36C25221Q0371 0001.docx

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A.

AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

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

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a r eference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

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

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AU

THORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communicat ion makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14.

DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

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.

15A. NAME

AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

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.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

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) 04-19-2021 607-21-1-026-0050 676-21-2-041-0011 36C252 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476 36C252 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476 To all Offerors/Bidders

36C25221Q0371 04-19-2021

X X X

X

See Attachment 1 for specific questions and corresponding answers/clarifications in bold.

See amended Statement of Work - "(including powered surgical instrumentation)" has been removed from bullet point two under 3. Scope.

Ashley Johnson Contracting Officer

ATTACHMENT 1

Questions & Answers/Clarifications

Question

1. The statement is to cover instrument sharpening and repair for Madison and Tomah. The inventories however have devices, scopes, handpieces etc. in the excel documents. Is this bid specific to the maintenance of the surgical trays and the instrumentation as the incumbent currently provides at Madison or is it for all items listed in the inventories?

We noted there are a lot of things on the Madison inventory that are implant related and not serviceable by any companies.

Answer

· The scopes and powered handpieces (dental drills, Stryker drills, etc.) are serviced through the Biomed department.

· We will not send implants; only instruments used with the implants. We take the instruments we need serviced out of the tray and leave the implants w/the container in the department.

· The current vendor services all instrumentation except for the scopes and power equipment

STATEMENT OF WORK (SOW)

1. Contract Title.

Instrument Sharpening and Repair

2. Background.

Surgical instruments need to be sharpened and maintained for optimal performance. The William S. Middleton Memorial Veterans Hospital (Madison VA Hospital) and Tomah VA Medical Center (VAMC) are currently seeking a company that can provide services to repair, refurbish, and assess for replacement surgical instruments for use in Operating Room, Ambulatory Care, Clinic, and CBOC procedures.

3. Scope.

· Vendor shall provide services that include, but are not limited to, sharpening, adjusting, aligning, straightening, refurbishing, calibrating, cleaning, extensive stain removal, polishing, lubricating, adjusting, chemical etching, and replacing parts of various individual surgical instruments sets and operating room (OR) procedural instrument trays. Instruments will be provided individually or as components of a specialty tray. All instruments shall be maintained in proper operating conditions as specified by the original manufacturer. Instruments are to be retrieved from and delivered to the Sterile Processing Service (SPS), located William S. Middleton Memorial Veterans Hospital, Madison WI, 53705 and Tomah VAMC, 500 East Veterans St, Tomah, WI 54660.

· All Surgical instrumentation trays that are utilized for Wm S Middleton Memorial VA Hospital or Tomah VAMC will be placed on a quarterly rotation program to ensure that all instrumentation is properly maintained and sharpened.

· All repairs will follow all approved recommendations in regard to third party surgical instrument repair as set forth by the following:

· Food and Drug Administration (FDA)

· Centers for Medicare/Medicaid Services (CMS)

· Centers for Disease Control (CDC)

· Association for the Advancement of Medical Instrumentation (AAMI),

· International Association of Healthcare Central Service Materials Management (IAHCSMM)

· Association of per-Operative Registered Nurses (AORN)

· Association of Professionals in Infection Control (APIC)

· Department of Veterans Affairs, Veterans Health Administration (VHA) Directives

· Vendor shall provide at no additional cost to the government, In-service education to SPS staff on issues such as cleaning, care and handling.

· Vendor shall provide at no additional cost to the government, a yearly SPS Management Seminar that includes but not limited to:

· Site visit to engineering and repair facility

· Discussion of repair issues and proper care and handling of instruments

· Discussion of programs to enhance management and administrative effectiveness.

. 4. Specific Tasks.

· Instruments are to be retrieved from and delivered to the Sterile Processing Service (SPS) located in William S. Middleton Memorial Veterans Hospital, Madison WI 53705 or Tomah VAMC, 500 East Veterans St, Tomah, WI 54660, SPS Office no earlier than 7:30 am.

· The Contractor's employee(s) shall report to the Sterile Processing Service (SPS) upon arrival at the Madison VA Hospital or Tomah VAMC for the pickup and return of instruments. If instruments cannot be repaired, they must be marked or tagged with set name and number and returned to SPS. Instrument sets and trays must be returned throughout the day when work is completed, not all at the end of a workday. If an instrument needs to be sent out for third party repairs by the contractor, authorization must be obtained from SPS.

· The repair vendor 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.

· Surgical instrument maintenance and repair will be handled with care. The contractor will be required to test instruments for accurate alignment, sharpness, insulation and calibration. The contractor will return instruments in as good as new condition. All instruments shall be repaired and maintained in proper operating conditions as specified by the original manufacturer

· New, original manufactured instruments and parts will be used.

· Repairs, maintenance, and testing of surgical instruments, laparoscopic instruments, pneumatic instruments, electric/battery (cordless) instruments, fiber optic light cables/cords, cameras, surgical instrument containers, and push carts, should be considered for repair. A comprehensive list is included below. SPS may not utilize all services. Instruments to be serviced include, but are not limited, to:

a. General Instruments

b. Open Heart

c. PV

d. Neuro

e. Ortho

f. Plastics

g. Gynecology

h. Outpatient/Ambulatory Care

i. Dental

j. Podiatry

k. ENT

l. Urology/GU

m. Audiology/Speech

n. Micro

o. Arthroscopic

p. Laparoscopic

q. Endoscopic

r. Ophthalmic

s. Needle Holder Insert Replacement

t. MIS Instrument Repair

u. Flexible Biopsy Forceps Repair

v. Phaco Ultrasonic Emulsifier Repair

w. Fiber Optic Light Cable & Adapter Repair

x. InsulScan Insulation Testing System

y. On-location Laparoscopic Rebuilds and Repairs

z. Replacement Biopsy Forceps and Endoscopic Accessories

aa. Chemical etch

· Suction tubes (Poole, Adson, Frazier Baron, and Yankauer) will be inspected, and interior lumens flushed and inspected.

· Specific custom-made instruments will be repaired in coordination with operating room surgeons (end user) specifications.

· Instruments will not be altered, changed or tampered with and will be repaired following manufacturers' original design specifications.

· All instruments that can be disassembled will be disassembled for maintenance and repair. They will also be sharpened and aligned in accordance with the manufacturer's original specifications. Any bio burden found once disassembled, should be photographed and submitted as part of the service documentation for that visit.

· Instruments will undergo appropriate, and sometimes extensive, cleaning processes to result in a stain-free 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 vendor will be responsible for returning within 24 hours to fix any instruments found to be in non-working order after the use of chemicals.

· Any etches should not interfere with instrument tracking barcodes. The manufacturer's part numbers, and catalog numbers shall be preserved on all repaired or refurbished instruments, as well. If that is not possible, the information should be chemically etched on to a different part of the instrument (i.e.- shaft or main component of the instrument).

· 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 the instrument was removed from. A list of all items removed from service should be provided after each visit.

· The repair vendor will not repair any surgical instruments that are on the “DO NOT USE” list. These instruments should be pulled from service. The list will be provided to the vendor at the initial visit, and new copies will be provided as the list is updated.

· No labels and/or stickers should be placed on instruments and/or sterilization containers. Only chemical etching is allowed. Any tape found on instruments needing service should be removed.

· 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.

· The contractor shall remove from the facility all excess materials, trash, debris, and barriers generated as a result of their services.

Reporting/Documentation

· All documentation should be provided on vendor letterhead.

· The repair vendor, with the input of the clinical and SPS staff, will implement a Surgical Instrument Quality Assurance Program (SIQAP) whereas instrument sets will be repaired, documented, and monitored by surgical service and specialty. The vendor will work with SPS to create maintenance schedules for instrument trays.

· 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 shall 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.

· The contractor shall provide a written or emailed summary of all items removed from service and the instrument tray name and number from which it was removed within one (1) business day.

· The contractor shall contact the Madison VA Hospital SPS Office or Tomah VAMC SPS Office to review all instruments that require offsite repair and the instrument tray name and number from which it was removed. Madison VA Hospital SPS Office and Tomah VAMC SPS Office must provide written approval prior to removal of any and all instruments that require offsite repair.

· Items that have been repaired for the last time before replacement is needed shall be reported after every visit. Additionally, any instrument nearing the end of useful life shall be noted for replacement prior to being removed so that the service can replace the instrument prior to removal. Included in this replacement & end of useful life report shall include the instrument name, catalog number, instrument set it is being removed from and a brief description as to why it is near its end of useful life.

· The repair vendor will provide education regarding instrument repairs, instrument care and handling, instrument testing, instrument processing, laparoscopic continuity testing, and endoscopy instrument repairs. An electronic presentation that details issues, problems, bioburden, etc., should be provided after every visit.

Requirements

· Repairs will be completed either on location at the William S. Middleton Memorial Veterans Hospital, Madison, WI 53705 or Tomah VAMC, 500 East Veterans St, Tomah, WI 54660 in a mobile repair vehicle, or offsite at the vendor's repair facility.

· 1S09001 and 1S013485 (medical device) certifications must be obtained by the repair vendor.

· Employees of the repair vendor responsible for repairing surgical instruments must be ASQ (American Society for Quality) certification and receive CQI (Certified Quality Inspector) training.

· The repair vendor will provide enough technicians for onsite service to be completed in one business day.

· Individual instrument repairs conducted at William S. Middleton Memorial Veterans Hospital will be performed Monday through Friday between the hours of 7:30am — 4:00pm, excluding weekends and national holidays (New Years Day, Martin Luther King Jr’s Birthday, Washington’s Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, Christmas Day). Visits should be 2 days with a 3rd if necessary, per month, scheduled yearly. Any repairs outside the scope of this contract require a Purchase Order prior to performing any additional work.

· Individual instrument repairs conducted at Tomah VAMC will be performed Monday through Friday between the hours of 7:30am — 4:00pm, excluding weekends and national holidays (New Years Day, Martin Luther King Jr’s Birthday, Washington’s Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, Christmas Day). Visits shall be 8 hours, per quarter, to be scheduled near the beginning of each quarter. Any repairs outside the scope of this contract require a Purchase Order prior to performing any additional work.

· Instrument repairs completed onsite at the William S. Middleton Memorial Veterans Hospital or Tomah VAMC in a mobile repair lab/vehicle must be repaired in a vehicle that is clearly labeled with the vendor's name 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 vendor 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 Sterile Processing Service (SPS) Contracting Officer Representative (COR) and the end users. 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.

· Contracting Officer's Representative (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, Sterile Processing Service (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 that must include total cost for work performed during each scheduled visit. The invoice will include costs related to all work performed on-site and work sent off-site for repair/maintenance. 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.

· The contracting Officer's Representative (COR) will be responsible for verifying contract compliance. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer by the COR.

· 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 actually 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 Madison VAMC COR, by the contractor. The COR, or designee, will verify that services were actually performed against contractors certified delivery repairs document. Only after verification are invoices submitted for payment.

· Quarterly invoices are submitted to the Tomah VAMC COR and A-COR, by the contractor. The COR, or designee, will verify that services were actually performed against contractors certified delivery repairs document. Only after verification are invoices submitted for payment.

· 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 Surgical Instrument Quality Assurance Program (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.

· Madison – VAMC - Upon entry into the William S. Middleton Memorial VA Hospital, Madison, WI 53705, vendor employees shall use the “Reptrax” self–service kiosk to sign-in, print and visibly display visitor photo identification badge.

· Tomah – VAMC – Upon arrival report to Building 400 (main VA entrance) for COVID-19 screening and then proceed to the Police Department to call SPS and check in. The Police Department is located in building 407 room 1709. Check in will include name and driver’s license.

· A vendor 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 mobile unit(s) shall be registered with the William S. Middleton Memorial Veterans Hospital’s Police Department and Tomah VAMC’s Police and Security Department.

Period of Performance. This contract is required for a base period of 12 months with four (4) one-year option periods.

Page 1 of Page 1 of

Page 1 of Page 1 of Amendment 1 revised 04.19.2021