STATEMENT_OF_OBJECTIVE_MAJ_M_Edit_21Jun16_Ms.D_11Nov16.docx

Statement of Objective (SOO) Dwight David Eisenhower Army Medical Center (DDEAMC) Fort Gordon GA 30905

EQUIPMENT: The requirement is for an automated Microbial Identification, Antibiotic Susceptibility Testing instrument (ID/AST) and a Matrix Assisted Laser Desorption Ionization Time of Flight (MALDI-TOF) Mass Spectrometry Microbial Identification Instrument; including Reagents, Supplies and Consumables. The contractor shall provide equipment and reagents on a cost per test basis beginning 01 January 2017, or date of award. The contractor shall provide all upgrades to the equipment hardware and operating system software to the extent without additional charge to the Government to the extent required to operate equipment according to the manufacturer’s original specification. The contractor is required to provide new equipment. Discontinued models are not acceptable. The system shall have the capability to communicate with existing interface equipment which shall provide automatic uploading of patient results into CHCA. Those results, once verified, will be updated in the patient record, eliminating transcription errors. This is a base plus four (4) option year contract (if exercised), through 30 September 2021. Funding will be subject to the availability of funds.

Title and ownership of contractor-furnished equipment and components will remain with the contractor.

The contractor shall perform complete correlation, precision, carry-over, and validation studies at the time of installation and for all new test added throughout the contract period on manufacturer supplied and or 3rd party assay. All studies shall meet guidelines recommended by CLSI, CAP and CLIA.

Reagents shall be provided bearing the same lot number within the designated shipments. The contractor shall provide stock that meets the proficiency testing standards of the College of American Pathologist (CAP), the Joint Commission on Accreditation of Health Organizations (JCAHO), the Clinical Laboratory Standards Institute (CSLI), and be approved by the Food and Drug Administration (FDA).

In the event that consumables are found to be defective, back order or recalls, the contractor agrees to shipping items overnight at no additional cost to the government.

The Government assumes liability for damage to or loss of contractor furnished equipment when such damage or loss is caused by negligence, wrongful acts or equipment misuse by Government users. The contractor owned equipment will be located in the room 1L31, Microbiology Laboratory at DDEAMC, Fort Gordon GA.

INSTALLATION AND SITE PREPARATION: Site preparation specifications shall be furnished in writing by the Contractor as a part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer’s claimed specifications. The Contractor shall be responsible for assessing the space available in the facility in order to ensure the right size equipment is provided; thereby not creating a safety hazard. The government shall prepare the site at its own expense and in accordance with the specification(s) furnished by the contractor.

Any alterations or modifications in site preparations, which are attributable to incomplete or erroneous specifications provided by the contractor, which would involve additional expense to the government, may result in request for reimbursement at the expense of the contractor.

The Contractor shall furnish, install, support, exchange, and replace any system improvements, including modifications, enhancements, upgrades, updates or revisions and supporting documentation, supply items and consumables at no additional cost to the Government. The Government has the option to reject or accept any changes. Such rejection shall not relieve the contractor of the responsibility to continue to provide the required supplies.

REMOVAL OF EQUIPMENT: All costs associated with the removal of contractor’s equipment shall be at the contractor’s expense. Within 15 days after expiration or termination of the contract the contractor shall remove the equipment from the Government premises, to include disconnection, packaging and shipping. All devices furnished by the contractor except those purchased by the Government under separate contract or credit card purchase, shall accompany the equipment when returned to the contractor. In the event the contractor fails to remove the equipment within the time specified herein, the Government shall return the equipment to the contractor at the contractor’s expense.

MAINTENANCE: The Contractor, in accordance with the manufacturer’s recommended PM schedule to meet the serviceability requirements and standards of the manufacturer and Joint Commission must perform PM inspections. If at any time the equipment malfunctions or becomes inoperable, the contractor must perform on-site repairs to the equipment at no cost to the Government. If the equipment is unable to be repaired on-site, the contractor must provide equitable replacement equipment while the off-site repair is conducted.

In no event shall the Government alter, repair or replace any parts or components on contractor-owned equipment.

TRAINING: Annual Training includes two (2) off-site training for key operators, includes room, board and airfare for each completed year of the customer agreement upon request at no additional cost to the government. The contractor provides supplemental off-site training for all four (4) option years, excluding airfare Twenty-four hours a day, 7 days a week maintenance at no additional cost to the government. All travel transportation/lodging should conform to the requirements of the Joint Travel Regulation (JTR). Onsite training will be provided to staff at mutually agreed upon times and dates according to a pre-set training schedule formulated at time of installation. All travel transportation/lodging should conform to the requirements of the Joint Travel Regulation (JTR).

Salient Characteristics:

MALDI-TOF Mass Spec Microbial Identification Instrument

The instrument shall be a 110-240 (V) volt, self-contained, FDA-approved with software system designed for rapid identification of clinically-relevant bacteria, yeasts/fungi.

System must facilitate sample preparation, identification of intact cells without extraction or purification. Instrument must not require further manual sample extraction steps other than on target slide addition of matrix (CHCA) for GP and GN or formic acid (FA) and matrix (CHCA) for Yeast. The matrix (CHCA) and Formic Acid (FA) must be ready to use and light stable at +4C.

1) Shall be geared towards walkaway operation.

2) Shall be a high throughput platform capable of processing at least 192 clinical samples plus QC controls in a single, uninterrupted run.

3) Each target slide should have a dedicated QC control spot for acquisition groups of 16 clinical samples

4) The system shall offer flexibility in workflow with multiple remote sample preparation stations and ability to load up to 4 target slides.

5) The system shall include an integrated software system that performs all required calculations as needed for a final result and is fully compatible with composite healthcare system (CHCS) in such a manner that results generated by the analytical platform are seamlessly transferred to CHCS.

6) The system shall report the ID result with a confidence value.

7) The system shall analyze raw spectral data not just by comparing a spectrum with a reference spectrum database but using a method that assigns probability values to individual peaks in a spectrum and calculates the confidence levels of a choice ID.

8) The system shall be able to distinguish Streptococcus pneumonia from non-pneumococcal species of Streptococcus mitis group.

9) The mass spec system shall provide a mass range no less than 1DA-500kDa.

10) The MALDI TOF shall have a linear flight tube (TOF) length up to 1.2 meters.

11) The MALDI TOF shall have the ability to run in both positive and negative ion modes (standards)

12) The MALDI TOF shall meet minimum sensitivity of 250amol Glu-Fib peptide, 250 fmol BSA protein with a resolution of 5000 FWHM ACTH 18-39 peptide.

13) The software shall maintain records of quality control materials. Results for non-clinically validated species shall be displayed in the report, alerting lab staff that additional testing should be conducted. These can include organisms with insufficient clinical performance data and organisms not found in human clinical samples as reported in the scientific literature. Such organisms shall be automatically highlighted in all printed, exported or audited files.

14) Users must be able to export all organisms via network-based software (middleware) for audit trail purposes or ID/AST trending, epidemiology, statistics, antibiogram, or other purposes. Furthermore, the same software shall be able to directly link the MALDI-TOF with the AST/ID instrument and blood culture instrument currently in use by the laboratory using common nomenclature to facilitate seamless data archiving, mining, and retrieval, and analysis.

15) The MALDI-TOF and AST platform shall be able to provide consolidated reporting for identification and antibiotic susceptibility testing.

16) The system shall meet standards set by the Risk Management Framework (RMF) for DoD Information Technology (IT).

17) The system shall have sensors to detect and notify the user of conditions that may result in erroneous results. Systems checks and maintenance should be performed and documented by the system at specified intervals.

18) The contractor shall provide all necessary personnel, reagents and consumable items to conduct validation of instrument and assays in accordance with the requirements of CAP and DDEAMC.

19) The instrument shall be delivered and installed by the contractor at no cost to the government. The instrument/assays shall be validated no later than 01 January 2016.

Microbial Identification (ID) and Antibiotic Susceptibility Testing (AST) Instrument

(1) The system shall provide self-contained, fully automated testing of suspensions of bacteria and yeasts isolated from patient specimens.

a. Instrument shall be capable of identification of yeasts/fungi

b. Instrument shall be capable of identification of Coryneform bacteria and anaerobic bacterial species

c. Instrument shall be capable of identification of Neisseria, Haemophilus, and Campylobacter species

d. Instrument shall be capable of antifungal susceptibility testing of yeasts/fungi

e. Instrument shall be capable of identification of gram negative bacteria

f. Instrument shall be capable of identification of gram positive bacteria

(2) The instrument shall be 110-240 (V) volts, FDA-approved or cleared

(3) The system shall be designed to provide identification and antimicrobial susceptibility (ID/AST) results in as little as 5 to 8 hours.

(4) The system shall provide reduced hands-on time, and require no additional reagents (no on-board reagents).

(5) The system shall optimize user safety with closed, disposable testing devices.

(6) The system shall provide maximum traceability with the pre-applied testing device barcodes.

(7) The testing devices shall reduce disposable costs by being lightweight and sealing all reagents and bio-hazardous waste.

(8) The system shall include software that enables easy access to ID and AST results. The software shall allow rapid result searches by patient, tech, date tested, and organism and accession number.

(9) The system software shall facilitate selection of appropriate antibiotics by providing rapid, accurate fingerprint recognition of bacterial resistance mechanisms. In addition, the software shall be capable of generating antibiogram.

(10) The system shall have sufficient capacity and throughput to meet the volume and service demands as defined in the Prices and Terms.

Bar-code System.

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.

Data Management System.

Integrated central processing unit with sufficient data storage and printing capability to accommodate and provide immediate access to patient records.

Ability to manage rules for optimal specimen handling with alert system with ability to send automated comments based on the rules to patient host record. Linearity limits, “Add-on” or reflex tests, repeats for critical value tests, review for specimen integrity and delta checks on previous patient results are examples of automatic rules functions required.

Specimen Integrity based rules to cancel/edit tests based on the test performed and the interfering substance. Cancelled test shall be able to transmit to the host along with the appropriate comment.

Interfacing pending Pathology & Laboratory Medicine and Lab Information System technology.

Bi directional Interface — shall be able to interface and automate the Microbiology instruments with orders and results separated for optimal transmission capable of automatically uploading test results.

Back up to network data management handling.

Software management features with rules capable of preparing data for auto validation prior to host transmission.

Data Management with record storage including instrument of record for all patient results.

All software and software licenses, interfaces, and hardware (e.g. servers, printers, monitors, UP, etc.) shall be included with cost of hardware required disclosed for removal if needed.

Safety.

The system must have sufficient safety features to avoid unnecessary exposure to bio-hazardous and chemical materials. The exposure to and the volume of bio-hazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.