of analyzing small sample volumes (less than 3 ml).

12) Capability to detect out of range quality control.

13) Ability to accept various types of sample containers.

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

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

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

g. Technical Features

1) The contractor will provide each facility with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, calibration materials, disposables, and any consumable parts necessary for analyzing/testing.

2) Equipment shall have accurate capability of monitoring reagent usage.

3) The contractor shall provide/install any routine and special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to printers, 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) Analyzer shall come with 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) 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 available space is 50 inches wide x 30 inches deep.

9) Printer with capability of printing a chartable patient report with the complete patient results on a single sheet.

10) 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 with no sample preparation necessary.

11) Analyzer shall have diluting capability with the analyzer calculating the final result.

12) System shall accept urine, and other body fluids.

13) System shall have positive sample identification to reduce possible sources of error/delay and to improve laboratory efficiency.

14) System shall have a design that removes the possibility of reagent or sample carryover, or at the very least have a mechanism in place that notifies the technician of the possible carryover.

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

16) Must process specimens through all steps so that specimen does not have to be carried by human hands between the components of the analyzer.

17) The analyzers must have a comprehensive QC Program for all tests which includes at a minimum the following options:

a) QC files with automatic calculations of 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

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

19) Must be able to perform assays listed below without manual confirmation with at least >98% of our samples.

h. Specific Equipment Requirements

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

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

3) Analyzer utilizes windows operating software.

4) Ability to continuously load specimens.

5) Ability to perform dilutions and perform dilution calculations is preferable.

6) The Microscopic analyzer shall be integrated with the macroscopic analyzer for true “walk-away” capabilities.

7) Primary and backup analyzers (for larger facilities) shall be from the same manufacturer and the same technology.

8) Capable of accepting both conical (i.e., KOVA and various style tubes) and round-bottom sample tubes (including varying sizes of evacuated tubes). Requirement can be met by use of different carriers or inserts, supplied by the Contractor at no additional charge.

9) Printer accommodates both single patient result (for STATS) or batch print options.

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

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

4. Consumables, Reagents, and Inventory.

a. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted.

These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

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 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 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 any additional preparation prior to use such as warming/mixing/reconstitution.

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

e. These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision and accuracy. The quality of the products shall be high enough to satisfy 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 a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe. 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. Contractor shall move instruments, free of charge, to final testing location upon completion of validation process. All proposed equipment must fit the existing space at each VA P&LMS site, without the need for renovation work. Small scale re-arrangement of furniture is acceptable. Fitting existing space shall include conforming to the current structural parameters of each lab, in each facility, in terms of delivery, installation and lab space. (i.e., equipment size, weight, packaged size for delivery, electrical/voltage).

d. Contractor shall provide the facility with all cross-over supplies and reagents needed at installation and during training of staff. 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. 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, 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 the contract for cause under the Termination for Cause clause.

6. Method Performance / Validation.

a. The contractor will make arrangements for validation to occur 30 days prior to the go live date of 12/01/2024.

b. Method performance/comparison shall be at the expense of the Contractor, 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. A minimum of 20 samples spanning the reportable range, shall be run by the present and the proposed method.

Contractor shall analyze results and provide statistical data to support acceptance of the new method. 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. Contractor shall provide interpretation of raw data the instrument installed. Contractor shall also provide documented evidence confirming the system design removes the possibility of any reagent or sample carryover. System must have documented evidence that there is 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 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:

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 obtained to provide a statistically valid verification.

b) If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference 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.

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 not acceptable, one of the two above items must be performed.

c. Throughout the life of the agreement, the contractor shall provide assistance to the user with setup, maintenance, and troubleshooting user-defined assays as additional tests are identified and utilized.

7. Training

a. The Contractor shall provide key operator training for 2 key operator(s) per instrument. Additional training shall be made available to remaining users on all tours with competency assessments performed and documented. Key operator training shall be arranged by the Contractor and include all costs associated with the Contractors off-site training expenses to include transportation (air and ground), room and board, etc.

b. Contractor shall provide/install/train users on any data management system with either off site or in house training.

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

8. Service and Maintenance

a. Instrument support service shall provide assistance with troubleshooting and repair of the analyzers. On-site service shall be available Monday through Friday during regular business hours (8am-5pm). The support service shall follow-up all down time calls within 1 hour.

b. The contractor shall provide a twenty-four hour/seven-day service hotline with technical support with a maximum call back response time of 1 hour.

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

d. The contractor shall supply engineering controls if necessary for any heat, humidity, or noise issues that may result from use of the proposed system.

e. 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 either the mechanical operations or software of the system and would keep the instrument performing optimally).

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

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

h. 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.

9. Interface Requirements.

a. The Contractor shall provide all necessary software support for ensuring 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.

b. The Contractor hardware and software proposed solution meets all VA Information Security, Hardware, Software and Network requirements (VA 6500). Any wireless equipment must be FIPS 140-2 compliant with 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. 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 there are 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 Laboratory Interface Middleware.

h. If the Operating System (OS) and/or Firmware is updated or the OS reaches end of life during the contract period, the Contractor shall update 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 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 to 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 to VA licensed Data Innovations Instrument Manager sending all appropriate information to complete auto verification rules processing within the VA licensed IM. Preferred, but not required, that no additional middleware be necessary to connect instruments beyond the VA licensed DI IM.

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

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

q. Contractor must have existing VA MOU/ISA or agrees to establish an MOU/ISA upon award to provide remote monitoring and support meeting all VA Security Requirements.

Contractor should use remote monitoring to prevent instrument or testing issues as possible in addition to troubleshooting and support.

10. Reports. The Contractor shall provide to the Contracting Officer and other individuals (designated post-award) a copy of a quarterly report of sales, by ordering facility, within 30 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 by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and 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. There will be no additional charges for any reports 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 that are 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. 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.

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 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.

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 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 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.

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, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 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. The user 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, 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.

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, contractor/sub-contractor 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/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, back-up 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 lease, for trade-in, or other purposes. The options are:

1) 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 time of turn-in; or

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

m. 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;

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) 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 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. Request 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 for modification of 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 not available through no fault of the facility due to reagent problems, other product issues, or other contractor related factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction.

p. In the event that the any consumable, reagent, or other necessary item 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 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 to the facility, the necessary consumables in sufficient quantity so testing is not delayed.

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

r. There 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 and 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. Contractor shall use caution signs as required by OSHA Regulations. Caution signs shall be on-site on commencement of 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. 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 VAMC. It is the responsibility of the contractor to obtain and pay for parking. The VAMC does not provide any parking. The VAMC will not invalidate or make reimbursement for parking violations or charges for the Contractor under any conditions. Smoking is prohibited inside any buildings at the VAMC.

b. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

14. Hours of Operation. Normal hours of operations at the VAMC are Monday through Friday from 8:00 am to 4:30 pm, excluding holidays. All work will be performed during normal hours of coverage unless requested or approved by Chemistry Supervisor or his designee.

Federal Holidays observed by the VAMC are:

New Years' Day Labor Day Martin Luther King Day Columbus Day Presidents' Day Juneteenth Veterans' Day Memorial Day Thanksgiving Day Independence Day Christmas Day

15. Information Security and Privacy. Contractor will not have access to information deemed to be “VA sensitive information”. Certification and accreditation (C&A) requirements do not apply.

a. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

b. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.