Small Business Set-Aside The Minneapolis VAMC requires Surgical Instrument Repair, Testing, Maintenance and Repair services in accordance with the Statement of Work (SOW) below. This is a sources sought/proof of capability solicitation looking for Small Business vendors to perform the services per the SOW for market research purposes. No awards of a contract will be made from this announcement. If you are a vendor that can complete the work described in the SOW with competitive pricing, please send your information with a description of proof of capability to:
[email protected] on or before January 10th, 2022. *If applicable, FAR Provision 52.219-14 Limitations on Subcontracting, will apply to the potential solicitation if set-aside for Small-Businesses.* STATEMENT OF WORK Surgical Instruments: Maintenance, Inspection, Testing and Repair  General Information The Minneapolis VA Health Care System, here in referred to as MVAHCS, is currently seeking a company that can provide a maintenance program for surgical instrumentation used in surgical and clinical procedures; including preventative maintenance, repair, refurbish and recommendation for replacement. Sterile Processing Services at the MVAHCS is a 24/7 department servicing the facility s 18 operating rooms, 2 hybrid ORs, 4 cath labs, and multiple specialty clinics that provide invasive procedures. Surgical Services include Orthopedic, Cardiovascular, Thoracic, General, Urology, Optometry, Neurology Gynecology, Audiology, Oncology, Dental, and ENT Specialties. The contractor shall provide Preventive Maintenance (PM) and As-Needed Repair, which may consist of aligning, calibrating, refurbishing, cleaning, stain removal, polishing, sharpening, oiling, straightening, adjusting, replacing parts, and maintaining the equipment, including all emergency calls necessary between regular maintenance. The scheduled pick up for repairs shall occur at a minimum of twice a week. Preventive Maintenance of individual surgical pans shall occur at a minimum of yearly. Instrumentation includes a wide variety of general and specialty surgical tools, but is not limited to curettes, hemostats, scissors, graspers, laparoscopic instruments, rongeurs, surgical knifes, power equipment (camera, drills & saws), etc. This contract shall not include endoscopes.  Introduction and Scope of Work Vendor shall provide preventative maintenance and repair services for various surgical and procedural instruments, in accordance with the original manufacturer s instructions, to include but not limited to; sharpening, adjusting, aligning, straightening, refurbishing, calibrating, cleaning, stain removal, polishing, oiling, adjusting, and replacement of parts. Instruments shall be provided individually or as components of a specialty tray. All preventative maintenance required by the Manufacture 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, is required to be completed. All instruments shall be maintained in proper operating conditions and must also be in compliance with ANSI-AAMI ST-79:2010 Part 7.7 (Servicing and Repairs of Devices in the Health Care Facility), and ISO-9001 standards. Vendor shall supply document clarifying company s scope of work, in which shall state what type of work shall be able to be accomplished on-site, locally, and what shall need to be sent to a 3rd party vendor. Contractor shall provide 3rd party information with response to solicitation to be found favorable for award.  Instruments are to be retrieved from and delivered to the Sterile Processing Services Department (SPS) located in VA Medical Center at One Veteran s Drive, Minneapolis, MN 55417. Contact phone number: 612-467-2537. Specific Mandatory Task and Associated Deliverables The Contractor's employee(s) shall report to Sterile Processing Services (SPS) upon arrival at the MVAHCS for the pickup and return of instruments. MVAHCS SPS departmental contacts include Chief of SPS, Assistant Chief of SPS, Quality Assurance Technician and/or the Program Support Assistant. Provide preventative maintenance, testing and repairs, of all surgical instruments owned by the MVAHCS, including, but not limited to orthopedic (including pneumatic orthopedic instruments), neurological, laparoscopic, cardiovascular/vascular, ENT, gynecological, bariatric, gastrointestinal, and dental. See Appendix A for list of surgical pans, and volume of instrumentation, owned by facility. All preventative maintenance required by the Manufacture 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, is required to be completed. All instruments shall be maintained in proper operating conditions and must also be in compliance with ANSI-AAMI ST-79:2010 Part 7.7 (Servicing and Repairs of Devices in the Health Care Facility), and ISO-9001 standards. If an instrument is unable to be repaired, instrument must be returned to MVAHCS with firmly affixed tag declaring why instrument is unrepairable. All instruments shall be returned to MVAHCS regardless of condition. All returned, inspected, and repaired instruments shall be stain free and polished to a mirror finish, while maintaining QR code, manufacturer name, and instrument catalog number. All instruments shall be inspected for the presence of a QR code. When an instrument does not have said QR code, vendor shall communicate with facility by placing all instruments requiring QR code placement in a container with a firmly affixed tag denoting QR code absence. All single instruments and surgical trays picked up/delivered by the contractor shall be properly documented with name of instrument, manufacture catalog number, and quantity of items for accountability verification. Vendor shall provide maintenance and repair for rigid instrument containers to ensure that all lid gasket vent devices are fully functional, in accordance with manufacturer specifications. The contractor must provide a summary document upon delivery of processed instruments containing the following information: date of repair, instrument name, manufacture catalog number, quantity, type of repair, and cost. Vendor shall communicate with facility when an instrument is expected to be returned outside of the preset allotted timeframe. When other instruments from the same invoice are returned to the facility, an estimated date of completion and cause of delay should be documented. No partial invoices can be submitted for payment until all instruments have completed their required repairs. Routine instrument repair service timeframe: 7 calendar days with day of pick up considered as day 1. If day 7 falls on a weekend or federal holiday, the next business day shall be considered day 7. Instruments and instruments sets shall be scanned by the MVAHCS using the inhouse Censitrac system to initiate date/time stamp on the vendor s prescribed service date. Instruments and instrument sets shall be scanned by the MVAHCS using the inhouse Censitrac system to place date/time stamp on return of items to the MVAHCS. Once a month a report will be run in Censitrac to show when items have been serviced and returned to the MVAHCS in the preset allotted time. When any deficiencies are noted, the vendor shall be notified and given a chance to discuss them with the MVAHCS POC and documented for review by the MVAHCS Contracting Officer. Urgent instrument repair service timeframe: 48 hours starts at time of notification by MVAHCS to the vendor. If the 48 hours ends on a weekend or federal holiday, the return timeframe shall be extended to the beginning of the next business day with return to MVAHCS within the first hour of the business day. Once item(s) have been determined to need urgent servicing, the MVAHCS shall scan the item(s) out to repair in Censitrac setting a date/time stamp and immediately call vendor to notify them of urgent needs. Urgent need item(s) shall be returned to the MVAHCS within 48 hours from time of notification where they shall be inspected for accurate servicing and scanned in Censitrac setting return date/time stamp. Once a month a report shall be run in Censitrac to show when items have been serviced and returned to the MVAHCS in the preset allotted time. When any deficiencies are noted, the vendor shall be notified and given a chance to discuss them with the MVAHCS POC and documented for review by the MVAHCS Contracting Officer. Emergency instrument repair service timeframe: 24 hours starts at time of notification by MVAHCS to the vendor. When the 24 hours ends on a weekend or federal holiday, the repair timeframe shall be extended to the beginning of the next business day with return to MVAHCS within the first hour of the business day. When item(s) have been determined to need emergency servicing, the MVAHCS shall scan the item(s) out to repair in Censitrac setting a date/time stamp and immediately call vendor to notify them of emergency needs. Emergency need item(s) shall be returned to the MVAHCS within the 24 hours from time of notification where they shall be inspected for accurate servicing and scanned in Censitrac setting return date/time stamp. Once a month a report shall be run in Censitrac to show when items have been serviced and returned to the MVAHCS in the preset allotted time. When any deficiencies are noted, the vendor shall be notified and given a chance to discuss them with the MVAHCS POC and documented for review by the MVAHCS Contracting Officer. The Vendor shall provide a clear pricing structure with details of any tiered billing.  Preventative Maintenance (By Specialty) Surgical Instrument Trays Preventative maintenance of surgical instrument trays shall be arranged for two days a week and must be performed Monday through Friday between the hours of 8:00am 4:00pm, excluding weekends and national holidays. Instruments will be returned only via: Vendor (Hand Delivery) or Courier Services (not parcel post, FedEx, etc.) Routine preventative maintenance timeframe: 7 calendar days with day of pick up considered as day 1. If day 7 falls on a weekend or federal holiday, the next business day shall be considered day 7. Instruments and instruments sets shall be scanned by the MVAHCS using the inhouse Censitrac system to initiate date/time stamp on the vendor s prescribed service date. Instruments and instrument sets shall be scanned by the MVAHCS using the inhouse Censitrac system to place date/time stamp on return of items to the MVAHCS. Once a month a report will be run in Censitrac to show when items have been serviced and returned to the MVAHCS in the preset allotted time. When any deficiencies are noted, the vendor shall be notified and given a chance to discuss them with the MVAHCS POC and documented for review by the MVAHCS Contracting Officer. Preventative Maintenance (PM) of Surgical Instruments shall be done by the inspection of entire trays. All trays shall be done at a minimum of annually, according to Appendix B: Preventative Maintenance Schedule. Maintenance is preferred to be performed in the contractor s mobile unit, on the grounds of the MVAHCS. When Contractor determines a better inspection will be completed off-site, arrangements will be made with MVAHCS SPS s departmental contacts. When off-site inspection is approved, instrument tray MUST be returned within 2 business days. During Preventative Maintenance inspections, instruments shall 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 shall be removed. Instruments should have a mirror finished appearance, with the exception of the QR Code, manufacturer name, and instrument catalog number, on return. Instruments shall be repaired following the manufacturer s original design specifications and in compliance with ANSI-AAMI ST-79 part 7.7. All instruments able to be disassembled, shall be disassembled according to manufacturer s specifications, and undergo a detailed contractor inspection. All cannulated items shall have interior lumen flushed and visually inspected. Any instruments that fail the quality check upon return to MVAHCS shall be resubmitted to the Contractor for repair at the Contractor s expense. Quality checks shall be performed by a GS-7 level personnel or above OR the RME Coordinator within 7 days of instrument being received by MVAHCS.  General Repair of Surgical and Procedural Instrumentation Individual instrument repairs shall be arranged for two days a week and must be performed Monday through Friday between the hours of 8:00am 4:00pm, excluding weekends and national holidays. Instruments will be returned only via: Vendor (Hand Delivery) or Courier Services (not parcel post, FedEx, etc.). Routine instrument repair service preset allotted timeframe: Vendor has 7 calendar days to complete routine instrument repairs. 7 calendar days with day of pick up considered as day 1. If day 7 falls on a weekend or federal holiday, the next business day shall be considered day 7. Instruments and instruments sets shall be scanned by the MVAHCS using the inhouse Censitrac system to initiate date/time stamp on the vendor s prescribed service date. Instruments and instrument sets shall be scanned by the MVAHCS using the inhouse Censitrac system to place date/time stamp on return of items to the MVAHCS. Once a month a report will be run in Censitrac to show when items have been serviced and returned to the MVAHCS in the preset allotted time. When any deficiencies are noted, the vendor shall be notified and given a chance to discuss them with the MVAHCS POC and documented for review by the MVAHCS Contracting Officer. Urgent instrument repair service preset allotted timeframe: Vendor has 48 hours to complete urgent instrument repairs. 48 hours starts at time of notification by MVAHCS to the Vendor. If the 48 hours ends on a weekend or federal holiday, the return timeframe shall be extended to the beginning of the next business day with return to MVAHCS within the first hour of the business day. Once item(s) have been determined to need urgent servicing, the MVAHCS shall scan the item(s) out to repair in Censitrac setting a date/time stamp and immediately call vendor to notify them of urgent needs. Urgent need item(s) shall be returned to the MVAHCS within 48 hours from time of notification where they shall be inspected for accurate servicing and scanned in Censitrac setting return date/time stamp. Once a month a report shall be run in Censitrac to show when items have been serviced and returned to the MVAHCS in the preset allotted time. When any deficiencies are noted, the vendor shall be notified and given a chance to discuss them with the MVAHCS POC and documented for review by the MVAHCS Contracting Officer. Emergency instrument repair service preset allotted timeframe: Vendor has 24 hours to complete emergency instrument repairs. 24 hours starts at time of notification by MVAHCS to the Vendor. When the 24 hours ends on a weekend or federal holiday, the repair timeframe shall be extended to the beginning of the next business day with return to MVAHCS within the first hour of the business day. When item(s) have been determined to need emergency servicing, the MVAHCS shall scan the item(s) out to repair in Censitrac setting a date/time stamp and immediately call vendor to notify them of emergency needs. Emergency need item(s) shall be returned to the MVAHCS within the 24 hours from time of notification where they shall be inspected for accurate servicing and scanned in Censitrac setting return date/time stamp. Once a month a report shall be run in Censitrac to show when items have been serviced and returned to the MVAHCS in the preset allotted time. When any deficiencies are noted, the vendor shall be notified and given a chance to discuss them with the MVAHCS POC and documented for review by the MVAHCS Contracting Officer.  Instruments shall 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 shall be removed. Instruments should have a mirror finished appearance, except for the QR code and instrument catalog number, on return. When any repair is estimated to be more than 50% of the replacement cost, written approval must be sought from the Chief of SPS, or designee. Vendor Representative shall meet with SPS Chief, or SPS Chief s specified designee, monthly about observations of trends in repairs and potential areas for increased education or cost saving initiatives. Frequency of this meeting is subject to change at any time during this contract period, based on Facility s need. Delicate sharp, pointed instruments shall be returned covered with appropriate tip protectors. 3rd party vendor repairs are acceptable when repairs exceed Contractor s capabilities. Any instruments that fail the quality check upon return to MVAHCS shall be resubmitted to the Contractor for repair at the Contractor s expense. Quality checks shall be performed by a GS-7 level personnel or above OR the RME Coordinator within 7 days of instrument being received by MVAHCS. The contractor shall provide repair service invoices. All correspondence invoices shall include the current contract number. Billings shall be made by certified invoice. All repairs shall be completed according with all terms within this Statement of Work. VA Monitoring: 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, shall be progressively and jointly monitored by the VA SPS and Surgical Service COR. COR shall designate appropriate VA personnel to monitor Contractor employee work services through one or a combination of the following mechanisms: The COR jointly with the Chief of SPS shall monitor Contractor instrument pick-up and drop-off through written logs and schedules to ensure that services called for in the contract have been received by the VA.  Documentation of services performed shall be reviewed by the COR prior to certifying payment. The COR shall perform periodic documents checks with the using service to ensure records monitoring. Periodic Customer Service interviews with End Users, to user quality work are being performed to their standards. VA shall pay only for services in strict accordance with the schedule of prices/costs shown in the schedule of items. Contract monitoring and recordkeeping procedures shall be sufficient to ensure proper payment and allow audit verification that services were provided. VA is not responsible for overage costs when a 3rd party vendor is used. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer (CO) by the COR. Weekly invoices shall be submitted to the Chief of SPS, or specified designee, at the beginning of the contract, until it is determined that billing documentation meets requirements. Weekly invoices must be approved by MVAHCS SPS s departmental contacts prior to the monthly invoices being submitted to Financial Services Center in Austin, Texas by the Contractor. The COR shall verify that services were performed against contractor s certified delivery repairs document. Only after verification are invoices certified for payment. Billing disagreements that cannot be resolved by the COR shall be forwarded to the Contracting Officer for review and resolution. A full instrument repair pricing catalog which includes repair costs for individual instruments and trays must be provided by Contractor to MVAHCS to facilitate billing audits.  Vendor/Contractor Requirements Vendor shall provide documentation of staff training, competencies, and any pertinent certifications in relation to the repairs they shall be conducting. This documentation shall be supplied with the solicitation response and those found noncompliant shall be unfavorable for award. The contractor performing the repairs, maintenance and inspections of surgical instruments shall be ISO-9001 certified or moving towards certification. This documentation shall be supplied with the solicitation response and those found noncompliant shall be unfavorable for award. Contractor shall be compliant with relevant VA Policies and with AAMI ST-79:2010 Part 7.7 standards (Servicing and Repairs of Devices in the Health Care Facility). A Mobile Repair Unit is required and shall properly display the contractor s name and permit numbers. The mobile unit should be self-sustained. MVAHCS shall not provide any items or utility services of any kind needed for sustainable functioning of the mobile unit. The contractor shall provide a minimum 3 references listing customer s name, address, timeline of services, and phone numbers of contacts. They shall also have a minimum of 5 years experience providing these services to Hospital or Major Medical Center. This documentation shall be supplied with the solicitation response and those found noncompliant shall be unfavorable for award. Vendor shall provide MVAHCS SPS staff with a total of six (6), two (2) per shift, CEU eligible in-services, on instrumentation, per year.  Documentation Requirements Contractor shall sign out all instruments /surgical trays removed from MVAHCS for repairs. Repaired instruments returned to SPS shall be on a detailed list document provided by the Contractor containing the following information: date of repair, instrument type, type of repair, and cost. A quarterly Surgical Instrument Trays Maintenance Inspection certification shall be provided to the COR in April, July, October, and January. Security Clearance Contractor mobile unit(s) shall be registered with the MVAHCS Police Department. Â