CHEYENNE VAMC Medline Surgical Instruments

Sources Sought Notice SURGICAL INSTRUMENTS DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Response Instructions: Do not provide more than 8 pages, including cover letter page. Submit your response via email to: barron.long@va.gov Submit your response NLT 12:00 (MST) on Monday August 11th Mark your response as Proprietary Information if the information is considered business sensitive. VA has identified the appropriate North American Industry Classification System (NAICS) Code 339112 Surgical and Medical Instrument Manufacturing with a Small Business size of 1000 employees. Please identify and explain any NAICS codes your company believes would better represent the predominated work included in the attached Statement of Work draft / Salient Characteristics List; Information Requested from Industry: In response to the Sources Sought, interested Contractors shall submit the following information and any Capabilities/Qualifications Statement to include but not limited to an overview of proposed solution(s) and a description of the product your company possesses in accordance with the Statement of Work draft / Salient Characteristics List. Vendor Name: SAM UEI #: Name of Manufacturer: Manufacturer Address: Manufacturing Country of Origin Estimated Delivery Time: ___________________________________________________ SAC FSS contract number Vendor Point of Contract (POC) Name POC Phone Number: POC Email Address: STATEMENT OF WORK (SOW) Sterile Processing Service (SPS) Back-up and Replacement Reusable Surgical Instruments. Introduction and Overview: The Veterans Healthcare System of Cheyenne, WY (CVAHCS) Sterile Processing requires the purchase of back-up and replacement reusable surgical instruments. Purpose and Background of Project: The Cheyenne VA is planning to enhance the Sterile Processing Services (SPS) with the acquisition of backup and replacement reusable surgical instruments. In alignment with SPS's commitment to excellence, we conduct meticulous inspections of all instruments that come through our department. This rigorous process ensures that only high-quality instruments are used in patient care, as it identifies and removes those that do not meet our stringent standards. To prevent potential delays in patient care, we aim to purchase additional reusable surgical instruments to serve as onsite backups. This allows for the immediate replacement of any instruments identified as substandard during inspections. Furthermore, these new instruments will support the replacement of current instrumentation that fails to meet our quality criteria, thereby ensuring the highest levels of safety and effectiveness in patient care. Additionally, these purchased instruments will match current instrumentation, ensuring surgeon and staff familiarity, which further increases safety and efficiency. Objectives: The objective of the request is to procure back-up and replacement of reusable surgical instruments for the Cheyenne VA Healthcare System, 2360 E. Pershing Blvd., Cheyenne, WY 82001. Scope: Contractor must furnish all requested instruments with electronic Instructions for Use (IFU s). Salient Characteristics: Back-up and replacement reusable surgical instruments shall be brand name or equal to V. Muller instrumentation. Salient characteristics equal products must meet: Construction: Shall be constructed of 300 (austenitic) and/or 400 (Martensitic) series stainless steel (Martensitic) or higher for scissors, hemostatic forceps, osteotomes, chisels, rongeurs, forceps, needle holders, retractors, cannulas, rib spreader and suction devices. May also be made of titanium, copper and silver for all other instruments not listed above. Shall be reusable Sterilization: Shall be able to be sterilized by a steam sterilizer. Must be sterilizable between 270-275 degrees Fahrenheit. Must require sterilization for 3-5 minutes. Must have a cooling time of 20 minutes or more. Shall not require EO or low temperature steam sterilization. Cleaning: Shall be cleanable with endozymatic cleaning detergent. Shall be able to go in a washer/disinfector. Shall be able to be placed in sonification. Warranty: Shall offer lifetime warranty for repairs. Instructions for use (IFU): Must offer IFU that complies with ANSI/AAMI ST81 which included the following: Name and address of the manufacturer. Manufacturer s model or product family designation. Instructions for safe and effective use of the containment device, including safety precautions to be taken during routine use. Instructions for disassembly, cleaning, and reassembly of the containment device, including recommended cleaning agents and cleaning methods. Decontamination methods or chemicals that could be harmful to the containment device. If applicable, instructions for a method of labeling the containment device. Information on the general categories of medical devices that the manufacturer has tested in the validation of the containment device. Instructions for inspection and routine maintenance, including a schedule for implementing inspection and routine maintenance procedures. a caution that these procedures should be carried out by trained personnel. specific directions concerning the maintenance of critical components; and a recommended inspection protocol that will enable the user to identify the end of the containment device s useful life. information regarding authorized service companies in the event that the containment device requires service or repair. Limitations and restrictions on reprocessing The manufacturer shall determine if processing in accordance with the provided instructions leads to a degree of degradation that will limit the useful life of the medical device. Where such degradation is established, the manufacturer shall provide an indication of the end of the medical device s ability to safely fulfill its intended use. Preparation at the point of use prior to processing Requirements for preparation at the point of use to ensure satisfactory reprocessing of the medical device shall be specified, if applicable. Where appropriate, at least the following information shall be included: the containers for transportation. a description of the support systems (for instance, accessories to hold and protect the instrumentation within the container for transportation, if applicable). the maximum period of time that may elapse between use and cleaning. a description of the precleaning techniques critical to further processing. the requirements for wet or dry transportation of items to the decontamination area. Preparation before cleaning Requirements for the preparation of the medical device prior to cleaning shall be specified, if applicable. Where appropriate, instructions for at least the following procedures shall be given: the requirements for capping/opening of ports. disassembly of the device. leak testing the device. soaking/brushing techniques required. ultrasonic treatment of the device. If special tools are required for disassembly/reassembly, these shall be specified in the instructions. Cleaning A validated method of manual cleaning shall be specified. At least one validated automated cleaning/washing method shall also be specified unless the medical device cannot withstand any such process, in which case a warning should be issued. Where appropriate, at least the following information shall be included: a description of the accessories required for the cleaning process. identification and concentration of chemicals required for cleaning. identification of water quality to be used for the process. limits and monitoring of chemical residues remaining on the device. limits on temperature, concentration of solution(s), exposure time to be used. the process temperature(s) and time to be used. the techniques to be used, including rinsing. Disinfection A validated nonautomated method of disinfection shall be specified. At least one validated automated method using a washer-disinfector shall also be specified unless the medical device cannot withstand any such process. Where appropriate, at least the following information shall be included: a description of the accessories required for the disinfection process. the contact time of the disinfectant. identification and concentration of chemicals required for the disinfection process. identification of water quality required for the process. the limits and monitoring of chemical residues remaining on the device. the limits on temperature, concentration of solution(s), exposure time. the process temperature(s) and time to be used. the techniques to be used, including rinsing. NOTE 1 In certain circumstances, disinfection may be carried out concurrently with cleaning of the medical device. NOTE 2 Equipment commonly utilized in health care facilities should be used. NOTE 3 Certain clinical procedures lead to an enhanced probability of contamination with infectious organisms. This should be considered in the risk analysis and in the choice of recommended disinfectants Drying Where drying is necessary, a validated method of drying shall be specified. Where appropriate, at least the following information shall be included: the accessories required for the drying process. the maximum temperature and exposure time for the device. specifications of the drying agent to be used. the techniques to be used. NOTE In certain circumstances, drying may be achieved as part of an automated cleaning and disinfection process. Inspection, maintenance, and testing When methods are required at any stage of processing to confirm the cleanliness or performance, or both, of the medical device, these shall be stated. Where particular maintenance actions are required during processing to ensure the proper performance and safety of the medical device, these shall be stated. Where appropriate, these shall include details such as any part or component that requires routine replacement and/or calibration and, where necessary, details for return to the manufacturer or other qualified organization. Where appropriate, at least the following information shall be given: the method to be used for adjustment/calibration of the device. a description of the lubrication to be used. the performance criteria for the device to ensure its safe use. the instructions for reassembly of the device. the method to be used for the replacement of components. a description of special tools to be used to maintain the device. the requirements for visual inspection. NOTE If instruction to return the medical device to the manufacturer or other qualified organization is specified, the manufacturer should give clear instructions as to when and how to process the device prior to its return. Packaging If a specific method for packaging or containing the medical device during and after sterilization is required, it shall be stated and be compatible with the sterilization process and the medical device. Sterilization A validated method of sterilization shall be specified. Where appropriate, at least the following information shall be given; this shall include set points and the upper and lower limits of critical process parameters that are capable of achieving sterility of the medical device: the accessories required for sterilization of the medical device. the identification and concentration of the sterilant required for the sterilization process. the identification of the quality and purity of the steam generated for the steam and/or ethylene oxide sterilization process. the humidity required for the sterilization process. the minimum holding or exposure time of sterilant. a description of post-sterilization techniques/activities (for instance, aeration for ethylene oxide processing). pressure required for the sterilization process. a description of the techniques to be used. the required temperature of the sterilant. other physical (critical) parameters. Storage Any specific limitations for the time or conditions of storage of the reprocessed medical instrument prior to use shall be stated. Contract Line Items (CLINS): Line Item/Description/Quantity 1 PROCTOSCOPE,FANSLER,35MM,2 3/8" - MDS6821022 2 2 RETRACTOR,HARRINGTON,40X127MM,12.5" - MDS1237040 5 3 FORCEP,ATRAUMATIC,DEBAKEY,2.0MM,9.5" - MDS1130824F 4 4 RETRACTOR,VOLKMANN,4-PRONG,SHARP,8.75 MDS1828004 6 5 RETRACTOR,RICHARDSON-EASTMAN,LARGE - MDS1814002 6 6 RONG,BONE,STIL-LUER,DBL,STR,17MM,9 - MDS1803671 6 7 FORCEP,ATRAUMATIC,DEBAKEY,1.5MM,9 1/2" - MDS1130624F 5 8 FORCEP,HEMO,KELLY,STR,5.5",14CM - MDS1224014 1 9 FORCEP,HEMO,PEAN,CVD,6.5",16.5CM - MDS123116 1 10 RETRACTOR,DEAVER,38MM,1.5",12" - MDS1818738 4 11 RETRACTOR,ARMY-NAVY,PAIR,D/E,8.25 - MDS1813121 4 12 RETRACTORS,DEAVER,25MM,1",10", MDS1818225 4 13 FORCEP,HEMO,KELLY,CVD,5.5",14CM - MDS1224114 1 14 SCISSOR,METZENBAUM,BABY,CURVED,4.5" - MDS0828111 6 15 FORCEP,HEMO,HALSTED-MOSQUITO,CVD,5 - MDS1222112 1 16 FORCEP,HEMO,KELLY,CVD,5.5",14CM - MDS1224114 1 17 FORCEP,SPONGE,FOERSTER,ST, SER, 9.75" - MDS1617025 10 18 NEEDLE HOLDER,WEBSTER,SMOOTH JAW,5" - MDS2410013 3 19 FORCEP, TISSUE, ADSON BROWN, 4 7/8" - MDS1018812 1 20 FORCEP,SEIZING,JUDD-ALLIS,3X4,7.5 - MDS6414019 6 21 CLAMP,COOLEY,BULLDOG,AUTRAMATIC,STR,60MM - MDS1209820 4 22 CLAMP,COOLEY,BULLDOG,AUTRAMATIC,CD,55MM - MDS1209920 4 24 CLAMP,COOLEY,MULTI PURP,60DEG ANG, 9 - MDG0437961 4 25 FORCEP,COOLEY,DBL ANGLED,ANG 60D,7" - MDS1345717 4 26 PROBE,WITH EYE,SILVER,2MM,6.25",16CM - MDS2010216 6 27 Hook, Micro, Single Prong, Sharp, 1MM, 5.5" / MDS1820602 2 28 RETRACTOR,VOLKMANN,4 PRNG,BLNT,8.75" - MDS1828104 5 29 FORCEP,TENACULUM,SCHROEDER,10",25CM -MDS7050225 8 30 SCISSOR,BANDAGE,LISTER, ANG,7.25" -MDS0890118 10 31 SCISSOR,IRIS,KNAPP,CVD,SHARP/SHARP,4" -MDS0838510 20 32 FORCEP,HEMO,KELLY,CVD,5.5",14CM -MDS1224114 30 33 FORCEP,HEMO,KELLY,STR,5.5",14CM - MDS1224014 30 34 FORCEP,HEMO,CRILE,CVD,5 1/2",14CM - MDS1225114 30 35 FORCEP,HEMO,CRILE,STR,5.5",14CM -MDS1225014 30 36 SCISSOR,METZENBAUM,CVD,BL/BL,7" -MDS0828118F 25 37 FORCEP,HEMO,PEAN,CVD,6.5",16.5CM -MDS1231116 30 38 FORCEP,HEMO,KOCHER,CVD,1X2,5.5" -MDS1232314 30 39 FORCEP,HEMO,KOCHER,STR,1X2,5.5" - MDS1232214 30 40 HOLDER,NEEDLE,MAYO-HEGAR,TC,7.5,19CM -MDS2418418 20 41 HOLDER,NEEDLE,CRILE WOOD,TC,7 1/8",18CM -MDS2416418 20 42 FORCEP, TISSUE, ADSON BROWN, 4 7/8"- MDS1018812 30 43 FORCEP,TISSUE,ADSON,MICRO,1X2,4.75" - MDS1018612 30 44 FORCEP,DRESSING,ADSON,SERR,MICRO,4.75" -MDS1017012 30 45 FORCEP,DRESSING,SERRATED,5 1/2",14.5CM - MDS1010214 20 46 FORCEP,TISSUE,USA,12TEETH,5 1/2,14.5CM- MDS1012214 20 47 SUCTION TUBE,POOLE,ABD,STR,30FR,9.25" -MDS0413010 10 48 FORCEP,HEMO,HALSTED-MOSQUITO,CVD,5 - MDS1222112 50 49 FORCEP,HEMO,HALSTED-MOSQUITO,STR,5- MDS1222112 50 50 FORCEP,ATRAUMATIC,DEBAKEY,2.0MM,625" - MDS1130816 20 51 RETRACTOR,WEITLANER,BLUNT,3X4,6.5" - MDS1867116 15 52 RETRACTOR,WEITLANER,SHARP,3X4,6.5" - MDS1867016 15 53 ELEVATOR,FREER,SEPTUM,D/E,SH/BL 7.75" - MDS4641518 15 54 FORCEP,HEMO,RANKIN,CVD,6.25" - MDS1224316 30 55 FORCEP,HEMO,ROCHESTER-RANKIN,STR,6.25 - MDS1224216 30 56 FORCEP,HEMO,CRILE,CVD,6.25",16CM - MDS1226316 30 57 FORCEP,HEMO,CRILE,STR,6.25",16CM - MDS1226216 30 58 SCISSOR,KNAPP,IRIS, STR, SH/SH, 4" - MDS0839011 20 59 Nipper, Nail, Straight-Jaw, 2 Spring, SS, 5- MDS7436013 10 60 CLAMP,TOWEL,HEMOSTAT,NON-PERF,LORNA,5.25 - MDS1412113 20 61 HOLDER,NEEDLE,NEW ORLEANS,TC, 7",18CM - MDS2419818 10 62 RETRACTOR,KLEINERT-RAGNELL,D/E,15CM,6 - MDS1816413 30 Delivery Schedule: The requested instruments are required to be delivered to the CVAHCS not later than 60 days after receipt of order (ARO). The Contractor must ensure all deliverables are delivered to the following address and reference the VA s purchase order number: Cheyenne VA Healthcare System, Attn: Sterile Processing, 2360 E. Pershing Blvd., Cheyenne, WY 82001. The contractor will ensure delivery is scheduled between Monday and Friday, 8am to 3pm, unless otherwise pre-arranged with the SPS Chief or RMD Coordinator. Inspection and Acceptance: The contractor must provide a bill of sale with delivery to include any missing items. The CVAHCS SPS Chief or RMD Coordinator must conduct an inspection upon delivery of the instruments and must provide logistics and the contractor with a list of missing or damaged items found upon inspection. The CVAHCS SPS must ensure all instruments have been delivered satisfactorily and notify Logistics prior to acceptance. Disputes must be resolved by the VA Contracting Officer. Contractor Performance Requirements: The contractor must coordinate and provide oversight for all products including managing, ordering, shipping, and delivery until final acceptance by the Chief of SPS or the RMD Coordinator. Payment: Contractor shall register and submit invoices through the 3rd party system Tungsten. Details to be provided in the contract. True invoice automation | Tungsten Network (tungsten-network.com)