Inactive Total Small Business Set-Aside (FAR 19.5)

Boise Veteran s affairs Medical center is in need surgical instrument repair, maintained, and sharpening. This is to ensure patient safety and care is consistent and not interrupted. The scope of this... Boise Veteran s affairs Medical center is in need surgical instrument repair, maintained, and sharpening. This is to ensure patient safety and care is consistent and not interrupted. The scope of this project includes all necessary services and equipment for the Boise VAMC s requirement to have regular RMD sharpening, maintenance, inspection, and repair.

Inactive

STATEMENT OF WORK SURGICAL INSTRUMENTS REPAIRS, TESTING AND INSPECTIONS BOISE VA MEDICAL CENTER, BOISE, ID Introduction: The Boise VA Medical Center (VAMC) is currently seeking a vendor that can provi... STATEMENT OF WORK SURGICAL INSTRUMENTS REPAIRS, TESTING AND INSPECTIONS BOISE VA MEDICAL CENTER, BOISE, ID Introduction: The Boise VA Medical Center (VAMC) is currently seeking a vendor that can provide services related to a Preventative Maintenance (PM) program for surgical instrumentation used in the operating room and in clinical procedures which includes repair, refurbish and assessment for replacement. General Information: Required services are to be completed onsite every two (2) weeks (biweekly) and 8 hours of services will be conducted approximately 10-12 trays per visit on average. Items that cannot be repaired on site shall be mailed into a repair facility. The vendor shall take full responsibility for all items as soon as the item is handed over on site or mailed to be repaired off-site. The Boise VAMC reserves the right to cancel a day and reschedule it up to 48 hours before the regularly scheduled visit at no additional charge. The expected performance period is a base year of twelve (12) months with four (3) option years. Each option year is twelve (12) months. The onsite visits can be scheduled on any day excluding all Federal holidays. Required Services: Preventative Maintenance: The contractor shall provide Preventative Maintenance (PM), which consists of aligning, calibrating, refurbishing, cleaning, stain removal, , sharpening, oiling, straightening, adjusting, replacing parts, demagnetizing, and maintaining the equipment. Sterilized instruments will be provided to the contractor individually or as components of a specialty tray. Requested services are periodic in nature and are required to maintain the equipment in such a condition that it may be operated in accordance with its intended manufacturer s design and functional capacity with no incidence of malfunction or inoperative conditions. Any item that cannot be fully repaired to full functional capacity without risk of malfunction, inoperative conditions, or other risk to patient and staff safety should be recommended for replacement and/or removal from use and tagged as such. However, the replacement of the items is not covered or authorized under the scope of this contract. Preventative Maintenance also includes the following (By Specialty): Contractor shall adhere to all industry standards for repair and preventative maintenance of the instruments, OEM guidance, as well as all OSHA and FDA guidance applicable to handling, repair, and preventative maintenance of surgical instruments. All instruments that can be disassembled, will be disassembled, and undergo a detailed contractor inspection. Instruments will not be altered, changed, or tampered with and will be repaired following manufacturers original design specifications as well as OEM guidance on repair. During preventative maintenance instruments will be sharpened, adjusted, aligned, straightened, refurbished, calibrated, cleaned, oiled, and parts replaced in accordance with the manufacturer s original specifications and configuration, Any stains, sharp edges and/or scratches will be removed. Instruments should maintain the original OEM finish without the removal of any barcodes, OEM markings, or other identifiers of the equipment. All cannulated items will have interior lumen flushed and inspected. 3.A.6. Delicate sharp, pointed instruments will be returned covered with appropriate tip protectors. Instrumentation: Instrumentation includes, but is not limited to the following: Specialty trays by service (Neuro, Ortho, ENT etc.); curettes, hemostats, scissors, graspers, laparoscopic instruments, rongeurs, dental instruments, repairing minor nicks, bents, rim alignments, remove minor burrs from containers that house the instruments, etc. The brands of instruments being repaired are: V. Muller, Katena, Koing, Skar, etc, per the attached list of instruments and possible manufacturers. PM Services and Instrumentation described herein consist of the following: On-site Repair Services Consists of instrumentation tasks that can be performed/completed on site Off-site Repair Services: Consists of repairs needed on instruments that must be done in the laboratory and which cannot be performed onsite. Specific Mandatory Task and Associated Deliverables: Instruments are to be retrieved from and delivered to Sterile Processing Services (SPS) located at: Boise VA Medical Center, SPS Preparation Area and OR Surgery Unit. Delivered to Boise VA Medical Center, SPS Decontamination area. The vendor shall provide their own van or other vehicle with all equipment needed to perform onsite repairs. Provide preventative maintenance, repairs, and testing of all surgical instruments owned by the VA, including, but not limited to: orthopedic (including pneumatic orthopedic instruments), ophthalmic, GU, dental, neurological, laparoscopic, vascular, ENT, gynecological, bariatric, gastrointestinal and insulated items). Surgical instruments maintenance and repair will be handled with care. All instruments shall be repaired and maintained in proper operating conditions, as specified by the original manufacturer. The contractor will return instruments in as good as new condition and shall provide a warranty as outlined in the warranty statement section of this Statement of Work. The contractor will be required to test instruments for accurate alignment, sharpness, insulation, and calibration per manufacturer s Instructions for Use (IFU). All returned, inspected, and repaired instruments will be stain-free and OEM finish maintained this can Any barcodes or OEM identification shall not be removed Instrument Barcodes: Boise VAMC instruments will have their 2-D barcodes verified at each inspection and re-etched by laser if necessary. If an instrument does not have barcode, vendor agrees to apply one that can be read by Censitrac. Vendor will be asked to etch barcodes on all new instrumentation. Instruments that are not clearly identifiable by 2-D barcode or OEM markings shall be marked as non-repairable and returned. All single instruments and surgical trays picked up/delivered by the contractor will be properly listed for accountability verification. Provide maintenance and repair for surgical instrument containers and systems components to ensure that all lid gasket vent devices are fully functional in accordance with manufacturer specifications. Documentation shall be provided by the contractor for the specific work that is performed. Upon completion of services the contractor must provide a summary document/end of day report (PowerPoint or equivalent) which contains the following information: before and after pictures of repairs, date of repair, instrument type, tray description, status of instrument repair or resolution, type of repair, and cost. Instruments that are non- repairable shall be annotated in this log. The Contractor's employee(s) shall report to Sterile Processing Services (SPS) upon arrival at the VA for the pickup and return of instruments. If an instrument cannot be repaired, it will be returned to SPS. If an instrument requires send out for laboratory repairs by the contractor, the contractor must have obtained verbal approval of a VA SPS Chief, or designee, prior to doing so. The contractor shall make recommendations for surgical instrument replacement which may be pertinent to meet the scope of surgical trays completion. Replacement or purchase of new instruments is not authorized within the scope of this contract. For all instruments requiring laboratory or other offsite repair services, the contractor shall provide a standard means of submitting the sterilized instruments for the work to be done, including overnight shipping to and from the repair facility, and will provide an estimated time for the repair to be completed when the VA notifies that they are sending instrument(s) to the repair facility. Single use instruments not already pulled by Boise SPS staff shall not be serviced. Single use instruments shall be tagged as non-repairable and returned to be disposed of by Boise SPS staff. VA Monitoring: SPS staff shall examine instruments on return from the vendor to ensure that work is performed satisfactorily, instruments are in proper working order with 0% risk of issues and will take out of use all instruments tagged as non-repairable. Continued monitoring of instrument repairs quality and turnaround time, as well as contract compliance, willbe progressively monitored by SPS Chief and/or Assistant Chief as the station point of contact. The Chiefs of SPS will monitor contractor instrument pick-up and drop-off through written logs and schedules toensurethat services have been received by the VA. The contractor's employee(s) shall report to SPS upon arrival at the VA for the pickup and return of instruments. The Station POC will be responsible for verifying contract compliance. Any incidents of contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer (CO). Documentation of services performed will be reviewed by SPS Chief/Assistant Chief prior to certifying payment The Chief/Assistant Chief SPS will perform periodic documents checks with the using service to ensure records monitoring. VA will pay only for services performed at VA and at the contractor s location, and in strict accordance with the schedule of prices/costs shown in the schedule of items. Contract monitoring and record- keeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided. The SPS Chief/Assistant Chief will verify that services were performed against the contractor's certified delivery repairs document. Only after verification are invoices certified for payment. Contractor Qualification Requirements: All individuals performing work shall have the appropriate knowledge, credentials, and certifications relating to the work that is to be performed for the entire duration of the performance period (which includes ISO-9001 certification or equal knowledge related to this certification). Contractor shall be compliant with relevant VA Policies) all applicable OSHA. FDA and similar regulator policies as well as industry standards. Work performed shall be in accordance with these policies and with the AAMI standard referenced in this section. SPS and Surgical Service Operating Room (OR) Support: VA SPS will be the point of contact for all surgical instrument pickups, returns will be to SPS decontamination area. The returned repaired instruments will be inspected and reprocessed in SPS. The Boise VAMC VA SPS staff will perform a serviceable quality check of instruments to ensure that they are usable and safe (for patient care). Any instruments deemed unusable or unsafe will be re-processed by SPS and returned to the contractor for additional repairs as necessary at no additional cost to the government. Security Requirements: Before work is performed and during the entire performance period when work is being conducted the contractor shall ensure they possess or obtain the necessary credentials/badges needed to enter/exit the facility to include obtaining access to needed and specific site areas where instruments are located. Coordination and check in with the VA police and other appropriate security personnel may be required. Contractor shall coordinate with the COR, other authorized representative, or the Contracting Officer if assistance is needed. Progress and Compliance: The contractor shall make recommendations for surgical instrument replacement which may be pertinent to meet the scope of surgical trays completion. Continued instrument repairs, quality improvement monitoring, and turnaround time, as well as contract compliance, will be progressively monitored by Boise VAMC VA SPS and the COR representative. All repairs shall be completed according with all terms within this Statement of Work. If the instrument is recommended for replacement or is deemed non-repairable for some other reason, a detailed report as to why shall be provided when the item is returned. If the instrument was sent to the repair facility for work, the report accompanying the returned instrument would include if the work had to be done by a third party (i.e., sent to manufacturer) in addition to the information to be reported for on-site. Warranty Statement: In addition to Clause 52.212-4(o) warranty, the Contractor warrants and represents that each of its employees, Subcontractors, or agents assigned to perform any services under the terms of this Agreement shall have the skills, training, and background reasonably commensurate with his or her level of performance or responsibility, to be able to perform in a competent and professional manner. The Contractor further warrants that the services provided hereunder will conform to the requirements of this Agreement and Statement of Work. Contractor shall warranty all Services against defects in performance consistent with the item s original equipment manufacture s standards, but no less than a period of ninety (90) calendar day following delivery. If defects are found the contractor will correct the defects within 14 calendar days and at no additional cost to the VA. Gray Market Language VAAR 852.212-72 GRAY MARKET AND COUNTERFEIT ITEMS (MAR 2020) No used, refurbished, or remanufactured supplies or equipment/parts shall be provided. This procurement is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be provided. Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory. No counterfeit supplies or equipment/parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics. Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.