36C25025Q0492.docx

36C25025Q0492

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

506-25-2-1030-0005 36C25025Q0492 04- -2025 Kellie Konopinski 734-222-4330 05-16-2025 4:30 pm

EDT

36C250 Department of Veterans Affairs Network Contracting Office 10 24 Frank Lloyd Wright Drive Lobby M, Suite M2200 Ann Arbor MI 48105 X 334516 1000 Employees N/A X 36C506 Department of Veteran Affairs VA Ann Arbor Healthcare System 2215 Fuller Road Ann Arbor MI 48105 36C250 Department of Veterans Affairs Network Contracting Office 10 24 Frank Lloyd Wright Drive Lobby M, Suite M2200 Ann Arbor MI 48105

Department of Veterans Affairs Financial Management System P O Box 149971 Austin TX 78714-9971 512-242-7300 N/A X See CONTINUATION Page RFQ for Protein Electrophoresis CPT 5-Year Ordering Period IDIQ All questions shall be submitted to Kellie.Konopinski@va.gov by May 7, 2025 at 4:30 pm.

Required Training: TMS 10203 Privacy & HIPAA and TMS 10176 VA Privacy & Information Security Rules of Behavior.

See CONTINUATION Page 506-3650160-1030-822300-2560 010022390 X X X Kellie Konopinski 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:___________________

POC: ___________________

EMAIL: ___________________

PHONE: ___________________

b. GOVERNMENT: Contracting Officer 36C250 Kellie Konopinski Kellie.Konopinski@va.gov 734-222-4330 Department of Veterans Affairs Network Contracting Office 10 24 Frank Lloyd Wright Drive Lobby M, Suite M2200 Ann Arbor MI 48105

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

3. INVOICES: Invoices shall be submitted in arrears:

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

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

B.2 STATEMENT OF WORK

CAPILLARY AND/OR AUTOMATED GEL ELECTROPHORESIS SYSTEMS

C.0 SCOPE:

C.0.1 VA ANN ARBOR HEALTHCARE SYSTEM (VAAAHS): The Contractor shall provide one (1) Capillary/Gel system and operating software that performs protein electrophoresis studies on serum, urine. Contract shall include: one (1) automated agarose gel electrophoresis system and operating software, one (1) auto-sampler, Personal Computer, monitor, scanner, and high definition color printer, Uninterrupted Power Supply (UPS), and all parts materials, labor, supervision, test equipment, Material Safety Data Sheets (MSDS), reagents, capillaries, agarose gels, calibrators, control materials, supplies, consumables, technical manuals, service manuals provided in hard copy format and in electronic format , operator training, preventative maintenance, troubleshooting of the various units installation and integration, service, support and preventative maintenance, 24 hour telephone hot-line service for 7 days a week and 365 days a year, with a Cost-Per-Test (CPT) Program to VAAAHS. VAAAHS requests a Cost per Test (CPT) five-year ordering period IDIQ.

VA Ann Arbor Healthcare System (VAAAHS) is located at:

C.1 DEFINTION OF NEED: VAAAHS requests a Cost per Test (CPT) five-year ordering period IDIQ contract to provide protein electrophoresis studies on serum, urine, and cerebrospinal fluids (CSF).

C.1.1 VA ANN ARBOR HEALTHCARE SYSTEM : The contract includes one (1) Capillary/Gel system and operating software, one (1) automated agarose gel electrophoresis system and operating software, one (1) auto-sampler, Personal Computer, monitor, scanner, and high definition color printer, Uninterrupted Power Supply (UPS), and all parts materials, labor supervision, test equipment, technical manuals, Material Safety Data Sheets (MSDS), reagents, capillaries, agarose gels, calibrators, control materials, supplies, consumables, technical manuals, service manuals, provided in hard copy format and in electronic format that may be edited to meet our laboratory requirements. The vendor will provide training in the operation, preventative maintenance, troubleshooting of the various units, installation, and integration of the system with service, support, and preventative maintenance, 24-hour telephone hot-line service, 7 days a week and 365 days a year. Attached, under the Operational Features Requirements section, is a list of tests to be done on the various electrophoresis platforms. Additional assays may be assayed on the analyzers as they become available from the vendor.

C.2 DUTIES OF CONTRACTOR:

C.2.1 VA ANN ARBOR HEALTHCARE SYSTEM: The Contractor shall provide all supplies, maintenance agreement, consumables, including shipping and handling of reagent orders. The vendor shall provide VAAAHS with (1) Capillary/Gel system and operating software, one (1) automated agarose gel electrophoresis system and operating software, one (1) auto-sampler, Personal Computer, scanner, and high definition color printer, Uninterrupted Power Supply (UPS), and all parts materials, labor supervision, test equipment, technical manuals, service manuals, provided in hard copy format and in electronic format, Material Safety Data Sheets (MSDS), reagents, capillaries, agarose gels, calibrators, control materials, supplies, consumables. The vendor shall provide training in the operation, preventative maintenance, troubleshooting of the various units, installation, and integration of the system with service, support, and preventative maintenance, 24-hour telephone hot-line service, 7 days a week and 365 days a year. Cost-Per-Test (CPT) program is requested.

C.3 OPERATIONAL FEATURES REQUIREMENTS:

C.3.1 Test Menu MUST include test kits for the various assays involved in:

*Serum Protein Electrophoresis (SPEP): Fractionation of various proteins in serum.

*Immunotyping (IT): Identification of abnormal proteins in serum and urine *Immunofixation (I-Fix): Identification of abnormal proteins in human serum, urine and/or other biological fluids.

*Urine Protein Electrophoresis (UPEP): Fractionation of various proteins in urine- Qualitative analysis *Detection and identification of gammopathies in human sera and other biological fluids.

*Detection and identification of Bence Jones protein in human urine or of free light chains in human serum *High Resolution (HR) multifractionation of proteins in neat or diluted human serum or urine, concentrated cerebrospinal fluid.

* Provide upgrades for new tests as available.

C.3.2 Capillary/Gel system must have automatic delimiting of curves and identification of fractions to minimize operator editing.

C.3.3 Capillary/Gel system must have the ability to import quantitative specific protein results with correct measuring unit required to provide a comprehensive chartable report. System must have patient’s demographic information available.

C.3.4 Capillary/Gel system must be able to import comment from a word processor for unlimited comment entry.

C.3.5 Capillary/Gel system must allow for customized, compressed printouts of results and curves.

C.3.6 The Capillary/Gel electrophoresis is the technique employed in the separation of proteins. Proteins are detected directly at a precise wavelength providing a high degree of precision and accuracy.

C.3.7 The Capillary/Gel system must have at least eight capillary tubes, which will increase throughput.

C.3.8 The Capillary/Gel system must provide walk-away technology from start to finish. System must have the capability to read barcodes and provide for a continuous feed of samples. The system must have Positive Sample Identification (PSI) capability for full traceability from primary tube placement to final result recovery.

C.3.9 The Capillary/Gel system must process at least 80 samples per hour.

C.3.10 The Capillary/Gel system must have a system that controls the temperature during sample migration for consistent reproducibility from analysis-to-analysis and from capillary–to-capillary.

C.3.11 The Capillary/Gel system must have reagent traceability technology.

C.3.12 An interpretive software package must be available to facilitate reporting of results.

C.3.13 A Personal Computer (PC), keyboard, mouse, monitor, imaging scanner and high-definition color printer must be provided with connection cables for communication between the Capillary and agarose gel electrophoresis systems. This will allow for importing and storage of immunofixation scans and Capillary/Gel results and images.

C.3.14 The automated multiparametric agarose gel electrophoresis instrument must have high resolution and clarity of the electrophoresis bands for easy interpretation. The densitometry system is integrated into the instrument. The software provides editing and quantification of results, customization of reports, archival and recall of patient results. The system must have a color LCD touch-screen display. Vendor must update the latest version of software as available to the customers free of charge.

C.3.15 The automated multiparametric agarose gel electrophoresis system must provide a sequential processing of each electrophoresis step from application, migration, incubation, staining, destaining, drying, and final reading allowing for “walk-away” operation.

C.3.16 The automated multiparametric agarose gel electrophoresis system throughput should be at least 80 protein samples per hour and at least 15 Immunofixation samples per hour.

C.3.17 The automated multiparametric agarose gel electrophoresis system must automatically regulate voltage, current, power and volt hour, and stable temperature for consistent results from agarose gel to agarose gel.

C.3.18 The automated multiparametric agarose gel electrophoresis system must have an easy-to-use keyboard and screen with up to 40 migration programs available.

C.3.19 The automated multiparametric agarose gel electrophoresis system must have at least 8 different reagents on-line that are available at once. Reagents need to be water based.

C.3.20 The system must have a processing system for sample preparation and dilution designed to complement the automated multiparametric agarose gel electrophoresis system. A processing system must deliver precise micro-volumes of sample directly from primary tubes to the sample applicators, therefore allowing accurate and precise delivery of sample to agarose gel.

C.3.21 Automated multiparametric agarose gel electrophoresis system must compress printouts of results and curves and allow the operator to customize the report(s).

C.3.22 Automated multiparametric agarose gel electrophoresis system must be able to import comments from a word processor for customizable comment entry. Report options should include items such as patient history, immunofixation image, UID, name, age, ordering physician, specimen collection date and time.

C.3.23 Automated multiparametric agarose gel electrophoresis system must have a three-level quality control per analysis program, and Levey-Jennings statistical program.

C.3.24 The Capillary/Gel and Automated multiparametric agarose gel electrophoresis system must have bidirectional (broadcast download & host query) Laboratory Information System (LIS) capabilities.

C.3.25 Automated multiparametric agarose gel electrophoresis system must have software to allow for extensive curve editing capabilities, including deletion of minima and fractions, baseline modifications, fraction identification, and curve overlay. System must also have automatic alignment, centering of the electrophoretic pattern during reading, and automatic demarcation of the electrophoretic patterns.

C.3.26 An auto-sampler is a must for full standardization of all pre-analytical steps associated with the agarose gel electrophoresis system. The auto sampler must have Positive Sample Identification (PSI) capabilities.

C.3.27 All systems that have Positive Sample Identification (PSI) must be able to utilize and read barcode type: Code 128.

C.3.28 All systems must be compatible with 110 – 120 Volt power outlets.

C.3.29 Must have adequate Uninterruptible Power System (UPS) to support each analyzer system.

C.3.30 Each system must have an on-board type of waste disposable system for liquid output with options of connecting to floor drains.

C.3.31 Sampling systems must accommodate primary sample tubes sizes of 13mm x 75mm; 13 mm x 100 mm; and 16 mm x 100 mm; 5, 7, 10 mL tubes, and micro tubes. Systems must be able to accept plastic tubes meeting current safety requirements.

C.3.32 System and tests must meet College of America Pathologists (CAP), Clinical Laboratory Improvement Act of 1988 (CLIA ‘88), Clinical and Laboratory Standards Institute (CLSI; formerly NCCLS) standards and demonstrate satisfactory performance on CAP peer group comparisons.

C.3.33 System must be able to analyze serum, urine, and cerebrospinal fluid (CSF) when applicable/dependent on the electrophoresis process.

C.3.34 System must have cap piercing mechanism.

C.3.35 System must be capable of integrating the workstation to pathologist’s desk.

C.4 QUALITY CONTROL:

C.4.1 The Capillary /Gel must have a comprehensive quality control (Q.C.) program with statistical reduction of three Q.C. levels including Levey-Jennings charts.

C.4.2 Automated multiparametric agarose gel electrophoresis system must have a statistical program with 3 levels of quality control per analyte, including Levey-Jennings charts.

C4.3 The multiparametric agarose gel electrophoresis system has an automatic calibration system that ensures the light source maintains homogeneity throughout all the readings.

C.4.4 Units must provide ability to print monthly Levey-Jennings graphs on 8” x 11” paper or units must have the ability to backup data to a storage device.

C.4.5 System must have electronic archiving and corrective action documentation capability.

C.5 VENDOR FLEXIBILITY:

C.5.1 Must provide ability to incorporate new methodologies from company as new products are released.

C.6 TECHNICAL SUPPORT:

C.6.1 Ability to provide on-site technical support to perform test/assay method validations, precision, method comparison with current analyzer, accuracy (recovery) and linearity (analytical measurement range) studies, carry over studies, calibration verification, establishment of standardized reference ranges, operator training, and all other tasks that are necessary for implementation of this agreement. Vendor shall perform all required statistical analyses and report data in an organized, clearly comprehensible format in a binder for on-site staff approval. This process must be completed within two weeks of installation of the analyzers. Contractor shall provide written procedures in CLSI Format on electronic media at the time of installation and whenever an update made using software compatible with laboratory’s computer system.

C.6.2 Vendor will provide a twenty-four hour/seven-day/365 days per year technical service hotline with support through one contractor; this includes on-site service during normal business hours 8:00 a.m. to 5:00 p.m., Monday through Friday.

C.6.3 Updates to all procedure manuals and Material Safety Data Sheets (MSDS) in electronic format must be provided when package inserts are modified.

C.6.4 Provide written procedures in CLSI format on electronic media whenever a new assay is added using software compatible with the VAAAHS laboratory’s computer system, currently Vista but eventually maybe CERNER Millennium Electronic Health Records Management System.

C.6.5 Currently, the Veterans Affairs facilities utilize Data Innovations (DI) as the universal interface. Contractor equipment must offer a bi-directional interface with Data Innovations and VISTA/DHCP. Contractor equipment must also offer a bi-directional interface with the existing Data Innovations and the CERNER Electronic Health Records Management (EHRM) System, which VAAAHS may be utilizing in the future. The contractor shall provide everything required for the installation, implementation, testing, and operations of the interface right up to the universal interface box, including the software license fee that may be required each time an instrument or software update is added to an existing system (e.g., ports, cards, panels, software, flash drives, licenses, etc.). If there are any software/hardware/panel upgrades for the contractor system during the life of the contract, the contractor is responsible for ensuring that the interface support system can accommodate any changes in the data stream going to and from the VA’s laboratory information system and VA’s computerized patient record system (CPRS), and the CERNER Electronic Health Records Management (EHRM) System, which may be utilized in the future. Any additional costs, e.g., consulting fees, travel expenses, and extra equipment, etc. will be borne by the contractor. During the life of contract if DI becomes obsolete, contractor shall provide the support to its successor.

C.6.6 The contractor shall provide support and resources during the validation and migration to new Laboratory Information System (CERNER Millennium) with no extra cost to the Government. This shall include connectivity testing by assisting with order and result transmission between CERNER, Data Innovations, Contractor middleware, automation lines, and analyzers. The contractor shall provide support services to interface the middleware systems to set up, configure and test the lab instruments, DI/IM systems, and CERNER LIS/EMR systems to validate that end-to-end lab tests orders, results and quality control metrics are all connected and functioning in an accurate and optimate manner at the VA facilities. This shall also include validation support in which the contractor shall be the sole point of contact and work with designated laboratory personnel at each site during their validation period to assist with troubleshooting issues, configuration, connectivity, written rules algorithm, auto-verification. The contractor shall also provide go-live support for all VA facilities in this contract during their CERNER transition and go-live. Go-live is defined as the time at which the modified rules are moved into the production environment and the sites begin reporting the first results. The contractor shall also provide training as required by new LIS configuration.

C.7 CONFORMANCE STANDARDS:

C.7.1 Vendor must maintain full compliance with applicable Federal and State regulations. All services provided under this contract must be performed in conformance with the Nation Fire Protection Agency (NFPA), Occupational Safety and Health Administration (OSHA) and other applicable national, state and local regulatory agencies. Vendor must maintain a CLIA certificate of accreditation, and The Joint Commission (JC), and/or the College of American Pathology (CAP) accreditation.

C.7.2 On-site warranty, for the Ann Arbor Healthcare System, includes preventative maintenance visits (per recommendation of the manufacturer), replacement parts, service, repairs, travel, for the entire agreement period with unlimited, on-demand service during normal business hours 8:00 a.m. to 5:00 p.m., Monday through Friday.

C.7.4 The contractor shall perform annual preventative maintenance inspections during the contract period arranged with the Contracting Officer Representative (COR), in accordance with the published preventative maintenance manuals for the equipment listed in the schedule. The contractor shall utilize the Original Equipment Manufacturer’s established procedures and checklists (or Contractor-supplied equivalent satisfactory to the Contracting Officer Representative). A Field Service Report shall be supplied to the Contracting Officer Representative at the completion of each preventative maintenance inspection and repair service call. During the service call, the Field Service Representative will inform the technologist on-duty of problems found and corrective action taken while performing the maintenance and repair call.

C.7.5 The contractor shall notify the Contracting Officer of the existence or development of any defects in, or repair to the equipment covered under this contract, which the contractor considers he/she is not responsible for under the terms of the contract (such as operator misuse).

C.7.6 All exceptions to the Preventative Maintenance Inspection schedule shall be arranged and approved in advance with the Contracting Officer. The Contractor shall notify the Contracting Officer of the existence or development of any defects in, or repair to the equipment covered under this contract which the Contractor considers he/she is not responsible for under the terms of the contract (such as operator misuse).

C.7.7 The instrumentation shall perform all analysis for the required tests with safety and precision as defined by the Clinical Laboratory Improvement Act of 1988(CLIA’88), the Clinical and Laboratory Standards Institute (CSLI), the College of American Pathologists (CAP), and the Food and Drug Administration (FDA). All analyzers MUST be FDA approved.

C.8 HOURS OF WORK:

C.8.1 Warranty for the entire agreement period to include unlimited, on-demand, service during normal business hours, 8:00 a.m. to 5:00 p.m., Monday through Friday, excluding the federal government holidays or as otherwise arranged with the Contracting Officer Representative.

C.8.2 Contractor’s technical support hotline shall return all technical service request calls within two hours. Technical hotline will be available 24 hours per day, 7 days per week and will perform emergency repair service within 24 hours of the time of notification of the malfunction. The vendor shall provide, at no extra charge, all labor, travel, and non-refurbished parts necessary to make repairs.

C.8.3 The eleven holidays observed by the Federal Government are Veterans Day, New Year’s Day, Martin Luther King Day, President’s Day, Memorial Day, Juneteenth Day, Independence Day, Labor Day, Columbus Day, Thanksgiving Day, and Christmas Day. Also, any other day declared by the President of the United States to be a national holiday.

C.9 PARTS:

C.9.1 The contractor shall furnish, at no extra charge, all non-furbished parts as necessary to maintain the equipment covered by this contract. The contractor stipulates that he/she has ready access to new non-furbished standard parts (manufactured, supplied by the manufacturer, or equal thereto). All parts supplied shall be of current manufacturer specifications and have compatibility with existing equipment. Documentation of intended parts source(s) shall be provided to the Contracting Officer upon request.

C.10 MEDICAL LIABILITY INSURANCE LIMITS:

C.10.1 In accordance with VAAR 852.237-7, Indemnification and Medical Liability Insurance, the contractor shall maintain liability insurance or self-insurance of not less than $1,000,000.00 per specialty per occurrence.

C.11 PAYMENT:

C.11.1 The COR or designee will make certification of invoices for Pathology and Laboratory Medicine Service (PALMS) for the VAAAHS. All invoices will be processed in accordance with the Prompt Payment Act. Any discrepancy between the terms of the contract and the amount of the invoice will be promptly referred to the VA Contracting Officer for resolution. Invoices for contract services shall be submitted online through the e-invoice/Tungsten website.

Fax Numbers for the Austin Finance Center are: 512-460-5432 512-460-5540

C.12 TERM OF CONTRACT:

C.12.1 The contract will be effective for one year from the date of the contract award. The contract is subject to the availability of appropriated funds.

C.12 UPGRADES:

The Contractor shall provide upgrades to both the equipment hardware and software, in order, to maintain the integrity of the system, and to incorporate new methodologies, 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 supported by Contractor. This does not refer to replacing the original piece of equipment, provided under this contract; however, it does refer to significant changes in the hardware operational capability.

C.13 MISSION, VISION, AND VALUES STATEMENT:

C.13.1 Mission: Honor America’s veterans by providing exceptional health care that improves their health and well-being.

C.13.2 Vision: To be a patient centered integrated health care organization for veterans, providing excellence in health care, research, and education; an organization where people choose to work; and an active community partner and back-up for national emergencies.

C.14 ACCREDIATION COMPLIANCE STANDARDS:

C.14.1 GENERAL: The contractor shall continuously meet or exceed all of the Joint Commission standards. All applicable VA and VHA policies, procedures and directives shall be followed by the contractor. The patient population treated at the VA Ann Arbor Medical Center, located in Ann Arbor, Michigan, Toledo Community Based Outpatient Clinic, Toledo, Ohio, Flint Community Based Outpatient Clinic, Flint, MI and Jackson Community Based Outpatient Clinic, Jackson, MI consists of veterans with varying physical, psychiatric, and psychological needs.

C.14.2 PATIENT RIGHTS: Protection of all patients’ rights is of highest priority. Patient privacy and confidentiality shall be always maintained.

C.14.3 SAFETY: The VAAAHS shall inform the contractor of all applicable Safety Alerts received by the VAAAHS. For every applicable alert, the contractor shall take the necessary steps to redesign processes to prevent occurrence and provide written feedback to the Contracting Officer Representative (COR) describing prevention actions taken within one (1) business day or sooner if the VAAAHS COR or medical center requests action.

C.14.4 PERFORMANCE IMPROVEMENT: The contractor shall comply with the VAAAHS Performance Improvement (PI) program as applicable to the Pathology and Laboratory Medicine Service. Pathology and Laboratory Medicine Service will monitor the vendors response time to requests for service, and time the service report is sent, e-mail, to the designee of the chemistry laboratory on a quarterly basis. Contractor PI activities may be directed by the VAAAHS, VISN or VHA, as well as accreditation or licensing bodies. The contractor shall abstract, compile and report PI data as requested by the VAAAHS. VA Data collection methodology, report format, and reporting deadlines will be defined by the VAAAHS. Examples of required PI activities may include the VHA Performance Measures/Clinical Practice Guidelines program, and the Joint Commission ORYX or Core Measurement program. It is noted that PI activities are dynamic and subject to change, as driven by current priorities and resources. In all cases, the contractor shall continually assess for, and act upon, clinical and administrative improvement opportunities. High priority shall be given by the contractor to the prevention of risk for the patient. The contractor shall implement process-related internal controls to prevent risk to the veteran. VA monitoring for continuous compliance with Joint Commission standards shall be directed by VAAAHS staff, and communicated to the contractor through the COR. VA aggregate and/or practitioner-specific data collected by the VAAAHS will be provided to the contractor in accordance with established reporting schedules. VA measures related to contract compliance will be identified by the COR.

C.14.5 LEADERSHIP: The contractor shall effectively manage daily operations, information and support systems, and conserve physical and financial assets while meeting the mission of the VAAAHS.

C.14.6 INFORMATION MANAGEMENT: The VAAAHS Information Management plan shall be followed by the contractor. Documentation and record keeping shall be in accordance with VAAAHS policies and procedures.

C.15 DOCUMENTATION/REPORTS:

C.15.1 The contractor shall submit a legible field service report which shall include detailed descriptions of the preventive maintenance inspection or emergency repair services performed, including replaced parts and estimated prices required for the service call. NOTE: Any additional charges claimed must have been approved by the Contracting Office Representative before service was performed.

C.16 REPORTING REQUIREMENTS:

C.16.1 The contractor shall be required to report to the Pathology and Laboratory Medicine Service chemistry department where the equipment is located (Building 1, Room E312) for maintenance or service calls. The Contractor must document the service call in the vendor logbook. When the service is completed, the contractor shall document services rendered on a legible field service report and present to the Contracting Officer Representative or designee for signature, during normal working hours. After normal business hours, the contractor will leave the service ticket with the medical technologist assigned to the chemistry section who will place the document in chemistry supervisor’s mailbox.

C.17 COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

C.17.1 The contractor’s staff shall include a “fully qualified” Field Service Representative assigned to this area and a “fully qualified” Field Service Representative who shall serve as the Backup. “Fully qualified” is based upon training and on experience in the field. For training, the Field Service Representative must have successfully completed a formalized training program for the equipment covered under the contract. For field experience, the Field Service Engineers must have a minimum of one (1) year of experience providing preventative maintenance and emergency repair services on the same make and model of equipment covered under this contract.

C.17.2 The contractor shall provide written assurance of the competency of their personnel by detailing a list of Field Service Representative along with applicable training and years of service experience on the specific devices used in this agreement.

C.18 TEST EQUIPMENT:

C.18.1 Upon request of the Contracting Officer Representative or the Contracting Officer, the Contractor shall provide copy of the current Calibration Certification of all test equipment which is to be used by the Contractor to perform service under this contract. Calibration of equipment shall be traceable and in conformance with test equipment Original Equipment Manufacturer standards.

C.19 SAFETY REQUIREMENTS:

C.19.1 In the performance of this contract, the contractor shall take such safety precautions as the Contracting Officer may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contracting Officer shall notify the contractor of any safety issues and the action necessary to correct these issues. Such notice, when served on the contractor or his representative at the work site shall be deemed sufficient for the corrective actions to be taken. If the contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work and hold the contractor in default.

C.20 HARDWARE/SOFTWARE:

C.20.1 Computer Interfacing Requirements – The fully operational interface (both hardware and software) must be immediately available for implementation to the VA Vista hospital information system at the time of contract award. Computer access will be granted on a need-to-know basis, and security of computerized information will be maintained at all times.

· Current instrument on site located in the Lab behind MDIA, does not have access to any data on the computer. Aside from the necessary power supply, this connects to the Data Innovations server.

C.20.2 The contractor is 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 (see requirements below). Likewise, the vendor will provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirement for the communication of the data streams will be unique to the instrument system in involved and dictated by the manufacture itself.

C.20.3 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 software, etc.) to the universal interfacing system. 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 VistA. If there are any software upgrades in the instrument during its life the contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VistA.

C.20.4 Currently, VAAAHS is operating with one universal interfacing system, i.e. Data Innovations. Support for autoverification shall be provided.

C.20.5 The contractor shall provide all ancillary support equipment to fully operate the instrumentation as defined in these specifications. Remote access for system troubleshooting shall be provided only through a VPN interface subject to Department of Veterans Affairs Information Management Service approval. Modems are no longer considered acceptable by the VA Information Security Office.

C.20.6 The contractor shall include all ancillary components that are customarily sold or provided to support the model of equipment proposed, (e.g., starter kits, tables/stands, etc.). The contactor shall provide their technical manual on a portable storage device (i.e., CD-ROM, disk, etc.) or an on-line technical manual in the instrument software in addition to a hard copy (printed) version for the respective analyzers. The technical manual shall be formatted in accordance with current, approved CLSI guidelines (GPS-A2 or GP2-A3).

C.20.7 The instruments must provide availability of printed (hard copy) patient results routinely and in the event of interface downtime.

C.20.8 Electronic archiving that complies with College of American Pathologist (CAP) and Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requirements.

C.20.9 Computer Hard Drives: Per VA information Security Policies, no hard drives or computers disks containing VA patient information shall be removed from VA facility. At the time of turn-in or removal due to failure, the VA facility shall remove all sensitive data from information systems storage devices or render the data from these systems unreadable, could mean hard drive is destroyed. No Federal Information Processing equipment shall be discontinued from rental/lease or exchange without compliance with this requirement.

C.20.10 Uninterruptible Power Supply (UPS) shall be provided for each analyzer. System shall be installed and maintained by the vendor. Preventative maintenance shall be performed in accordance with manufacturer’s recommended guidelines.

C.21 TRAINING:

C.21.1 The contractor, without additional charge to the Government, shall provide onsite training for four (4) operators on all systems provided by the vendor. In addition, the contractor shall provide supplemental operating training to the Government personnel, without additional charge to the Government, upon initial installation and during any upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished under this solicitation.

C.21.2 At the Government’s request, the contractor shall furnish training for additional personnel.

C.21.3 Additionally, the contractor, at its discretion may make training available at its facility on terms and conditions mutually agreed upon by the agency and the contractor consistent with commercial offerings.

C.22 SUPPORT FEATURES:

C.22.1 The contractor shall perform all the statistical analysis and report data in an organized, clearly comprehensible format, a sample of which is to be provided with the proposal. The contractor shall provide assistance, with reference ranges, to include handling of data with appropriate software to establish reference intervals.

C.23. COR DESIGNATION:

C.23.1 The Contracting Officer Representative (COR) is Neelam Palande, M.S; MT (ASCP), Pathology and Laboratory Medicine Service (113), VAAAHS, 2215 Fuller Road, Ann Arbor, MI, 48105. Email address is: Neelam.Palande@va.gov. Telephone number is 734-845-5986. This individual is a VA employee and free from any financial or organizational conflict of interest.

B.3 VA INFORMATION AND INFORMATION SYSTEM SECURITY AND PRIVACY LANGUAGE FOR INCLUSION IN CONTRACTS

1. GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

2. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor shall not release VA records protected by Title 38 U.S.C. § 5705, Confidentiality of medical quality-assurance records and/or Title 38 U.S.C. § 7332, Confidentiality of certain medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above-mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA.The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA…