DRAFT SOO_Microbiology.pdf

STATEMENT OF OBJECTIVES

The Keesler Medical Center Clinical Laboratory at Keesler AFB, Mississippi requires one (1) automated system that performs microbial identification and antimicrobial susceptibility testing and one (1) automated microbial detection system for the monitoring of the presence or absence of microorganisms from both blood and other sterile body fluid samples. The successful offeror shall furnish all equipment, reagents, and any necessary services (e.g., maintenance of furnished equipment) to Keesler Medical Center, Keesler AFB, MS for the purpose of Microbiology testing. The requirement must include equipment and reagents to perform the following number of tests per year:

Required capability Estimated test quantity per year Bacterial Gram-negative identification 900 Bacterial Gram-positive identification 500 Neisseria/Haemophilus identification 120 Anaerobic bacterial identification 100 Yeast identification 100 Bacterial Gram-negative susceptibility testing 1,500 Bacterial Gram-positive susceptibility testing 1,300 Bacterial Streptococcus susceptibility testing 120 Yeast susceptibility testing 100 Aerobic bottles for microorganism monitoring 1,500 Anaerobic bottles for microorganism monitoring 1,500 Pediatric bottles for microorganism monitoring 600

All equipment and reagents shall be supplied and serviced through the Contractor to include all parts, equipment, supplies, and other services required to ensure Keesler Medical Center is able to meet its objectives as listed herein.

Period of Performance:

Base: 1 October 2024 – 30 September 2025 Option 1: 1 October 2025 – 30 September 2026 Option 2: 1 October 2026 – 30 September 2027 Option 3: 1 October 2027 – 30 September 2028 Option 4: 1 October 2028 – 30 September 2029

1. Authorization to Operate (ATO) Subfactor 1A)

1.1. Instrument should have the capability to interface with the laboratory information system (LIS), MHS Genesis. Newly installed instruments will require an approved authorization to operate (ATO) on the DHA network in order to interface with the LIS as listed on https://info.health.mil/apps/HIT/cstar/Pages/Systems.aspx.

1.2 Middleware must have an approved ATO prior to use and any subsequent billing.

Military Health System (MHS) Genesis FFP.

The analyzers must have an interface that is compatible to the current Government Laboratory Information System (LIS), Composite Health Care System (CHCS), and new Government LIS, Military Health System (MHS) Genesis. Each interface must allow for recognition and interpretation of CHCS and MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Contractors instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance. Location: 81MDTS/SGQC Clinical Laboratory, Keesler Medical Center, Keesler Air Force Base, MS

2. Instruments/Equipment and Reagents/Consumables (Subfactor 1B)

2.1. Instruments/Equipment

2.1.1. Keesler AFB has the required equipment in house under contract that ends March 31, 2025. There have been no updates to the current analyzers and all equipment is working as intended.

2.1.2. Instrument must be Food and Drug Administration (FDA) approved for microbial identification and antimicrobial susceptibility testing. Testing must include confirmatory identification and minimum inhibitory concentration of microorganisms.

2.1.3. Must supply benchtop for instrument to fit in a space approximately 28” wide by 27” deep with the instrument approximately 24” in height.

2.1.4. Instrument must use existing 100/120 VAC (50-60 HZ) power capability that is within 5’ of the installation location.

2.1.5. The instrument must have the capability of sample and reagent bar-code reading.

2.1.6. The instrument must have automatic dilution of patient samples, so that no manual predilutions are necessary.

2.1.7. The contractor will include all equipment and supplies capable of comprehensive microbial identification and susceptibility testing to include Gram negative, Gram positive, aerobic, and anaerobic bacteria and yeast for the estimated annual quantities in the table below.

Required capability Estimated test quantity per year Bacterial Gram-negative identification 900 Bacterial Gram-positive identification 500 Neisseria/Haemophilus identification 120 Anaerobic bacterial identification 100 Yeast identification 100 Bacterial Gram-negative susceptibility testing 1,500 Bacterial Gram-positive susceptibility testing 1,300 Bacterial Streptococcus susceptibility testing 120 Yeast susceptibility testing 100

2.1.8. Instrument and reagents must have the ability to determine inducible clindamycin resistance, extended-spectrum beta-lactamase producing organisms and methicillin resistant Staphylococcus aureus.

2.1.9. Instrument and reagents must have the ability to produce minimum inhibitory concentration results, following CLSI recommendations and breakpoints, for the following antimicrobials and organisms with the opportunity to expand to test for additional antimicrobials as deemed necessary by the Keesler Medical Center Antimicrobial Stewardship Committee:

Gram Negative Organisms Ampicillin Ampicillin/Sulbactam Cefazolin Piperacillin/Tazobactam Ceftazidime Ceftriaxone Cefepime Aztreonam Ertapenem Meropenem Amikacin Gentamicin Ciprofloxacin Tigecycline Nitrofurantoin Trimethoprim/Sulfamethoxazole

Gram Positive Organisms Ampicillin Ciprofloxacin Clindamycin Daptomycin Doxycycline Erythromycin Gentamicin Gentamicin High Level

(synergy) Levofloxacin Linezolid Moxifloxacin Nitrofurantoin Oxacillin Rifampicin Tetracycline Streptomycin High Level

(synergy) Tigecycline Vancomycin Trimethoprim/Sulfamethoxazole

Streptococcus sp.

Ampicillin Benzylpenicillin Cefotaxime Ceftriaxone Clindamycin Erythromycin Levofloxacin Linezolid Moxifloxacin Tetracyclines Tigecycline Trimethoprim/Sulfamethoxazole Vancomycin

Yeast Caspofungin Fluconazole Micafungin Voriconazole

2.1.10. Contractor must provide instrument training.

2.1.11. Contractor must perform periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational.

Response to service needs provided not later than 24 hours and resolution not later than 48 hours (local service personnel preferred) from report of service need or receipt of replacement parts within standard business hours (5 days, 8 hours).

2.2. Microbial detection system for the monitoring of the presence or absence of microorganisms

2.2.1. Keesler AFB has the required equipment in house under contract that ends March 31, 2025. There have been no updates to the current analyzers and all equipment is working as intended.

2.2.2. Instrument must be Food and Drug Administration (FDA) approved for the monitoring of the presence or absence of microorganisms from both blood and other sterile body fluid samples.

2.2.3. The analyzers must meet all necessary power and waste requirements as dictated by the current laboratory workspace. Instrument must fit in a space approximately 48” wide by 36” deep for the blood culture platform. This equipment is 12” from an outlet. The microbial identification and susceptibility testing platform must fit into a space of 60” wide by 36” deep, with approximately 40” from two (2) wall outlets. For a benchtop instrument, a workbench must be provided. (Please see attachment 1 & 2)

2.2.4. Instrument must use existing 100/120 VAC (50-60 HZ) power capability.

2.2.5. Instrument must have minimum capacity to monitor 120 bottles at one time.

2.2.6. Bottles must be plastic and be FDA approved for the detection of microorganisms in blood and other sterile body fluids to include synovial fluid for the estimated quantities listed in the table below:

Required capability Estimated test quantity per year Aerobic bottles for microorganism monitoring 1,500 Anaerobic bottles for microorganism monitoring 1,500 Pediatric bottles for microorganism monitoring 600

2.2.7. Instrument should have the capability to interface with the laboratory information system (LIS), MHS Genesis. Newly installed instruments will require an approved authorization to operate (ATO) on the DHA network in order to interface with the LIS as listed on https://info.health.mil/apps/HIT/cstar/Pages/Systems.aspx.

2.2.8. Middleware must have an approved ATO prior to use and any subsequent billing.

Military Health System (MHS) Genesis FFP. The analyzers must have an interface that is compatible to the current Government Laboratory Information System (LIS), Composite Health Care System (CHCS), and new Government LIS, Military Health System (MHS) Genesis. Each interface must allow for recognition and interpretation of CHCS and MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Contractors instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance. Location: 81MDTS/SGQC Clinical Laboratory, Keesler Medical Center, Keesler Air Force Base, MS

2.2.9. Usage of all computer components, printers and accessories needed to operate instrument and middleware.

3. Service and Maintenance (Subfactor 1C). The Contractor shall meet the following service and maintenance requirements:

3.1 Contractor must perform periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational.

Response to service needs provided not later than 24 hours and resolution not later than 48 hours (local service personnel preferred) from report of service need or receipt of replacement parts within standard business hours (5 days, 8 hours).

3.2 Contractor shall provide product service and support to include updates to operational software throughout the life cycle of the equipment.

4. Training (Subfactor 1D)

Instrument training.

4.1. The Contractor shall provide the following training at no additional cost to the Government:

4.1.1. Initial training (upon award) for two (2) key operators including lodging (hotel), per diem, and travel (airfare) expenses to/from Keesler AFB, hotel, and training location (offsite location).

Additional training, upon request, for one operator per year per instrument (if offsite, lodging (hotel), per diem, and travel (airfare) expenses included to/from Keesler AFB, hotel, and training location). Alternative training delivery (i.e., distance training), if determined by the Government customer to be of equivalent quality, may be entertained in lieu of offsite, in-person training for non-initial training.

4.1.2 All training shall include basic analyzer operation, troubleshooting procedures, performance of operator level periodic preventive maintenance procedures, and the use of any data management/quality control software.

5. Delivery and Installation (Subfactor 1E).

5.1. All systems shall be delivered to the appropriate location indicated below.

Keesler Medical Center Clinical Laboratory 81 MDTS/SQQC 301 Fisher St Keesler AFB, MS 39534

5.2. The Contractor shall assign a Program Manager to oversee all operations required for successful implementation and execution of the requirement.

5.3. Within 10 working days after contract award, Contractor shall coordinate and conduct a post award site visit for the purpose of coordinating the schedule for equipment installation.

5.4. Contract must include instrument installation, set-up, validation, supplies and labor.

Instruments must be installed, validated and ready for patient testing within 60 days of award.

This includes all correlation, precision, linearity, normal range and any other required validation studies by a contractor provided technical service representative (TSR). The TSR should possess a thorough knowledge of method validation/verification and, where applicable, is familiar with the use of clinical laboratory statistical evaluation software (e.g. EP Evaluator®). The assigned TSR will be responsible for the entire method validation to the standards of the acting medical director. The completed validation studies and raw data must be provided to the Microbiology management staff electronically and, in a binder, at least 3 weeks prior to analyzer functionality.

5.5. Method validation/verification will be conducted in accordance with CLIA and/or the College of American Pathologists (CAP) and to the ultimate satisfaction of the medical director.

5.6. The method validation/verification will be completed and approved by the Laboratory Director prior to reporting of patient results. Payment for services will not begin until the analyzer system has been approved for reporting of patient results.

5.7. All instrument reagents, calibrators, linearity materials and other required reagents/materials used in the method validation/verification study will be provided by the Contractor at no additional cost to the Government. Assay lots will be quality checked upon delivery.

Contractor’s customer samples may also be used. These materials will not be used in the analysis of specimens for patient care.