36C25919Q0325-002.docx

DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTERS

VISN 19

STATEMENT OF WORK

CLINICAL LABORATORY MICROBIOLOGICAL SYSTEM

FOR IDENTIFICATION AND ANTIBIOTIC SUSCEPTIBILITY OF MICROORGANISMS

1. Scope:

The Contractor shall provide VISN 19 facilities 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 VISN 19 facilities. The instruments 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 VISN 19 sites that meet the requirements of the facility.

Contractor shall provide all equipment, reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, Uninterruptible Power Supply UPS, 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 VISN 19. The Contractor shall provide analyzers and supplies to each facility in accordance with the estimate given. Participating VISN 19 Medical Centers are located as follows:

a. VAMC Grand Junction, Colorado, 2121 North Avenue, Grand Junction, CO 81501

b. VA Montana Healthcare System, Ft. Harrison (Helena), Montana, 1892 Williams Street, off Hwy 12 West, Fort Harrison, MT 59636

c. VAMC Cheyenne, Wyoming, 2360 East Pershing Blvd., Cheyenne WY 82001

d. VAHCS Sheridan, Wyoming, 1898 Fort Road, Sheridan, Wyoming 82801

2. Definitions:

Cost Per Reportable Result (CPRR): The per reportable result price shall include costs covering (a) equipment use, (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, Uninterruptible Power Supply UPS, printers, barcode and laser 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. This per patient reportable result price shall also encompass all costs associated with dilution, repeat and confirmatory testing required producing a single patient reportable result. 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 Clinical and Laboratory Standards Institute (CLSI) (c) All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs and (d) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

3. Pricing Schedule:

VISN 19 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. The CPRR shall include all costs for:

a. Equipment use

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

c. All necessary maintenance to keep equipment in manufacturer's operating conditions, both preventive maintenance, and emergency repairs

d. Training for VISN 19 personnel operating equipment

e. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

4. Requirements:

a. Each model of clinical laboratory analyzer offered 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 equipment offered meets the requirement.

b. The Contractor shall provide FDA approved automated identification and antibiotic susceptibility systems/analyzers. Remanufactured or discontinued models are unacceptable.

c. 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.

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

e. Utilities specification

5. Microbiologic System Specific Requirements:

The Contractor shall assess equipment, work flow, volumes and space to meet the individual VISN 19 site’s requirements with minimum cost.

General Requirements:

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

b. The system shall have a data management system with varied options for analysis and reporting/review of cumulative patient data on organism’s isolated and antimicrobial profiles, and allow for manual modification of susceptibility breakpoints to comply with new CLSI guidelines until the vendor applies necessary software updates.

c. Clinical laboratory assays currently performed at the VISN 19 Pathology and Laboratory Medicine Services shall include, but may not be limited to the following assays:

d. Organism Identification

e. Antimicrobial Susceptibility, by true measured MIC method if applicable

f. Detection of antibiotic resistance

g. Expert rule for Unusual ID & AST results

h. Software to prepare site specific reports

i. The system shall have battery backup UPS capable of maintaining data for at least 24 hours in the event of a facility power failure. This will be maintained or replaced by contractor

j. The Contractor shall provide hardware/software upgrades necessary to maintaining the integrity of the system at no additional charge to the government. These must be provided as they become available and as they are being offered to commercial customers. Changes in CLSI guidelines shall be implemented into the software upgrades in a timely manner.

k. The Contractor shall provide to each facility a copy of operating procedures in Clinical and Laboratory Standards Institute (CLSI) digital format at time of installation using software compatible with VA (Microsoft Office WORD).

l. 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 shall provide accurate test assay result for sample specimens up to the manufacturer's defined maximum testing capabilities without excessive malfunctions, breakdowns, or service calls.

m. The Contractor shall provide hardware and operating system software upgrades necessary to maintaining the integrity of the system at no additional charge to the Government during the lifetime of the instrument. These enhancements shall be delivered and installed at each participating VISN 19 medical facility within 60 days of issuance to the commercial market. Changes in CLSI guidelines shall be implemented into the software upgrades in a timely manner.

n. A printer for each analyzer shall be provided by the contractor. This will be maintained or replaced by contractor.

o. The system shall also offer independent, manual processing and printing of a chartable result in the event of LIS downtime.

p. Contractor offered equipment shall perform satisfactorily at any laboratory temperature between 50 and 90 degrees Fahrenheit (10 and 32⁰C) and relative humidity between 15 and 85 percent.

q. Contractors offered ID/AST microbiology analyzers shall conform to VISN 19 existing laboratory space.

6. Interfacing:

Instrumentation proposed shall be capable of bi-directional, bar-coded, and uploading to the host computer). All contractor computer systems need to have Windows 7 or higher to be compatible with VA security requirements.

Provide bi-directional interface for Data Innovations (other facilities) and for Dawning (RMRVAMC, Denver) using VISTA. Contractor shall provide to all Dawning Users Secure Network Interface (SNI) box and cables and all necessary software and licensing required for Dawning operations/interfacing with contractor’s equipment.

The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA VISTA hospital information system at the time of award and includes all medical center facilities. The Contractor shall provide all necessary software support for insuring that successful interfacing has been established with these systems. Specific requirements for the communication of the data streams shall be unique to the instrument system involved and dictated by the manufacturer itself. The Computer must interface with VISTA (at a minimum shall be capable of downloading patient demographics from host computer, integrating this information with test results and have the ability to recall and re-transmit test results to host computer

7. Ancillary Equipment and Supplies:

The Contractor shall provide, install and maintain, as indicated, any and all ancillary support equipment, consumables/supplies, parts and accessories necessary to fully operate the ID &AST analyzer(s) as defined in these specifications, e.g., McFarland standards, cabinetry to support/house the analyzer (if necessary) and universal interface equipment, Uninterruptible Power Supply (UPS) capable of supporting the full scope of equipment operation with a built-in line conditioner, for each proposed analyzer. The Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc. Contractor shall provide a report printer and replace such if needed.

8. Maintenance and Repair:

The Contractor shall be able to provide emergency equipment repair and preventative maintenance and any incremental support equipment, e.g. water system, offered according to the following terms:

a. With the exception of the specific maintenance and repair requirements stated herein, which shall have precedence; preventive maintenance, emergency repair, maintenance credit for equipment malfunction, and replacement laboratory equipment.

b. A technical assistance or support center shall be available by telephone hot-line 24/7 days/week with a maximum call back response time of 1 hour with on-site service provided, not to exceed 24 hours following determination that site service is required. The technical assistance center shall be staffed with personnel who are fluent in English without the use of an interpreter.

c. Emergency repairs shall be performed after initial telephone notification that the equipment is inoperative. The contractor shall provide the Government with a designated point of contact and telephone number and shall plan to enable his maintenance representative to receive such notification.

d. Ability to provide equipment service on a 24-hour/day 7 days/week basis for hospital-based systems.

e. Scheduled preventative maintenance calls shall occur at a frequency to meet the minimum manufacturer’s requirements to keep the equipment in optimal operating condition.

f. Every notification for a repair service call shall be treated as a separate and new service call.

g. The Contractor shall be on-site at the affected VA facility to perform emergency repair service to testing and ancillary instruments within twenty-four (24) hours after receipt of initial telephone notification of a malfunction. Contractor shall provide medical center maintenance coverage 24 hours per day, seven days per week including all Federal holidays. Contractor shall be required to provide maintenance for each participating site Monday through Friday from 8:00 a.m. until 5:00 p.m., excluding Federal holidays. Contractor shall provide technical support service to assist in troubleshooting 24 hours per day, seven days per week including Federal holidays.

h. The following facilities require business hours (on-site Monday through Friday, except holidays; 7:30 am – 4:00 pm, local Mountain Time).

· VAHCS Sheridan, Wyoming

i. The following facilities require extended hours (on-site 7 days per week, including contractor’s holidays; at least 8:00 am – 5:00 pm, local Mountain Time) service in accordance with the contractor’s FSS contract.

· VAMC Grand Junction, Colorado

· VA Montana Healthcare System, Ft. Harrison (Helena), Montana

· VAMC Cheyenne, Wyoming

j. In addition to above the contractor shall furnish a malfunction incident report to the installation upon completion of each repair call. The report shall include, as a minimum, the following:

· date and time notified;

· date and time of arrival;

· serial number, type and model number(s) of equipment;

· time spent for repair;

· description of malfunction and repair; and

· proof of repair that includes documentation of a sample run of quality control verifying acceptable performance

k. The Contractor shall not leave a service call open pending verification that repairs completed by the contractor’s maintenance personnel. For each instrument provided the contractor shall treat each notification for an emergency/repair service call from the Government as a separate and new service call.

l. Should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the contractor. The Government agrees to maintain the equipment according to manufacturer’s specifications. Each instrument provided by the contractor shall maintain an uptime of 90% in each month of the term of the agreement.

9. Inventory Control Reagents, Supplies and Disposable:

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 VISN 19 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).

Consumables 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 from the Government activity. If either circumstance has occurred, the contractor shall deliver to the requesting VISN 19 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.

10. Invoicing:

Test counts for invoicing by CPRR.

It is understood that it may not be possible to meet all VA specific requirements utilizing a single instrument. As such, Contractors shall be required to submit pricing in different formats. Contractors shall provide an all-inclusive cost to perform all tests and requirements as outlined herein, as applicable and offers shall provide a price based on each individual color code as provide in the price schedule.

11. Training:

The Contractor shall provide training on the operation of the system, data manipulation, preventative maintenance and basic trouble shooting and repair for 2 key operators (see site specific training requirement). Any training program that involves off-site travel shall include the cost of airfare, room and board for each participant. A training or competency checklist shall be provided by the Contractor.

Provide on-site vendor operator training for all personnel who will run instrument with training provided for all applicable staff.

12. Site preparation:

Specifications shall be furnished in writing by the Contractor as a part of the equipment quote. 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 each facility to ensure the right size equipment is provided; thereby not creating a safety hazard. Equipment offered shall fit existing space with no alterations or requirements for site prep work.

13. Implementation and Transition:

The Contractor shall provide with its quotation a transitioning plan for the complete transition including installation and 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.

14. Comparison and Validation of Analyzer:

The Contractor shall perform at each site, 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 and Federal Regulations.

15. Site-Specific Requirements:

Equipment must meet the volume and turnaround time requirements, if specified, of the using facilities. See the Facilities’ Specific Requirements and Proposed Equipment below.

c. VA Montana Health Care System, 1892 Williams Street, off Hwy 12 West, Fort Harrison, MT 59636:

· Walk-away capability required

· 2 key operators to all-expense paid off site training.

· Provide in-house training for other technologists.

· Repair or replacement of printers, UPS, and any other equipment required is at the expense of contractor.

· Conventional and rapid ID panels.

· Vendor shall supply all interface software support, and cables needed for bidirectional interface. These cables will be sufficient in length to reach from the analyzer to the DI server.

· The contractor shall be on site at the affected VA facility to perform emergency repair within 24 hours after receipt of initial telephone notification of a malfunction.

d. Grand Junction VA Medical Center, 2121 North Avenue, Grand Junction, CO 81501:

· Walk-away capability required.

· 2 key operators to all-expense paid off site training.

· Provide in-house training for other technologists.

· Conventional, rapid, and synergy panels

· Repair or replacement of printers, UPS, and any other equipment required is at the expense of contractor.

· Vendor shall supply all interface software support, and cables needed for bidirectional interface.

· The contractor shall be on site at the affected VA facility to perform emergency repair within 24 hours after receipt of initial telephone notification of a malfunction.

· Vendor shall supply all interface cables needed for bidirectional operation. These cables will be sufficient in length to reach from the analyzer to the DI server.

e. Sheridan VA Medical Center, 1898 Fort Road, Sheridan, Wyoming 82801:

· Walk-away capability required.

· 2 key operators to all-expense paid off site training.

· Conventional, rapid, and synergy panels

· Repair or replacement of printers, UPS, and any other equipment required is at the expense of contractor.

· Contractor shall supply all interface cables needed for bidirectional operation. These cables will be sufficient in length to reach from the analyzer to the DI server.

· The Contractor shall be on site at the affected VA facility to perform emergency repair within 24 hours after receipt of initial telephone notification of a malfunction.

f. Cheyenne VA Medical Center, 2360 East Pershing Blvd., Cheyenne WY 82001:

· Walk-away capability required.

· 2 key operators to all-expense paid off site training.

· Provide in-house training for other technologists.

· Conventional, rapid, and synergy panels

· Repair or replacement of printers, UPS, and any other equipment required is at the expense of contractor.

· Vendor shall supply all interface software support, and cables needed for bidirectional interface.

· The contractor shall be on site at the affected VA facility to perform emergency repair within 24 hours after receipt of initial telephone notification of a malfunction.

· Vendor shall supply all interface cables needed for bidirectional operation. These cables will be sufficient in length to reach from the analyzer to the DI server.

16. Technical Requirements:

In addition to the general requirements for the Microbiology Cost-Per-Reportable Result (CPRR) stated above, the Contractor shall make every attempt to provide equipment, peripherals and supplies meeting the following requirements, characteristics and capabilities:

Characteristics:

a. The system shall have a comprehensive and extensive data base of bacteria and yeast species that is consistent with CLSI guidelines. Vendor shall 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, ID of anaerobes, fastidious, and yeast organism.

c. 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 shall offer a comprehensive array of bacterial antimicrobial susceptibility panels which each individual facility may select to meet individual needs. 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 laked Horse blood broth

f. Rapid anaerobic, and yeast ID panel.

g. 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.

h. Resistance detection and confirmation mechanism for the following but not limited to ESBL confirmation, carbapenemase resistance enterobactericeae 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.

i. AST results by direct measure rather than calculated MIC’s.

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

k. Provides and performs bar-code operations for specimens, panels, and controls.

l. System shall be an open system which can accommodate user-defined methods such as, entering susceptibility for drugs, selection of organisms, etc.

m. Contractor may provide variants of instrument accommodating various workload requirements and backup needs. Geographical location of like instruments is sufficient to assist in reagent/supply crisis situations.

n. Additionally, Contractor shall provide details of the location of maintenance personnel in relation to VISN 19 and the amount of territory covered by that personnel and experience of maintenance personnel servicing VISN 19.

o. Contractor shall supply all interface cables needed for bidirectional operation. These cables will be sufficient in length to reach from the analyzer to the DI server.

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

q. 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.

r. If manual reading and interpretation of identification and sensitivity panels not available, vendor must supply a back-up instrument with similar/same capabilities as primary instrument.

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

t. Operation and maintenance procedures shall be provided on electronic media, instrument or website. Contractor shall state which medium the procedures are provided.

17. Software:

Instrument software shall be versatile and easy to use with following capabilities:

a. Cost of auto-verification programming and validation covered in contract should the VA software change allow for this option during the duration of this contract.

b. Contractor shall provide, as part of its offer, a list of VA sites currently using interfaces for the instrument offered.

c. As part of your offer provide the number of instruments operating in the United States and provide information on said equipment, to include record of hardware and software reliability, reagent recall history in past two years, percentage of downtime and average number of service calls per month for each piece of equipment/systems offered.

d. Look up capabilities for results on samples being processed.

e. Ability to store Quality control of reagents/panels.

f. Ability to alarm/flag repeat testing of unusual isolates, susceptibilities, and drug-bug combination.

g. Contributes to enhanced workflow efficiency and improved patient outcomes

h. Ability to detect and alert/flag operator of instrument problem.

i. Ability to detect and alert/flag operator of empty reagent containers/vials

j. Ability to alarm/flag reflex testing to confirm unusual results per CLSI & FDA guidelines.

k. On-board sample inventory

l. Software allows review of QC and patient results for to help in troubleshooting.

m. Software is upgradeable (provide list of versions).

n. Desirable features of software include programmable rules for reporting, auto-verification, and reflex testing.

o. Recognizes isolates that are declared public health risks and isolates that should be reported to the public health department.

p. Above software features can be accomplished by instrument software or middleware. If middleware is needed, include necessary hardware and software in contract and CPRR calculation.

q. The system shall also offer independent, manual processing and printing of a chartable result in the event of LIS downtime.

r. Software allows user defined configurations such as, suppressions of antibiotic results, antibiotic reporting order, and interpretation and warning flags, etc.

s.

Equipment shall be versatile and provide efficient hardware capabilities.

a. Uninterruptible power supply (surge protection + battery backup) provided and serviced by vendor for sites requiring such.

b. Hardware upgrades are available as needed and include any necessary training.

c. Laboratory has space for instrument and peripherals. Vendor will supply plan for placement of new analyzer(s) prior to initial method validation and after when transitioning to new instruments. Plans must be site-specific and accurately reflect available space at each site.

Equipment and software shall at a minimum, provide operator-friendly maintenance requirements.

a. Routine maintenance takes minimal tech time.

b. Routine maintenance, function checks cause little or no delay to testing.

c. Reliable technology used for detection of drug resistance.

d. Instrument troubleshooting is easy and straightforward

e. Instrument is connected via modem to hotline that can view instrument status and remotely control troubleshooting process. Contractor has high percentage of technical services calls answered directly by technician (no message left for call-back).

18. Reagent and Standards:

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

b. Extended reagent shelf life.

c. 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. On-board reagent inventory.

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

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