The Black Hills VA Healthcare System requires sterile instrument maintenance and repair services in accordance with the draft Statement of Work (SOW) below. This is a sources sought/proof of capability solicitation looking for 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 contact and organization information with a descriptive proof of capability to: Jeffrey.Brown8@va.gov on or before May 30th, 2025. Only emailed responses will be considered. Additionally, please provide answers as appropriate to the following questions in the table below with your response to this sources sought. Failure to respond to the following questions may affect the acquisition strategy. 1. Identify your organization's socio-economic category. 2. State whether any of the requested services may be ordered against a government contract awarded to your organization (e.g Federal Supply Schedule (FSS), General Services Administration (GSA), etc.). 3. State if subcontracting is contemplated for this requirement and what percentage of the work will be subcontracted and for what tasks.  *If applicable, VAAR 852.219-75 VA Notice of Limitations on Subcontracting Certificate of Compliance for Services and Construction, will apply to the potential solicitation if set-aside for Veteran Owned Small-Businesses or Service Disabled Veteran Owned Small-Businesses.* *If applicable, FAR 52.219-14 Limitations on Subcontracting, will apply to the potential solicitation if set-aside for Small-Businesses.* Statement of Work Veterans Health Administration Black Hills Health Care System Surgical Instrument Maintenance and Repair The Veterans Health Administration Black Hills Health Care System (VHABHHCS)requires surgical instrument Preventative Maintenance (PM) and repair services for their Surgical Processing Suite (SPS). The Contractor shall provide an online digital inventory system, or digital tracker, to track instrument repair status and requests that is accessible by the VHABHHCS. Preventative Maintenance and Repair Instrument(s) for this requirement mean: individual general surgical instrument identified during assembly inspection or front line use as not functional and requires evaluation and repair. Instrument Set(s) for this requirement mean: a uniquely named instrument tray used to contain a series of instruments defined by an instrument count sheet. Sets are between 2 and up to 141 individual instruments used during invasive procedures. The instrument set is assembled and held inside of a container system where most instruments will stay inside the set over repeated use. An instrument set may include multiple levels of instruments inside one instrument set. All instruments sent out within the instrument set must return with the instrument set. Preventative maintenance of surgical instruments shall be done by the inspection of entire trays. Repairs MUST align with the original manufacturers design and product specifications. Any modification or repair performed during repair that deviates from the OEM standards will render the instrument damaged beyond repair and will need to be replaced at the expense of the repairer. The Contractor shall ensure repairs and service functions are performed in conformance with manufacturer s specifications, the Center for Disease Control (CDC) regulations, Healthcare Sterile Processing Association (HSPA), Association of Peri-Operative Registered Nurses (AORN) Standards, Associate for Professionals in Infection Control and Epidemiology (APIC), the American National Standards Institute (ANSI) and Association for the Advancement of Medical Instrumentation (AAMI). Instruments submitted for repair and preventative maintenance shall be: sharpened, adjusted, aligned, straightened, calibrated, cleared of rust or debris, oiled removal of stains, sharp edges and/or scratches cannulated/lumened items shall have interior lumen flushed and visually inspected. all instruments able to be disassembled, shall be disassembled and undergo a detailed inspection. Returned Instruments shall: have a mirror finished appearance, have legible QR Code, manufacturer name, and instrument catalog number Contractor 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. Items deemed unrepairable need to be returned to facility with clear identification as such. Any non-OEM parts used to repair an instrument must have product part numbers provided and must have a Food and Drug Administration (FDA) approved Instructions for Use (IFU) that outlines all steps for reprocessing. Site visits should follow a set monthly schedule and be arranged so there is a minimum of 2-3 days advance notice. During repair and PM, all instruments are to be evaluated for a 2D QR scan code. When a device does not have a 2D code, the repairer will notify the SPS department. Once the facility has placed the new QR codes the instrument shall be returned as part of the set it arrived in. Delicate, sharp, pointed instruments delivered in puncture proof containers shall be returned in puncture proof containers. Any instruments that fail the quality check upon return to VHABHHCS shall be resubmitted to the Contractor for repair at the Contractor s expense per Federal Acquisition Regulations (FAR) 52.212-4(a). All single instruments and surgical trays picked up and delivered back to the hospital should be updated by the Contractor on the digital tracker and following information should be included for each: Instrument Name of instrument, Manufacture catalog number, Serial number (when applicable), Quantity of items for accountability, QR code number assigned to the item. Instrument set: Instrument set name, Tray actual number, # of instruments included. Instruments include a wide variety of general and specialty surgical tools to include but is not limited to curettes, hemostats, scissors, graspers, laparoscopic instruments, rigid telescopes, rongeurs, surgical knifes, power equipment (camera, drills & saws), etc. This contract shall not include flexible endoscopes or camera heads. Prohibited Repairs Any instrument found having an unreadable or non-existent Manufacturer s name AND product number visible on the instrument are NOT considered valid reusable instruments. These instruments shall be marked as damaged beyond repair and returned to SPS. Any repairs performed on these instruments will not result in compensation. Repairer is prohibited from knowingly altering or modifying an original instrument in ANY WAY from the original manufacturers intended design. Any instrument rendered damaged beyond repair due to performance of the repair or preventative maintenance will be replaced at the Contractor s expense. This can include but not limited to: Sandblasting shiny instruments to make them dull. Removing the manufacturer s name or product number found on the instrument. Altering the product dimensions, angles, length, or adding/removing materials. Creating a custom instrument. Repairer Response window: Urgent instrument repair service: Unscheduled repair of individual instrument or instrument set which the following applies: The damage is identified on a day where no onsite visit is anticipated. Damaged item is a critical instrument for the instrument set. No alternative substitution available in house to meet the need while waiting for repair. Patient care delays or cancellations. The Contractor has 48 hours to complete urgent instrument repairs. Forty-eight hours starts at time of notification by VHABHHCS to the Contractor. Instruments or sets necessitating emergency repairs may be shipped to Contractor facilities if necessary. Scheduled PM for Routine Instruments Sets: See Appendix A for the list of routine instrument sets. The Contractor shall have one (1) calendar day to complete routine preventative maintenance on surgical instrument trays. If a set will be removed from circulation for longer than one (1) day, this needs to be directly communicated with the SPS designee and an explanation as to why. Mobile Repair Lab Requirements Instrument repairs completed onsite at the Black Hills Health Care System (BHHCS) shall occur in a mobile repair lab/vehicle in a designated space. VHABHHCS is not responsible for the supply of any items or utility services of any kind needed for sustainable functioning of the mobile unit. Safety cones shall be utilized around the perimeter of the mobile repair vehicle to ensure the safety of hospital and Contractor staff. Any equipment requiring set up at the mobile repair lab at the hospital shall be done at the expense of the Contractor. Mobile Repair Unit shall properly display the Contractor s name and permit numbers. Contractor shall provide access to repair facilities (mobile or otherwise) upon request by the VA to ensure compliance with the contract and applicable regulatory standards. Contractor mobile unit(s) shall be registered with the VHABHHCS Police Department. Contractor documentation and tracking requirements Contractor will provide a detailed service report for each service visit. This shall include a preventative maintenance checklist with at least: Repair performed, What parts were ordered, Invoices, Any other related documentation, Repair services that Interface with current equipment and Censitrac program are preferred. Contract Monitoring: The VHABHHCS SPS shall designate a representative to monitor Contractor employee work services through one or a combination of the following mechanisms: The SPS representative, SPS Chief, Reusable Medical Device (RMD) Coordinator and/or Contracting Officer Representative (COR) shall monitor Contractor instrument pick-up and drop-off through the inhouse Censitrac system to ensure that services called for in the contract have been received by the VHABHHCS. Documentation of services performed shall be reviewed by the Contracting Officer Representative prior to certifying payment. The SPS representative will conduct periodic customer service interviews with end users to confirm quality repair services are being performed to their standards. Contract monitoring and recordkeeping procedures shall be sufficient to ensure proper payment and confirmation that services were provided. Monthly invoices shall be submitted to the SPS Representative and COR at the beginning of the contract, until it is determined that billing documentation meets requirements. Once billing practices have been found to be acceptable then invoices may be directly submitted to Tungsten. 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. Contractor Requirement Contractor shall provide VHABHHCS SPS staff with in-service training on as needed basis, at the request of the facility. Up to a total of six (6) hours, two (2) per shift, CEU eligible in-services, on instrumentation, per year. Security Clearance The following security language is applicable to Contractor staff who will enter VHABHHCS facilities. Contractor staff will utilize a temporary Contractor s security badge until a permanent security PIV badge can be issued. Temporary badge use will not exceed 30 calendar days. The Contractor shall comply with Black Hills VAMC security, access, and badging requirements. Employees must provide fingerprints and be able to pass a background check so they can obtain a security access badge. All Contractor staff will need a valid individual personal or professional email account that can be easily checked. Notifications regarding fingerprint scheduling/appointments, background investigation tasks, and Training Management System (TMS) required classes will be sent to their email address throughout the badging process. The Contractor will submit all required security badging documents for each employee within fifteen (15) business days from the award date of contract to the COR. All documents must be legible. The following documents will be sent to the Contractor via email after contract is awarded. OF 306 Must be Typed. Submission of handwritten forms will not be acceptable. Self-Certification VA 10-2417 Employee Fingerprint Resource Form Appropriate Contractor staff (as determined by the VA) performing the duties of the Statement of Work shall complete the computer-based training course TMS 10176 Infosec/Rules of Behavior . Contractor staff shall be escorted while in VHABHHCS sensitive locations or without a security badge or PIV badge. Additional Information National Holidays. There are eleven (11) holidays observed by the Government as follows: New Year s Day, Martin Luther King Day, Presidents Day, Memorial Day, Juneteenth Independence Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day. SPS is a 24/7 operation and continues sterilization operations on these holidays. The lists provided below are not all inclusive of the instruments that will be on the contract over its lifetime and may be subject to change over time. APPENDIX A: Routine Sets: Appendix B: Preventative Maintenance Schedule On site same day turn around Container Quantity Item Count 70 DEGREE HOPKINS II TELESCOPE 1 3 ABDOMINAL HYSTERECTOMY 2 16 ARTHREX 4K 30 DEGREE SCOPE 4 3 ARTHREX SHAVER/DEBRIDER 7 1 ARTHREX SHEATH AND OBTURATOR 4 5 ARTHREX TELESCOPE 70 DEGREE 4 3 ARTHROSCOPY SUPPLEMENTAL INSTRUMENTS 2 11 BACK-UP SHOULDER ARTHROSCOPY INSTR. 2 38 BASIC INSTRUMENTS SET 1 60 BASIC ORTHOPEDIC SET 1 33 BASIC ORTHOPEDIC SOFT TISSUE SET 2 44 BONE CURETTERS- LONG 1 3 BONE CURETTES 0-6 1 9 BONE HARVESTING SET 2 8 BONE HOLDING TRAY-ZIMMER 1 17 BOOKWALTER 2 29 BUGBEE ELECTRODE & CORD 2 3 CENTURION PHACO HANDPIECE- ALCON 10 5 CYSTOSCOPE PEDIATRIC-DR. ECKRICH 1 8 CYSTOSCOPE-RIGID STORZ 3 49 D&C 1 28 DERMATOLOGY PACK 7 4 DRESSING SET - OR 3 4 DRILL BIT RACK WITH BITS 1 15 EYE INSTRUMENTS (SUPPLEMENTAL) 3 12 FINE BASIC 1 62 FINE BASIC SOFT TISSUE SET 4 51 FM CATARACT TRAY 10 24 FM MINOR TRAY 8 14 HAND SET 6 34 HEGAR UTERINE DILATORS 2 10 HEMORRHOIDECTOMY TRAY 2 38 HEMRRHOID BANDING SET FM ENDO 1 6 HENLEY RETRACTOR SET SURGICAL DIRECT 1 10 HENLEY RETRACTOR SET VMUELLER 3 11 Karl Storz Camera Head 6 1 LAPAROSCOPIC INSTRUMENT SET 3 64 LAPAROTOMY INSTRUMENTS 2 69 LAPAROTOMY RETRACTORS 2 19 LONG INSTRUMENTS 1 7 MICROSCOPE HANDLES 10 12 MINOR EYE TRAY 2 26 MINOR TRAY- HOT SPRINGS OR 8 18 NECK DISSECTION TRAY 1 45 NO SCALPEL VASECTOMY SET 1 14 OR MINOR TRAY 2 35 PERIPHERAL VASCULAR INSTRUMENTS 1 83 PODIATRY INSTRUMENTS TRAY 1 52 Podiatry Pack 10 10 RESECTOSCOPE 24/26FR--STORZ 3 37 RESECTOSCOPE 27FR--STORZ 2 29 S&N ORTHOPEDIC INSTURMENTS 2 12 SEPTOPLASTY 3 24 SHOULDER / KNEE SET 3 46 SHOULDER ARTHROSCOPY SET 2 13 SKLAR HEGAR DIALATOR DOUBLE ENDED 1 9 Sklar Hemorrhoid Bander 3 4 STRYKER F1 SMALL BONE POWER SYSTEM 3 13 STRYKER REM-B TPX 3 18 Telescope Hopkins 0 Degree 5MM 4 4 TROCAR MINI-K WIRE RACK 4 30 URETHROTOME 1 30 UROLOGY BASIN 8 1 UROLOGY INNER PAN 3 1 VAN BUREN URETHRAL SOUNDS 8-30 4 12 VASECTOMY SET 4 15 ZIM CLIP 4 2 ZIMMER DERMATOME 1 7 ZIMMER MESH GRAFT II DERMATIOME 2 2
