36C25724Q0847.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C25724Q0847 07-24-2024

Kathryn Prose (kathryn.prose@va.gov) (254) 217-2835 08-13-2024

3:00 PM CDT

36C257 Department Of Veterans Affairs Network Contracting Office (NCO) 17 5441 Babcock Road Ste. 302 San Antonio TX 78240

X

334516

1000 Employees

N/A

X

36C671

Department of Veterans Affairs VA South Texas Health Care System Core Laboratory, P&LMS 7400 Merton Minter Street San Antonio TX 78229-4401

36C257

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

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

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

This solicitation is for the procurement of Erythrocyte Sedimentation Rate (ESR) Cost Per Test for the VA South

Texas Health Care System.

This will be a single award Indefinite Delivery / Indefinite Quantity (IDIQ) Contract for 5 one-year ordering periods.

Technical questions regarding this solicitation shall be submitted in writing to Kathryn Prose, at kathryn.prose@va.gov, no later than 08/02/24 at 12:00 PM CDT

X X

X 1

36C25724Q0847

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

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

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

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

C.3 52.216-18 ORDERING (AUG 2020)

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

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

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

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

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

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

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

(NOV 2018)

C.11 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ..35

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

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

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

1998) E.2 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

E.3 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

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

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

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

SERVICES (NOV 2021)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

E.8 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021)

E.9 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.10 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.11 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE

RESOLUTION (OCT 2018)

E.12 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.13 VAAR 852.273-70 LATE OFFERS (NOV 2021)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR: POC Name: _____________________________ Address: _______________________________ City/State/Zip: ___________________________ POC Phone: ____________________________ POC Email: _____________________________

b. GOVERNMENT: Contracting Officer 36C257

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

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. This is accomplished through the Tungsten Network, located at:

http://www.fsc.va.gov/einvoice.asp. This is mandatory and the sole method for submitting invoices.

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

The South Texas Veterans Health Care System (STVHCS) has a need for a contract for two fully automated Erythrocyte Sedimentation Rate (ESR) analyzers that will include onsite service and maintenance, reagents, controls, calibrators, and supplies using the Cost Per Test (CPT) invoicing method. The fully automated ESR analyzer must be a walk-away device with continuous feed and random access. The analyzer must utilize a whole blood Ethylenediaminetetraacetic acid (EDTA) tube. The fully automated ESR analyzer shall directly measure the intensity of the red cell aggregation which is responsible for the ESR. The Fully Automated ESR analyzer shall express the values in mm/hr.

Place of Performance:

VA South Texas Health Care System Core Laboratory, Pathology and Laboratory Medicine Service’s 7400 Merton Minter Street San Antonio, TX 78229

1. General Requirement.

a. Cost-Per-Test: The offeror is required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (a) equipment use (offeror retains title), (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, test cards, and any other item required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of a test result, (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (d) training for Government personnel.

Contractors are required to provide delivery, installation and removal of equipment.

b. The equipment models being offered shall be in current production. Current production means 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.

c. Startup reagents. The contractor shall provide all reagents, calibrators controls, consumable/disposable items, parts, accessories required to establish analyzers for operation for performance of acceptance testing. This applies to all equipment as well as additional, or replacement equipment placed place under the term and conditions of this agreement. The contractor shall perform or assist to the satisfaction of the government all validation studies including precision, the method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval and determination of sensitivity and specificity at no cost to government. The control shall perform all statistical analysis discussed below.

d. The contractor(s) shall furnish all clinical laboratory supplies, materials, equipment, and services necessary for the performance of the work as described herein to the STVHCS facilities.

e. Assessment of test volumes and testing needs shall be done on a yearly basis to account for patient increases.

f. Estimated yearly quantities are based upon prior history of actual volumes and are intended to provide the potential contractor a basis for calculating their pricing. They are not a guaranteed minimum or maximum.

g. Contractors shall provide each participating facility with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, calibrators/standards, mailing system for mailing/transport, disposables, and any consumable part necessary for analyzing/testing. Contractor shall list the consumable parts provided. Contractor shall state any parameter/function that is pending FDA approval at the time of this contract submission.

h. Method performance and comparison shall be at the expense of the contractor shall include linearity material and reagents and be consistent with current Clinical and Laboratory Standards Institute (CLSI) guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. All studies performed will be appropriate for the test menu of the respective laboratory to include serum, plasma, urine, and body fluids, as applicable to all new testing analyzers.

i. 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. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of the lease mean, bias slope, y-intercept, correlation coefficient, Receiver Operating Characteristic (ROC) analysis, and meet current standards defined by CLSI.

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

k. Precision Study using normal and abnormal control material. This shall include at a minimum with urn precision study of 10 normal and 10 abnormal controls, Intra-VISN facility variation should be kept at an absolute minimum.

l. Sensitivity. Sensitivity may be validated concurrently with correlation studies.

Mathematical calculations to determine efficiency, sensitivity false positive and false negative rate.

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

n. Reference Range. A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. One of the following protocols shall be used:

1) A verification of the manufacturer’s suggested reference range may be performed if the suggested 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 range individuals shall be sued to verify the manufacturer range. Any apparent outlier should be discarded dan new specimens obtained to provide a statistically valid verification.

2) If the suggested manufacture range is not appropriate for the patient population a refence range shall be established. Establishing a refence must follow CLSI guidelines. This requires a minimum of 120 reference individuals to establish the reference range. The reference interval shall be determined using the nonparametric method.

2. Deliverables/Supplies.

a. Two (2) Automated ESR analyzers.

b. Services, maintenance and training for 2 ESR analyzers.

c. All required reagents, controls, calibrators standards, and supplies.

d. Two (2) Uninterruptible Power Supplies (UPS).

e. Laboratory Information System (LIS) interface support and installation compatible with the VA Veterans Health Information System Technology Architecture (VistA), Data Innovations and Cerner systems.

3. Estimated Quantities.

VA Facility Number of

Primary Analyzers

ESR Estimated Annual Volume

Frequency of Quality Control

Desired Service Option

Audie Murphy VA Hospital

2 4440 Test Every 24 hours and per analyzer specifications

Mon - Fri 7:30 am to 4:00 pm

4. Installation / Implementation / Transition Period

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

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

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

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

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

5. System Requirements:

a. The automated ESR analyzer shall be capable of producing accurate and reproducible results on whole blood EDTA specimens by established in vitro immunochemical diagnostic methods. Models shall provide accurate test assay results for sample specimens up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

b. Model must be capable of specifically detecting the early phase of Red Blood Cell (RBC) sedimentation-the rouleaux formation.

c. Contractor shall specify calibration frequency and time required to perform calibration.

d. Contractor to provide at least two levels of commercial quality controls to be analyzed to meet facility and regulatory agency requirements. Contractor to specify requirements for frequency of quality control testing.

e. Analyzer shall have the capability of providing printouts for all patient results, calibrators, and controls. Printer must have capability of printing the patient report with patient demographic information that includes minimally the patients name and accession or unique identifier (UID).

f. All consumable supplies (reagents, standards, controls, disposable, etc.…) required for the proper operation of the contractor’s equipment and that are necessary to perform tests on the equipment shall be included and furnished by the contractor for each ESR analyzer.

g. The contractor shall maintain at each facility a continuously stocked inventory of shipping supplies/containers, reagents, standards, controls, supplies, disposables, and any other material required to properly perform tests on the offered equipment. These items shall be of the highest quality ensuring sensitivity, specificity, and have been previously tested to assure their precision and accuracy. The quality of the products shall be within the acceptable proficiency testing standards of the CAP and Joint Commission (JC).

h. The system shall have a design that supports the result integrity/removes the possibility of sample carryover. Contractor shall provide documented evidence confirming the system design removes the possibility of any sample carryover.

i. The contractor shall state the on-board reagent stability.

j. The contractor shall list all reagents and quantities needed for ESR testing, state if the reagents are stored at room temperature or refrigerated and state the format/size of reagents.

k. The contractor is to define the actual hands-on maintenance time required for daily, weekly, monthly, quarterly, and as needed maintenance. The contractor is to include the analyzer/technologist time required to perform each maintenance task. The contractor shall list which tasks are user level and which tasks are service level.

l. The contractor shall supply equipment that shall perform satisfactorily at any laboratory relative humidity between 15 and 85 percent and any laboratory temperature between 50- and 90-degrees Fahrenheit (10 to 30 degrees Celsius).

6. Support Systems (service, preventative maintenance and shipping of supplies).

a. Contractor will provide technical support services at no additional charge to all

STVHCS facilities. Technical support by telephone shall be available 7 days a week, 24 hours a day. Technical support shall return all downtime calls within one hour.

Should on-site service be required, the contractor’s field service organization shall provide on-site service response within 24 hours after being contacted. All replacement analyzer/equipment must be received within 24 hours from the time the on-site service arrives. The repair person shall also, prior to departure, provide the visited site with written documentation of services performed.

b. 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 technologists may be unable to work with the hotline due to the facilities staffing.

c. Service is to include, at no charge, all labor, travel, and parts necessary to make repairs.

d. Requests for services will be through one contractor.

e. The contractor shall provide analyzer support service sufficient to aid with troubleshooting and repair of the analyzer. The contractor may list their service options available. Or the following service option may be available: 24 hours/day, 7 days/week basis for hospitals, and 5 days/week basis for clinics. The support service shall follow-up all down calls within 1 hour. The Field Service Representative (FSR) always shall keep the facility/clinic informed of the timeline for when repairs are to be completed. All repairs on analyzer shall be complete (at no cost to the facility/clinic) within 24 hours from the time the field service engineer arrives.

f. If the consumables are found to be defective and unsuitable for use with the contractor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to the requesting STVHCS facility site, in the most expeditious manner possible, without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they will be honored by the contractor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory will result in default.

g. Frequency of shipments. Contractor will provide initial inventory based on expected use, then establish a standing weekly/monthly/quarterly shipment based on current use, with the capacity to fill emergency requests on demand.

h. Contractor will pay all routine shipping fees for all supplies, consumables, and equipment to perform testing and will pay for shipping for volume adjustments should additional supplies be required.

i. The contractor must provide replacement parts at no charge and any components necessary for the operation of theanalyzer(s) to produce patient results.

j. Ancillary Support Equipment. The contractor shall provide, install at maintain through the life of the agreement, as indicated and all ancillary support equipment to fully operate the analyzer as defined int these specifications, e.g., cabinetry to support/house the analyzer, if necessary, water systems (including consumable polishers, filters, preventative maintenance, and repair, etc.), printers and universal interface equipment, etc. In addition, the contactor shall include all ancillary components that are customarily sold or provide with the model of equipment propose, e.g., starter kits, tables/stands, etc.

k. This contract should assist the STVHCS to pursue the goal of being a good steward in our community by eliminating, minimizing, or mitigating adverse environmental impacts.

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

Benzene Carbon tetrachloride Chloroform Dichloromethane Methyl ethyl ketone Toluene Methyl isobutyl ketone Xylenes Tetrachloro-ethylene Cadmium 1,1,1-Trichloro-ethane Chromium Trichloro-ethylene Cyanide Lead Mercury Nickel

7. Training and Procedures.

a. Contractor must provide all education/training on site during installations or update to the equipment. Training to include staff on all shifts. Training must include basic operation, quality control, interpretation, and reporting of results, required user performed maintenance, and troubleshooting. Contractor must provide a documented record of training (training checklist) completed for all trained staff before leaving site following installation at the site.

b. Provide initial in-depth training for two key operators at each site and annual training for one VA equipment operator, per participating VISN 17 Medical Center. Key operator training is to include all costs of off-site training, i.e., transportation (air and ground), room and board, etc. The contractor shall provide on-site refresher analyzer training in renewal option years of the contract if so exercised.

c. Contractor shall supply all necessary procedure manuals, troubleshooting manuals, operator manuals, and MSDSs (also available on CD format or on-line). Procedures must be in the Clinical and Laboratory Standards Institute (CLSI) format. Contractor must aid in creating preventive maintenance and quality control records or logs to meet the needs of the facility.

8. Data/Analyzer Management System and required hardware. The data and analyzer management system must incorporate the minimum requirements:

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

b. Patient status display for technologist review and workflow management for all integrated testing instrumentation.

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

d. Technology to automatically repeat testing based on customer configurable testing criteria.

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

f. Contractor must collaborate with lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity.

g. Contractor must assist customer with optimizing operation and utilization of the data management system to fully integrate desired testing instrumentation enhancing productivity and management of workflow.

h. Hardware must meet the following requirements:

1) Total equipment footprint, when installed in the laboratory must not impact the functionality/operations of laboratory.

2) All monitors/screens will clearly display information in all light conditions.

3) Printer(s) that have the ability of printing a patient report automatically with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID). Contractor is responsible for maintain and replacing Printers.

4) An uninterruptible power supply (UPS) with line conditioner for each analyzer provided. This includes UPS units for sites with automation lines, specimen management systems, data management systems, and refrigerated storage. Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the analyzer and data records. Contractor is responsible for maintaining and replacing UPS systems provided.

i. The Contractor is responsible for providing all hardware, software and ancillaries required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an analyzer is added to an existing universal interface system.

j. The Contractor must 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 analyzer system involved and dictated by the manufacturer itself. If a site already has a universal interface system, the Contractor is responsible for everything leading up to the connection to the software system, including any incremental fee required to add additional equipment (e.g., licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

k. If a site does not have a universal interface and one is needed to optimally interface the analyzer, 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. If there are any software upgrades in the analyzer 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 and any hardware/software replacements needed to accomplish this task.

9. Interfacing requirements.

a. The contractor shall provide A bi-directional, bar-coded computer interface with ability to read standard barcode format such as Code 128 and Code 39. The fully operational interface (both hardware and software) must be immediately available for implementation to the VA Veterans Health Information System Technology Architecture (VistA) hospital information system at the time of contract award. If the host system software requires the use of non-proprietary universal interfacing system to provide bi-directional interfacing capabilities using Data Innovations systems. To achieve connection with those systems, the awarded contractor will be responsible for the cost of the interface including hardware and software. Refer to the following section entitled “Support Features – Computer Interfacing Requirements” for specific details.

b. Summary of VistA Functionality. VistA is a public domain system with functionality that includes:

• Management of patient information through a database,

• Acceptance of test ordering information,

• Transmittal of patient laboratory test results.

• Storage and retrieval of patient laboratory test results.

• VistA is very limited in its functionality to manage laboratory quality control, provide Levy-Jennings plots or administer an analyzer maintenance program.

10. Middleware System.

a. Interface must be compatible with Data Innovations and Cerner.

b. Instrument connection to middleware service must be provided.

c. Contractor must provide onsite and remote support as needed for installation and duration of the contract.

11. 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 they are being provided to commercial customers. This requirement “system upgrades” that enhance the model of equipment offered, i.e., new version of software, correction of hardware defect, upgrade offered to commercial customer 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 agreement; however, it does refer to significant changes in the hardware operational capability.

12. Inherently Governmental Functions. The contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

13. Contractor Security Contract Requirements. This contract is for test kits, supplies, and the leasing of equipment, service and maintenance and all ancillary supplies needed for the equipment or printers. The Contractor does not require access to any VA Information System or any routine access to any STVHCS laboratory.

14. Information Systems Officer, Information Protection. The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

15. Privacy Officer. The contractor will have access to protected Patient Health Information

(PHI) but will not have the capability of accessing patient information during the services provided to the VA. Contractor is required to be in compliance with the American Association of Blood Banks (AABB) and College of American Pathologists (CAP) accreditation policies and all applicable Federal, State and Government laws.

16. Records Manager. STX-HCR671-04 General Information Security Requirements.

a. All information and records provided to Contractor by VA, in whatever medium, as well as all information and documents, including drafts, emails, back-up copies, hand-written notes and copies that contain such information and records gathered or created by Contractor (collectively referred to as “VA information”) in the performance of this contract, regardless of storage media, are the exclusive property of VA. Contractor does not retain any property interest in these materials and will not use them for any purpose other than performance of this contract.

b. Upon completion or termination of the contract, Contractor will either provide all copies of all VA information to VA or certify that it has destroyed all copies of all VA information as required by VA in a method specified by VA, at VA’s option. Medical records of any kind including notes shall be returned to the VA. The Contractor will not retain any copies of VA information. Where immediate return or destruction of the information is not practicable, Contractor will return or destroy the information within 30 days of completion or termination of the contract. All provisions of this contract concerning the security and protection of VA information that is the subject of this contract will continue to apply to VA information for as long as the Contractor retains it, regardless of whether the contract has been completed or terminated.

c. Prior to termination or completion of this contract, Contractor will not destroy VA information received from VA or gathered or created by Contractor in the course of performing this contract without prior written approval by VA.

d. Contractor will receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in accordance with the terms of this contract and applicable federal and VA information confidentiality and security laws, regulations, and policies.

e. The Contractor shall not make copies of VA information except as necessary to perform this agreement or to preserve electronic information stored on Contractor electronic storage media for restoration in case any electronic equipment or data used by the Contractor needs to be restored to an operating state.

f. Contractor shall provide access to VA information only to employees, subcontractors, and affiliates only: (1) to the extent necessary to perform the services specified in this Contract, (2) to perform necessary maintenance functions for electronic storage or transmission media necessary for performance of this contract, and (3) only to individuals who first satisfy the same conditions, requirements and restrictions that comparable VA employees must meet in order to have access to the same VA information. These restrictions include the same level of background investigations, where applicable.

g. Contractor will store, transport, or transmit VA information only in an encrypted form, using an encryption application that meets the requirements of FIPS 140-2, and is approved for use by VA.

h. 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 other situations: (i) in response to an order of a court of competent jurisdiction, or (ii) with VA’s prior written authorization. The contractor will refer all requests for, demands for production of, or inquiries about, VA information to VA for response.

i. If VA information subject to the contract includes information protected by 38 USC 7332, or 5705, include the following after the last sentence of the paragraph immediately above: Contractor shall not release information protected by either 38 USC 5705 or 7332 in response to a court order, and shall immediately refer such court orders to VA for response.

j. Prior to any disclosure pursuant to a court order, the Contractor shall promptly notify VA of the court order upon its receipt by the Contractor, provide VA with a copy by fax or email, whichever is faster, and notify by telephone the VA individual designated in advance to receive such notices. If the Contractor cannot notify VA before being compelled to produce the information under court order, the Contractor will notify VA of the disclosure as soon as practical and provide a copy of the court order, including a copy of the court order, a description of the records provided pursuant to the court order, and to whom the Contractor provided the records under the court order. The notice will include the following information to the extent that the Contractor knows it, if it does not show on the face of the court order: the records disclosed pursuant to the order, to whom, where, when, and for what purpose, and any other information that the Contractor reasonably believes is relevant to the disclosure. If VA determines that it is appropriate to seek retrieval of information released pursuant to a court order before Contractor notified VA of the court order, Contractor will assist VA in attempting to retrieve the VA information involved.

k. The Contractor will inform VA by the most expeditious method available to Contractor of any incident of suspected or actual access to, or disclosure, disposition, alteration, or destruction of, VA information not authorized under this Contract (“incident”) within one hour of learning of the incident. An incident includes the transmission, storage, or access of VA information by Contractor or subcontractor employees in violation of applicable VA confidentiality and security requirements. To the extent known by the Contractor, the Contractor’s notice to VA will identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information was placed at risk or compromised), and any other information that the contractor considers relevant.

l. Contractor will simultaneously report the incident to the appropriate law enforcement entity of jurisdiction. The Contractor, its employees, and its subcontractors and their employees will cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The Contractor also will cooperate with VA in any civil litigation to recover VA information, to obtain monetary or other compensation from a third party for damages arising from any incident, or to obtain injunctive relief against any third party arising from, or related to, the incident.

m. VA will provide the Contractor with the name, title, telephone number, fax number and email address of the VA official to whom the Contractor will provide all notices required by this Contract.

n. VA has the right during normal business hours to inspect the Contractor’s facility, information technology systems and storage and transmission equipment, and software utilized to perform the contract to ensure that the Contractor is providing for the security of VA data and computer systems in accordance with the terms of this Contract.

o. Contractor will receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with all applicable Federal Information Processing Standards (FIPS) and Special Publications (SPs) issued by the National Institute of Standards and Technology (NIST) concerning VA information that is the subject of this contract. If NIST issues or updates an applicable FIPS or SP after execution of this contract, the parties agree to negotiate in good faith to implement the FIPS or SP in this contract.

p. A determination by VA that the Contractor has violated any of the information confidentiality and security provisions of this contract, including a violation of any applicable FIPS or SP, shall be a basis for VA to terminate the contract for cause.

q. If anyone performing this contract, including employees of subcontractors, accesses VA computer systems or data in the performance of the contract, VA may monitor and record all such access activity. If VA monitoring reveals any information of suspected or potential criminal law violations, VA will refer the matter to the appropriate law enforcement authorities for investigation.

r. Contractor shall inform its employees and other individuals performing any part of this contract that VA may monitor their actions in accessing or attempting to access VA computer systems and the possible consequences to them for improper access, whether successful or not. The Contractor shall ensure that any subcontractors or others acting on behalf of, or for, the Contractor in performing any part of this contract inform their employees, associates or others acting on their behalf that VA may monitor their access activities. Execution of this contract and any subcontract or agreement constitutes consent to VA monitoring.

s. The Contractor will ensure that all individuals who will access VA data or systems in performing the contract are appropriately trained in the applicable VA confidentiality and security requirements. Contractor may do this by requiring and documenting that these individuals have completed the VA training for its employees.

t. To the extent practicable, Contractor shall mitigate any harmful effect on individuals whose VA information was accessed or disclosed in an incident.

u. Contractor shall require subcontractors, agents, affiliates, or others to whom Contractor provides access to VA information for the performance of this contract to agree to the same VA information confidentiality and security restrictions and conditions that apply to the Contractor before providing access.

v. The contractor shall abide by FAR clauses 52.224-1 and 52.224.2.

w. The contractor shall abide by FAR clauses 52.239-1 and 52.224.1-2 for Privacy or Security Safeguards

x. In the performance of any part of the work on this contract, the contractor shall utilize only employees, subcontractors or agents who are physically located within a jurisdiction subject to the laws of the United States. Contractor will ensure that it does not use or disclose Patient Health Information (PHI) received from Covered Entity in any way that will remove the PHI from such jurisdiction. Contractor will ensure that its employees, subcontractors, and agents do not use or disclose PHI received from Covered Entity in any way that will remove the PHI from such jurisdiction.

17. Access to VA Information and VA Information Systems. VA Handbook 6500.6 Appendix C Paragraph 2.

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information.

The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts.

The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

18. Security Incident Investigation. VA Handbook 6500.6 Appendix C Paragraph 6.

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

19. Training. VA Handbook 6500.6 Appendix C Paragraph 9.

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems.

2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training.

3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each…