S06 Responses to Vendor Questions Instrument Maintenance BHHCS 36C26325Q1002 0001.docx

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The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

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is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

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Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

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Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

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IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

07-31-2025

None 36C263 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101 To all Offerors/Bidders

36C26325Q1002 07-22-2025

X

X

X

See CONTINUATION Page

See following pages.

Jeffrey Brown Contracting Officer

VA-VHA-RPOC-2024-0033

CONTINUATION PAGE

The purpose of this amendment is to:

1. Respond to vendor questions.

2. Edit the Statement of Work in response to vendor questions.

1. Vendor questions in bold, VA responses in red.

1. Clarification Request: Service Days Per Week We understand that the RFP specifies the need for "twice-weekly repairs for unscheduled repair needs and same-day PM services for critical sets" (Statement of Work 1.q). Could you please confirm whether the two service days per week are a mandatory requirement and expected as part of the regular service schedule, or if these visits are to be provided on an as-needed basis depending on the volume of instruments or maintenance needs?

We will only need monthly visits. The SOW has been edited to reflect that.

1. Device Inventory – Scopes, Power, Pneumatic, and Phaco Handpieces The Statement of Work (SOW) references service coverage for scopes, power/pneumatic tools, and phaco handpieces. To provide accurate pricing and service planning, could the Government please provide an inventory list of these device categories, including make, model, and quantity?

Note: This is not requested for general stainless-steel instrumentation.

Here are the current Black Hills Health Care System Scopes:

The power instruments as well as the Phaco Hand Pieces will not need any coverage as they will be sent back to the vendor/manufacturers for any issues as well as will the telescopes. These item classes have been removed from the set list.

The inventory set list is comprehensive and includes sets of instruments that will not need to be maintained or repaired.

1. Repair Costs for Specific Devices:

The current B.2 Price/Cost Schedule includes general instrumentation sets (critical and routine) and case carts, but it does not seem to address the repair costs for advanced devices such as scopes, power equipment, phaco handpieces, mentioned in question 2. How does the Government intend for the repair costs of these devices to be incorporated into the overall contract pricing? Will the Government issue a separate line item specifically for repairs of the aforementioned advanced devices, or should we consider time and materials for repairs under a separate purchase option?

See response to question 2.

1. Off-Site Repairs for Complex Cases For general surgical instruments that require more complex repairs than what can be accomplished on-site or in the mobile lab, will off-site repair services be allowed? Should the cost for these types of repairs be factored into the overall instrument set rate, or will there be a separate approval/payment process?

Yes, off-site repairs will be allowed. The cost for off-site repairs should be incorporated into the line items given.

1. Welding Case Carts Could you please confirm whether welding is within the intended scope of this solicitation? If so, we’d like to note that any welding, while infrequent, would need to be performed offsite and could require additional service time. Would that be acceptable?

The Black Hills Health Care System should not require any welding on their carts, only caster service or replacement. If for any reason a cart does require welding, it would be within scope.

1. We have a question around the following OEM language:

Can this language be altered to "any non-OEM or non-OEM Equivalent"?

No, but the language will be altered to:

p. Any non-OEM parts, equivalent to the 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.

The SOW has been edited to reflect this.

2. Changes highlighted below in Yellow.

B.3 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, including case carts, 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.

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 2 and up to 141 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 identified with a pink container label and are 1 or 2 of a kind. Critical sets cannot be removed from circulation.

d. “Routine Instrument Set”: All non-critical instruments sets.

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

f. Repairs MUST align with the original manufacturers design and product specifications.

g. 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.

h. 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).

i. 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. Shaft re-insulation or total re-insulation as appropriate

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

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

j. In addition to the repairs/maintenance under 1.j. rigid telescopes shall also receive:

i. diagnostic testing,

ii. exterior cleaning of scope,

iii. diamond polishing of lens tip,

iv. fiber optic light connection re-bonding & polishing,

v. comprehensive leak & shock test,

vi. disassembly & cleaning of optical system,

vii. replacement of rod lens,

viii. optical system plus replacement of objective lens,

ix. replacement of distal or proximal window,

x. replacement of eyepiece,

xi. replacement of prism and complete rebuilds included.

k. In addition to the repairs/maintenance under 1.j. power/Pneumatic instruments shall receive:

i. disassembly,

ii. internal cleaning and lubrication,

iii. minor adjustments,

iv. reseal testing,

v. battery pack refurbishment.

l. In addition to the repairs/maintenance under 1.j. bi-Polar shall also received:

i. cleaned and cleared channels,

ii. replaced caps,

iii. repotted.

m. Returned Instruments shall:

i. have a mirror finished appearance,

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

n. 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.

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

p. Any non-OEM parts, equivalent to the 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.

q. Repairer must be able to provide onsite, monthly repairs for:

i. Unscheduled repair needs.

ii. Same day PM services for critical sets.

r. Site visits should follow a set schedule and be arranged so there is a minimum of 2-3 days advance notice.

s. 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 or has a code in place that is taped on, the repairer will place a key dot or laser marked QR code to the instrument, as part of the PM service contract.

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.

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

u. 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.

v. 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).

w. 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.

x. The contractor shall be able to repair closed surgical case carts & transport carts on site which includes but not limited to latch, caster & bumper replacement including welding services.

i. Case Cart/Transport Cart Repair/Maintenance: Maintenance and repair of stainless-steel surgical case carts, replacing hinges, repair or replace casters and wheels, restore one piece wrap-around bumper as needed. Replace any stainless-steel parts as needed. Must be able to source and replace dirty & clean indicators for closed case carts.

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. 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. 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. 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 time of notification by VHABHHCS to the Contractor.

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

4. Scheduled PM for Critical Instrument Sets:

a. See Appendix A for the list of critical instruments sets, identifiable by a pink container label.

b. Preventative maintenance of critical instrument sets shall be scheduled, and work completed with same day turnaround.

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.

5. 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.

6. Mobile Repair Lab Requirements

a. Instrument repairs completed onsite at the Black Hills Health Care System 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.

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. 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 VHABHHCS Police Department.

7. 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. 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. 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.

8. Contract Monitoring:

a. The VHABHHCS 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 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.

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 shall 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 VHABHHCS 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.

g. Offerors will be required to go to the following places of performance with their mobile repair lab/vehicle:

i. VA Black Hills Medical Center – Hot Springs 500 N 5th St Hot Springs, SD 57747-1480 Fall River County

ii. Fort Meade Medical Center 113 Comanche Road Fort Meade, SD 57741 1002

9. Contractor Requirement

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

b. 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.

10. Security Clearance

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

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 VHABHHCS sensitive locations or without a security badge or PIV badge.

11. 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.

12. Inventory 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 their lifetime and may be subject to change over time at VHABHHCS discretion.

Appendix A:

· Critical Sets: No instrument sets are currently listed as critical.

Appendix B:

· Routine Sets:

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