Statement of Work MALDI_TOF AST.pdf

STATEMENT OF WORK (SOW)

MATRIX – ASSISTED LASER DESORPTION/ IONIZATION – TIME OF FLIGHT

(MALDI – TOF), BACTERIAL IDENTIFICATION (ID) / ANTIBIOTIC

SUSCEPTIBILITY (AST) REQUIREMENT

DWIGHT DAVID EISENHOWER ARMY MEDICAL CENTER (DDEAMC)

FORT EISENHOWER, GA 30905

1. Scope

1.1. Requirement: This requirement is to provide DDEAMC, Department of Pathology and Area Laboratory Services (DPALS) medical equipment, reagents, supplies and consumables needed to provide cost-effective and continuous means to identify bacteria, yeast, and expedient AST test results, enabling authorized physicians, clinicians and providers critical diagnostic information (Bacterial ID and corresponding results should be available for conveyance within 12 hours, confirmatory presence of yeast and ID results should be available for conveyance within 24 hours) without exception, interruption or delay. This contract is comprised of one base year, plus four (4) additional Option Years (OY). The total cost of this contract, including one base year and four (4) additional OY is estimated at $ 1,874,097.36. All payment invoices will be submitted by the Contractor via Wide Area Work Flow (WAWF). The Contractor will be responsible for establishing a WAWF account and submitting payment requests via WAWF throughout the duration of this contract.

Monthly invoices will be submitted via WAWF not later than thirty (30) days after delivery of supplies, consumables and/ or reagents. Monthly invoices will incorporate reagent use from the first day of the month through the last day of the month.

1.2. Equipment: The Contractor shall provide DDEAMC with one (1) analyzer capable of providing bacterial identification and AST results, and one (1) MALDI

– TOF mass spectrophotometry. This acquisition includes equipment, services, periodic maintenance, consumables, and reagents necessary to perform testing and/ or diagnostic analyses. This equipment must possess connection compatibility with the organization’s Laboratory Information System (LIS), Military Health System – Genesis (MHS – G). The Contractor shall provide and install all necessary supplemental equipment for full functionality to include, but not limited to a device such as an Uninterrupted Power Supply (UPS), to serve as a back-up in case of power instability or power failure. Discontinued models are not acceptable. The title and ownership of contractor-furnished equipment and components will remain with the Contractor.

1.3. Reagents, Supplies, and Consumables: All reagents, consumables and supplies must be approved by the Food and Drug Administration (FDA) for human diagnostic testing purposes. The reagents, consumables and supplies must be delivered in the amounts specified within a week of the supply schedule delivery dates, to cover projected workload demands. The reagents, consumables and supplies must have expiration dates no less than six (6) months from the delivery date. The reagents, consumables and supplies must function properly, passing all lot-to-lot tests. The analyzer must be able to interface with the organization’s LIS (MHS – G) to enable electronic transfer or conveyance of testing results. The analyzer will be highly utilized for performing analysis of bacteria, yeast, and for identification and antimicrobial sensitivity. The Contractor shall deliver replacement supplies and/ or consumables within twenty-four (24) hours of receipt of verbal order in the event contracted consumables are found to be defective and/ or unsuitable for use.

1.4. Equipment Phase In/ Phase out Period: The Contractor must have the analyzers built and delivered in a pre-phase period at least two (2) months prior to the start date of the contract. A mandatory 30 – day quality control analysis of antimicrobial sensitivities is required before testing can commence in accordance with Clinical and Laboratory Standards Institute (CLSI) guidelines and FDA requirements. If the pre-phase period is not feasible, the existing system must remain in place and useable within DDEAMC until analyzer(s) are built, developed, and tested in accordance with CLSI and FDA. The Contractor shall provide connectivity support ensuring the seamless transition to the LIS (MHS- G). The Contractor shall provide all necessary maintenance (except for regular, daily user maintenance). The Contractor shall be responsible for all equipment repairs and provide repairs on-site within 24 hours of maintenance requests. The Contractor shall provide alternate testing equipment and perform equipment validations for any equipment downtime that exceeds three (3) days. Upon completion of services, a written service report will be provided to the Chief, Microbiology and Chief, Bio - Medical Maintenance. The service report shall be filled out within 24 hours from completion of service, provide detailed information regarding the cause of equipment malfunction and corrective action taken, to include the time required to complete the work, and a list of parts replaced with a price for each part. The Contractor shall provide the balance of the required information in writing to the Chief, Microbiology and Chief, Bio - Medical Maintenance, not later than ten (10) days after services are completed.

Contractor will furnish a malfunction incident report to the Contracting Officer Representative (COR) within 24 hours of the completion of any maintenance call or maintenance action.

2. General Information

2.1. The contractor shall be responsible to ensure that the quality of service and materials provided under this contract meet or exceed the statement of work.

2.2. Hours of Operation: The DDEAMC Microbiology section operates twenty-four (24) hours per day seven (7) days per week. The contractor shall provide 24/7 support qualified to maintain equipment in accordance with manufacturer’s specifications with a guaranteed 97% uptime.

2.3. Security Requirements: Contractor personnel or any representative of the contractor entering Fort Eisenhower shall abide by all security regulations and shall be subject to security checks. Contractor and all associated subcontractor employees shall comply with all applicable installation, facility, and area commander installation and/or facility access and local security policies and procedures (provided by government representative). The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshall Office, Director of Emergencies Services, or Security Office. Contractor workforce must comply with all personal identity verification requirements as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

2.4. Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

2.5. Access and general protection/security policy and procedures. This standard language is for contractor employees with an area of performance within Army controlled installation, facility, or area. Contractor and all associated sub-contractors’ employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office.

Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

2.6. Common Access Cards (CAC): For contractors that do not require CAC but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC- III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190- 13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

2.7. iWATCH Training. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility, or area. The contractor and all associated sub-contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new employees commencing performance with the results reported to the COR NLT 30 calendar days after contract award.

iWATCH Training Link:

https://training.reliaslearning.com/resources/SwankMigr/902-SWK-1961- 233435/256609/iWatch%20Anti- Terrorism%20Awareness%20Month%20PSA.mp4

2. 8. AT Level I Training: All contractor employees, to include subcontractor employees, requiring access Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 90 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the KO, if a COR is not assigned, within 10 calendar days after completion of training by all employees and subcontractor personnel.

AT level I awareness training is available at the following website:

https://atlevel1.dtic.mil/at.

2.9. Phase In/Phase Out Period: To minimize any decrease in laboratory productivity and to prevent possible negative impact to patient care, the Contractor shall provide 90 days phase in/ phase out period. During the phase in period, the Contractor shall become familiar with all requirements to commence full implementation of contract on start date.

2.10. Contracting Officer Representative (COR): The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration.

3. Specific Tasks: Contractor Furnished Items and Responsibilities

3.1. Quality Assurance, Quality Control: The Contractor shall ensure the quality of service and materials provided under this contract meet or exceed the Performance Work Statement (PWS).

3.2. Training: The Contractor shall provide on-site operator training. Additional training needs will be conducted by on-site vendor implementation representatives. The Contractor shall provide two (2) funded training slots at the https://training.reliaslearning.com/resources/SwankMigr/902-SWK-1961-233435/256609/iWatch%20Anti-Terrorism%20Awareness%20Month%20PSA.mp4 https://training.reliaslearning.com/resources/SwankMigr/902-SWK-1961-233435/256609/iWatch%20Anti-Terrorism%20Awareness%20Month%20PSA.mp4 https://training.reliaslearning.com/resources/SwankMigr/902-SWK-1961-233435/256609/iWatch%20Anti-Terrorism%20Awareness%20Month%20PSA.mp4 https://atlevel1.dtic.mil/at vendor’s facility or training site. The Contractor shall provide a diagnostic system specialist to facilitate the analyzer implementation. Contractor personnel shall perform the initial instrument qualification testing and provide guidance to the DDEAMC Microbiology staff for tasks such as the development of Standard Operating Procedures (SOP) and performance of parallel testing studies.

3.3. Software coverage: The Contractor shall update all software to the customer and must notify to the customer when updates are released. All software and hardware upgrades must be performed by trained personnel. The Field Service Engineer shall schedule with the section supervisor of the upgrade.

3.4. Equipment installation: The Contractor shall provide and install all instrumentation and components and perform necessary qualifications or validations. The Contractor shall be responsible for qualifying or validating new instrumentation and reagents on the analyzer. All activities performed by the Contractor shall be documented with appropriate checklists and forms. The Contractor shall develop a site-specific implementation plan prior to the delivery of the instrument. The Contractor shall validate the new system, providing needed reagents to complete validation. The contractor shall provide the validation guidelines. The Contractor shall provide DDEAMC within one (1) analyzer that provides bacterial identification and AST results: Capacity to provide greater than or equal to (≥) Fifty (50) results per hour; one (1) MALDI – TOF mass spectrophotometry in accordance with specific requirements for ID/AST analyzer and MALDI – TOF outlined in table 3.5.

3.5. ID/AST Analyzer and MALDI – TOF:

MALDI – TOF:

Communicate results to the ID/AST analyzer Be able to have random access to load multiple slides at once Have automated fine tuning performable by the lab tech.

Be able to provide information if the result is not supported by the ID/AST analyzer for AST testing.

Have a device designed to collect and smear colonies on the MALDI - TOF slide.

All reagents must be ready to use and require no rehydration.

Slides must be ready to use and disposable needing no precleaning steps.

ID/AST Analyzer:

Receive results from the MALDI - TOF Possess yeast sensitivities Perform all bacterial ID and AST analyses completed within 12 hours.

Perform all yeast ID and AST analyses completed within 24 hours Require no more than 5 on-board reagents All reagents must be ready for use and require no reconstituting, All reagents must be ready for use and require no mixing.

Capable of testing for all antibiotics listed below, Table 3.7.

Generate minimal to no regulated medical waste.

3.6. Contracted instrumentation must be able to meet requirements established by the DDEAMC antibiotic pharmacy formulary and organizational Antimicrobial Stewardship Committee; departmental space constraints and organizational Regulated Medical Waste (RMW) guidelines and initiatives. All antibiotics and antifungals outlined within Table 3.7 must be FDA approved at the time of contract award.

3.7. Antibiotics and Antifungals:

Gram Negative Doxycycline Gram Positive Nitrofurantoin Amikacin Ertapenem Amoxicillin Oxacillin

Amoxicillin/Clavulanic Acid ESBL Confirm Ampicillin Penicillin Ampicillin Fosfomycin Cefoxitin Screen Rifampin

Ampicillin/Sulbactam Gentamicin Ceftriaxone Tetracycline Aztreonam Imipenem Clindamycin Trimethoprim/

Sulfamethoxazole Cefazolin Levofloxacin Daptomycin Vancomycin Cefepime Meropenem Doxycycline Yeast

Cefpodoxime Nitrofurantoin Erythromycin Caspofungin Ceftriaxone Piperacillin/ Tazobactam Ind. Clindamycin

Resistance Fluconazole

Ciprofloxacin Tobramycin Levofloxacin Voriconazole Trimethoprim/Sulfamethoxazole

3.8. Removal of Equipment: Within 30 days after the expiration or termination of the contract the contractor shall remove the equipment from the Government premises, to include disconnection, packaging, and shipping. 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.

3.9. Materials: Contractor will ensure reagents meet or exceed proficiency testing standards of CAP, TJC, CSLI, and be approved by the FDA. A process will be available for peer comparison of quality control. The vendor shall provide monthly replenishment shipments based upon metering (or other mutually agreeable method). If consumables are found to be defective, back order or recalls, the contractor agrees to shipping items overnight at no additional cost to the government.