P09 Final SOW 2.docx

Rocky Mountain Regional VA Medical Center Statement of Work Reverse Transcription Polymerase Chain Reaction (RT-PCR) GI and Respiratory Testing

A. BACKGROUND

Department of Veterans Affairs, Veterans Health Administration, Rocky Mountain VA Medical Center (RMRVAMC) located at 1700 N. Wheeling Street, Aurora, CO, 80045, has a requirement for a firm-fixed price contract for Reverse Transcription Polymerase Chain Reaction (RT-PCR) GI and Respiratory Testing.

B. SCOPE

Contractor shall provide all equipment, reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, and any other item required for the proper operation of it’s contractor owned real-time polymerase chain reaction (PCR) testing instrument and peripherals necessary for the generation of reportable patient test results for GI and Respiratory Testing services on behalf of Rocky Mountain Regional VA Medical Center (RMRVAMC) Pathology and Laboratory Medicine department at 1700 N. Wheeling St., Aurora, CO 80045. A service component is necessary to provide all maintenance, repairs, upgrades, training, and a quality control program. Equipment, supplies, and services shall be provided.

C. DEFINITIONS

Cost Per Kit (CPK): Contractor is required to provide a price for each Reagent Kit that can be used on its equipment.

D. GENERAL REQUIREMENTS

1. Contractors are required to provide delivery, installation, set-up, validation and method comparison studies (including the supplies required to perform them) and removal of equipment at the completion of this agreement at no additional charge to the Government.

2. All hard drives are to be removed and handed over to the facilities for destruction upon removal of equipment at the completion of this agreement.

3. Offered models of clinical laboratory PCR instrumentation shall be capable of producing accurate and reproducible assays on stool and respiratory specimens.

4. Instruments shall provide accurate test assay result for sample specimens up to the manufacturer’s defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

5. Current waste stream analysis and Safety Data Sheets (SDS) shall be provided to RMRVAMC.

6. The awarded contractor shall provide all upgrades to the equipment hardware and operating system software at no additional cost to the Government. These enhancements shall be delivered and installed at the medical facility within 60 days of issuance to the commercial market and must remain in compliance with VA security and medical device operating system security compliance.

7. Offered equipment shall be in current production as of the date of this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

8. An operator’s manual shall be furnished with each instrument supplied to RMRVAMC and updates to the manual shall be provided in a timely manner.

9. Editable electronic copy in Clinical and Laboratory Standards Institute (CLSI) format of operating procedures shall be furnished with each instrument supplied to RMRVAMC.

10. Contractors offered PCR instrument shall conform to RMRVAMC’s existing space and structural parameters in terms of delivery, installation, and lab space (i.e., equipment size, weight, packaged size for delivery, electrical/voltage).

11. Laboratory assays performed, and organisms tested within, shall include but may not be limited to the following:

a. Gastrointestinal Panel RT-PCR

1. FDA-Approved assay for bacteria and parasite targets

2. Targets: bacterial and parasites

ii. Bacterial:

i. Campylobacter (C. jejuni, C. coli and C. upsaliensis)

ii. Shigella/Enteroinvasive Escherichia coli (EIEC)

iii. Enteropathogenic Escherichia coli (EPEC)

iv. Enterotoxigenic Escherichia coli (ETEC) It/st

v. Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 (including specific identification of E. coli O157 serogroup within STEC)

vi. Salmonella

vii. Plesiomonas shigelloides

viii. Yersinia enterocolitica

iii. Parasite:

i. Cryptosporidium

ii. Cyclospora cayetanensis

iii. Entamoeba histolytica

iv. Giardia lamblia** (Giardia intestinalis and Giardia duodenalis)

b. Respiratory panel

1. FDA-Approved SARS-CoV-2

2. Targets: Bacterial and Viral:

ii. Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

c. Testing Requirements:

1. Open platform for RT-PCR, closed, and independent modules.

2. Ease of use - intuitive workflow with minimal hands-on time for ease of use by all shifts

3. Load sample and walk away

4. Real-time PCR to deliver comprehensive results in about an hour preferred. Final result should be available in not more than 70 minutes.

5. Internal control included in test kit

6. ≤3% run failure due to reagent/instrument failure (based on quarterly data)

7. Delivers Ct values and amplification curves for all detected pathogens directly on the instrument touchscreen

8. No precision pipetting required and direct swab protocol for input into the cartridge

9. Bi-directional interface

10. Minimum of 4 modules to accommodate the test volume.

11. Minimum maintenance – daily, weekly, monthly, and annual. Daily, weekly maintenance not more than 1-5 minutes.

12. No special specimen collection kit requirement.

13. Room temperature reagent/kit storage

12. Pricing: Offerors shall provide pricing for each test, in accordance with the CPK definition contained above in Section B, that can be performed on the equipment. The pricing shall include all costs for:

a. Equipment use.

b. All reagents, calibrators, 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 patient test result.

c. All printers, computers, and uninterruptible power supply (UPS), and water systems required to produce and store results shall be provided and maintained by the Contractor.

d. All necessary maintenance to keep the equipment in good manufacturer’s operating condition, both preventative maintenance and emergency repairs.

e. Training for Government personnel operating the equipment.

13. Consumables

a. All consumable supplies (reagents, standards, controls, disposables, parts, accessories, etc.) required for the proper operation of the Contractor’s equipment and necessary to perform tests on the equipment shall be included.

b. 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. If either circumstance has occurred, the contractor shall deliver to RMRVAMC 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 RMRVAMC of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory may result in default.

14. Inventory Controls, Calibrators, Reagents, Supplies, Disposables, Parts, Accessories: The contractor shall maintain on Government provided space a continuously stocked inventory of controls, calibrators, reagents, supplies, disposables, parts, accessories, 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 tested to assure precision and accuracy. The quality of the products shall be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and The Joint Commission (TJC).

15. Maintenance and Repairs

a. With the exception of the specific maintenance and repair requirements stated herein, which shall have precedence; contractor shall also provide preventative maintenance, emergency repair, maintenance credit for equipment malfunction, and replacement equipment, with service available 24/7.

b. Emergency repairs shall be performed after initial telephone notification that the equipment fails any parameters. The contractor shall provide the Government with a designated point of contact and telephone number and shall make arrangements to enable vendor maintenance representative to receive such notification.

c. The contractor shall be on-site at RMR to perform emergency repair service within twenty-four hours after receipt of the initial telephone notification of a malfunction. Contractor shall provide maintenance coverage from 7 A.M. to 5 P.M. Monday through Friday. Contractor shall provide technical support services to assist in troubleshooting 24 hours per day, seven days per week, including Federal holidays.

d. The Contractor shall furnish a malfunction incident report to the installation upon completion of each repair call. The report shall include, as a minimum, the following:

i. Date and time notified;

ii. Date and time of arrival;

iii. Serial number, type and model number(s) of equipment;

iv. Time spent for repair;

v. Description of malfunction and repair; and

vi. Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance and any other testing as needed.

e. Should the repair record of any individual piece of laboratory equipment reflect a downtime of greater than 5% of the normal working days in one calendar month, a determination will be made by the designated representative of the Government at RMRVAMC to replace the initial laboratory equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instruction shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 95% in each month of the term of the agreement.

f. The Contractor shall not leave a service call open pending verification that repairs are completed by the contractor’s maintenance personnel. For each instrument provided the contractor shall treat each notification for an emergency/repair service call from the Government as a separate and new service call.

16. Training – The Contractor will provide on-site operator training for all personnel who will run the instrument(s) with training provided for all applicable shifts.

17. Space Availability – All proposed equipment must fit the existing space at RMRVAMC 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 the RMRVAMC laboratory in terms of deliver, installation, and lab space (i.e. equipment size, weight, packaged size for delivery, electrical/voltage).

a. Spatial measurements and electrical requirements – 120 V, Counter model which fits in 14 x14 (L & W)”

E. SPECIAL REQUIREMENTS

In addition to the general requirements for the PCR instrumentation requirements stated above, the contractor shall meet the following special requirements.

1. Equipment shall have a fully established VA VistA computer system interface program via Data Innovations Middleware with all downloads/software necessary to transfer data into patient file in VA VistA computer system via Data Innovations at no cost the Government.

2. Provide bi-directional interface with Data Innovations and appropriate quality control analysis system and all components necessary to interface with VA VistA computer system.

3. Equipment shall be capable of operating at high altitudes with no interferences.

4. Shall provide data backup.

5. Systems shall provide ease of use with uncomplicated menus and with minimal maintenance required.

6. Shall provide flexibility in test volumes.

7. Shall be easy to troubleshoot.

F. TRANSITION PERIOD

1. Upon award, the transition period for the awarded contractor to have all equipment and peripherals installed at RMRVAMC shall be 30 calendar days after award. During this same period all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed.

2. Offerors shall provide with its quotation, a plan for equipment installation and training with estimated dates and times of completion.

3. All transition of equipment, supplies, and services under this agreement to include all validations and correlation studies shall be completed within 60 calendar days after award and accepted in writing by the Contract Specialist. At this time, the awarded contractor shall have full and sole responsibility.

G. CESSATION OF TESTING

If for any reason, a contractor ceases testing of any assays, the contract must notify the Contracting Specialist or equivalent, 60 calendar days prior to the change. Until a new solicitation can be issued or the problem resolved, the contractor shall be held liable for all costs if performance is ceased, as RMRVAMC may have to resort to outsourcing the testing in order to continue patient care.