DOCUMENT
66 -- Microbiology CPT - Attachment
- Notice Date
- 10/15/2018
- Notice Type
- Attachment
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of Veteran Affairs;Network Contracting Office 10;5500 Armstrong Rd.;Battle Creek MI 49037
- ZIP Code
- 49037
- Solicitation Number
- 36C25019Q0053
- Response Due
- 10/22/2018
- Archive Date
- 12/21/2018
- Point of Contact
- Brooke Hansen
- Small Business Set-Aside
- N/A
- Description
- This is a REQUEST FOR INFORMATION and SOURCES SOUGHT for a Cost-Per-Reportable Result (CPRR) contract that will include all equipment [including uninterruptible power supply (UPS)], installation, reagents, startup Quality Control (QC) and validation cards/panels, (if the contractor discontinues cards/panels, the contractor shall provide the requested number of cards/panels and reagents to perform the extra QC for validation studies at no charge), appropriate ATCC microorganisms for startup and weekly QC, all preventative maintenance, consumable supplies, bi-directional interface bar-coded computer interface compatible with the VA laboratory information system for the VA Ann Arbor Healthcare Center, Aleda E.Lutz VA Medical Center, Northern Indiana Healthcare System, Battle Creek VA Medical Center, John D. Dingell VA Medical Center and Richard L. Roudebush VA Medical Center. This is in preparation for a 5-year, single award, BPA or IDIQ. Contractors that deem themselves capable of meeting the requirement shall provide the below information to Brooke Hansen, Contracting Officer, at Brooke.Hansen@va.gov no-later-than Monday, October 22, 2018, 4:00PM EDT, referencing (36C25019Q0053). Responses shall include: (1) Business Name and Address, (2) GSA Contract Number and expiration date, if applicable (3) Point of Contact Name, Phone Number and E-mail Address (4) DUNS and NAICS code (5) Business Size SMALL or LARGE (6) Type of Small Business (if applicable): service disabled veteran owned, veteran owned small business, 8a, HUBZone, woman-owned, etc. (7) A concern that is not a manufacturer of the supply shall provide the manufacturers name and size standard. If the concern is the manufacture and the sole distributor, please provide documentation to that effect. Please see requirements below: C.0.1 The contractor shall provide to the Veterans Affairs facilities (listed below) a Cost-Per-Reportable Result (CPRR) contract that will include all equipment [including uninterruptible power supply (UPS)], installation, reagents, startup Quality Control (QC) and validation cards/panels, (if the contractor discontinues cards/panels, the contractor shall provide the requested number of cards/panels and reagents to perform the extra QC for validation studies at no charge), appropriate ATCC microorganisms for startup and weekly QC, all preventative maintenance, consumable supplies, bi-directional interface bar-coded computer interface compatible with the VA laboratory information system. Veterans Affairs facilities: VA Ann Arbor Healthcare System 2215 Fuller Rd. Ann Arbor, MI 48105 Battle Creek VA Medical Center 5500 Armstrong Road Battle Creek, MI 49037 Richard L. Roudebush VA Medical Center 1481 W. 10th Street Indianapolis, IN 46202 John D. Dingell VA Medical Center 4646 John R St. Detroit, MI 48201 Northern Indiana Healthcare System (VANIHCS) Ft. Wayne Campus 2121 Lake Avenue Fort Wayne, IN 46805 Aleda E. Lutz VA Medical Center 1500 Weiss Street Saginaw, MI 48602 C.2.1 The contractor shall provide all equipment necessary to provide Cost-Per-Reportable Result (CPRR)analysis of susceptibility and identification of select microorganisms, any start up supplies for validation studies, monitors, keyboards, personal computers, barcode scanners, external hard drives, laser printers and ink cartridges/jets. The contractor shall provide all cables and hardware/software necessary to connect any of the system components. The contractor shall include all parts materials, labor supervision, calibrators, technical manuals, operator training, and necessary transportation to perform preventative maintenance. C.3.1 BRIEF SUMMATION OF SUPPORT FEATURES: The contractor shall provide all labor, materials, equipment, and equipment parts and service, reagents, supplies, consumable, disposable items, parts, accessories, shipping and handling costs, and any other item(s) required to establish fully operational microbiology testing systems including appropriate start up and weekly ATCC quality control strains, to comply with CAP and CLSI regulations. Shipping and handling costs shall be the responsibility of the contractor and shall be included in the offer. The contractor shall provide at no charge software upgrades in order to maintain the integrity of the system as a state of the art system. These shall be provided as they become released, installed by the contractor (as appropriate) and supported by in-house technical training (as appropriate). The contractor shall provide all ancillary support equipment to fully operate the instrumentation as defined in these specifications. Remote access for the system troubleshooting shall be considered on a case by case basis. If provided, it shall only be through a VPN interface subject to the Department of Veterans Affairs IMS approval. Modems are no longer considered acceptable by the VA Information Security Office. The contractor shall provide any and all universal interface equipment in order to interface equipment with the VA laboratory information system. Currently, the Veterans Affairs facilities utilize Data Innovations as the universal interface. Contractor equipment must offer a bi-directional interface with Data Innovations and VISTA/DHCP. The contractor shall provide everything required for the installation, implementation, testing, and operations of the interface right up to the universal interface box, including the software license fee that may be required each time an instrument or software update is added to an existing system (e.g. ports, cards, panels, software, flash drives, licenses, etc.). If there are any software/hardware/panel upgrades for the contractor system during the life of the contract, the contractor is responsible for ensuring that the interface support system can accommodate any changes in the data stream going to and from the VA s laboratory information system and VA s computerized patient record system (CPRS). Any additional costs, e.g. consulting fees, travel expenses, and extra equipment, etc. will be borne by the contractor. In addition, 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.). The contractor shall provide an up to date procedure manual in CLSI format on a portable storage device (i.e. CD-ROM, disk, etc.) and/or an on-line CLSI formatted procedure manual in the instrument software. In addition, there is to be a printed hard copy version. C.4 ENVIRONMENT OF CARE/QUALITY CONTROL: Routine and recurrent preventative maintenance inspections shall be the responsibility of the contractor. All significant problems shall be reported verbally to the Contracting Officer Representative (COR) within 24 hours. A written corrective plan of action shall be submitted to the COR within 5 working days. The Veterans Affairs facilities timeframes and priorities for completion of action plan items will be mutually agreed upon by the contractor and the Contracting Officer. An annual compliance report addressing preventative maintenance inspections, as well as Safety, Environmental, and Infection Control inspections, shall be reported to the COR. The contractor shall perform preventative maintenance inspections, during the contract period arranged with the COR, in accordance with the published preventative maintenance schedule for the selected system, but preventive maintenance shall be performed no less than annually. The contractor shall utilize the original equipment, manufacturer s established procedures and checklists, (or contractor-supplied equivalent satisfactory to the COR). A Field Service Report shall be supplied to the COR at the completion of each preventative maintenance inspection, and repair service call. In addition the Field Service Representative will inform the technologist on duty during the service call regarding problems found and any corrective action taken while performing the maintenance and repair call. C.5 TECHNICAL SUPPORT: The contractor will provide technical support, perform method validation as outlined and submit all data and/or required statistical analysis in a binder(s) for on-site staff approval. Contractor will provide written procedures in CLSI format on electronic media at the time of installation and whenever an update is made using software compatible with Veterans Affairs facilities computer system. In addition, there is to be a printed hard copy version. *Availability of a support hotline 24 hours a day, 7 days a week including all holidays. *Provide in-house assistance in validating new test/assays. C.6 CONFORMANCE STANDARDS: C.6.1 The contractor must maintain full compliance with applicable Federal and State regulations. All services provided under this contract must be performed in conformance with the National Fire Protection Agency (NFPA), Occupational Safety and Health Administration and any other applicable national, state and local regulatory agencies. C.6.4 All exceptions to the preventative maintenance inspection schedule shall be arranged and approved in advance with the CO. The contractor shall notify the CO of the existence of development of any defects in, or repair to the equipment covered under this contract which the contractor considers he/she is not responsible for under the terms of the contract (i.e. operator misuse). C.6.5 The system, software and reagents shall meet the standards of: College of American Pathologists (CAP), Clinical and Laboratory Standards Institute (CLSI), The Joint Commission (TJC), 1988 Clinical Laboratory Improvement Act (CLIA), Federal Drug Administration (FDA), Federal, State, and local policies. C.7 HOURS OF WORK: C.7.1 Veterans Affairs facilities warranty for the entire agreement period to include unlimited, on-demand, onsite service visits for the selected equipment, 7 days per week 8:00 am to 5:00 pm, including Federal holidays or as otherwise arranged with the COR. C.7.2 The contractor will provide a Technical hotline 24 hours per day, 7 days per week including Federal holidays. C.8 THE JOINT COMMISSION COMPLIANCE STANDARDS: C.8.1 GENERAL: The contractor shall continuously meet or exceed all The Joint Commission Hospital standards. All applicable VA and VHA policies, procedures and directives shall be followed by the contractor. The patient population treated at the Veterans Affairs facilities consists of veterans with varying physical, psychiatric, and psychological needs. Their conditions are in many cases, directly related to the individual s service to this country. C.8.2 PATIENT RIGHTS: Protection of all patients rights is of highest priority. Patient privacy and confidentiality shall be maintained at all times. Computer access will be granted on a need-to-know basis, and security of computerized information will be maintained at all times. No patients shall be subject to any research activity without his/her fully informed consent, subject to study approval by the Investigational Research Board (IRB). The contractor shall abide by the VAMC Code of Ethics, which addresses marketing, admission/transfer/referral/discharge processes, and billing issues. C.8.3 PATIENT SAFETY: The VAMC shall inform the contractor of all applicable Sentinel Event or other Patient Safety Alerts received by the VAMC. For every applicable alert, the contractor shall take the necessary steps to redesign processes to prevent occurrence, and provide written feedback to the COR describing preventative actions taken. All events related to patient injury, medication errors, and other breeches of patient safety will be reported to the COR utilizing the VAMC Incident Report. All events related to patient injury, medication errors, and other breeches of patient safety will be documented utilizing the contractor s format, and reported to the COR. The VAMC shall provide the contractor with VAMC Sentinel Event definitions in the start-up phase. The contractor shall verbally notify the VAMC COR immediately when a Sentinel Event has occurred, which is to be followed by written notification within one (1) business day or sooner if requested by the medical center. The VAMC shall determine when a Root Cause Analysis (RCA) is required of the contractor. The contractor shall conduct all Root Cause Analysis according to VAMC policy and within established guidelines. Completed RCAs shall be provided to the VAMC COR. C.8.4 PERFORMANCE IMPROVEMENT: The contractor shall fully participate in the VAMC Performance Improvement (PI) program. This will entail monitoring of clinic processes, data analysis, and collaborative design and operationalization of improvement opportunities. Contractor PI activities may be directed by the VAMC, VISN or VHA, as well as accreditation or licensing bodies. The contractor shall abstract, compile and report PI data as requested by the VAMC. VA Data collection methodology, report format, and reporting deadlines will be defined by the VAMC. In all cases, the contractor shall continually assess for, and act upon, clinical and administrative improvement opportunities. VA monitoring for continuous compliance with The Joint Commission standards shall be directed by VAMC staff, and communicated to the contractor through the COR. VA aggregate and/or practitioner-specific data collected by the VAMC will be provided to the contractor in accordance with established reporting schedules. VA measures related to contract compliance will be identified by the COR. C.8.5 LEADERSHIP: The contractor shall effectively manage daily operations, information and support systems, and conserve physical and financial assets while meeting the mission of the VAMC. The provision of contracted services will be described in writing the nature and scope of services provided through contractual agreement. Leaders monitor contracted services by establishing expectations for the performance of the contracted services. Leaders take steps to improve contracted services that do not meet expectations. C.8.6 INFORMATION MANAGEMENT: The VAMC Information Management plan shall be followed by the contractor. Documentation and record keeping shall be in accordance with VAMC policies and procedures. VAAR-852.273-75 SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (Interim Oct 2008) must be included in the document. C.8.7 CONFLICT OF INTEREST: Conflict of Interest acknowledgement document(s) must be signed by all procurement officials and copies filed in the OPF in accordance with VHA Handbook 1660.3. Contracting Officials, CORs, selection officials, and others involved in the contracting processes are free from any actual or perceived conflicts of interest. The Contracting Officer will monitor compliance and will review the selection board for conflicts. C.9 DOCUMENTATION/REPORTS: C.9.1 The contractor shall submit a legible field service report which shall include detailed descriptions of the preventive maintenance inspection or emergency repair services performed, including replaced parts and estimated prices required for the service call. NOTE: Any additional charges claimed must have been approved by the CO before service was performed. C.9.3 The contractor shall perform all validation/statistical analyses and report this data in an organized, clearly comprehensible format, a sample of which is to be provided with the proposal to the CO. The contractor shall provide assistance with the establishment of reference parameters to include the handling of data with appropriate software in order to establish references based on current CAP, TJC, CLSI, and FDA standards. C.10 REPORTING REQUIREMENTS: C.10.1 Upon arrival, the contractor (agent) is required to sign as required by each facility. When the service is completed, the contractor (agent) shall document services rendered on a legible Field Service Report and present to the COR for signature, during normal working hours. After normal business hours, the contractor will e-mail the Field Service Report to the COR or designee. C.11 COMPETENCY OF PERSONNEL SERVICING EQUIPMENT: C.11.1 The contractor s service personnel staff shall include a fully qualified Field Service Representative assigned to each Veterans Affairs facilities and a fully qualified Field Service Representative (FSR) who shall serve as the Backup to ensure 7 days per week 8:00 am to 5:00 pm including holiday coverage. Fully qualified is defined as training and experience in the field. The Field Service Representative (FSR) has successfully completed a documented formalized training program for the equipment covered under the contract. For field experience, the Field Service Representative (FSR) must have minimum of one (1) year of experience providing preventative maintenance and emergency repair services on the same make and model of equipment covered under this contract. C.11.2 The contractor shall provide written assurance of the competency of their personnel by detailing a list of Field Service Representative along with applicable training and years of service experience on the specific devices covered in this agreement and a written assurance of competency. All related documentation, such as completed competency checklists or educational training records, shall be maintained by the contractor and available for VAMC upon request. The contractor shall maintain a culture that promotes self-development and learning which is designed to maintain or enhance learning competencies. C.12 TEST EQUIPMENT: C.12.1 Upon request of the COR, or the CO, the contractor shall provide copy of the current Calibration Certification of all test equipment which is used by the contractor to perform service under this contract. Calibration of equipment shall be traceable and in conformance with test equipment Original Equipment Manufacturer standard C.13 SAFETY REQUIREMENTS: C.13.1 In the performance of the contract, the contractor shall take such safety precautions as the CO may determine to be reasonably necessary to protect the lives and health of the occupants of the building. The CO shall notify the contractor of any safety issues and the action required to correct these issues. Such written or verbal notice, when served on the contractor or its representative at the work site shall be deemed sufficient for the corrective actions to be taken. If the contractor fails or refuses to comply within 24 hours on the notification of the safety issue, the CO may issue an order stopping all or part of the work and hold the contractor in default. C.14 HARDWARE/SOFTWARE: C.14.1 Computer Interfacing Requirements The fully operational interface (internal or native to the system) network (Ethernet) interface (Hardware and software) must be immediately available for implementation to the Veterans Affairs facilities laboratory information system at the time of contract award. Network interface shall be capable of supporting TCP/IP network protocol in both IPV4 and IPV6. If the contractor is not capable of supporting TCP/IP network interface, then it shall be the contractor s responsibility to provide a Lantronix serial to Ethernet conversion unit with all associated cabling and connectors. The Veterans Affairs facilities laboratory shall determine the model or Lantronix requirement (MSS100 or MSS4) and provide the contractor with the model needed. Computer access will be granted on a need-to-know basis, and security of computerized information will be maintained at all times. The Veterans Affairs facilities shall be interfaced for instrumentation that is being provided. The contractor shall ensure interfacing for all instrumentation that is offered. C.14.2 The contractor is responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see requirements below). Likewise, the contractor will provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system selected. All cables and hardware necessary to connect any of the systems together are included if required, and all parts materials, labor supervision, calibrators, technical manuals, operator training and transportation necessary to perform preventative maintenance on the selected system. C.14.3 If a site already has a universal interface box, the contractor is responsible for contractor provided equipment and hardware that leads to the interface box. This responsibility includes assuming any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables software, etc.) to the universal interfacing system. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the contractor is responsible for the acquisition of the universal interface box and all other parts, equipment, or other hardware needed to connect the system with the Veterans Affairs facilities laboratory information system. If there are any software upgrades in the instrument during the life of the contract, the contractor is responsible for assuring that the interface can accommodate any changes in the data stream going to the Veterans Affairs facilities laboratory information system. C.14.5 The contractor shall provide all ancillary support equipment to fully operate the instrumentation as defined in these specifications. Remote access for system troubleshooting shall be provided only through a VPN interface subject to Department of Veterans Affairs Information Management Systems (IMS) approval. Modems are no longer considered acceptable for use by the VA Information Security Office and are prohibited from use. C.14.6 The contractor shall provide without additional cost all ancillary components that are customarily sold or provided with the model of equipment proposed, (e.g., starter kits, tables/stands, etc.). The contractor shall provide an up to date procedure manual on a portable storage device (i.e. CD-ROM, disk, etc.) and/or an on-line procedure manual in the instrument software. In addition, there is to be a printed hard copy version. The procedure manual shall be formatted in accordance with current, approved CLSI guidelines. C.14.7 The contractor must provide availability of printed (hard copy) patient results routinely and in the event of interface downtime for the system. C.14.8 The contractor must provide electronic patient data, quality control, and maintenance (when applicable) archiving that complies with College of American Pathologist (CAP), and The Joint Commission (TJC) requirements for the system. C.14.9 In addition to software, the analyzer must have a hardware data manager to meet the facilities operational goals and shall include the following capabilities. Archiving of results Data collection Interference management LIS backup and storage management Rule based decision processing Auto verification, if applicable C.15.3 Additionally, the contractor may make training available at its facility on terms and conditions mutually agreed upon by the Veterans Affairs facilities and the contractor that are considered with commercial offerings. C.16 SUPPORT FEATURES: C.16.1 The contractor shall coordinate all validation analyses and report this data in an organized, clearly comprehensible format, a sample of which is to be provided with the proposal to the CO. The contractor shall provide assistance with the establishment of references to include the handling of data with appropriate software in order to establish references based on current CAP, TJC, and CLSI regulations. C.17 Estimated Volumes Total Number of ID Tests for 5 Year Period Facility Year 1 Year 2 Year 3 Year 4 Year 5 Total Tests Ann Arbor 3,600 3,672 3,745 3,820 3,897 18,735 Battle Creek 440 449 458 467 476 2,290 Detroit 3,300 3,366 3,433 3,502 3,572 17,173 Indianapolis 2,775 2,831 2,887 2,945 3,004 14,441 NIHCS 2,000 2,040 2,081 2,122 2,165 10,408 Saginaw 1,640 1,673 1,706 1,740 1,775 8,535 13,755 14,030 14,311 14,597 14,889 71,582 Note: Increase 2% per year Total Number AST Tests for 5 Year Period Facility Year 1 Year 2 Year 3 Year 4 Year 5 Total Tests Ann Arbor 4,657 4,750 4,845 4,942 5,041 24,235 Battle Creek 1,120 1,142 1,165 1,189 1,212 5,829 Detroit 3,600 3,672 3,745 3,820 3,897 18,735 Indianapolis 3,330 3,397 3,465 3,534 3,604 17,329 NIHCS 3,000 3,060 3,121 3,184 3,247 15,612 Saginaw 2,320 2,366 2,414 2,462 2,511 12,073 18,027 18,388 18,755 19,130 19,513 93,813 Note: Increase 2% per year Total Number of Yeast ID Cards for 5 Year Period Facility Year 1 Year 2 Year 3 Year 4 Year 5 Total Bottles Ann Arbor 100 102 104 106 108 520 Battle Creek 0 0 0 0 0 0 Detroit 123 125 128 131 133 640 Indianapolis 250 255 260 265 271 1,301 NIHCS 60 61 62 64 65 312 Saginaw 120 122 125 127 130 624 653 666 679 693 707 3,398 Note: Increase 2% per year Total Number of Yeast Susceptibility Cards for 5 Year Period Facility Year 1 Year 2 Year 3 Year 4 Year 5 Total Bottles Ann Arbor 120 122 125 127 130 624 Battle Creek 0 0 0 0 0 0 Detroit 123 125 128 131 133 640 Indianapolis 275 281 286 292 298 1,431 NIHCS 0 0 0 0 0 0 Saginaw 0 0 0 0 0 0 518 528 539 550 561 2,696 Note: Increase 2% per year Total Number of Neisseria/Haemophilus Cards for 5 Year Period Facility Year 1 Year 2 Year 3 Year 4 Year 5 Total Bottles Ann Arbor 100 102 104 106 108 520 Battle Creek 0 0 0 0 0 0 Detroit 300 306 312 318 325 1,561 Indianapolis 125 128 130 133 135 651 NIHCS 40 41 42 42 43 208 Saginaw 40 41 42 42 43 208 605 617 629 642 655 3,148 Note: Increase 2% per year
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