36C24818Q9572-004.pdf

Statement of Work

I. Introduction

The Contractor shall provide Fecal Occult Tests, for NF/SG VHS system, including: VA hospitals in

Gainesville and Lake City; VA Outpatient Clinics in Jacksonville, The Villages and in Tallahassee, Florida, performing tests according to the test menu provided. The vendor(s) selected is responsible for equipment and service components.

II. Period of Performance

The anticipated contract period of performance will be 1 October 2018 through 30 September 2019 with four (4) one (1) year options. The contractor shall be required to begin providing supplies as required on effective date of contract award.

III. Specifications

The award for Cost per Test will be based from this Request for Quote (RFQ). The offeror shall provide to NF/SG VHS laboratories, all supplies and services as described herein. CPT shall also include service of all equipment for the life of the agreement as identified below.

Cost per Test: CPT is an all-inclusive price. The contractor is required to furnish all reagents and supplies necessary to operate the contractor’s equipment for the required tests, including calibrators, control tests, disposables, and any instrument part required for operating all analyzers and equipment.

I. Requirements

Support Services: Vendor shall provide telephone assistance 24-hours/day, 7 days/week 365 days per year. Following determination that service is required, technical on – site support must be provided and vendor must provide for emergency repairs seven days per week within twenty-four (24) hours of the time of notification of the malfunction.

The contractor shall provide maintenance (labor and parts) to keep the equipment in good operating condition and subject to security regulations. The government will provide the contractor access to the equipment to perform maintenance service.

Testing Menu: Vendor shall provide the test menu listed herein. Annual test volumes provided with this contract are based upon prior history and are not a guaranteed minimum. If at any time during the contract period, tests are not available on this list, the vendor shall reimburse NF/SG VHS any additional costs associated with the procurement of another source of test performance.

Basic Requirements: The system must contain random access technologies that improve workflow.

Microbiology Analytical Systems for DVA, NF/SG VHS:

Expected throughput: Ability to manage testing workflow of high volume laboratory with approximately 12,000 tests/year where at least 90% of the testing is performed during the day shift (6:30am-4pm) Sunday through

Saturday.

Instrument integration plan: DVA, NF/SG VHS facilities on similar platforms; utilizing same supplies.

Specimen integrity evaluation on all supplies as needed at no additional cost.

Quality controls are performed upon arrival of new supplies and weekly due to patient specimen testing.

Automation System – Pre/ Post Analytic and Line Processing- DVA, NF/SG VHS Processing — receives specimen and record time, accession specimens, attach barcode labels to specimen.

The information system component of this laboratory automation system (LAS) must be able to communicate with

Lab information system for ordering information to be sent from Lab information system to the System manager and shall include but not be limited to: order code or name, order priority, type of specimen, accession number, container id, collect date and time, and receipt date and time. Patient Identification- the barcode of the patient specimen must be validated multiple times throughout the automation system to assure positive patient identification at all times.

Optimized automated delivery of specimens to Microbiology analyzers for parallel processing to provide best turnaround times and meet specimen handling requirements.

Automated tracking of specimen location and testing status of a specimen.

Capping and recapping system in an enclosed environment to prevent distribution of bio-hazardous aerosols.

Reagents and Supplies:

Inventory Management: The Contractor is required to provide a continuously stocked inventory of reagents, required consumable supplies including all routinely replaced parts, disposables and any other materials required to properly perform tests on the equipment. Unexpected changes in methodology/technology shall be at the expense of the vendor. Alert/Notification of all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to lab chiefs or designee. Separate deliveries of products shall be shipped to each site (DVA, NF/SG VHS facilities).

Failure to reserve adequate inventory will result in default.

Items Included: The vendor shall provide/install any routine and special items required to operate / maintain the equipment/analyzer in optimal condition such as but not limited to: linearity standards, consumable equipment parts, required replacement parts for maintenance or service etc.

Special Handling for Emergency Orders of Supplies: If additional requests for emergency supply delivery are required by the government, the contractor shall honor them until the arrival at the government site of the monthly standing order or routine supply delivery. 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 routing supply delivery or inventory management, the contractor is required to deliver the consumable supplies within 24 hours of receipt of a verbal order for priority delivery from the government activity. 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).

Quality of Reagents, Supplies and Disposables:

The contractor shall assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality product. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations (JCAHO). If the supplies are found to be defective and unsuitable for use with the contractor's equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order, if verbal order is received by 1 pm EST time, for priority delivery from the government activity. This shall be done at no cost to the government, in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal government test load volume). The vendor shall reimburse each facility for any costs/supplies related to tests performed by another vendor or sent to a referral laboratory when reagents were not available due to product issues or instrumentation failure.

Returned Goods: The VA is responsible for inspecting all products shipped hereunder and give the contractor written notice of rejection within thirty (30) calendar days following receipt or installation by the contractor.

After acceptance, no products purchased hereunder may be returned without the prior authorization of the contractor and in conformity with their return policy. All returns of non-defective products are subject to a restocking charge. No returns will be authorized after 120 days following shipment to VA

Shipping Charges: For reagents with hazardous constituents, vendor must provide a mechanism for the

Laboratory to meet local discharge requirements. No delivery charges for shipping or fee handling.

Additional System Requirements:

Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed/annually with communication to the vendor for modification of the contract. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with another analyzer(s) that can produce the required criteria of this contract satisfactorily to the user. Removal of instrument by the vendor shall be performed within 60 days after request.

Comprehensive on-board QC Program, including Troubleshooting or System Validation QC material. The system must have quality control data storage and reporting capabilities, the ability to view and print daily and monthly QC results, troubleshoot unsatisfactory results and system errors, validate archive data document all information as applicable to the Polymedco system.

Upgraded Software/ Equipment: The Contractor shall provide all upgrades to the equipment hardware and operating system software without additional charge to the government. These enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.

Bar Codes:

All bar code readers must be capable of reading and decoding any label when manually applied to a specimen tube in accordance with the guidelines described in the Clinical and Laboratory Standards

Institute (CLSI) standard, Laboratory Automation: Bar Codes for Specimen Container Identification, NCCLS Document Auto2-A, Approved Guideline, Vol. 20, No. 19, October 2005.

New Test Methods: New tests on-line vendor/technical support specialist shall perform all validation studies including: installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy

CAP standards) and normal range studies at no initial charge.

Maintenance and Service Support Requirements:

Minimal System Maintenance required, including limited reagent preparation prior to use.

Computer Patient Data Handling:

No hardware, containing any VA patient information is to be removed from any location, without the approval and removal of data by the VA information technology department. Failure to comply with this

VA requirement may result in prosecution.

Preventative Maintenance:

Contractor shall provide regular, scheduled maintenance to assure the continued reliable operation of the equipment. These preventive maintenance visits shall be of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment. Minimum of 2 per year per instrument unless documentation for volume performed denotes not required for optimum quality of operation.

Emergency Repair:

Emergency repairs shall be performed after notification that the equipment is inoperative. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable its maintenance representative to receive such notification. The contractor shall perform emergency repair service within 24 hours of time of notification of the malfunction except when an ordering facility elects reduced service at contract agreed reduction. The contractor shall provide all parts and labor needed to repair the malfunction. Travel, per diem and other expenses associated with the repair shall be borne by the contractor. The contractor shall furnish a malfunction incident report to the installation upon completion of each maintenance call. The report shall include, as a minimum, the following: (a) date and time of arrival. (b) Serial number type and model numbers(s) of equipment (c) time spent for repair, (d) description of malfunction and (e) proof of repair.

Maintenance Support:

Service repair person locally based within NF/SG VHS geographical area.

Maintenance Credit for Equipment Malfunction:

If a machine remains inoperative due to a malfunction through no fault or negligence of the government for a total of 24 hours or more, the contractor shall be assessed damages at the rate of 1/30 of the preceding average three month CPRR billings times the total number of days certified as downtime for each incident shall start from the time the user makes a bona fide attempt to contact the contractor's designated representative at the prearranged contact point until the machine is returned to good operating order less any non-contracted maintenance (emergency repairs) days.

Replacement of Laboratory Equipment:

During the contract period, should the repair record of any laboratory equipment reflect a downtime of

10% or more of the normal working days in one calendar month, a determination will be made by the representative of the government to replace the initial laboratory equipment with new equipment. The responsibility of maintaining the equipment furnished in good condition shall be solely that of the contractor.

Failure Mean Time Disclosure:

The contractor shall state the failure mean time (between failure and mean time to repair) for each piece of equipment offered. The Contractor shall provide emergency backup equipment.

FDA Approved Instruments and Methods: Only instruments which are FDA approved will be considered, and must be operational and interface with VA Laboratory Computer systems and upgrades.

Test methods must be FDA approved with limited recalls due to product failures. This must be a "turn-key" system.

Operator Procedure Manuals:

Two Operator and Service manuals along with CLSI compliant procedures must be furnished for each instrument model supplied.

OWNERSHIP OF EOUIPMENT: Ownership of the equipment shall remain with the contractor. All accessories

(unused consumables, etc) furnished by the contractor shall accompany the equipment when returned to the contractor. The contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for decontamination of the system, packing and shipping required to remove the analyzer within ten (10) calendar days.

STANDARD AND ACCEPTANCE OF PERFORMANCE: This paragraph establishes a standard of performance that must be met before any equipment listed on the deliver order is accepted by the government. This also includes replacement, substitute machines and machines that are added or field modified after a system has completed a successful performance period. The performance 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 contract at an effectiveness level of

99% or more. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the government makes a bona fide attempt to contact the contractor's designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition.

During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will 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.

The government will maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period. Operations use time and downtime shall be measured in hours and whole minutes.

GOVERNMENT's RESPONSIBILITY: The user will perform routine maintenance and cleaning as required in the manufacturer's operation and maintenance instructions. The user will maintain appropriate daily records to satisfy the requirements of this paragraph.

Special Requirements for Awarded Contractor:

Vendor must meet, or improve, each Laboratory's existing turn-around times as a minimum, by any change in instrumentation. Proposal should include provisions for back-up instrumentation so the Laboratory can provide essential testing without compromising turn-around for all tests on menu. Method Performance/Comparison shall be at the expense of the Vendor, shall include linearity material and reagents, and be consistent with current

NCCLS and related documents, CAP Standards and Federal Regulations, for the following:

Correlation studies for each analyte. A minimum of 30 samples, spanning the reportable range, shall be run by the present and the new contracted method. Vendor shall analyze numbers and provide statistical data to accept the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, analysis, and meet current standards defined by NCCLS.

Linearity analysis shall be performed on new contracted instrument(s) for each analyte to determine reportable range with data reduction in accordance with CLSI guidelines.

Precision study shall be performed utilizing normal and abnormal control material. This should consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal and abnormal controls.

Reference Range: Determine a reference range for each test following CLSI guideline C-23A. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols should be used:

A verification of the manufacturer's suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer must provide specific information defining how the suggested range was determined. A minimum of 30 reference individuals must be used to verify the manufacturer's range. Any apparent outliers should be discarded and new specimens obtained to provide a statistically valid verification.

If the suggested manufacturer's range is not appropriate for the patient population, a reference range must be established. Establishing a reference must follow NCCLS C-28A guidelines. This requires a minimum of 100 reference individuals be used to establish a reference range.

If a laboratory is currently using the proposed instrument/reagent system, the "in-use" reference range can be transferred to the "new" system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, then an alternate test must be provided.

All technical procedures must be provided electronically by vendor in CLSI format, using software compatible with each Laboratory's computer system, for local modification to meet CAP requirements. Carryover studies must be performed, as applicable, as part of the initial evaluation of the instrument. Vendor shall provide interpretation of raw data for each instrument installed and validate no carryover exists within the test platforms.

Vendor to provide all reagents, calibrators, and controls needed along with technical assistance to perform correlation studies from a single lot at no additional cost for new test methods or changes in test menus. (i.e., vendor is to provide all manpower and reagents/supplies to do correlation studies).

Equipment Removal:

The vendor shall remove all equipment within 60 days after notification of the expiration of the terms of this contract but not until the completion of new vendor’s equipment installation inclusive of completed cross over studies. Vendor shall not remove hard drive from premises. All drives with VA information remains the propriety of VA. All service personnel shall be instructed regarding this requirement.

IV. JCAHO, VHA (VETERANS HEALTH ADMINISTRATION) AND OTHER STANDARDS:

The contractor shall notify the VA Contracting Officer immediately of any change in the licensure, or status as non-excluded or sanctioned by HHS (Health & Human Services) or Office of Inspector General.

The contractor shall immediately notify the Contracting Officer of any merger, acquisition, or affiliation agreement;

any legal or governmental action initiated against the contractor for professional negligence, violation of law, bankruptcy, lapse or material change in liability insurance coverage, any other problem or situation that might impair the ability of contractor (offeror) to carry out its obligations under the contract.

The contractor represents and warrants that it is in compliance with Medicare, Medicaid and any other related

Federal or State Statutes, regulations, rules or policies and that neither they nor their agents, officers, employees, independent practitioners assignees or successors in interest are excluded from participation in the Medicare, Medicaid or related federal or state programs.

Further, contractor shall immediately notify the Contracting Officer of the exclusion from such programs of any of its agents, officers, employees, independent practitioners assignees or successors in interest.

Contractor agrees to maintain services as specified, reporting systems and quality control as specified herein.

Immediate (within 24 hours) notification must be given to VA regarding adverse reports and action by a regulatory agency.

The contractor shall furnish the services specified in the Schedule of Services to this contract to VA when authorized by VA Chief of Staff or designee.

HIPAA: Contractor agrees to comply with the requirements of the Health Insurance Portability and Accountability

Act (HIPAA) and with the provision of other appropriate federal laws, rule and regulations.

Qualifications: Proposals shall be considered only from offerors whose Pathology and Laboratory Medicine

Services are licensed as required by CLIA 88.

License: Prior to award the offeror shall submit proof that he holds an un-revoked U.S. License which is issued required by CLIA 88.

Personnel Policy: The Contractor shall assume full responsibility for the training, certification and protection of its personnel furnishing services under this contract, in accordance with the personnel policy of the Contractor, such as providing worker’s compensation, professional liability insurance, health examinations, income tax withholding, and social security payments. The parties agree that the contractor, its employees, agents, and subcontractors shall not be considered VA employees for any purpose.