SUBJECT: Instrument Cleaning DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFQ will not be entertained. SUBJECT: The Department of Veterans Affairs is conducting market research in order to provide Instrument Cleaning for the Martinsburg, WV VA Medical Center. The government anticipates awarding a one Firm Fixed Price contract that will provide the support services listed within the below attachment. OBJECTIVE: See attachment. RESPONSE INSTRUCTIONS: Name and Address of Company Any small business designation as certified by the Small Business Administration A through description of experience in managing support requirements of this nature. CONTACT INFORMATION: Any questions related to this RFI shall be directed to Caitlin Hippensteel at [email protected]. All information regarding Capabilities Statements or any other proprietary information relative to this RFI shall be submitted via email to [email protected] no later than 3:00 pm EST on 9/14/2018. ATTACHMENT 1 1. General Information The Veterans Medical Center, Martinsburg, WV; hereafter referred to as the VA, is currently seeking a vendor that can provide services related to all preventative maintenance (PM) for surgical instrumentation used in the operating room and clinical procedures; including repairs, refurbish and assessment for replacement. The contractor shall provide PM, which may consist of aligning, calibrating, refurbishing, cleaning, stain removal, polishing, sharpening, oiling, straightening, adjusting, replacing parts and maintaining the equipment. These 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 minimal incidence of malfunction or inoperative conditions. Scheduled repairs, refurbishment and assessment for replacement will occur minimally once every two weeks at the VA facility. Instrumentation includes, but is not limited to, specialty trays by service (Ortho, ENT, Dental, Gastrointestinal, Vascular, Urology, etc.); curettes, hemostats, scissors, graspers, laparoscopic instruments, rongeurs, surgical knifes, etc. The vendor shall ensure that the repairs and service functions are performed in conformance with ANSI-AAMI ST-79:2010 Part 7.7 (Servicing and Repairs of Devices in the Health Care Facility), ISO-9001 and specifications used by the instrument manufacturer. Upon completion of processing the submitted trays and instruments the contractor must provide a summary document upon completion of processed instruments containing the following information; date of repair, instrument type, type of repair and cost. 2. Introduction and Scope of Work Vendor shall provide these preventative maintenance and repair services, to include but not limited to; sharpening, adjusting, aligning, straightening, refurbishing, calibrating, cleaning, stain removal, polishing, oiling, adjusting and replacing parts of various individual surgical instruments and procedural instrumentation trays. Instruments will be provided individually or as components of a specialty tray. All instruments all be maintained in proper operating conditions as specified by the original manufacturer and in compliance with ANSI-AAMI ST-79:2010 Part 7.7 (Servicing and Repairs of Devices in the Health Care Facility). 3. Specific Mandatory Task and Associated Deliverables 3.1 Instruments are to be retrieved from and delivered to Sterile Processing Services (SPS) located at: 510 Butler Avenue, BLDG 500 Room GD100, Martinsburg, WV 25405 ATTN: SPS 3.2 Provide preventative maintenance, repairs and testing of all surgical instruments owned by the VA, including, but not limited to: orthopedic (including pneumatic orthopedic instruments), laparoscopic, vascular, ENT, gynecological, urological, Dental, gastrointestinal and insulated items. Items may be added or deleted from the facilities inventory as required. 3.3 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. 3.4 The contractor will be required to test instruments for accurate alignment, sharpness, insulation and calibration per manufactures instructions for use. All returned inspected and repaired instruments will be stain free and polished to a mirror finish. 3.5 All single instruments and surgical trays picked up/delivered by the contractor will be properly listed for accountability verification. 3.6 Provide maintenance and repair for surgical instrument containers and systems components to insure that all lid gasket vent devices are fully functional in accordance with manufacturer specifications. 3.7 The contractor must provide a summary document upon delivery of processed instruments containing the following information: date of repair, instrument type, type of repair and cost. 3.8 The contractor s employee(s) shall report to SPS upon arrival at the VA for the pickup and return of instruments. If instrument cannot be repaired it will be returned to SPS. If the instrument requires send out for third party repairs by the contractor, the contractor must obtain verbal approval of the VA SPS Chief, or designee, prior to doing so. 3.9 Individual instrument repairs will be arranged for one day every two weeks in the Martinsburg VA Medical Center. Repairs must be performed Monday through Friday between the hours of 8:00am 4:00pm, excluding weekends and holidays. Instruments should be returned only via: Vendor (hand delivery) or Courier Services (not parcel post, FedEx, etc.). 3.10 Vendor will supply document clarifying company s scope of work which will state what type of work can be accomplished on-site, locally, and what will need to be sent to a third party vendor. 3.11 A Mobile Repair unit is required and will properly display the contractor s name and permit numbers. The mobile unit should be self-sustained with electrical power, air compressor, etc. 3.12 Single instrument sent out to corporate office or third party for repairs will be picked up once every 2 weeks. Instruments shall be returned no later than 7 business days after pick up. 3.13 All urgent instrument repairs will have a 48-hour turnaround time. 3.14 All emergency instrument repairs will have a 24-hours turnaround time. 3.15 The contractor shall provide repair service invoices. All correspondence invoices shall include the current contract number. Billings shall be made in arrears by certified invoice. All repairs shall be completed according with all terms within this Statement of Work. 4. VA Monitoring 4.1 The contractor shall make recommendations for surgical instrument replacement which may be pertinent to meet the scope of surgical trays completion. 4.2 Continued monitoring of instrument repairs quality and turnaround time, as well as contract compliance, will be progressively jointly monitored by each sites SPS. 5. Vendor/Contractor Requirements 5.1 Vendor will provide documentation of staff training, competencies and any pertinent certifications, in relation to the repairs they will be conducting. 5.2 Contractor shall be compliant with relevant VA Policies, Directive 1116 and with AAMI ST-79:2010 Part 7.7 standards (Servicing and Repairs of Devices in the Health Care Facility). 5.3 The contractor will provide a minimum 3 references listing: customers name, address, timeline of service, and phone numbers of contacts. They will also have a minimum 5 years experience providing these services to Hospital or Major Medical Center. 5.4 Vendor will provide VA-SPS staff with one (1) CEU eligible in-service on instrumentation per year. 6. Documentation Requirements 6.1 Contractor will sign out all instruments/surgical trays removed from SPS for repairs. 6.2 Repaired instruments returned to SPS will be on a detailed list document provided by the contractor containing the following information: date of repair, instrument type, type of repair and cost. 6.3 The hand written checklist/delivery slip will be checked against the instruments returned after repairs. 6.4 A quarterly Surgical Instrument Tray Maintenance Inspection certificate shall be provided to SPS. 7. SPS and Surgical Service Operating Room (OR) Support 7.1 Each VA SPS site will be the point of contact for all surgical instrument pickups and returns. The returned repaired instruments will be inspected and reprocessed in SPS. 7.2 The Martinsburg VA SPS staff will perform a serviceable quality check of instruments. Any instruments that fail this quality check will be re-processed by SPS and returned to the contractor for additional repairs, at no additional cost to the facilities. 8. Security Clearance 8.1 Contractor shall be required to complete a security clearance with the VA Police. 8.2 The VA Police will issue an ID badge, which needs to be presented by contractor s employee at the VA entrance security check points. The issued badge is for official pickup and deliveries of surgical instruments and trays. 8.3 Contractor mobile unit(s) shall be registered with the VA Police. 9. Surgical Instrument Trays: Preventative Maintenance (By Speciality) 9.1 Surgical Instrument Trays maintenance repairs inspections will be done at a minimum of biannually at the VA Martinsburg. 9.2 Vendor is required to complete a joint, initial wall-to-wall inventory of instrumentation so as to assist in prioritization of preventative maintenance. Vendor will work with the SPS staff to establish a preventative maintenance inspection schedule for the items identified during this inventory. 9.3 All instruments that can be disassembled, will be disassembled and undergo a detailed contractor inspection. 9.4 Instruments will not be altered, changed or tampered with and will be repaired following manufacturers original design specifications and in compliance with ANSI-AAMI ST-79 part 7.7. 9.5 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 have a mirror finished appearance on return. 9.6 All cannulated items will have interior lumen flushed and inspected. 9.7 Delicate sharp, pointed instruments will be returned covered with appropriate tip protectors. 10. Progress and Compliance 10.1 The contractor shall make recommendations for surgical instrument replacement which may be pertinent to meet the scope of surgical trays completion. 10.2 Continued instrument repairs, quality improvement monitoring and turnaround time, as well as contract compliance, will be progressively and jointly monitored by the VA SPS staff. 10.3 The contractor shall provide repair service invoices. All correspondence invoices shall include the current contract number. Billings shall be made in arrears by certified invoice. 10.4 All repairs shall be completed according with all terms within this Statement of Work. Instrument List Arthrex ACL Toolbox Arthrex Shoulder Arthroscopy Set Arthroscopy Primary Set Basic Vascular Set 1 Basic Vascular Set 2 Clear Cornea Tray Clear Cornea Tray Clear Cornea Tray Clear Cornea Tray Deep Belly Set Dental JDH Finals Dental JDH Finals Dental JDH Finals Dental Scaling & Root Planing Dental Suture Removal Set Dental Suture Removal Set Dental Suture Removal Set Dental Suture Removal Set Dental Suture Removal Set Dental Suture Removal Set Dental Universal Tray Dental Universal Tray Dental Universal Tray Dental Universal Tray Dental Universal Tray Dental Universal Tray Dental Universal Tray Excision Lesion Set Excision Lesion Set Excision Lesion Set Excision Lesion Set Excision Lesion Set Excision Lesion Set Excision Lesion Set Excision Lesion Set Excision Lesion Set Excision Lesion Set Excision Lesion Set GU Set Hand Foot Set Hand Foot Set K Storz Cysto Tray K Storz Cysto Tray K Storz Cysto Tray K Storz Cysto Tray K Storz Cysto Tray K Storz Cysto Tray K Storz Resectoscope Set K Storz Resectoscope Set K Storz Resectoscope Set Lamina Spreader Set Lap Set Lap Set Lap Set Lap Set Lap Set Lap Set Lap Set Laparoscopic Instruments - Wolf Laparoscopic Instruments - Wolf Laparoscopic Instruments - Wolf Laparoscopic Instruments - Wolf Laparoscopic Instruments - Wolf Minor Set Minor Set Occuloplasty Tray Ortho Tray Ortho Tray Ortho Tray Ortho Tray Plastic Set Pod Tray Pod Tray Scope, ENTCl Rigd, 30 Deg, 2.7 mm 1871902 Shoulder Set Dental JDH Finals Dental Suture Removal Set Dental Universal Tray Excision Lesion Set Excision Lesion Set Shoulder Set Clear Cornea Tray Dental JDH Finals GU Set K Storz Resectoscope Set Arthrex Shoulder Arthroscopy Set Dental Universal Tray Dental, Apico Tray Excision Lesion Set Excision Lesion Set Hemorrhoidectomy Set K Storz Cysto Tray Lamina Spreader Set Lap Set Potts Intestinal Set Total Hip Set Arthroscopy Primary Set Bone Reduction Forceps/Clamps Charnley Retractor Clear Cornea Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Excision Lesion Set Excision Lesion Set Hand Set K Storz Cysto Tray Lap Set Lap Set Pod Tray Potts Intestinal Set Arthrex Knee Arthroscopy Set Arthroscopy Primary Set Clear Cornea Tray Clear Cornea Tray Curettes, Long Handle Deep Belly Set Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental Scaling & Root Planing Excision Lesion Set Neck Set Plastic Set Arthrex Knee Arthroscopy Set Arthrex Knee Arthroscopy Set Arthrex Shoulder Arthroscopy Set Basic Vascular Set 1 Basic Vascular Set 2 Basic Vascular Set 2 Dental JDH Finals Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental New Universal Tray Dental Scaling & Root Planing Dental Scaling & Root Planing Dental, Sinus Lift, Osteotome Kit Dental, Sinus Lift, Osteotome Kit Excision Lesion Set Excision Lesion Set Excision Lesion Set Hand Set Plastic Set Pod Tray Potts Intestinal Set Basic Vascular Set 1 Curettes, Long Handle Dental Perio Surgery Dental Scaling & Root Planing Dental Scaling & Root Planing Dental Scaling & Root Planing Excision Lesion Set Hand Set Ortho Tray Osteotomes Curved and Straight Amputation Knife Arthroscopy Primary Set Curettes, Long Handle Dental New Universal Tray Dental Scaling & Root Planing Dental Scaling & Root Planing Hand Set Osteotomes Curved and Straight Plastic Set Sinus Endoscopy Total Hip Set Arthrex Knee Arthroscopy Set Basic Vascular Set 1 Bookwalter Retractor - OLD Dental Alveo Tori Removal Kit Dental Scaling & Root Planing EEA Circular Sizer Set Excision Lesion Set Excision Lesion Set Hand Foot Set K Storz Resectoscope Set K Storz Urethrotome Set Osteotomes Curved and Straight Pod Tray D&C Tray Dental Bony Impaction Tray Dental New Universal Tray Dental Universal Tray Dental, Apico Tray GYN Laparscopic Hysterectomy Extras OR GYN Laparoscopic Tray Osteotomes Curved and Straight Pod Tray Potts Intestinal Set Basic Eye Tray Bookwalter, Aluminium New Deep Vascular Deep Vascular Dental Perio Surgery Dental Scaling & Root Planing Dental Scaling & Root Planing Excision Lesion Set GU Set Hand Set Hohmann Retractor Minor Set Prostatectomy Set Total Hip Set Amputation Knife Arthrex Shoulder Arthroscopy Set D&C Tray Deep Belly Set Dental Scaling & Root Planing Dental Suture Removal Set Excision Lesion Set Excision Lesion Set Excision Lesion Set Excision Lesion Set Excision Lesion Set GYN Laparscopic Hysterectomy Extras GYN Laparscopic Hysterectomy Extras Hemorrhoid Banding Set Hysterectomy Tray Occuloplasty Tray Omniflex Retractor Omniflex Retractor OR GYN Laparoscopic Tray Plastic Set Basic Eye Tray Basic Vascular Set 1 Basic Vascular Set 2 D&C Tray D&C Tray Dental JDH Finals Dental Scaling & Root Planing Dental Scaling & Root Planing Dental Scaling & Root Planing Dental Scaling & Root Planing Dental Universal Tray Hohmann Retractor Hysterectomy Tray K Storz Resectoscope Set Neck Set Occuloplasty Tray OR GYN Laparoscopic Tray OR GYN Minor set Ortho Tray Osteotomes Curved and Straight Osteotomes Curved and Straight Prostatectomy Set Basic Vascular Set 2 Charnley Retractor Clear Cornea Tray Clear Cornea Tray D&C Tray D&C Tray Deep Belly Set Deep Vascular Dental Universal Tray Excision Lesion Set Excision Lesion Set GYN Cold Knife Set GYN Cold Knife Set Hemorrhoidectomy Set Hohmann Retractor K Storz Urethrotome Set OR GYN Minor set OR GYN Minor set OR GYN Minor set OR GYN Minor set Septoplasty Short Curette Rack Arthrex Chondro Pick Set Basic Eye Tray Basic Eye Tray Charnley Retractor Chest Tube Tray Chest Tube Tray Chest Tube Tray Dental Scaling & Root Planing Dental Universal Tray Dental Universal Tray Excision Lesion Set GU Set GU Set Hysterectomy Tray Neck Set OR GYN Minor set Shoulder Set Sinus Endoscopy Extra Total Hip Set Arthroscopy Primary Set Bookwalter Retractor - New Chest Tube Tray Deep Belly Set Deep Hip Set Dental Scaling & Root Planing Dr. Morris Instruments/OR Hemorrhoid Banding Set Myringotomy Tray Rigid Sigmoidoscope Set Arthrex Shoulder Arthroscopy Set Arthroscopy Primary Set Deep Vascular Dental Fracture Tray Dr. Ablan's Vascular Tray Dr. Ablan's Vascular Tray EEA Circular Sizer Set Long Handle Cobb Style Curettes Septoplasty Arthrex Knee Arthroscopy Set Bookwalter, Aluminium New Chest Tube Tray Gore Needle Lamina Spreader Set Needle Holders, Dr. Golub Short Curette Rack Tonsil Set Arthrex Shoulder Arthroscopy Set Minor Set Occuloplasty Tray Trach Tray Trach Tray Trach Tray

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