Statement_of_Objectives_BioMerieux.docx

STATEMENT OF OBJECTIVES

Reagents for Automated Mass Spectrometry Rapid Microbiology Identification, Automated Antimicrobial Susceptibility Testing, Automated Biochemical Identification and Blood Culture Testing Department of Pathology and Area Laboratory Services (DPALS) Brooke Army Medical Center (BAMC)

1. GENERAL REQUIREMENT:

The Department of Pathology and Laboratory Services at Brooke Army Medical Center, JBSA - Fort Sam Houston, Texas has a requirement for automated mass spectrometry rapid microbiology identification testing; automated antimicrobial susceptibility testing; automated biochemical identification testing; and blood culture monitoring. The number of tests per year are identified in the workload data table.

2. SCOPE OF WORK:

2.1. The successful contractor shall furnish all equipment (to include instrument/equipment/(s)), reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) to conduct testing under a Cost-per-Test (CPT) Agreement (except as paragraph 2.2 in which contractor will provide only reagents compatible with government equipment). All equipment and reagents/consumables to conduct testing for automated mass spectrometry rapid microbiology identification, automated antimicrobial susceptibility, and automated biochemical microbial identification shall be supplied and serviced through the Contractor to include all parts, equipment, supplies, and other services required to ensure BAMC is able to meet its objectives as listed herein.

2.2 Blood culture testing- Contractor shall provide reagents compatible with government owned Biomerieux BacT/Alert Virtuo equipment and data management/quality control software that interfaces with each of the systems required.

2.3 The instruments and software provided to conduct testing as per paragraph 2.1 above will not be government owned, and therefore the contractor will be responsible for maintenance and service of their own instrumentation and software.

3. ORDERING PERIOD:

Base Period: 1 October 2019 – 30 September 2020 Option 1: 1 October 2020 – 30 September 2021 Option 2: 1 October 2021 – 30 September 2022 Option 3: 1 October 2022 – 30 September 2023 Option 4: 1 October 2023 – 30 September 2024

3.1 The Government will order items on as-needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the Government. The quantities listed in the workload data table represent anticipated test volumes for the period of performance listed; however, quantities could increase and/or decrease during certain periods and/or months.

3.2 The inspection and acceptance for all deliverables rendered under this contract will be by the appointed Ordering Officer. The performance by the contractor technician, the quality of services rendered, and any documentation or written material in support of same, shall be subject to continuous inspection, surveillance and review for acceptance by the designated ordering officer representative. Other evaluation factors will be monitored that are not quantified by numerical measurements.

4. HOURS OF OPERATION:

The microbiology lab is in operation 24 hours a day, 7 days a week. Normal business hours for administrative personnel are Monday through Friday between the hours of 0730 – 1630 CST. Contractor shall coordinate maintenance scheduled with Ordering Contracting Officer and appointed on duty staff in absence of OCOR no less than 48 hours.

5. SECURITY REQUIREMENTS AND SAFETY:

5.1 SECURITY. The Contractor shall ensure its personnel comply with the local installation requirements for vehicle registration and operation on the military facility. Any vehicle entering the military installation must have the minimum liability coverage required by the state in which the performance is located. The Contractor shall ensure its personnel comply with installation and MTF personnel identification and access requirements.

5.2 SAFETY. The Contractor shall ensure its personnel comply with all installation and MTF safety regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal. Copies of these regulations are available in the medical activity safety office or may be obtained through the appointed personnel. The use of cellular phones and 2-way radios is expressly forbidden in all Medical Treatment Facilities and Health Clinics. The government and the contractor’s service representative will exchange hazard communication information before the commencement of any repair. When required, the contractor’s service representative will comply with the Office of Safety and Health Administration (OSHA) lockout/tag-out standards while performing sustainment on MD/MDS.

6. INSTRUMENT/EQUIPMENT REQUIREMENT (OWNED BY CONTRACTOR):

6.1 Contractor shall provide all instruments/equipment necessary to conduct testing as per workload data table on the testing identified. The instrument/equipment provided will be utilized for BAMC's automated mass spectrometry rapid microbial identification, automated antimicrobial sensitivity, and automated biochemical microbial identification needs. In addition, the instrument/equipment must include an automated component that facilitates ease of sample preparation and seamless input of data via barcode scanning. A printer for the production of hard copy patient reports and other reports generated shall also be provided.

6.2 The contractor shall provide redundancy in the form of multiple instruments and/or equipment used to perform automated antimicrobial sensitivity, and automated biochemical microbial identification testing.

6.3 These instruments, to include any connections between the instruments/equipment, shall be approved by the US Food and Drug Administration (FDA).

6.4 The instruments will be able to correctly identify and perform antimicrobial sensitivities from a pure culture of unknown microbiological organism.

6.5 The instruments supplied, all of its associated parts, and all accessories must be maintained at the most up-to-date hardware and software. When necessary to maintain hardware updates, the existing instrument/equipment, associated parts, and accessories must be exchanged by the contractor. All software updates or file exchange shall be completed using CD/DVDs only. At no time will USB, internet or cloud-based services be allowed.

6.6 The server database must be SQL 2016. SQL 2016 Express is not acceptable. The server operating system must be Microsoft 2016 Server.

6.7 The instrument system shall be equipped with an Uninterruptible Power Supply (UPS) capable of providing all necessary electrical power to the instrument/equipment system for at least 45 to 60 minutes.

6.8 The instruments shall be able to be connected to the hospital LIS, currently Composite Health Care System (CHCS), or whichever LIS system the hospital uses in the future. The contractor must provide full technical support to ensure that the LIS connectivity is functioning properly.

6.9 The instruments, reagents, and software provided shall comply with the specific requirements listed in this SOO. The instruments and software provided for Automated Microbial Identification and Antimicrobial Susceptibility Testing will not be government owned, and therefore the contractor will be responsible for maintenance and service of the instrumentation and software.

6.10 The data management/quality control software shall be able to generate the following type of reports:

a. Statistical reports - to include positive incidence summary reports, days to detection summary reports, detail reports, positive rate reports, blood culture volume reports, and unconfirmed positive rate reports;

b. Epidemiology reports- to include trending reports, phenotype occurrence reports, phenotype trending reports, susceptibility reports, cumulative by MIC reports, bio-number distribution reports and incidence detail reports; Instrument reports- to include workload reports, load reports, unload reports, and calibration reports.

6.11 Software upgrades. Contractor shall have access to all necessary diagnostic software. All software upgrades, corrective in nature, or which enhance MD/MDS features shall be at no-cost to the government.

6.12 . Contractor shall provide all documentation required to meet all regulatory compliance testing procedures and shall comply with DHA Cyber Security RMF Requirements (see Technical Exhibit 2/attachment 2).

6.13 Contractors shall coordinate and conduct a site visit if necessary to the BAMC Microbiology section, for the purpose of surveying and assessing current laboratory set-up, laboratory environmental control, and available utilities with regard to potential placement of their instruments in the laboratory. Any changes to the layout of the laboratory, environmental control, or to utilities as currently in existence to accommodate placement of their proposed instruments must be identified.

6.14 Method Verification (Correlation Studies) will include parallel runs with existing equipment. Specificity and Sensitivity shall be equal to or exceed the manufacturer stated claims.

6.15 The Contractor will provide one (1) paper copy and one (1) CD copy of the Operator’s and Maintenance manuals and a statement of the warranty terms.

6.16 Lab Layout. The contractor shall provide a diagram or other graphical representation demonstrating how its proposed equipment fits within the dimensions below with its quote.

7. PREVENTATIVE MAINTENANCE, FAILURES AND REPAIRS:

7.1 The contractor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of their equipment. Contractor shall coordinate with the designated point of contact all scheduled maintenance within ten (10) business days prior to performing preventative maintenance services.

7.2 The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level will be performed by contractor service personnel in accordance with requirements as specified in the contractor’s instrument maintenance manual. The contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required by manufacturer in order to maintain the system in optimal operating condition.

7.3 The contractor shall provide a full service plan to include the recommended unscheduled and preventive maintenance service for their instrument/equipment period. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer’s maintenance manuals), and hotline telephone service, in order to assist customer in troubleshooting problems.

7. 4 Preventive maintenance services shall be performed in accordance with the manufacturer’s standard/procedures. A preventive maintenance service shall include, but is not limited to, safety, calibration, complete operational testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation.

7.5 Upon notification of equipment failure own by contractor, the contractor shall respond to telephonic requests for unscheduled repair within 24 hours. Should the instrument/equipment become inoperable, the contractor’s Repair Service Engineer / technician shall be on-site within 24 hours of initial notification for routine/emergency failures. If the equipment is out of service for longer than 72 hours (from the time of service technician’s arrival on site), the contractor shall notify the government point of contract on duty, in writing, as to the reason(s) (i.e. non-availability of parts, etc.) for non-compliance.

7.6 If the equipment cannot be repaired, a replacement instrument shall be provided within seven (7) days. If the equipment cannot be replaced, the Government may seek remedies for non-compliance with terms and conditions of this contract.

7.7 Within one (1) business day after completion of a repair, the contractor’s representative shall furnish the Point of Contact (POC) one (1) copy of a service report for all services performed. The service report shall contain, at a minimum, the following information:

a. Nomenclature, date, description of services performed (i.e. preventative maintenance service, or unscheduled repair service)

b. Location of services performed, duration of services performed, list of parts replaced and;

c. Other actions taken to restore operability of the instrument/equipment, name of technician.

**Full report shall be submitted to designated government point of contact**

7.8 Contractor shall notify government of any hazard information before beginning equipment repair and shall comply with the Occupational Safety and Health Administration while performing maintenance on electrical equipment.

7.9 When appropriate, the contractor’s representative shall attach and complete a DD Form 2163 (sticker), entitled “Medical Equipment Verification/Certification” to the equipment upon completion of calibration services. The Point of Contact will provide the DD Form 2163 to the contractors’ representative. If the DD Form 2163 is already attached to the equipment, the contractors' representative shall update the existing DD Form 2163. Procedures for updating the 2163 will be provided by the Point of Contact.

8. CUSTOMER SERVICE:

8.1 The Contractor shall provide direct customer service and support, during normal business hours and on-call emergency repair service support, to assist operators in correcting equipment operation problems.

8.2 For Emergency Services and unscheduled services the Contractor’s qualified service technician shall be on-site to provide emergency service (service requiring immediate repair) within 24 hours. The equipment shall be repaired and operational at the minimum of 72 hours after arrival of contractor on site.

8.3 The Contractor shall perform preventive maintenance services (PMS), safety tests, calibrations, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment. Scheduled routine services shall be performed between 0730-1630 LOCAL Monday-Friday, excluding U.S. Holidays.

8.4 The Contractor shall provide a full unscheduled and preventive maintenance service for the instrument/ equipment owned by contractor. All maintenance and repairs shall be inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor’s instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

8.5 The contractor’s qualified service technician shall be on site to provide routine services; service requiring immediate repair; and scheduled services for preventive maintenance (as specified in the Contractor’s instrument maintenance manual), safety and calibration as required by this statement of work. The equipment shall be repaired and operational within 72 hours after arrival of contractor on site.

8.6 Upon analyzer failure, the Contractor’s qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement) within 24 hours. The equipment shall be repaired and operational within 72 hours after arrival of contractor on site.

8.7 Should the analyzer at BAMC become inoperable, the Contractor’s technical repair specialist shall be on-site within 24 hours of initial notification and make the repair within 72 hours after arrival of contractor on site. If the analyzer cannot be repaired within 72 hours after arrival of contractor on site, a replacement analyzer, at no additional cost to the U. S. Government, will be provided within seven (7) days of the initial notification to be utilized by the U.S. Government until the original instrument is fully repaired and accepted for service.

8.8 During the period when the analyzer is inoperable, the Contractor will arrange the pickup and delivery of critical specimens to a College of American Pathologists accredited clinical laboratory of their choice. The selected laboratory will provide patient reports. Each patient report shall include the testing laboratory’s reference range for the test being performed. The Contractor will be responsible for all costs associated with the provision of this service, including those for delivery of hardcopy patient results, for as long as the analyzer remain inoperable.

8.9 The Contractor shall provide all necessary user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks, at no additional cost to the U.S. Government.

9. DELIVERY OF EQUIPMENT

9.1 All equipment (owned by contractor) shall include delivery, installation, maintenance, and removal upon termination of contract. Contractor shall furnish all necessary calibrators/standards and quality control materials necessary to perform the initial method verifications per CLIA/NCCLS guidelines.

9.2 The instrument (s)/ equipment shall be delivered to the Brooke Army Medical Center (4th floor) within 30 days or less after contract award. Exact installation location shall be coordinated by contractor and government point of contact (OIC and/or NCOIC). Equipment setup, LIS connectivity, on-site training, and method verification studies, shall be completed by vendor personnel within six (6) weeks or less after contract award to ensure that equipment is fully operational.

9.3 SAFETY DATA SHEETS (SDS): The contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall contain at a minimum the following information: identification of the specific hazard, the required practice for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident.

10. REAGENTS/CONSUMABLES:

10.1 All assays shall be FDA approved and must have a minimum shelf life of six (6) months upon receipt by the Government, or, if this shelf life requirement cannot be met the Contractor shall identify the guaranteed shelf life after receipt that can be accommodated in their response to the Solicitation for Bid.

10.2 The manufacturer will provide the required quality control materials and test reagents and ensure that there is minimal change in lot numbers during the contract year.

10.3 The blood culture reagents provided must be compatible with the government owned Biomerieux BacT/Alert Virtuo Microbial Detection System.

10.4 All reagents and quality control material shall be provided by the manufacturer of the equipment; be marked with the required storage temperature and expiration dates; be maintained at the proper storage temperature during transportation from the Contractor’s storage facility to the U.S. Government acceptance site and be delivered on time at the appropriate storage temperature. Preservation and packing - Preservation and packing shall be performed in accordance with the best commercial practices and in such a manner to afford adequate protection against any damage during shipment from source to destination.

10.5 The reagents and quality control material must perform within the manufacturer’s stated/published package inserts. Deliveries of required items will be called in to the Contractor by the designated Contracting Officer’s Representatives. Orders will be delivered within five (5) business days of requested date of delivery.

10.6 Emergency orders will be delivered using overnight shipping, or, if this shipping requirement cannot be met, the Contractor shall identify the guaranteed emergency order shipping method that can be accommodated in their response to the Solicitation for Bid.

11. TRAINING:

11.1 The Contractor will provide initial operator training to all technicians assigned to the U.S. Government site (BAMC Department of Pathology Microbiology staff), as well as annual refresher training, as needed, to ensure adequate user competency during times of personnel turnover.

11.2 All training manuals/guides, instructional literature, and any other related written/electronic material shall be provided. Training shall include basic operation of the analyzers, trouble shooting procedures, performance of operator-level periodic preventive maintenance procedures, and use of the data management/quality control software.

11.3 In the case of any significant software or assay procedural updates, the Contractor shall provide one (1) primary (key) operator training slot per major instrument/equipment. This training can be on or off-site at the Contractor’s full expense.

WORKLOAD DATA TABLE 1.

TYPE OF TEST

(BASE YEAR)

(OPTION 1)

(OPTION 2)

(OPTION 3)

(OPTION 4)

Automated mass spectrometry rapid microbiology identification testing (cost per test)

60,000 test per year

60,000 test per year

60,000 test per year

60,000 test per year

60,000 test per year

Automated antimicrobial susceptibility testing (cost per test)

Blood culture monitoring (reagents only)

EXHIBITS AND ATTACHMENTS:

a. Exhibit 1/ Attachment 1 – Reagents List (Excel sheet)

b. Exhibit 2/ Attachment 2 – DHA Cyber Security – RMF Requirements image1.png