P02 Sources Sought 36C26326Q0758.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

NETWORK CONTRACTING OFFICE 23

316 ROBERT STREET N, SUITE 506

SAINT PAUL MN 55101

POINT OF CONTACT*

Contracting Officer Jeffrey Brown Jeffrey.Brown8@va.gov 651-293-3009

PLACE OF PERFORMANCE

3600 30TH ST

Des Moines IA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

The Des Moines VA Healthcare System requires surgical 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 June 22nd, 2026. 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.

*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.* Draft Statement of Work Central Iowa Veterans Health Administration Health Care System Surgical Instrument Maintenance and Repair

The Central Iowa Administration Health Care System (CIHCS) 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 CIHCS.

1. Preventative Maintenance and Repair

a. “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.

b. “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 1 and up to 612 individual instruments used during invasive procedures.

i. The instrument set is assembled and held inside of a container system where most instruments will stay inside the set over repeated use.

ii. An instrument set may include multiple levels of instruments inside one instrument set.

iii. All instruments sent out within the instrument set must return with the instrument set.

c. “Critical Instrument set”: Instrument sets listed below in Appendix A. Critical sets cannot be removed from circulation for more than two to three days at a time without approval of the SPS Chief or designee.

d. “Routine Instrument Set”: All non-critical instruments sets, identified in Appendix B.

e. Preventative maintenance of surgical instruments shall be done by the inspection of entire trays.

f. Repairs and preventative maintenance shall align with the original manufacturer’s design and product specifications.

g. Equipment subject to repairs and preventative maintenance shall be returned to a state near or at its original OEM specifications in terms of functionality and appearance.

h. Any modification or repair performed during repair that deviates from the OEM functional or physical specifications for the instrument will render the instrument “damaged beyond repair” and will need to be replaced at the expense of the repairer per FAR 52.212-4(b).

i. The Contractor shall ensure repairs and service functions are performed in conformance, 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).

j. Instruments submitted for repair and preventative maintenance shall be:

i. sharpened,

ii. adjusted,

iii. aligned,

iv. straightened,

v. calibrated,

vi. cleared of rust or debris,

vii. oiled

viii. removal of stains, sharp edges and/or scratches

ix. cannulated/lumened items shall have interior lumen flushed and visually inspected.

x. all instruments able to be disassembled, shall be disassembled and undergo a detailed inspection.

k. The following miscellaneous repairs shall also be required as applicable: Gasket Replacement Baffle, Inner, Outer Latch Assembly, Single Action Latch Assembly, Upper Latch Plate Replacement, Lower Latch Replacement, Single Action Latch Replacement, Single Action Latch Sheer Block Replacement, Single Action Latch (w/o handle) Replacement, Double Action Latch (w/o handle), Retention Plate Repla cement, Retention Plate Repair, Handle, Replacement, E-Clip Replacement, Hex Nut Replacement, Stud Nut Replacement, Instrument Holding Pin Replacement, Nut Plate Replacement, Screw Replacement for End Plates, Fastener Replacement, Tag Replacement, General Repair, Bent Container, Burr Removal, Dent Removal, Basket Handle Replacement, Basket Handle Bracket, and Basket Handle Leg Bracket.

l. Returned Instruments shall:

i. have a mirror finished appearance,

ii. have legible QR Code, manufacturer name, and instrument catalog number

m. The 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.

n. Items deemed unrepairable need to be returned to facility with clear identification as such.

o. 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.

p. The repairer must be able to provide onsite, twice weekly repairs for:

i. Unscheduled repair needs

ii. same day PM services for critical sets

q. Site visits should follow a set schedule and be arranged so there is a minimum of 2 weeks between service site visits.

r. During repair and PM, all instruments are to be evaluated for a 2D QR scan code. When a device does not have a 2D laser code, the repairer will place a laser marked QR code on the instrument, as part of the PM service contract or will flag the instrument.

i. Devices with new QR codes shall be returned as part of the set it arrived in.

ii. Notification of code placement needs to be communicated to facility via the digital tracker for entry into Censitrac, information to be documented on the digital tracker are:

1. Device product number,

2. Device description

3. Device serial number (if applicable)

4. QR code numeric assignment.

iii. The Contractor shall place a QR code on the instrument using a laser etching system if no etch is present.

s. Delicate sharp, pointed instruments delivered in puncture proof containers shall returned be returned in puncture proof containers.

t. Routine individual instruments that need to have part replacements or more complex repairs, can be relocated to facility repair shop with updates of location change provided via the digital tracker.

u. Any instruments that fail the quality check upon return to CIHCS shall be resubmitted to the Contractor for repair at the Contractor’s expense per Federal Acquisition Regulations (FAR) 52.212-4(a).

v. 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:

i. Instrument

1. Name of instrument,

2. Manufacture catalog number,

3. Serial number (when applicable),

4. Quantity of items for accountability,

5. QR code number assigned to the item.

ii. Instrument set:

1. Instrument set name,

2. Tray actual number,

3. # of instruments included.

2. Prohibited Repairs

a. 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.

i. These instruments shall be marked as “damaged beyond repair” and returned to SPS.

ii. Any repairs performed on these instruments will not result in compensation.

b. The Repairer is prohibited from knowingly altering or modifying an original instrument in ANY WAY from the original manufacturers intended design.

c. 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:

i. Sandblasting shiny instruments to make them dull.

ii. Removing the manufacturer’s name or product number found on the instrument.

iii. Altering the product dimensions, angles, length, or adding/removing materials.

iv. Creating a “custom” instrument.

3. Refusal to Repair

a. The contractor shall not classify any instrument(s) as irreparable without providing, concurrently with the return of the instrument(s) to CIHCS:

i. Written justification citing the specific conditions preventing repair.

ii. Photographic documentation.

iii. Evidence of repair attempt.

iv. Approval of the instrument(s) by a CIHCS representative.

b.

4. Repairer Response window:

a. Urgent instrument repair service: Unscheduled repair of critical individual instrument or instrument set which the following applies:

i. The damage is identified on a day where no onsite visit is anticipated.

ii. The damaged item is a critical instrument for the instrument set.

iii. No alternative substitution available in house to meet the need while waiting for repair.

iv. Patient care delays or cancellations.

b. The Contractor has 48 hours to complete urgent instrument repairs. Forty-eight hours starts at the time of notification by CIHCS to the Contractor.

c. Instruments or sets necessitating emergency repairs may be shipped to Contractor facilities if necessary.

5. Place of Performance

a. The mobile repair lab will provide onsite repairs at the VA Central Iowa Health Care System, 3600 30th Street, Des Moines, Iowa 50310.

b. Instruments are to be picked up from the SPS Preparation Area and OR.

c. Instruments are to be returned to the SPS Decontamination Area.

d. Off-site repairs: For Contractor's designated facility the address and certification (ISO 13485:2016 certification or VA determined equivalent) provided to COR prior to performance and upon any change.

6. Scheduled PM for Critical Instrument Sets:

a. See Appendix A for the list of critical instruments.

b. Preventative maintenance of critical instrument sets shall be scheduled, and work completed with the same day turnaround. Any exception to the same day turnaround time may only from the COR or another CIH representative.

c. In the event this is not attainable this is to be communicated directly and immediately with SPS Designee to include what complications are creating a barrier and an ETA of expected downtime.

d. Off-site repair is allowable for critical instrument sets assuming the repairs are completed within the required timelines for critical instrument sets.

7. Scheduled PM for Routine Instruments Sets:

a. See Appendix B for the list of routine instrument sets.

b. The Contractor shall have seven (7) calendar days to complete routine preventative maintenance on surgical instrument trays with day of pick up considered as day one (1).

c. If a set will be removed from circulation for longer than seven (7) days, this needs to be directly communicated with the SPS designee and an explanation as to why.

d. Off-site repair is allowable for routine instrument sets.

8. Mobile Repair Lab Requirements

a. Instrument repairs completed onsite at the Central Iowa Veterans Administration Medical Center (VAMC) shall occur in a mobile repair lab/vehicle in a designated space. CIHCS is not responsible for the supply of any items or utility services of any kind needed for the sustainable functioning of the mobile unit.

b. Safety cones shall be utilized around the perimeter of the mobile repair vehicle to ensure the safety of hospital and Contractor staff.

c. Any equipment requiring set up at the mobile repair lab at the hospital shall be done at the expense of the Contractor.

d. Mobile Repair Unit shall properly display the Contractor’s name and permit numbers.

e. The 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.

f. Contractor mobile unit(s) shall be registered with the CIHCS Police Department.

9. Contractor documentation and tracking requirements

a. Accessible online service dashboard that displays and tracks all repair and maintenance activities.

b. Contractor uses an online dashboard that displays and tracks all repair and maintenance activities.

c. The dashboard must be online and must be accessible to SPS designees 24 hours a day, 365 days a year except for maintenance related down times.

d. The following dashboard functions must be included:

i. Repair request function,

ii. Scheduled maintenance request function,

iii. Critical repair request function,

iv. Display request is received with date of anticipated repair,

v. Status updates while active repair is being performed,

vi. Closed “completed” repairs with all associated documentation attached,

vii. Visible annual calendar that establishes an annual PM schedule for sets attached in the appendixes,

viii. The dashboard should allow for all repairer documentation to be attached directly to the repair request

ix. This shall include a preventative maintenance checklist with at least:

1. Repair performed,

2. What parts were ordered,

3. Invoices,

4. Any other related documentation,

e. Repair services that Interface with current equipment and Censitrac program are preferred.

10. Contract Monitoring:

a. The CIHCS SPS shall designate a representative to monitor Contractor employee work services through one or a combination of the following mechanisms:

i. The SPS representative, SPS Chief, Reusable Medical Equipment (RME) 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 CIHCS.

ii. SPS shall utilize Contractor’s digital dashboard to request services from Contractor. Daily monitoring of digital dashboard and repair status to ensure all requests are being handled appropriately.

iii. Documentation of services performed shall be reviewed by the Contracting Officer Representative prior to certifying payment.

iv. The SPS representative will conduct periodic customer service interviews with end users to confirm quality repair services are being performed to their standards.

v. Contract monitoring and recordkeeping procedures should be sufficient to ensure proper payment and confirmation that services were provided.

vi. 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.

vii. The CIHCS SPS representatives retain the option to perform site visits of Contractor repair facilities to confirm that repairs are being performed in accordance with the requirements listed above.

viii. The Contractor shall provide monthly reports as requested, detailing the work performed that month.

11. Contractor Requirement

a. The Contractor shall provide documentation of staff training, competencies, and any pertinent certifications in relation to the repairs they shall be conducting.

b. The contractor shall provide CIHCS 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.

12. Security Clearance

a. The following security language is applicable to Contractor staff who will regularly enter CIHCS facilities.

b. 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.

c. The Contractor shall comply with Central Iowa 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.

d. 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.

e. 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.

i. OF 306 – Must be Typed. Submission of handwritten forms will not be acceptable.

ii. Self-Certification

iii. VA 10-2417

iv. Employee Fingerprint Resource Form

f. 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”.

g. Contractor staff shall be escorted while in CIHCS sensitive locations or without a security badge or PIV badge.

13. Additional Information

a. 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.

b. Repairs must be performed in a clean and orderly environment.

14. Instrument Classes (Including but not limited to):

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:

· Critical sets: Appendix A- high risk, low volume.

APPENDIX B:

Routine Sets: Appendix B: Preventative Maintenance Schedule – May be removed from site for up to 7 DAYs

Sources Sought Notice