36C24818Q0571-001.pdf

RFQ #: 36C24818Q0571

PROJECT TITLE: Cost Per Test (CPT) AUTOMATED ERYTHROCYTE SEDIMENTATION RATE (ESR)

ANALYZER FOR ORLANDO VA HEALTHCARE SYSTEM

This is a combined synopsis/solicitation for commercial services/items prepared in accordance with the format in FAR Subpart 12.6 in conjunction with FAR Part 13, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a separate written solicitation will not be issued. This combined synopsis/solicitation is issued as a Request for Quote (RFQ) 36C24818Q0571.

TIERED EVALUATIONS INCLUDING SMALL BUSINESS CONCERNS

This solicitation is being issued as a tiered evaluation for SDVOSB concerns, or in the alternative, as a tiered evaluation for VOSB concerns, or in the alternative, a set-aside for other small business concerns with HUBZone small business concerns and 8(a) participants having priority. If an award cannot be made, the solicitation will be cancelled and the requirement resolicited.

Submit written quotes in accordance with Addendum to FAR 52.212-1, Instruction to Offerors outlined in pages 39-41 of this solicitation. Oral quotes will not be accepted. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition

Circular (FAC) 2005- 97 / 01-24-2018. North American Industrial Classification Standard (NAICS)

334516, Analytical Laboratory Instrument Manufacturing, with a Size Standard of 1,000 employees, apply to this procurement.

Orlando VA Healthcare System intends to award a base period with (4) option years fixed price contract for Cost Per Test (CPT) Automated Erythrocyte Sedimentation Rate (ESR) Analyzer.

This procurement is being conducted under FAR Part 13 – Simplified Acquisition Procedures.

This procurement is a SDVOSB set-aside with Tiered Evaluation procedures. All eligible Small

Businesses are encouraged to submit quotes. To be eligible for award as an SDVOSB or VOSB quoter, the concern must be Verified in the Vendor Information Pages (VIP)

(https://www.vip.vetbiz.gov) at the time of award. All concerns must be registered with the System for Award Management (SAM) (https://www.sam.gov) at the time of award.

1. Quote shall be valid for 60 days from the close of this RFQ.

2. Please see RFQ for detailed description of requirements.

3. All questions or comments must be provided to the Contract Specialist in writing via email no later than June 11, 2018 at 1:00 PM ET. Answers will be posted no later than June 13, 2018 at 4:30 PM ET. Telephone and other means of oral communication is not permitted.

4. Quotes are due on June 20, 2018 at 1:00 PM ET. Quotes will only be accepted by email to:

Contract Specialists Duwane Snyder, duwane.snyder@va.gov or Contracting Officer Pedro

Catinchi at Pedro.CatinchiJaime@va.gov https://www.vip.vetbiz.gov/ https://www.sam.gov/ mailto:duwane.snyder@va.gov mailto:Pedro.CatinchiJaime@va.gov

RFQ #: 36C24818Q0571

PROJECT TITLE: Cost Per Test (CPT) AUTOMATED ERYTHROCYTE SEDIMENTATION RATE (ESR)

ANALYZER FOR ORLANDO VA HEALTHCARE SYSTEM

Table of Contents

SECTION B - CONTINUATION OF COMBINED SYNOPSIS/SOLICITATION

B.1 CONTRACT ADMINISTRATION DATA

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN

2011)

B.3 STATEMENT OF WORK

B.4 PRICE/COST SCHEDULE

ITEM INFORMATION

B.5 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—

COMMERCIAL ITEMS

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

C.3 52.216-18 ORDERING (OCT 1995)

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 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.8 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984) ... 25

C.9 VAAR 852.246-70 GUARANTEE (JAN 2008)

C.10 VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED

SMALL BUSINESS SET-ASIDE (JUL 2016) (DEVIATION)

C.11 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2012)

C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2018)

C.13 GRAY MARKET LANGUAGE

C.14 TOTAL VETERAN-OWNED SMALL BUSINESS SET-ASIDE CLAUSE

C.15 TOTAL SMALL BUSINESS SET-ASIDE CLAUSES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

ITEMS

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

E.3 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.4 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED BY

REFERENCE (JAN 2008)

E.5 TOTAL SMALL BUSINESS SET-ASIDE PROVISION

Addendum “A” – Characteristics

36C24818Q0571

SECTION B - CONTINUATION OF COMBINED

SYNOPSIS/SOLICITATION

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C248 NCO - 8, Orlando

Department of Veterans Affairs

Orlando VA Medical Center

13800 Veterans Way

Orlando FL 32827

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 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.

Tungsten Network https://www.tungsten-network.com

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the

Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND

COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.219-10 VA Notice of Total Service- Disabled Veteran-Owned Small

Business Set-Aside. If needed and in accordance with the Tiered Evaluation Procedures herein, VAAR

852.219-11 VA Notice of Total Veteran-Owned Small Business Set-Aside and FAR 52.219-6 Notice of

Total Small Business Set-Aside have been included. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-

Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

B.3 STATEMENT OF WORK

Automated Erythrocyte Sedimentation Rate (ESR) Analyzer

1. LANGUAGE:

1.1. INTENT: It is the intent of the Orlando VA Healthcare System (OVAHS) to establish a Cost Per

Test Agreement (CPT) for Automated Erythrocyte Sedimentation Rate (ESR) Instrumentation.

The Government will award a Cost per Test (CPT) contract to a single Contractor for Automated

Erythrocyte Sedimentation Rate (ESR) Instrumentation. Contractor agrees to the following terms of the contract exclusively with Orlando VA Healthcare System. Additional tests/reagents/instrumentation may be added to the contract as new technology becomes available and on the commercial market.

1.2. ORDERS: The Government is obligated only to the extent of authorized orders issued under this contract by authorized individuals.

1.3. PRICES AND TERMS: Orlando VAMC will provide an estimated volume by test as reflected in Attachment A for each individual facility. Pricing is based on the AVERAGE daily test volume per instrument/analyzer for each facility. The Government estimates the volumes per facility as listed in Attachment A, but does not guarantee volumes as listed; they are estimates ONLY. Pricing shall be the same for each facility. The agreement shall include all new facilities and/or outpatient clinics acquired into Orlando VA Healthcare System during the contract period. When additions occur, a bi-lateral contract modification will be executed.

1.4. TERM OF AGREEMENT: The government intends a single award, firm-fixed price with one base period and four, one-year options. This agreement is not a contract.

1.5. ORDERING METHOD: A Reagent/supply standing order will be set up by the contractor with

Orlando VA Healthcare System approval. Orlando VA Healthcare System may also order products via telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2.1. SCOPE OF PROCUREMENT:

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

Clinical and Laboratory Standards Institute (CLSI).

2.1.2. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. Equipment must maintain or, preferably, reduce the number of work stations or overall labor required to accomplish the required testing by each laboratory. The equipment must streamline all aspects of testing, thereby enhancing operational efficiency, improving turnaround times, supporting improved patient outcomes, improving patient and provider satisfaction, and improving the productivity of the facility.

2.1.3. Equipment shall be acquired for each of the clinical laboratories located at the Orlando VA

Healthcare System facilities listed in Attachment B. The Contractor needs to be aware that since this is a fixed price estimated order with one base year and four one-year options, there is the possibility that a laboratory may require equipment installation and possible reinstallation due to demolition, new construction, laboratory redesign and/or relocation. The contractor will provide this relocation/reinstallation service.

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

Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts, should be forwarded to the designated individuals determined at contract award.

2.1.5. Special handling for emergency orders of supplies: If supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government 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 shall be honored by the

Contractor until the arrival at the laboratory of the regularly scheduled standing order/routine supplies delivery.

2.2. DEFINITIONS:

2.2.1. Cost per Patient Reportable Result (CPRR) is defined as Cost-Per-Test Clinical

Laboratory Analyzers - The per patient reportable result price shall include costs covering:

(1) Base year, and up to (4) option years equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel.

Contractors shall provide delivery, installation and removal of equipment at no additional charge.

2.2.2. Cost per Test (CPT) is defined as Cost- Per-Test Clinical Laboratory Analyzers –

Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) Base Year and up to (4) option years equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories 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, (3) all necessary maintenance to keep the equipment in good operating condition

(This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge

2.2.3. Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require

VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses

VHA PHI to perform some activity for VHA. These BAAs obligate the VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

2.3. Test Menu – Refer to Attachment A for each facility’s estimated annual test volumes.

2.4. Facility or Facilities - Will refer to the primary Orlando VAMC and affiliated Outpatient Clinics

(OPC).

2.5. GENERAL REQUIREMENTS

2.5.1. Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations

(minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer may serve as a back-up analyzer and shall replace the requirement for offering that category of equipment.

2.5.2. Contractor shall provide quality control material at a minimum of two levels, normal and abnormal levels, for each analyzer or per the requirements of each facility.

2.5.3. Operational and Technical Features- The instrumentation offered shall be approved by the

Food and Drug Administration (FDA) and have the following:

A. Testing Instrumentation -

1. The capability and throughput to meet the volume and service demands as defined in Attachment A.

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

3. Equipment must be able to support multiple barcode formats (Code 39, Code

128) that may be enabled concurrently.

4. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric that may be enabled concurrently.

5. A barcode reading accuracy rate of 99% or greater.

6. Analyzer must function using an operating system that is approved to connect to the VA computer systems.

7. Vendor must complete the following documentation: 6550 Pre-Procurement

Assessment and MDS2

8. ACL Communication Profile

9. QC data management system and includes Levy-Jennings graphs. Analyzer must have the ability to capture & store QC data.

10. Capability to detect and alert operator of out of range quality control results via flagged results on QC printout and visual alerts on display monitor.

11. Ability to participate in peer data management system for quality control results.

12. On board reagent inventory management, must have:

a) A system that provides reagent data to include but not limited to lot number and expiration date of reagents and quality control.

b) Barcoding of reagents.

c) On board reagent stability, sufficient to accommodate both high and low volume use.

13. Primary tube sampling from evacuated whole blood EDTA collection tubes from various manufacturers.

14. The ability to continuously load patient specimens.

15. The ability to detect short samples.

16. The ability to perform testing on samples with 0.5 ml of whole blood.

17. The ability to perform mixing of samples on board the analyzer.

18. The ability to measure directly the intensity of the red cell aggregation.

2.5.4. Hardware Features – The instrument shall have the following:

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

2.5.4.2. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID)

2.5.4.3. Serial RS232 DB9 port for LIS connection.

2.5.5. Method Performance/Validation Requirements

2.5.5.1 Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current 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. These validation requirements are applicable to all new testing analyzers.

2.5.5.2 Correlation studies for each analyte. A minimum of 20 samples spanning the reportable range, shall be run comparing the present and the proposed method.

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

2.5.5.3 If applicable, Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) 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 for the clinical specimens assayed by that method. A 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum.

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

Intra-VISN facility variations should be kept at an absolute minimum.

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

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

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

2.5.6. 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:

2.5.6.1 A verification of the manufacturer’s suggested reference range may be performed if the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used to verify the manufacturer’s range. Any apparent outliers should be discarded and new specimens obtained to provide a statistically valid verification.

2.5.6.2 If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval shall be determined using the nonparametric method.

2.5.7. Support Features

2.5.7.1 Commercial marketing. The equipment models being offered shall be in current production. Current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

2.5.7.2 Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories required to establish instruments for operation for performance of acceptance testing. This applies to all equipment as well as additional or replacement equipment placed under the terms and conditions of this agreement. The Contractor shall perform/assist, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The

Contractor shall perform all statistical analysis as stated in the Method

Performance/Validation section above and provide a hard-copy of data in an organized, clearly comprehensible format.

2.5.7.3 Training. The Contractor shall provide an instrument training program that is coordinated and timely to the equipment installation, sufficient to the size and scope of the facility’s services. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the

Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed.

Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

2.5.7.4 In addition to the training above the following shall be provided:

A. Basic operator training shall be provided by Contractor on-site for all operators on all shifts, as applicable.

B. Advanced training shall be provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization.

2.5.7.5 Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support/ancillary equipment, e.g. printers, etc. offered in accord with the following terms:

A. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

B. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of

2 hour(s).

C. Equipment repair service shall be provided during core business hours. See Attachment A, defining core business hours of each facility included in this solicitation. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours.

All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

D. Equipment repair response time shall be no more than 24 hours.

E. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

1. date and time notified

2. date and time of arrival

3. serial number, type and model number of equipment

4. time spent for repair

5. proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

F. Each notification for an emergency repair service call shall be treated as a separate and new service call.

G. If the Contractor chose to send a replacement equipment in lieu of repairs, the replacement equipment must be the same model and manufacturer. Replacement must be received within 24 hours after the service call.

2.5.7.6. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer

Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the agreement; however, it does refer to significant changes in the hardware operational capability.

2.5.7.7. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the agreement, as indicated, and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, preventative maintenance and repair, etc.), printers and universal interface equipment, etc.

In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

2.5.7.8. Interface Requirements - The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see Attachment A).

A. The Contractor shall provide all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A.

B. 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.

C. 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 VA computerized hospital information system.

2.5.7.9. Commercial Offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software.

2.5.7.10 Characterization of waste – The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal

Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data

Sheets (SDS) meeting the requirements of the Occupational Safety and Health

Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal

Regulations Title 40 to determine if the waste is a hazardous waste or otherwise regulated.

The determination and description shall address the following:

A. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

B. Waste ignitability (Reference 40 CFR §261.21)

C. Waste corrosivity (Reference 40 CFR §261.22)

D. Waste reactivity (Reference 40 CFR §261.23)

E. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)

F. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed)

Reference 40 CFR §261.33)

G. Solid Waste (Reference 40 CFR §261.2)

H. Exclusions (Reference 40 CFR §261.4)

I. The contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill

Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

J. Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local

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

• Barium (Total)

• Cadmium (Total)

• Chromium (Total)

• Copper (Total)

• Cyanide (Total)

• Lead (Total)

• Mercury (Total)

• Nickel (Total)

• Silver (Total)

• Zinc (Total)

• Arsenic (Total)

• Selenium (Total)

• Tin (Total)

• pH

• Flash point (to higher than 200°F)

• BOD; biochemical oxygen demand

K. The documentation the contractor provides will be used to work with the

OVAHS and the public and/or private organization (e.g., POTW) to determine whether the waste from each device can legally be disposed of via the sewerage system.

2.5.7.11. Implementation/transition timeframe - The implementation of the service and requirements described in this solicitation shall be completed no later than 90 days after the award of the agreement. This timeline is based on a reasonable attempt of the

Contractor to complete all necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 90-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

A. Upon award of an agreement the transition period for the awarded agreement to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period all initial training of

VA personnel in the operation and maintenance of said award shall also be completed.

B. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed days for the transition of all services under the awarded agreement 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 agreement for cause under the

Termination for Cause clause of the agreement.

C. At the end of days from award of the agreement, the awarded Contractor shall have full and sole responsibility for services under the awarded agreement.

2.5.8. Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the contract [or agreement] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any proposal at an effectiveness level of 90% or more.

2.5.8.1 If the equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

2.5.8.2 If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled

“Termination for cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

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

Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

2.5.8.4 During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of

100 hours.

2.5.8.5 The Government will maintain daily records to satisfy the requirements of the

Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

2.5.8.6 During the term of the agreement laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR and/or contracting officer to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the

Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. The same terms and conditions apply to ancillary/support equipment provided under this agreement, i.e., water system

UPS, etc.

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

2.5.10 Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The

Contractor shall disconnect the analyzer and shall be responsible for all packing and shipping required to remove the analyzer.

2.5.10.1 The Contractor will identify if removable media is required to perform their duties.

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

2.5.10.2 Prior to termination or completion of this agreement, Contractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this agreement without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with

National Archives and Records Administration (NARA) requirements as outlined in VA

Directive 6300, Records and Information Management and its Handbook 6300.1 Records

Management Procedures, applicable VA Records Control Schedules, and VA Handbook

6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the agreement.

2.5.10.3 All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the agreement or (ii) disposal or return of the IT equipment by the

Contractor or any person acting on behalf of the Contractor, whichever is earlier. Media

(hard drives, optical disks, CDs, back-up tapes, etc.) used by the

Contractors/subcontractors that contain VA information must be retained by the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the agreement or disposal or return of the IT equipment, whichever is earlier.

2.5.10.4 Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the

Contractor at the end of lease, for trade-in, or other purposes. The options are:

• Contractor must accept the system without the drive;

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

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

2.5.11 Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

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

2.5.11.2 Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or agreement.

A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information

Security Officer (ISO) needs to maintain the documentation.

2.5.12 Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor.

3.0 ATTACHMENT A

VA Facility

No. of

Primary

Analyzer

ESR

Estimated Annual

Volume

Frequency of Quality

Control

Desired

Service

Option

Orlando VAMC 2 6,000

At least 2 levels every

24 hours

24/7

Daytona Beach

VAOPC

1 2,000

2 levels every 24 hours

M-F

8am-5pm

Viera VAOPC 1 2,000

2 levels every 24 hours

M-F

8am-5pm

Total Annual

Volume

4 10,000

4.0 ATTACHMENT B

B.4 PRICE/COST SCHEDULE

ITEM INFORMATION

Minimum and Maximum Contract Amounts:

During the contract period of performance, the minimum contract value is $3,000.00. The cumulative amount of all delivery orders shall not exceed $500,000.00 for the entire life of the contract.

The first Delivery order will be issued against the contract at the time of award with a delivery order value that meets or exceeds the contract minimum. While the government anticipates at least one delivery order will be issued against this IDIQ contract each contract year, it has no obligation to issue delivery orders to the contractor beyond the minimum amount specified above.

Delivery Location Business Hours

Laboratory

Hours of

Operation

13800 Veterans Way, Orlando FL

32827 0730-1600 M - F 24/7

551 National Health Care Drive, Daytona Beach FL 32114 0730-1600 M - F

0700 -1630 M -

F

2900 Veterans Way, Viera FL

32940 0730-1600 M - F

0700 -1630 M -

F

Estimated POP Base Period 07/01/2018 – 09/30/2018

Item No. Description of Supplies Est.

Quantity

Unit Unit Price Amount

Automated Erythrocyte

Sedimentation Rate (ESR)

Instrumentation. (VA Orlando

Medical Center)

EA

Included

Sedimentation Rate (ESR)

Instrumentation. (VA Daytona

Outpatient Clinic)

Sedimentation Rate (ESR)

Instrumentation. (VA Viera

Cost Per Test (CPT) in accordance with the Statement of Work

MO

Reagents (list quantity and unit of issue based on CPT volume)

Quality Controls (list quantity and unit of issue based on CPT volume)

Other Consumable (list quantity and unit of issue based on CPT

Installation and Training

JB

Grand Total

Estimated POP Option Year I 10/01/2018 – 09/30/2019

Item No. Description of Supplies Est.

Sedimentation Rate (ESR)

Sedimentation Rate (ESR)

Sedimentation Rate (ESR)

Estimated POP Option Year II 10/01/2019 – 09/30/2020

Item No. Description of Supplies Est.

Sedimentation Rate (ESR)

Sedimentation Rate (ESR)

Sedimentation Rate (ESR)

Estimated POP Option Year III 10/01/2020 – 09/30/2021

Item No. Description of Supplies Est.

Sedimentation Rate (ESR)

Sedimentation Rate (ESR)

Sedimentation Rate (ESR)

Estimated POP Option Year IV 10/01/2021 – 09/30/2022

Item No. Description of Supplies Est.

Sedimentation Rate (ESR)

Sedimentation Rate (ESR)

Sedimentation Rate (ESR)

B.5 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY

DELIVERY

DATE

0001 SHIP TO: Orlando VA Healthcare System

Building 5 Warehouse

13800 Veterans Way

Orlando, FL 32827

2.00 15 Days ARO

MARK

FOR:

Esther Murphy

407-631-2622

Esther.Murphy@va.gov

0002 SHIP TO: Same as Above

1.00 15 Days ARO

FOR:

Same as Above

0003 SHIP TO: Same as Above

1.00 15 Days ARO

FOR:

0004 SHIP TO: Same as Above

833 15 Days ARO

FOR:

0005 SHIP TO: Same as Above

15 Days ARO

FOR:

0006 SHIP TO: Same as Above

FOR:

0007 SHIP TO: Same as Above

FOR:

0008 SHIP TO: Same as Above

1 15 Days ARO

FOR:

SECTION C - CONTRACT CLAUSES

C.1 ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—

COMMERCIAL ITEMS

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

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

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these addresses:

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

(End of Clause)

FAR

Number

Title Date

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

JUL 2016

52.204-19 INCORPORATION BY REFERENCE OF REPRESENTATIONS

AND CERTIFICATIONS

DEC 2014

52.211-17 DELIVERY OF EXCESS QUANTITIES SEP 1989

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

ITEMS

JAN 2017

52.232-1 PAYMENTS APR 1984

52.232-8 DISCOUNTS FOR PROMPT PAYMENT FEB 2002

52.232-39 UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS JUN 2013

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

DEC 2013

52.247-34 F.O.B. DESTINATION NOV 1991

852.203-70

852.246-71

COMMERCIAL ADVERTISING

INSPECTION

JAN 2008

JAN 2008

C.3 52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from 07/01/2018 through 09/30/2022.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

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

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $100.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $3,750.00;

(2) Any order for a combination of items in excess of $40,000.00; or

(3) A series of orders from the same ordering office within 3 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the

Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph

(b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 3 days after issuance, with written notice stating the Contractor's intent not to ship the item

(or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

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

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule.