SOURCES SOUGHT SYNOPSIS The Department of Veterans Affairs is issuing this sources sought synopsis as a means of conducting market research to identify firms having an interest in and the resources to support a requirement for medical instrument sharpening and repair and cleaning of the sterilizers at Edward Hines, Jr., VA Hospital. The result of this market research may contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 811219 Other Electronic and Precision Equipment Repair and Maintenance. THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for proposals; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred. Requirements: PLEASE SEE SOW Interested firms shall provide a response that includes the following information: (1) Identification (including name, address, phone number and DUNS number), and your firm s applicable small business socio-economic status (e.g. Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Small Business, HUBZone, 8(a), or Women Owned Small Business (WOSB)). (2) A narrative of your experience and capabilities, to include how you will be able perform the service. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements. The government will evaluate market information to ascertain potential market capacity to provide services consistent in scope and scale with those described in this notice and otherwise anticipated. Based on the responses to this synopsis and other market research, this requirement may be set-aside for veteran-owned small businesses (SDVOSBs or VOSBs), small businesses or procured through full and open competition. Limitations on Subcontracting 13 CFR §125.6 will apply to any procurement set-aside for veteran-owned small businesses (SDVOSBs or VOSBs) or small businesses. 13 CFR §125.6 states: (a) General. In order to be awarded a full or partial small business set-aside contract with a value greater than the simplified acquisition threshold (as defined in the FAR at 48 CFR 2.101) in paragraph (a) introductory text; and an 8(a) contract, an SDVOSB contract, a HUBZone contract, a WOSB or EDWOSB contract pursuant to part 127 of this chapter, a small business concern must agree that: (1) In the case of a contract for services (except construction), it will not pay more than 50% of the amount paid by the government to it to firms that are not similarly situated. Any work that a similarly situated subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Before any small or large business can be awarded a federal contract, a contracting officer (CO) must affirmatively determine that the firm is responsible to perform the specific contract it is otherwise in line to receive. If an apparent small business successful offeror is denied a contract award because it lacks certain elements of responsibility, the CO will refer the matter to the Small Business Administration. Once a CO s referral is received by the SBA s area office, the SBA will then inform the small business of the CO s determination and offer it the opportunity to apply to the SBA for a Certificate of Competency by a specific date. Burden of proof is on the small business to demonstrate that it meets specific COC eligibility criteria. After award, if a CO or other VA officials determine a review of limitations on subcontracting compliance is warranted based upon reasonable information of possible noncompliance, a request for review will be submitted to VA s Subcontracting Compliance Review Program. Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this Sources Sought Notice by 4:00 PM on June 8, 2021. All responses under this Sources Sought Notice must be emailed to michele.trudell@va.gov. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. STATEMENT OF WORK 1. Contract Title. Instrument Sharpening, Repair and Sterilizer Cleaning 2. Background. Surgical instruments need to be sharpened, maintained, and repaired for optimal performance. Sterilizers are required to be cleaned annually. The Edward Hines Jr VA Hospital is currently seeking a company that can provide services to repair, refurbish, and assess for replacement surgical instruments for use in Operating Room, Ambulatory Care, Clinic, and CBOC procedures. Provide annual cleaning of the five sterilizers on site. Three large steam sterilizers- Steris brand, AMSCO Evolution model. Two smaller sterilizers- Steris brand, IUSS model. Five Hydrogen Peroxide sterilizers- Sterrad brand, models V-Promax, 100NX All Clear, 100NX and NX. 3. Scope. Vendor shall provide services that include, but are not limited to, sharpening, adjusting, aligning, straightening, refurbishing, calibrating, cleaning, extensive stain removal, polishing, lubricating, adjusting, resoldering, laser welding, chemical etching, and replacing missing or damaged parts and repair of older or obsolete instruments of various individual surgical instruments sets and operating room (OR) procedural instrument trays. Instruments will be provided individually or as components of a specialty tray. All instruments shall be maintained in proper operating conditions as specified by the original manufacturer. Annual cleaning of the pre-vacuum sterilizers. Instruments are to be retrieved from and delivered to the Sterile Processing Service (SPS), located at Edward Hines Jr VA Hospital 5000 S. 5th Ave. Hines IL 60141. All Surgical instrumentation trays (including powered surgical instrumentation) that are utilized for Edward Hines Jr VA Hospital will be placed on a quarterly rotation program to ensure that all instrumentation is properly maintained and sharpened. All repairs will follow all approved recommendations in regard to third party surgical instrument repair as set forth by the following: o Food and Drug Administration (FDA) o Centers for Medicare/Medicaid Services (CMS) o Centers for Disease Control (CDC) o Association for the Advancement of Medical Instrumentation (AAMI), o International Association of Healthcare Central Service Materials Management (IAHCSMM) o Association of per-Operative Registered Nurses (AORN) o Association of Professionals in Infection Control (APIC) o Department of Veterans Affairs, Veterans Health Administration (VHA) Directives Vendor shall provide at no additional cost to the government, In-service education to SPS staff on issues such as cleaning, care and handling. Vendor shall provide at no additional cost to the government, a yearly SPS Management Seminar that includes but not limited to: § Site visit to engineering and repair facility § Discussion of repair issues and proper care and handling of instruments § Discussion of programs to enhance management and administrative effectiveness. 4. Specific Tasks. Sterilizer Service Sterilizer cleaning must be performed annually, for each device, following manufacturer s guidelines. The cleaning should be performed on weekends or Federal Holidays, to avoid disruption in SPS and surgical case workflow. This service is to be staggered throughout the year. Three large steam sterilizers- Steris brand, AMSCO Evolution model. Two smaller sterilizers- Steris brand, IUSS model. Five Hydrogen Peroxide sterilizers- Sterrad brand, models V-Promax, 100NX All Clear, 100NX and NX. The times and machines to be cleaned will be coordinated between the COR (or SPS Leadership designee) and the vendor. In the case of equipment failures of other sterilizers in the SPS or the OR departments, the cleaning service would need to be rescheduled; workflow disruption should be avoided if possible. The vendor will be responsible for providing all necessary chemicals and equipment for this process. Any water hoses available in the area may be used by the vendor. Vendor will provide documentation that cleaning was performed, per manufacturer s guidelines. Instrument Service Instruments are to be retrieved from and delivered to the Hines Sterile Processing Service (SPS) located in Edward Hines Jr Veteran Hospital, 5000 S. 5th Ave, Hines Il 60141. A physical inventory count of all instruments and trays, will be performed at the start of the contract and every year after, for the length of the contract. The Contractor's employee(s) shall report to the Sterile Processing Service (SPS) upon arrival at the Edward Hines Jr Veteran Hospital for the pickup and return of instruments. If instruments cannot be repaired, they must be marked or tagged and returned to SPS. If an instrument needs to be sent out for third party repairs by the contractor, authorization must be obtained from SPS. The repair vendor will provide multiple levels of repair service including, but not limited to, same-day turn-around, 24 hour turn-around, weekend service, mail-in repair service, and onsite repair service. All Urgent instrument repairs will have a 48-hour turnaround time. All Emergency Instrument Repairs will have a 24-hour turnaround time. Urgent and Emergency status will be determined by the using service and/or SPS. A loaner service for all power instruments, if the power instrument is to be removed from the facility for maintenance or repair, would be desirable. Surgical instrument maintenance and repair will be handled with care. The contractor will be required to test instruments for accurate alignment, sharpness, insulation and calibration. The contractor will return instruments in, as good as new condition. All instruments shall be repaired and maintained in proper operating conditions as specified by the original manufacturer New, original manufactured instruments and parts will be used whenever possible. Repairs, maintenance, and testing of surgical instruments, laparoscopic instruments, pneumatic instruments, electric/battery (cordless) instruments, fiber optic light cables/cords, rigid and flexible endoscopes, video equipment and cameras, surgical instrument containers, push carts, and case carts should be considered for repair. A comprehensive list is included below. SPS may not utilize all services. Instruments to be serviced include, but are not limited, to: General Instruments Open Heart PV Neuro Ortho Plastics Gynecology Outpatient/Ambulatory Care Transplant Podiatry Otolaryngology (ENT) Urology/GU Audiology/Speech Micro Arthroscopic Laparascopic Endoscopic (rigid and flexible) Ophthalmic Needle Holder Insert Replacement MIS Instrument Repair Flexible Biopsy Forceps Repair Power Equipment Repair Phaco Ultrasonic Emulsifier Repair Fiber Optic Light Cable & Adapter Repair InsulScan Insulation Testing System On-location Laparoscopic Rebuilds and Repairs Endoscope Leak Testers function testing Replacement Biopsy Forceps and Endoscopic Accessories Ultrasound Transducer Repair Chemical etch Video Equipment (video cameras, camera control units, endocouplers, light sources, printers, beansplitters, video processors, and video pigtail cables) Case cart, push cart, table and IV pole repair services Dental Saws Rigid containers Suction tubes (Poole, Adson, Frazier Baron, and Yankauer) will be inspected, and interior lumen flushed and inspected. Provide repair service, and validate repairs, for Aesculap Sterile Containers and Sterile S Containers, baskets, and filters Specific custom-made instruments will be repaired in coordination with operating room surgeons (end user) specifications. Instruments will not be altered, changed or tampered with and will be repaired following manufacturers' original design specifications. All instruments that can be disassembled will be disassembled for maintenance and repair. They will also be sharpened and aligned in accordance with the manufacturer's original specifications. Any bio burden found once disassembled, should be photographed and submitted as part of the service documentation for that visit. Instruments will be stain-free with a finish that complies with the manufacturer's specifications. All instruments must be in working order after any chemical exposure. The vendor will be responsible for returning within 24 hours to fix any instruments found not to be in working order after the use of chemicals. Chemical date etching should be provided on each instrument for warranty tracking purposes. It is understood some instrument materials cannot be etched; these dates should be documented in the visit report. These etches should not interfere with instrument tracking barcodes. The manufacturer's part numbers and catalog numbers shall be preserved on all repaired or refurbished instruments, as well. Instruments that cannot be repaired or refurbished due to cracking, pitting, corrosion, or exceeding life expectancy will be tagged or marked for removal and/or replacement. Information should include the reason for removal, and which instrument set the instrument was removed from. The repair vendor will not repair any surgical instruments that are on the DO NOT USE list. These instruments should be pulled from service. The list will be provided to the vendor at the initial visit, and new copies will be provided as the list is updated. Sterilization guidelines should be provided for any labels and/or stickers placed on sterilization containers. The label used must be validated for the type of sterilization required for that instrument set (Steam, H2O2, and PA). Free shipping containers and materials will be provided for offsite repairs Pre-paid shipping labels and transportation insurance will be provided for offsite repairs Case cart, push cart, table and IV pole repair services should be available, including, but not limited to, caster replacement, custom fabricating, molding replacement, realign doors, repair latch assemblies, replace hinge pins, replace washer/sterilizer racks, reweld door hinges, racks and shelf brackets, wheel replacement, hinge replacement, bumper replacement, and rust removal. The contractor shall remove from the facility all excess materials, trash, debris, and barriers generated as a result of their services. Reporting/Documentation All documentation should be provided on vendor letterhead. The repair vendor, with the input of the clinical and SPS staff, will implement a Surgical Instrument Quality Assurance Program (SIQAP) whereas instrument sets will be repaired, documented, and monitored by surgical service and specialty. The vendor will work with SPS to create maintenance schedules for instrument trays and input the information into the Censitrac Instrument Tracking Program on a regular basis. This should be at no additional charge to Hines or the government. Instruments are to be handled with care to avoid further damage. While instruments are in the contractor s possession, the contractor take full responsibility and accountability for all instruments removed from the VA facility. Contractor will provide an inventory of instruments and instrument sets removed from and returned to the facility that are to be serviced or repaired. The contractor must provide a summary document upon delivery of processed instruments containing the following information; date of repair, instrument tray, instrument type, type of repair, and cost. The contractor shall provide a written or emailed summary of all items removed from service and the instrument tray name and number from which it was removed within one (1) business day. Items that have been repaired for the last time before replacement is needed should be reported after every visit. Additionally, any instrument nearing the end of useful life shall be noted for replacement prior to being removed so that the service can replace the instrument prior to removal. Included in this replacement & end of useful life report shall include the instrument name, catalog number, instrument set it is being removed from and a brief description as to why it is near its end of useful life. The contractor shall contact the Edward Hines Jr VA Hospital SPS Office to review all instruments that require offsite repair and the instrument tray name and number from which it was removed. Edward Hines Jr VA Hospital SPS Office must provide written approval prior to removal of any and all instruments that require offsite repair. The repair vendor will provide education regarding instrument repairs, instrument care and handling, instrument testing, instrument processing, power equipment repairs, laparoscopic continuity testing, and endoscopy instrument repairs. An electronic presentation that details issues, problems, bioburden, etc., should be provided after every visit. Requirements Repairs will be completed either on location at the Edward Hines Jr Veteran Hospital, 5000 S. 5th Ave, Hines Il 60141 in a mobile repair vehicle, or offsite at the vendor's repair facility. 1S09001 and 1S013485 (medical device) certifications must be obtained by the repair vendor. Employees of the repair vendor responsible for repairing surgical instruments must be ASQ (American Society for Quality) certification and receive CQI (Certified Quality Inspector) training. The repair vendor will provide enough technicians for onsite service to be completed in one business day. Individual instrument repairs will be performed Monday through Friday between the hours of 6:00am 4:00pm, excluding weekends and national holidays. This service will be provided two times per week, every week. There will be at a minimum, 2872 instrument trays, which will need to be serviced/maintained every year. Each tray will need to be serviced/maintained twice per year and/or on an as needed basis. 30-50 of these trays will need to be serviced/maintained each week. Instrument repairs completed onsite at the Edward Hines Jr Veterans Hospital in a mobile repair lab/vehicle must be repaired in a vehicle that is clearly labeled with the vendor's name and permit numbers. The mobile repair vehicle should be self- sustained with electrical power, air compressor, tools, etc. Safety cones must be utilized around the perimeter of the mobile repair vehicle to ensure the safety of hospital and vendor staff. The vehicle must be parked in a pre-determined area, to be determined by the Warehouse. Continued instrument repairs quality improvement monitoring and turnaround time as well as contract compliance will be progressively monitored by Sterile Processing Service. This will be a periodic inspection. The government reserves the right to consider changing the method of inspection from Periodic to 100% Inspection at any time; however, deteriorating contractor performance may result in immediate 100% surveillance. Contracting Officer's Representative (COR) and SSL Program Manager will designate appropriate VA personnel to monitor contractor employee work hours/services through one or a combination of the following mechanisms: Overall Performance, Appearance of instruments, Function of Instruments, Provide technically skilled personal. The VA personnel designee jointly with the Chief, Sterile Processing Service (SPS) will monitor Contractor instrument pick-up and drop-off. This will be accomplished by the contractor's employee(s) reporting to SPS upon arrival at the facility, and again before departure. On-line access to account should be made available to SPS and SSL Admin. The contractor shall provide itemized repair service invoices. All correspondence invoices shall include the current contract number. Billings shall be made in compliance with OB10 requirements. All repairs shall be completed according with all terms within this Statement of Work. The contracting Officer's Representative (COR) 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 by the COR. Documentation of services performed will be reviewed by the COR prior to certifying payment. The COR will perform periodic documents checks with the using service to ensure records monitoring. VA will pay only for services actually 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 recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided. Monthly invoices are submitted to the COR, by the contractor. The COR, or designee, will verify that services were actually performed against contractors certified delivery repairs document. Only after verification are invoices submitted for payment. The contractor will provide a minimum 3 references listing customers name, address, timeline of services, and phone numbers of contacts. They will also have a minimum of 5 years of experience providing these services to Hospital or Major Medical Center. In addition to the per visit requirements listed above, a quarterly repair report, business review, and Surgical Instrument Quality Assurance Program (SIQAP) update shall be provided to the COR, and Chief of SPS. This report should be free of charge The Contractor must provide validation letters certifying contractor s competency of all representatives performing service. Letters are to be provided to Chief, SPS no later than the 5th business day of each fiscal year. Validation letters must be provided within one week for all new representatives that are sent to perform repair, sharpening and educational services. Contractor shall be required to complete a security clearance with the VA Police. A vendor ID badge will be issued by the VA Police 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. Contractor mobile unit(s) shall be registered with the Edward Hines Jr Veterans Hospital s Police Department. Period of Performance. This contract is required for a base period of 12 months with 4 one- year options.
