36C24624Q0059.docx

36C24624Q0059

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

Multiple 36C24624Q0059 12-11-2023 LaToya Glover 910-488-2120 x5823 12-22-2023 12pm

EST

Department of Veterans Affairs Network Contracting Office 6 201 Hay Street, Suite 305 Fayetteville

NC

28301 X 325413 1250 Employees Net 30 N/A X See Attch D - VISN 6 Facilites

Department of Veterans Affairs Network Contracting Office 6 201 Hay Street, Suite 305 Fayetteville

NC

28301

Financial Services Center P.O. Box 149971 Austin

TX

78714-9971 512-460-5049 512-460-5221 X See CONTINUATION Page This is a request for quote for VISN 6 Urinalysis Cost Per Reportable Result (CPRR) base and 4 option year contract.

See SOW, attachments, Section C, D, and E for additional details.

Period of Performance: Base: 02/01/2024 -09/30/2024 Option Year 1: 10/01/2024 - 09/30/2025 Option Year 2: 10/01/2025 - 09/30/2026 Option Year 3: 10/01/2026 - 09/30/2027 Option Year 4: 10/01/2027 - 09/30/2028 Prospective offeror shall submit an offer that conforms to all requirements of this solicitation.

All quantities are estimates only.

See CONTINUATION Page X X X Cherisse Hall Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C246 Cherisse Hall

Network Contracting Office 6 201 Hay Street, Suite 305 Fayetteville NC 28301

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

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

VA Financial Service Center (FSC) Electronic Invoice Presentment and Payment System https://www.fsc.va.gov/einvoice.asp ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

36C24624Q0059

Page 1 of Page 1 of

B.2 STATEMENT OF WORK

Instruction to Offeror:

The offeror is responsible for ensuring that their proposal is complete. The proposal shall be clear, concise, and shall include sufficient detail for effective evaluation and for substantiating the validity of any stated claims. The proposal shall not simply rephrase or restate the Government's requirements, but rather shall provide convincing rationale to address how the offeror intends to perform the requirement. Statements that the Offeror understands, agrees, can, or will comply to the requirements, will be considered unacceptable.

1. SCOPE OF PROCUREMENT:

1.1 The VISN 6 facilities requests a base year Cost Per Reportable Result (CPRR) contract that includes 4 additional option years to provide an automated urine chemistry/microscopic analyzer with true walk away capability. The CPRR program shall include equipment, service/repair, preventative maintenance, technical support, training, all reagents, controls, calibrators, and all consumables (i.e. reagent strips, calibration strips, cleaning solutions, diluent solutions, sheath fluid, etc.) necessary to operate the Contractor’s equipment.

1.2 The desired urinalysis instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have positive sample identification, random access capability, and be able to simultaneously perform the complete profile as described below to meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

1.3 Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory due to the shortage of laboratory personnel. The equipment must streamline all aspects of testing, thereby enhancing operational efficiency, improving turnaround times, supporting improved patient outcomes, improving patient and provider satisfaction, and improving the productivity of the facility.

1.4 If Contractor offers a family of analyzers, VISN 6 technical evaluation panel will determine if instrumentation proposed meets needs of using facility. The Contractor may provide the options in their pricing schedule to allow each facility to choose the analyzer(s) that is best suited to their laboratory (mirror image redundancy). The Contractor shall work with each facility to place an analyzer/system that best accommodates their defined space requirements.

1.5 New equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment D – VISN 6 facilities. Remanufactured or used models will not be accepted. The testing instrumentation must be approved by the Food and Drug Administration (FDA) to perform chemistry/microscopic analysis for urine.

1.6 This contract is for a total of 5 years. Therefore, there is the possibility that some of the facilities may require equipment installation and possible reinstallation due to plans of the facility’s mission and goals, demolition, new construction, laboratory redesign, and/or relocation. The Contractor shall specify if the relocation/reinstallation service is included at no cost to the government if the situation should occur.

1.7 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 PHI or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receive, use, or disclose VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

1.8 The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, calibrators, linearity material, supplies, disposables and any other consumable parts or materials required to properly perform tests on the equipment such that equipment operations are not interrupted. This is inclusive of replacement parts per manufacturers guidelines (e.g. sampling or dispensing probes, filters, racks, etc.) 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.

1.9 Alert/Notification of any delays in shipment or backordered products should be forwarded to the designated individuals [see Attachment – VISN 6 Facilities Point of Contact (POC)] within seven (7) business days or less. Technical advisory/recalls and field alerts should be forwarded to the designated POC within fourteen (14) business days or less of their publication. The Contractor shall electronically deliver the alert/notifications to the designated POC for each facility.

1.10 Special handling for emergency orders of supplies: In the event the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery without additional cost to the Government. If additional requests for emergency supply deliveries are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

2. BACKGROUND:

2.1 The reagent quality must be high enough to stratify proficiency testing standards of the College of American Pathologist (CAP) and the Joint Commission (TJC).

2.2 The microscopic analyzer for sediment analysis must be able to connect to the chemistry analyzer for an integrated system.

2.3 The automated macroscopic system must be capable of performing Urine Chemistry strip testing to include Urine Color, Appearance, Clarity, Specific Gravity, pH, Leukocytes Esterase, Nitrites, Protein, Glucose, Blood/Hemoglobin, Ketones, Urobilinogen and Bilirubin. The Contractor shall explain how the analyzer detects color, clarity, and if it has an automatic color correction method.

2.4 The Contractor shall describe how the automated microscopic system distinguishes the cellular components of a urine sample and if the images are digitally displayed. The system must be able to recognize, identify and enumerate all types of urine sediment particles/constituents, such as but not limited to red blood cells, white blood cells, casts, crystals, bacteria, etc.

2.5 Refer to Attachment A – VISN 6 Estimated Workload for each facility’s estimated annual workload (i.e. October 1, 2021 through September 30, 2022).

3. GENERAL REQUIREMENTS:

3.1 Primary analyzer(s) – Base equipment offered shall fully support the scope of operations. 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. Those additional analyzer(s) shall be equivalent to a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment.

3.2 Back-up analyzer(s) - Equipment required in support of operations for the VA laboratories in the event the primary analyzer becomes non-operational/non-functional or is required for increased capacity due to projected increase in workload.

3.3 There shall be standardization of hardware, software, and consumables between the primary and back-up analyzer(s) throughout the network (mirror image redundancy). The Contractor shall provide options in their pricing schedule to allow each facility to choose the solution/option best suited to their laboratory needs (see Attachment A – VISN 6 Requested Equipment).

3.4 The Contractor shall state all possible configurations/set-up options for integration of the primary/base equipment plus proposed back-up equipment.

3.5 Contractor shall provide quality control (QC) material at a minimum of two levels, normal and elevated/ abnormal levels for all chemistry tests per CAP URN.24370 – Daily QC and two levels of microscopic controls per CAP URN.31600 - Daily QC – Automated Microscopy Systems for analysis for each day of patient testing. The Contractor shall state the size (in mLs), type (liquid – ready to use or lyophilized – needs to be reconstituted), and stability of the controls. The Contractor shall provide a copy of the package inserts for the proposed QC.

4. OPERATIONAL FEATURES:

The instrumentation offered shall have the following:

4.1 The capability of performing analysis on 100% of the analytes/tests listed in Attachment A – VISN 6 Estimated Workload.

4.2 Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A. The proposed system, both Chemistry and Microscopy, shall have a minimum throughput of 50 or greater samples per hour for the primary analyzer and 50 or greater samples per hour for the backup analyzer.

4.3 Safety features to avoid unnecessary exposure to bio-hazardous and chemical material. The exposure to and the volume of bio-hazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

4.4 A bi-directional, barcoded 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.

4.5 The accuracy of the barcode reading, for either the urine chemistry unit or the automated microscopy unit, must have less than a 1% failure rate.

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

4.7 Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha and/or numeric depending on site.

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

4.9 The urinalysis solution shall the ability to continuously load patient specimens. The system must not require monitoring during a run and should be a walkaway system.

4.10 Maintenance procedures need to be user friendly and require minimal downtime. Contractor shall define the actual hands-on time to perform each maintenance task (i.e. daily, monthly, and periodic maintenance). Contractor shall list which tasks are user level and which tasks are service level.

4.11 Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. The contractor shall state how many samples can be stored. The system shall have the ability to edit sample/patient identifier after interface downtime and then be able to resend the sample/patient information to the host for verification.

4.12 On board reagent stability sufficient to accommodate both high and low volume use. The Contractor shall state the on-board stability of reagents and supplies once they have been opened/loaded on the equipment. Contractor shall provide each facility with reagents and supplies that have at least 6 months remaining prior to the expiration date.

4.13 Analyzer shall have the ability to detect short samples. The Contractor shall state what is the minimum volume of urine for patient testing.

4.14 Capability to detect and alert the operator of out-of-range quality control by flagged results on QC printout and visual alerts on display monitor.

4.15 Enumeration of formed elements either numeric or semi-quantitative result format (i.e., mg/dL or large/4+) and the ability to set user defined clinical validation rules/flags for reflex microscopic testing.

4.16 Ability to set facility developed flags for reflex to automated microscopic testing and the ability to not perform a microscopic evaluation on samples that do not meet the criteria.

4.17 The Contractor shall state the reportable range for each parameter of its automated microscopy system per CAP URN.31700 – Reportable Range or each parameter of the automated microscopy system.

5. TECHNICAL FEATURES:

5.1 On-board quality control (QC) data management system with storage capacity for QC files and includes Levy-Jennings graphs. Analyzers must have the ability to capture, store and electronically transfer QC data. The Contractor shall supply the storage capacity of the proposed system.

5.2 Continuous monitoring of vital instrument functions and performance with immediate operator notification of failure(s). The Contractor shall describe their notification of equipment failure.

5.3 On board reagent inventory system. Contractor shall state if reagents needed are stored at room temperature or refrigerated. Contractor may state if reagents, controls, or calibrators are color-coded.

5.4 Minimal reagent, calibrator, and control preparation. The Contractor shall specify the calibration frequency and the time required to perform calibration.

5.5 The analyzer shall have a design that supports result integrity by removing the possibility of sample carryover per CAP URN.31425 – Carryover detection. The Contractor shall provide documented evidence/study confirming the system design removes the possibility of any sample carryover.

5.6 Long calibration stability. Contractor shall specify calibration and calibration verification frequency per CAP URN.24355 Calibration/Calibration Verification Criteria and time required to perform calibration for both the chemistry and microscopic systems.

5.7 The urinalysis system shall have the ability to set-up flagging criteria for specimen requiring manual review.

5.8 Contractor shall provide manufacturer verified documentation of sample stability for specimens up to 48 hours after collection per the JC QSA.07.01.01 – The laboratory establishes and follows a defined system for handling, testing, and reporting urine specimens that exceed stability requirements.

5.9 Contractor shall list all known interferences for urine chemistry analysis and identify what type of urine specimens that may give erroneous microscopic results per CAP URN.31400 – Erroneous Morphology Results.

5.10 Ability to perform dilutions and capable of performing the calculations of the dilution for microscopic analysis. The Contractor shall describe the dilution process.

6. HARDWARE FEATURES:

The instrumentation shall have the following:

6.1 A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. The offered clinical urinalysis analyzer(s) shall a scalable design for unique workflows and configurations that can conform to the facilities existing and/or renovated space. The Contractor shall provide the dimensions of their proposed analyzer(s).

6.2 The Contractor shall list analyzer/utility requirements (electrical, water, plumbing, reagent, and bio-hazardous disposal, etc.). The Contractor shall provide weight and dimensions of proposed primary and back-up analyzers.

6.3 An on-board monitor/screen that is easily readable. The system shall be compatible with the customer Laboratory Information System (LIS) software. The Contractor shall be responsible for the replacement should it become dysfunctional.

6.4 A laser jet printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID). The Contractor is to provide a replacement printer for each analyzer as needed should it become inoperable. The replacement printer needs to be the same make and model as the original printer so that printer and toner cartridges remain the same. When a printer becomes dysfunctional or inoperable, the contractor shall furnish a letter to the customer stating that the old printer can be destroyed or is now the property of the VA.

6.5 An uninterruptible power supply with line conditioner for each piece of equipment provided. Each UPS must provide electrical power after the main electrical power fails. The Contractor shall state how long the UPS will provide backup for each piece of equipment. The Contractor shall be responsible for replacing the UPS, should it become dysfunctional and provide battery replacement as needed.

6.6 The Contractor may state if a cart, wagon, or table is available for the analyzers to be placed on and whether it is capable of housing the reagents for the primary analyzers. This requirement is facility dependent (see Attachment A – VISN 6 Requested Equipment).

6.7 Primary tube sampling. Ability to accept various types of sample containers. The Contractor shall state acceptable sample containers.

6.8 The back-up analyzer shall be capable of being interfaced. The interface shall meet the same VACO interface requirements as the primary instrument.

6.9 The system shall have an automatic back-up function to store all data from the hard drive. The Contractor will describe the back-up option in the submitted technical response to this solicitation. The preferred back-up option is storage directly to a VA SAN or other VA storage system. Only the instrument configuration can be stored on removable media. VA patient information cannot reside at the contractor’s location or on removable media.

6.10 The analyzer may have on-board integrated maintenance and trouble-shooting procedures.

6.11 The Contractor may have the ability to remotely monitor the instrument performance to minimize the down time. The Contractor shall explain how this process can be accomplished.

7. SPECIFIC EQUIPMENT REQUIREMENTS:

7.1 The urinalysis system shall have auto-particle recognition/identification/classification to standardize microscopy result reporting that requires minimal user manual microscopic verification of less than 5% of patient samples requiring a microscopic review.

7.2 The results from the back-up analyzer shall correlate and/or compare to the reporting units/grading criteria used on the primary analyzer.

7.3 The back-up analyzer shall have the same result format as the primary analyzer for result standardization.

7.4 The Contractors proposed analyzer shall cease/stop patient testing if a QC failure occurs.

7.5 The proposed analyzer(s) shall be capable of producing accurate and reproducible results by established diagnostic methods. The analyzer(s) shall provide accurate test results without excessive malfunctions, breakdowns, or service calls.

7.6 The Contractor shall supply equipment that performs satisfactorily at any laboratory humidity between 15 – 85% and laboratory temperature between 50 - 90ºF (10 - 30ºC).

7.7 Should a facility, that currently does not have backup analyzer, have a substantial increase in volume or patient services have become impacted (i.e. not meeting turnaround times) a backup analyzer may be required.

8. METHOD PERFORMANCE/VALIDATION REQUIREMENTS:

8.1 Method performance/comparison shall be performed at the expense of the Contractor. All studies performed will be appropriate for the test menu of the respective laboratory to include urine as applicable.

8.2 Correlation studies for each analyte. A minimum of 20 samples spanning the reportable range shall be run comparing the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed.

8.3 Precision study using normal and abnormal control material. This shall include, at a minimum, within run precision study of 10 normal and 10 abnormal controls.

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

8.5 Specificity studies can be determined by a review of product literature and assay inserts to determine any adverse effects for interfering substances or drugs.

8.6 Carryover studies per CAP URN.31425 – Carryover Detection shall be completed by the Contractor on all analyzers during installation, after major maintenance or repair of the pipetting assembly of the instrument. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge.

8.7 Analytical Measurement Range (AMR) shall be performed on proposed instrument(s) for each test to validate the reportable range per CAP URN.31700 – Reportable Range – Upper and lower limits of all quantitative reportable parameters on automated microscopy system. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimen assayed by that method.

8.8 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:

8.8.1 A verification of the manufacturer’s suggested reference range may be performed if 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.

8.8.2 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.

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

8.9 At installation/setup the technical support specialist shall perform all validation studies including precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity. The Contractor shall perform the statistical analysis in an organized, clearly comprehensible format, and place in a labeled binder. Evaluation/comparison data shall be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards, the Joint Commission, and Federal regulations. The studies shall be completed within two weeks of installation at each facility.

9. REPORTS:

9.1 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 30–60 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.

9.2 The Contractor shall supply accurate data for annual contract renewal by the required time frames, ensure timeliness of billing reconciliations and have the appropriate billing method required by the VA (i.e. Invoice Payment Processing System (IPPS)].

9.3 Test counts for billing will begin after all CAP required studies, performed at installation of new equipment, are reviewed, and approved by the Laboratory Director.

10. SUPPORT FEATURES:

10.1 Commercial marketing - The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Refurbished or grey market equipment is not acceptable.

10.2 The Contractor shall pay all routine shipping fees for supplies, consumables, and equipment to perform testing at initial installation and with routine supply delivery.

10.3 At the installation of the new equipment the Contractor shall provide the physical installation of the equipment and possible relocation of the equipment after validation studies have been performed if the new equipment needs to be validated at some location outside of the main laboratory due to space constraints. The Contractor shall provide a field service representative and any technical support specialist needed to assist in the equipment installation and set-up.

10.4 The Contractor shall provide four references: two VA (not within VISN 6) and two from the private sector. References are to include the facility address, telephone number, email address, and contact person’s name which can validate their experience with the Contractor within the last three years.

10.5 Start-Up Reagents - The Contractor shall provide each participating facility for the duration of the contract, reagents, calibrators, controls, consumable/disposable items, parts, accessories, and any other item included on the list of supplies (inclusive of replacement parts per manufacturers maintenance guidelines, specimen racks, sample holders, calibrator strips/standards, QC racks, microscopic dilution labels, paper, etc.), necessary for analyzing/testing on both the primary and back-up analyzers to produce a patient result and are required to establish instruments for operation for performance of acceptance testing.

10.5.1 The Contractor shall include enough supplies (listed above) to perform repeat testing for 10% of the patient samples. All linearity material is to be provided for the initial set-up and may be provided in the option years to meet CAP requirements.

10.5.2 The Contractor shall pay all shipping costs for the analyzer(s) and any crossover supplies needed at installation and during training of staff.

10.6 Training - The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room, and board for each participant.

10.6.1 The Contractor may provide what options are available for training in the option years of the contract if a facility chooses not to send someone to training (facility dependent).

10.6.2 The Contractor shall provide on-site refresher instrument training, wet workshops, advanced troubleshooting, or any appropriate training in renewal option years of the contract if exercised at no cost to the facility.

10.6.3 The Contractor shall provide all education/training on site during installation or update to the equipment. The training is to include staff on all shifts. Training shall include basic operation, quality control, required user performed maintenance, troubleshooting, interpretation of results, and reporting of results. The Contractor or Application Specialist shall provide a documented record of training (i.e. training checklist) completed for all staff before leaving the site following installation at each facility.

10.6.4 The Contractor shall state what training options are available for new personnel such as web-based training, on-line self-paced courses, or on-board tutorials/instructions.

11. EQUIPMENT PREVENTATIVE MAINTENANCE/REPAIR SERVICE:

The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all analyzers and any incremental support/ancillary equipment, offered according to the following terms:

11.1 The Contractor shall provide Hotline technical assistance 24 hours per day, 7 days per week by telephone with a maximum call back response time of one (1) hour.

11.2 Request for service is to be made through one Contractor for both the chemistry and microscopic components of the analyzer.

11.3 The Contractor shall provide a preventative maintenance schedule to include a minimum of two scheduled preventative visits per year for the duration of the contract.

11.4 Service shall include all travel, parts for repair or replacement, and labor.

11.5 The Contractor shall provide all replacement parts at no charge and any components necessary for the operation of the instrument(s) to produce patient results. All repairs or replacement of parts or hardware shall be done with new non-refurbished parts or hardware.

11.6 The Contractor shall provide instrument support service to assist with troubleshooting and repair of the analyzers. The Contractor may list their service options available. Or the following service options shall be available: 24 hours per day, 7 days per week basis for hospitals, and 7am – 6pm Monday through Friday and 7am – 1pm Saturday for the Health Care Centers. Additional service options shall be available to the HCCs if their projected workload increases and/or their hours of operation are extended on the weekends.

11.7 For facilities maintaining mirror image analyzers, service may be available from 08:00a.m. – 5:00p.m., 7 days per week. For any site that may encounter the rare occasion when both the primary and back-up analyzers are both inoperable (service has now escalated to emergency status), service will immediately dispatch a Field Service Engineer (FSE) for repair. The Contractor is to explain their policy in relation to service if the occasion should occur when both the primary and back-up analyzers are both inoperable.

11.8 The support service shall follow-up all down calls within 1 hour. The Facility Service Representative (FSR) shall keep the facility/clinic (COR or LEAD Technologist) informed of the repair completion timeline. All repairs on instrument shall be complete (at no cost to the facility) within 24 hours from the time the FSE arrives.

11.9 A service report shall be furnished to the identified points of contact (see Attachment A – VISN 6 Facilities POC) upon completion of each repair call. The service report shall include, at a minimum, the following: Date and time notified; date and time of arrival; serial number, type, and model number of equipment; time spent for repair, proof of instrument repair including documentation of a sample run of quality control verifying acceptable performance.

11.10 Technical support shall place a service call for repairs if the technologist is unable to repair the analyzer within one hour of troubleshooting with the hotline or on weekends/holidays/irregular tours when the technologists may be unable to work with the hotline due to the facility’s staffing.

11.11 The Contractor shall supply the national average of service calls per analyzer.

11.12 The Contractor’s personnel shall display an identification badge while on the VA premises. The contractor’s technical service representatives shall comply with each facility’s requirements for onsite contractor representatives including the use of personal protective equipment (PPE), masking due to COVID, and no smoking on site. This requires the contractor to register at the vendor credentialing system at https://app.ortrax.com to obtain a Digital Badge. This Credentialing service is paid for by the contractor.

11.13 This may require a low-risk background investigation by federal authorities paid for by the Contractor.

11.14 This shall require annual compliance with completing the required VA Talent Management System (TMS) Privacy and HIPAA Focused Training (10203) and VA Privacy and Information Security Awareness and Rules of Behavior (10176).

11.15 Upgrades - 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 commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the contract; however, it does refer to significant changes in the hardware operational capability. The Contractor shall maintain compatibility of systems with whatever host LIS or TCP/IP interface is in place, especially when the Contractor software is upgraded.

11.16 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.

11.17 Interface requirements – The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system.

11.17.1 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.

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

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

11.17.4 The specimen management system must be a computer interface that is compatible with the current VA laboratory information system and existing universal interface. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

11.17.5 The Contractor is to conduct and complete the medical Equipment Pre-Procurement Assessment (VA Directive 6550), if an existing ERA (Enterprise Risk Analysis) exists only Appendix A is to be completed and supplied to each site. If there is no existing ERA, then the vendor must provide the following with consultation with Biomedical Engineering:

11.17.5.1 6550 Appendix A – the manufacturer completes the 6550 Appendix A, but BME is responsible for validating and finalizing the document with site-specific information and forwarding the document for signature and approval

11.17.5.2 Manufacturer Disclosure Statement for Medical Device Security (MDS2) – vendors complete the MDS2 and submit to BME

11.17.5.3 Complete Ports, Protocols, and Services (PPS) list – BME prepare the ports and protocols list using information within the 6550 Appendix A and MDS2

11.17.5.4 Topology diagram – either BME or vendors prepare the topology diagram showing data flow and assessment boundary

11.17.5.5 Complete hardware/software inventory – BME provides a full system hardware/software inventory with a description of component purpose

11.17.5.6 Facilities or VISNs can execute procurements for medical devices/systems while the ERA is being developed by the Medical SCA; however, deployment cannot proceed until the ERA is completed.

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

11.17.7 The Contractor will maintain compatibility of systems with whatever host LIS is in place, especially when the Contractor’s software is upgraded.

11.17.8 The Contractor shall provide, maintain, and upgrade the antivirus software on the analyzer(s) and/or middleware for the duration of the contract.

11.17.9 In lieu of an LIS interface, the Contractor may provide a TCP/IP interface preapproved/ certified by VACO for use with VA computer systems and applications such as VistA. Proof of certification must be provided. The Contractor shall provide all necessary information, including logical ports, for VA staff to write an access control list.

11.17.10 Interface shall be host query to download sample IDs, test requests, and patient demographics.

11.17.11 Instrument interface shall transmit test results to the host computer system via automatic upload.

11.17.12 Automatic host query shall seamlessly integrate with onboard patient sample barcode scanning and translation.

11.17.13 Provide documentation of successful interfacing with other VA facilities (provide two (2) VAMC references to include contact person, address, telephone number and email address.

11.18 Commercial offerings - The Contractor shall provide any additional support material, e.g. procedure manuals, trouble-shooting manuals, or operator’s manual, that is routinely provided to equivalent commercial customers and assist in the regulatory compliance, e.g. computer disc containing this material in the Clinical and Laboratory Standards Institute (CLSI) format or an online procedure manual in the instrument software.

11.19 Characterization of waste – The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

11.20 The determination and description shall address the following:

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

11.20.2 Waste ignitability (Reference 40 CFR §261.21)

11.20.3 Waste corrosivity (Reference 40 CFR §261.22)

11.20.4 Waste reactivity (Reference 40 CFR §261.23)

11.20.5 Hazardous waste from non-specific sources (F-listed)

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

11.20.7 Solid Waste (Reference 40 CFR §261.2)

11.20.8 Exclusions (Reference 40 CFR §261.4)

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

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

11.22.1 Barium (Total)

11.22.2 Cadmium (Total)

11.22.3 Chromium (Total)

11.22.4 Copper (Total)

11.22.5 Cyanide (Total)

11.22.6 Lead (Total)

11.22.7 Mercury (Total)

11.22.8 Nickel (Total)

11.22.9 Silver (Total)

11.22.10 Zinc (Total)

11.22.11 Arsenic (Total)

11.22.12 Selenium (Total)

11.22.13 Tin (Total)

11.22.14 pH

11.22.15 Flash point (to higher than 200º F)

11.22.16 BOD biochemical oxygen demand

11.23 The documentation the Contractor provides will be used to work with the VA and the public and/or private organization (e.g., POTW) to determine if the waste from each device can legally be disposed of via the sewerage system.

12. IMPLEMENTATION/TRANSITION TIMEFRAME:

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

12.1 The support specialist shall assist with staff training, in-services to laboratory personnel and…