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 the Federal Health Care Center in North Chicago, IL. 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 9:00 AM on March 15, 2022. All responses under this Sources Sought Notice must be emailed to Frederick.Weddington@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 Contract Title: Instrument Sharpening, Repair, and Sterilizer Cleaning Introduction: The Captain James A. Lovell Federal Healthcare Center is currently seeking a contractor that can provide In-House services related to a complete maintenance program for surgical instrumentation used in the operating room and in clinical procedures which includes repair, refurbish and assessment for replacement. In addition, a one-time, joint, wall-to-wall inventory of all surgical instruments contained within the Surgery Department and Sterile Processing Services (SPS) is required within 30 days of the start of the contract and every year after, for the length of the contract. This inspection is required to establish a comprehensive and repair inspection schedule. General Information: Required services are to be completed once per week and will be conducted on 5-10 trays per visit. The expected performance period is a base year of twelve (12) months with four (4) option years. Each option year is twelve (12) months. Contractor shall coordinate this scheduled work with the Chief of SPS or designee. Instruments are to be retrieved from and delivered to the Sterile Processing Service (SPS), located the Captain James A. Lovell Federal Healthcare Center (FHCC), 3001 Greenbay Rd, North Chicago, IL 60064. Required Services: Comprehensive Maintenance: Contractor shall provide services that include, but are not limited to, cleaning of five (5) Medium and Small Prevacuum sterilizers, aligning, calibrating, refurbishing, cleaning, stain removal, polishing, sharpening, oiling/lubricating, straightening, adjusting, replacing parts, and maintaining the equipment. Instruments will be provided individually or as components of a specialty tray. This will include general instruments, cleaning and repairing case carts, laproscpic, power equipment, power cords, handpieces, video equipment, RIGID containers and flexible endoscope. 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 minimal incidence of malfunction or inoperative conditions. Recommendations for replacement and/or removal of surgical instruments is also covered within this scope. Upon completion of the one-time, joint, wall-to-wall inventory of all surgical instruments contained within the facility (described herein), the contractor will work with the Sterile Processing Services (SPS) to establish a preventative maintenance inspection schedule for the items identified during this inventory. 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 and in compliance with ANSI-AAMI ST-79 part 7.7. During 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, in compliance with ANSI-AAMI ST-79 part 7.7. Any stains, sharp edges and/or scratches will be removed. Instruments should have a mirror finished appearance, except for the locator barcode, on return. All cannulated items will have interior lumen flushed and inspected. 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 (Vascular, Ortho, ENT etc.); curettes, hemostats, scissors, graspers, laparoscopic instruments, rongeurs, dental instruments, repairing minor nicks, bents, rim alignments, remove minor bur from containers that house the instruments, etc. There are variety of brands of instruments being repaired are: V. Muller, Katena, Koing, Skar, etc. Maintenance services and Instrumentation described herein consist of the following: Clinic Repair Services: Consists of instrumentation tasks that can be performed/completed on site Laboratory Repair Services: Consists of repairs needed on instruments that must be done in the laboratory and which cannot be performed on site. Repair Bin: Comprised of instruments (collected from patient care areas) that may require clinic repair services and/or laboratory repair services The repair contractor 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. New, original manufactured instruments and parts will be used. Suction tubes (Poole, Adson, Frazier Baron, and Yankauer) will be inspected, and interior lumen flushed and inspected. Provide repair services and validate repairs for FHCC rigid instrument containers, baskets, rubber mask and filters. Instruments will be stain free with a finish that complies with the manufacturer's specifications. All instruments must be in working order after any chemicals that may be used on them. The contractor will be responsible for returning within 24 hours to fix any instruments found to be in non-working order after the use of chemicals. 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 and set # the instrument was removed from. 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 and push cart repair services should be available, including, but not limited to, wheel replacement, hinge replacement, bumper replacement, and rust removal. Specific Mandatory Task and Associated Deliverables: Sterilizer Service: Each of the Sterilizers located in FHCC and 1017, cleaning must be performed quarterly, for each device, following manufacturer s guidelines. The cleaning should be performed on weekends or Federal Holidays, to avoid disruption in SPS workflow. This service is staggered throughout the year; no more than one medium and one small sterilizer may be cleaned at one time. The times and machines to be cleaned will be coordinated between the Contracting Officer Representative (COR) (or designee) and the contractor. In the case of equipment failures of other sterilizers in the SPS or OR departments, the cleaning service would need to be rescheduled; workflow disruption should be avoided. The contractor will be responsible for providing and disposal all necessary chemicals and equipment for this process. Any water hoses available in the area may be used by the contractor. The Contractor will provide maintenance documentation , per manufacturer s guidelines. Low Temperature Sterilizers: Contractor will follow the manufacture s equipment maintenance such as but limited to cleaning, inspection, vacuum pump oil change and filter change. 7 Washers Disinfectors: Weekly descaling Weekly rotary arms cleaning and inspection Water inlet pressure test inspection Monthly inspection and cleaning of door gasket Quarterly door safety test, pick up tube inspection and chemical empty switches inspection Inspection of emergency stop bush button and perform safety levels twice a year. Contractor will follow manufacture recommendation. Instruments are to be retrieved from and delivered to Sterile Processing Services (SPS) located at: Captain James A. Lovell Federal Healthcare Center, SPS Preparation Area and OR Surgery Unit. Delivered to Captain James A. Lovell Federal Healthcare Center, SPS Decontamination area. All instrument sets shall be scanned in censitrac as repaired or sharpened for tracking purpose 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). 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. The contractor will be required to test instruments for accurate alignment, sharpness, insulation and calibration per manufacturers Instructions For Use (IFU). All returned, inspected, and repaired instruments will be stain-free and polished to a mirror finish while maintaining locator barcodes. Instrument Barcodes: If an instrument does not have barcode, contractor agrees to apply one. The contractor will be asked to etch barcodes on all new instrumentation. 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: date of repair, instrument type, tray description, department, 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 tagged and returned to SPS management. If an instrument needs to be send out for third party repairs by the contractor, the contractor must have obtained verbal approval of a VA SPS Chief, or designee, prior to doing so. Contractor will provide an electronic report for tracking purposes. The contractor shall make recommendations for surgical instrument replacement which may be pertinent to meet the scope of surgical trays completion. VA Monitoring: The contractor shall make recommendations for surgical instrument replacement which may be pertinent to meet the scope of surgical trays completion. Continued monitoring of instrument repairs quality and turnaround time, as well as contract compliance, will be progressively monitored by SPS and Contracting Officer Representatives (CORs). The Chiefs of SPS will monitor contractor instrument pick-up and drop-off through written logs and schedules to ensure that 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 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: Repairs will be completed at Captain James A. Lovell FHCC, 3001 Greenbay Rd, North Chicago, IL 60064 in a mobile repair vehicle, or offsite at the contractor s repair facility 1S09001 and 1S013485 (medical device) certifications must be obtained by the repair contractor. Employees of the repair contractor responsible for repairing surgical instruments must be ASQ (American Society for Quality) certified and receive CQI (Certified Quality Inspector) training. The repair contractor 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 7:00am 4:00pm, excluding weekends and national holidays. Visits should be once per week, scheduled at least a week in advance. 75% of the repairs shall be completed onsite at the FHCC in a mobile repair lab/vehicle must be repaired in a vehicle that is clearly labeled with the contractor s name a 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 contractor 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 jointly monitored by SPS and the COR. 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. The COR 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 COR jointly with the Chief, 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. 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. 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 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 performed against contractors certified delivery repairs document. Only after verification are invoices submitted for payment. Any incorrect invoices will be denied and will need to be electronically re-submitted. 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 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 identification (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 will comply with all VAMC policies related to the grounds (i.e. smoke- free campus) Reporting/Documentation All documentation should be provided on contractor letterhead. 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. Items that have been repaired for the last time before replacement is needed should be reported after every visit. The repair contractor will provide education regarding instrument repairs, instrument care and handling, instrument testing, instrument processing, power equipment repairs, laparoscopic continuity testing, and endoscopy instrument repairs. SPS and Surgical Service Operating Room (OR) Support: VA SPS site and OR Surgery Unit 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 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 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. 9.3 Continued instrument repairs, quality improvement monitoring, and turnaround time, as well as contract compliance, will be progressively monitored by Chief of SPS and the COR representative. 9.3 All repairs shall be completed according with all terms within this Statement of Work.
