DRAFT_Statement of Work - Reagents Supplies.docx

STATEMENT OF WORK

DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTERS

VA Palo Alto Healthcare System (VAPAHCS)

CLINICAL LABORATORY MICROBIOLOGICAL SYSTEM

FOR IDENTIFICATION AND ANTIBIOTIC SUSCEPTIBILITY OF MICROORGANISMS

CONSUMABLES

1. Scope:

The Contractor shall provide VAPHCS with standardized microbiological system for the identification (ID) and antimicrobial susceptibility testing (AST) of microorganisms which shall have the capability of performing or reporting the clinical parameters as defined for the VAPHCS facilities. The system shall be able to simultaneously perform the complete profile and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). The Contractor shall quote the suggested/recommended equipment/reagents for VAPAHCS sites that meet the requirements of the facility.

Contractor shall provide all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, printers, barcode and laser, and any other item required for the proper operation of contractor owned organism identification (ID) and antimicrobial susceptibility (AST) analyzer for microbiology and peripherals necessary for the generation of Microbiology Cost Per Reportable Result (CPRR) services for VAPHCS. The Contractor shall provide supplies to facility in accordance with the estimate given.

Definitions:

The price shall include costs covering (a) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, barcode and any other item required for the proper operation of the contractor’s equipment and necessary for the generation of a patient reportable result. This does not include those items approved for exclusion by the government such as printer paper, labels etc. It will also include the material to perform as well as all other costs associated with quality control, and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI).

2. Pricing Schedule:

VAPHCS will provide estimated volumes of tests for each individual medical center. Pricing shall be based on the average daily test volume per instrument/analyzer. The Government estimates the volumes per facility but does not guarantee volumes. They are ESTIMATES ONLY.

Offers must include a schedule of items offered and per item cost with any tiered pricing for volumes.

Offerors shall provide pricing for each test that can be performed on the quoted equipment. They shall include all costs for:

a. All consumables, reagents, McFarland standards, controls, supplies, inter-laboratory comparison program, and new/change of panels quality control requirement to meet CLSI guidelines.

3. Requirements:

a. Continuous supply of consumables for a total period of 1 year.

b. Each offer shall comply with all general requirements stated herein. Each Contractor shall submit as part of their offer, technical data or descriptive literature to ascertain that the items offered meets the requirement.

c. The Contractor shall provide FDA approved automated identification and antibiotic susceptibility test systems. Discontinued models/items are unacceptable.

d. The Contractor shall state the failure mean time (between failure and mean time to repair) for each piece of equipment offered. Emergency replacement of equipment shall be provided by the Contractor.

e. Offered testing equipment shall be new state-of-the-art equipment. Remanufactured and discontinued models will not be accepted

f. Utilities specification

4. Microbiologic System Specific Requirements:

The Contractor shall assess equipment, workflow, volumes and space to meet the individual VAPAHCS site’s requirements with minimum cost.

General Requirements:

a. The consumables shall be FDA approved for clinical use

b. The consumables shall be compatible with current VAPAHCS Pathology & Laboratory equipment

c. The system shall provide self-contained, automated identification and antibiotic susceptibility testing system for aerobic, facultative, fastidious, and anaerobic microorganisms and yeasts.

d. Clinical laboratory assays currently performed at the VAPAHCS Pathology and Laboratory Medicine Services shall include, but may not be limited to the following assays:

e. Provide organism identification

f. Test antimicrobial susceptibility, by truly measured MIC method

g. Detect antibiotic resistance

h. The Contractor shall provide to each facility a copy of Assay Instructions for Use (IFU) in Clinical and Laboratory Standards Institute (CLSI) digital format at time of installation using software compatible with VA (Microsoft Office Word).

i. Offered models of organism identification and antimicrobial susceptibility analyzers for clinical microbiology laboratory shall be capable of producing accurate and reproducible assays on biological and other specimens by established in vitro diagnostic methods. Models provide accurate test assay results for sample specimens up to the manufacturer's defined maximum testing capabilities without excessive malfunctions, breakdowns, or service calls.

j. Contractor offered products shall perform satisfactorily at any laboratory temperature between 10 and 32⁰C and relative humidity between 15 and 85 percent.

k. Inventory of consumables shall fit within VAPAHCS existing laboratory storage space.

5. Ancillary Supplies:

The Contractor shall provide any and all ancillary support consumables/supplies, parts and accessories necessary to fully operate the ID &AST analyzer(s) as defined in these specifications, e.g., McFarland standards. The Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits etc.

6. Inventory:

a. DELIVERY OF SUPPLIES. Any unexpected changes in methodology/technology shall be at the expense of the Contractor.

b. ALERT/NOTIFICATION OF DELAYS. In shipments as well as all technical advisory/recalls/alerts, prior to or simultaneously with field alerts shall be forwarded to the department supervisor, lab chiefs, and the clinical systems program office manager.

c. SPECIAL HANDLING FOR EMERGENCY ORDERS OF SUPPLIES: 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 routing supply delivery, the contractor is required to deliver the consumable supplies within 24 hours of receipt of a verbal order for priority delivery from the government activity. If either circumstance has occurred, the contractor will deliver to the government site in the most expeditious manner possible without additional cost to the Government.

d. QUALITY OF SUPPLIES: The contractor shall maintain on Government provided space a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other material or commonly stocked parts 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/reproducibility and accuracy. The quality of the products shall be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP), Clinical Laboratory Standards Institute (CLSI) and the Joint Commission on Accreditation (JC).

If 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 by the Government activity. If either circumstance has occurred, the contractor shall deliver to the requested facility site, 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 will be honored by the contractor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory may result in default.

7. Invoicing:

Counts per unit of consumable (e.g. box, pack, kit, case etc.)

8. Implementation and Transition:

The Contractor shall provide with its quotation a transitioning plan for the complete transition including training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all comparisons and validations. This transition shall be completed no later than 60 days after the award. This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe.

Deliver to:

VA Palo Alto Healthcare System Pathology & Laboratory Medicine Service Microbiology Laboratory E4-304 3801 Miranda Ave., Palo Alto, CA 94304

9. Comparison and Validation of Analyzer:

The Contractor shall perform to the satisfaction of the Government, at no cost to the Government all comparison and validation/verification studies to include any material and reagents needed for such correlation. The Contractor shall perform all the statistical analysis and report data in an organized, clearly comprehensible format. The Contractor shall accommodate clinical preferences and requests by the laboratory. This process shall be completed within two weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards, TJC standards and Federal Regulations.

10. Site-Specific Requirements:

Equipment must meet the volume and turnaround time requirements—Identification if using Maldi Biotyper analyzer within 18-24 hours from incubation and Identification from Panel 24-48 hours from incubation. Susceptibility turnaround time should be within 18-48 hours from incubation time. See the Facilities’ Specific Requirements and Proposed Equipment below.

11. Technical Requirements:

In addition to the general requirements stated above, the Contractor shall make every attempt to provide supplies meeting the following requirements, characteristics and capabilities:

Characteristics:

a. The system should have a comprehensive and extensive database of bacteria and yeast species that is consistent with CLSI guidelines. Vendor should provide software upgrades at no charge to the government when CLSI guidelines change or are updated, or changes in bacterial nomenclature.

b. Provides a broad test menu available with reliable methodologies and has capability to expand menu options for ID & AST for gram-positive, gram-negative organism and yeast organism, Identification of anaerobes, fastidious, and yeast organisms.

c. The range of FDA approved ID panels for the accurate detection of gram-positive, gram-negative, anaerobes, Haemophilus, Neisseria, fastidious, HACEK, and yeast organisms, such as conventional, rapid, combo, and synergy panels.

d. The system should offer a comprehensive array of bacterial antimicrobial susceptibility panels to meet facility needs. The contractor shall supply a list of available susceptibility panels as well as a list of antibiotic exceptions for their methodology at time of quote.

e. Strep microbroth dilution MIC panel with leaked Horse blood broth

f. Rapid anaerobic, and yeast ID panel.

g. Identification of organisms in the method of Mass Spectrometry Time of Flight (MALDI-TOF).

h. Broad range of FDA approved AST panels with lower concentration of current antibiotics for the detection of resistance patterns which includes D-test, cefoxitin screen, ESBL, KPC, NDM-1, metallo, etc.

i. Resistance detection and confirmation mechanism for the following but not limited to ESBL confirmation, carbapenemase resistance Enterobacteriaceae and/or Acinetobacter (CRE/CRAB), NDM-1, AmpC, Vancomycin resistance Enterococci (VRE), Methicillin resistance S. aureus (MRSA), Vancomycin intermediate resistant S. aureus (VISA/VRSA), etc. with microbroth dilution MIC, panels.

j. AST results by direct measure rather than calculated MICs.

k. Panels should not require a great deal or comprehensive or extra testing menu to achieve an accurate ID/AST result.

l. Organism identification and sensitivity panels can be used on all the automated, semi-automated and manual systems in the manufacturer’s line of instruments.

m. Organism identification and sensitivity panels can be read manually if automated or semi-automated analyzer is non-functional or to confirm interpretations from automated or semi-automated analyzers.

n. The QC material shall be included in the contract for all tests in use.

12. Reagent and Standards:

a. Convenient Reagent look-up and Standard Use of instrument

b. Extended reagent shelf life

c. Energy and space efficient reagent storage (room temperature vs. refrigerated)

d. Reagents have prolonged shelf life and stability once opened/on board

e. Various reagent sizes for large/small volume facilities

f. Equipment interface compatible for onboard reagent level inventory

g. Instrument alerts operators to reagents/consumables needed to complete testing

h. As new methods are released for instruments, the updates are automatically enabled promptly and at no cost to user

(End of SOW)