W9114F22Q0004.pdf

SEE ADDENDUM

(No Collect Calls)

W9114F22Q0004 30-Mar-2022

b. TELEPHONE NUMBER

+49 6371 9464 6789

8. OFFER DUE DATE/LOCAL TIME

04:00 PM 02 May 2022

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA X ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

W9114F9. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

HENNING MAYER-GOLDSTEIN

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

1 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.X

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

W40M RHCO USAHCA EUROPE

REGIONAL HEALTH CONTR OFC EUROPE

CMR 402

APO AE 09180

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE 16. ADMINISTERED BY

SEE SCHEDULE

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

FAX:

TEL: 011 49 6371 86 113 SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

NAICS:

811219

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF77

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

W9114F22Q0004

Section SF 1449 - CONTINUATION SHEET

CLAUSE(S) 52.212-4 - ADDENDUM TO 52.212-4

Paragraph 52.212-4(w) is hereby added:

(w) The non-FAR Part 12 discretionary FAR and DFARS clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 herein for locations where full text can be found.

(End of Addendum)

CLAUSE(S) 52.212-5 (Dev) - PWS

Performance Work Statement (PWS)

1. GENERAL INFORMATION:

1.1. NON-PERSONAL SERVICES. The Contractor shall provide all labor, material, personnel, and transportation necessary to provide surgical instrument sharpening and repair services for handheld general, specialty, and micro-surgical instruments from numerous manufacturers. Instruments are to be aligned, sharpened, tightened, lubricated, and returned to manufacturer's specifications. The services shall be provided on-site and will be completed prior to the end of each work day. The reason why on site services are required is that most surgical sets need to be available at all times since LRMC is now a Level II Trauma Center and mission’s readiness is expected. Also, it enhance communication within Contractor and the Contracting Officer’s Representative; moreover would decrease expenditure in extra instruments to replace in sets. Non-repairable instruments shall be communicated by the Contractor. The schedule of trays to be serviced will be provided by the contractor within seven (7) days after the establishment of the Contract to the Contracting Officer Representative (COR). The following are lists of the types of instruments to be sharpened and/or repaired, not all inclusive:

1.2. SHARPENING

1. Curettes

2. Bone Hooks

3. Trocars

4. All Scissors

5. Rongeurs, to include laminectomy ronguers

6. Bone Cutters

7. Microsurgical Instruments

8. Pin cutters

9. Biopsy punches and forceps

10. Clamps with teeth and without teeth

11. Osteotomes

12. Chisels

13. Gouges

14. Elevators

15. Reamers

16. Burrs

17. Wire Cutters

18. Twisters

19. Bolt Cutters

1.3. REPAIR

1. Ring-handled forceps, clamps, clips

2. All forceps

3. Hand-held retractors, speculas, dilators, and sounds

4. Suction tubes and cannulas

5. Knives, rasps, needles

6. Mallets

7. Microsurgical instruments

8. Punches (nasal, biopsy arthroscopy, and adenoid)

9. Hand-held drills

10. Snares

11. Self-retaining retractors, speculas, dilators

12. Tungsten carbide insert replacement

13. Microsurgical forceps (teeth rebuilt)

14. Endoscopic instruments sharpening/repair

15. Endoscopic instrument re-insulation

16. Speculum

17. Graspers

18. Obturators

2. The Contractor shall perform an inspection of the instruments to determine what service needs to be provided.

The Contractor shall repair, refurbish, and/or refinish only those instruments that require service. Replacement parts shall be included in the standard repair charge. The Contractor shall ensure replacement parts are available a required. All parts shall be new or remanufactured to original product manufacturer’s specifications.

3. The Contractor shall provide the following services:

3.1. Laparoscopic insulation testing and re-insulation repair.

3.2. Demagnetize stainless steel handheld instruments.

3.3. Acid etching for instrument identification.

3.4. Power hose leakage evaluations.

3.5. Replacement of tungsten carbide inserts in needle holders and tissue forceps.

3.6. Improvement plans.

3.7. Training of Government personnel.

4. PERSONNEL.

4.1. The Contractor’s on-site technician shall have documented formal instrument sharpening and repair training in general surgery, GYN/OB surgery, ortho surgery, neuro surgery, eye surgery, ENT surgery, microsurgery, laparoscopic surgery, thoracic surgery, vascular surgery, DaVinci or Robotic surgery, and plastic surgery instrumentation.

4.2. Contractor personnel providing services shall have a minimum of 3 years of experience in the servicing of surgical instruments following FDA and U.S. National Standards.

4.3. Contractor personnel shall be able to read, write, speak, and understand English.

4.4. Contractor personnel shall present a neat appearance commensurate with that required of a professional.

4.5. Contractor shall have liability insurance coverage that will cover any loss or damage to instruments in the possession of Contractor personnel.

4.6. Contractor shall provide the standard commercial warranty for all services provided under the contract.

4.7. No human-use instrument sharpening or repairs under this contract will be done on equipment that has been used to sharpen or repair non-human-use instrumentation

4.8. The Contractor’s representative shall report or telephonically notify the COR prior to commencing services at any time. The Government will provide the Contractor with the names and telephone numbers of authorized personnel. Contractor personnel shall comply with installation access

4.9. All materials and equipment that is not the property of the Government shall be removed from the work site at the completion of work and the area shall be left in a neat and orderly condition.

4.10. Sexual Harassment/Assault Response and Prevention (SHARP) Program.

4.10.1. The contractor shall comply with OTSG/MEDCOM Policy Memo 21-040, Sexual Harassment/Assault Response and Prevention Program, 7 October 2021, or superseding DHA or DOD policy once issued and provided to the contractor. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

4.10.2. The contractor shall require all CSPs with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours, after gaining knowledge) report the incident in writing to the Government's COR. This reporting policy also applies to sexual assault incidents involving MEDCOM personnel that occur on the contractor’s owned or leased facility under this contract.

All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals, when the incidents occur on a Government facility or a Government leased facility.

4.10.3. Government Unique Training. The contractor shall ensure all service providers receive Sexual Harassment/Assault Response and Prevention (SHARP) Program training not later than 60 calendar days after contractor personnel begin performance under this contract. Training can be obtained either online or in person.

Contractor personnel can attend SHARP training provided by MEDCOM on an every other month basis by contacting (210) 221-6118 for class date/ time availability. If the employee has an AKO account, they can access online the Team Bound Self Study course through Army Learning Management System (ALMS) at http://www.atsc.army.mil/tadlp/delivery/alms.asp

5. QUALITY CONTROL: Contractor shall establish and maintain a Quality Control Plan (QCP) to ensure that the quality of service and materials provided meet or exceed the terms and conditions of this contract. At the discretion of the Government, an inspection of the Contractor-maintained equipment will be conducted by the COR. Upon request of the COR, the Contractor shall participate in any Government quality assurance inspection.

5.1. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). QUALITY ASSURANCE SURVEILLANCE

PLAN (QASP). A Government-developed document used to determine if the Contractor's performance meets the performance standards contained in the contract. The QASP establishes procedures on how this assessment/inspection process will be conducted. It provides the detailed process for a continuous oversight process.

5.2. Performance Requirements Summary (PRS). The COR will monitor the Contractor’s performance of the tasks under this contract, utilizing the PRS (PWS Attachment 1). The COR will upload the completed PRS in the

Surveillance and Performance Monitoring (SPM) module of the Procurement Integrated Enterprise Environment (PIEE) at https://piee.eb.mil upon the completion of each service.

6. GOVERNMENT FURNISHED SERVICES: The Government will provide the necessary power source and space required by Contractor to perform services.

7. APPLICABLE TECHNICAL ORDERS, SPECIFICATIONS, REGULATIONS, AND MANUALS:

7.1. The following is a list of basic publications applicable to this contract. Current issues of many DA publications can be accessed at https://armypubs.army.mil. Current issues of many forms can be accessed at https://armypubs.army.mil/ProductMaps/PubForm/DAForm.aspx. Publications and forms not on the internet can be obtained from the Military Treatment Facility (MTF).

7.1.1. The Publications have been coded as mandatory or advisory. The contractor is obligated to follow those coded as mandatory only to the extent they apply to this contract. Supplements, amendments or changes to these mandatory publications may be issued during the life of the contract. Advisory publications may be used for information and guidance, but are not binding for compliance.

7.2. Publications.

7.2.1. Mandatory:

Army in Europe Regulation 190-16 Installation Access Control, 27 April 2017 NFPA 99, Chapter 7, Standard for Health Care Facilities.

TB 38-750-2, Maintenance Management Procedures for Medical Equipment.

Advisory:

Army Regulation 600-20, Army Command Policy, 24 July 2020 OTSG/MEDCOM Policy Memo 21-040, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under Sexual Harassment/Assault Response and Prevention (SHARP) Program, 7 October 2021.

8. Exclusion from Participation in Federal Health Care Programs.

8.1. The Contractor shall not employ or contract with any individual or entity (hereinafter collectively referred to as “person”) to provide items or services that will be included in invoices submitted to the Government under this contract if such person is listed on the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) List of Excluded Individuals and Entities (LEIE) or the TRICARE Sanctioned Provider List. The Government is legally prohibited from paying for provision of items or services by such persons. The prohibition extends to services beyond direct patient care, such as services of persons in executive or leadership roles and administrative and management services, whether or not such services are billed separately. The LEIE may be found at https://oig.hhs.gov/exclusions/index.asp, and the TRICARE Sanctioned Provider list at https://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Quality-And-Safety-of- Healthcare/Program-Integrity/Sanctioned-Providers. The LEIE and TRICARE Sanctioned Provider List are hereinafter collectively referred to as “the Lists.”

8.2. Prior to start of contract performance, the Contractor shall (a) query the Lists to determine whether the name of any person the Contractor employs or contracts with to provide services or items for which payment may be made under this contract appears on the Lists, and (b) certify to the Contracting Officer that the Contractor has queried the Lists and no such names appear on either of the Lists.

8.3. During performance of the contract, and prior to persons other than those whose names were queried in accordance with paragraph 2, above, (hereinafter “new persons”) providing services or items under the contract, the Contractor shall (a) query the Lists as in paragraph 2, and (b) certify to the Contracting Officer that the names of such new persons do not appear on either of the Lists.

8.4. The Contractor is advised that during performance of the contract, MTF personnel will periodically recheck the names of contractor personnel working in the MTF against the Lists. The Government will notify the Contractor in the event names of any contractor personnel working in the MTF appear on either of the Lists.

8.5. Should the name of any person providing items or services under the contract appear on either of the Lists at any time during contract performance, the Contractor shall promptly remove that person from the contract.

8.6. Violation of any aspect of the above paragraphs shall be considered a material breach of the contract and may result in termination of the contract.

8.7. The Contractor is further advised that, in accordance with Civil Monetary Penalties Law [CMP] (codified at 42 USC § 1320a-7a):

a. There are steep civil monetary penalties associated with billing the Government for providing items or services by a person on either of the Lists, and with failing to return to the Government any overpayments received for provision of such items or services.

b. Billing under the contract for provision of items or services by a person on either List may also result in exclusion of the person that employs or contracts with such person.

8.8. HHS OIG has issued a Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs with additional information on the CMP. The Special Advisory Bulletin may be found at https://oig.hhs.gov/exclusions/files/sab-05092013.pdf.

9. TOBACCO FREE MEDICAL CAMPUS (TFMC).

In accordance with Army Regulation 600-63, paragraph 7-3, 14 April 2015; Operations Order 15-48 (Army Medical Command (MEDCOM) Tobacco Free Living – USAMEDCOM), 8 May 2015; and any Operations Order, regulation or other instruction implementing, defining or otherwise addressing the Tobacco Free Medical Campus (TFMC) on any military installation or DoD-controlled location, Contractor personnel are prohibited from using any tobacco product on or within any TFMC while performing under this contract. TFMCs are established at each installation or DoD-controlled location and include:

(1) any property or non-residential building that is operated, maintained or assigned to support medical activities, including but not limited to, hospitals, medical laboratories, outpatient clinics (including medical, dental, and veterinary facilities), or aid stations operating for the primary purpose of delivering medical care and services for DOD eligible beneficiaries and /or meeting the mission of the Army Medical Command;

(2) all other facilities in which medical activities or administration take place, to include HQ MEDCOM and Defense Health Headquarters;

(3) all internal roadways, sidewalks and parking lots; and

(4) all sidewalks, parking lots and grounds external but adjacent to the building or related to the migratory corridors surrounding the medical facility. The Contractor shall obtain from the COR any orders, regulations, instructions or other documents implementing, defining or otherwise addressing the TFMC for any given installation or DoD-controlled location where Contractor personnel may perform under this contract and shall instruct Contractor personnel on the TFMC limitations for installations or DoD-controlled locations where they may perform under this contract.

(End of Performance Work Statement)

ITEM NO SUPPLIES/SERVICES MAX

QUANTITY

UNIT UNIT PRICE MAX AMOUNT

0001 8 Job Surgical Instrument Repair & Maintenance

FFP

Ordering Period 1: 1 June 2022 - 31 May 2023 The contractor shall provide non-personal on-site Surgical Instrument Repair and Maintenance Services for all items specified in the Schedule of Estimated Items (Exhibit A).

FOB: Destination

PSC CD: J065

MAX

NET AMT

UNIT UNIT PRICE MAX AMOUNT

1001 8 Job Surgical Instrument Repair & Maintenance

FFP

Ordering Period 2: 1 June 2023 - 31 May 2024 The contractor shall provide non-personal on-site Surgical Instrument Repair and Maintenance Services for all items specified in the Schedule of Estimated Items (Exhibit A).

UNIT UNIT PRICE MAX AMOUNT

2001 8 Job Surgical Instrument Repair & Maintenance

FFP

Ordering Period 3: 1 June 2024 - 31 May 2025 The contractor shall provide non-personal on-site Surgical Instrument Repair and Maintenance Services for all items specified in the Schedule of Estimated Items (Exhibit A).

UNIT UNIT PRICE MAX AMOUNT

3001 8 Job Surgical Instrument Repair & Maintenance

FFP

Ordering Period 4: 1 June 2025 - 31 May 2026 The contractor shall provide non-personal on-site Surgical Instrument Repair and Maintenance Services for all items specified in the Schedule of Estimated Items (Exhibit A).

UNIT UNIT PRICE MAX AMOUNT

4001 8 Job Surgical Instrument Repair & Maintenance

FFP

Ordering Period 5: 1 June 2026 - 31 May 2027 The contractor shall provide non-personal on-site Surgical Instrument Repair and Maintenance Services for all items specified in the Schedule of Estimated Items (Exhibit A).

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 1001 Destination Government Destination Government 2001 Destination Government Destination Government 3001 Destination Government Destination Government 4001 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 N/A N/A N/A N/A

1001 N/A N/A N/A N/A

2001 N/A N/A N/A N/A

3001 N/A N/A N/A N/A

4001 N/A N/A N/A N/A

CLAUSES INCORPORATED BY REFERENCE

52.202-1 Definitions JUN 2020 52.203-3 Gratuities APR 1984 52.203-6 Alt I Restrictions On Subcontractor Sales To The Government

(JUN 2020) -- Alternate I

DEC 2021

52.203-12 Limitation On Payments To Influence Certain Federal Transactions

JUN 2020

52.203-17 Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights

JUN 2020

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper

MAY 2011

52.204-7 System for Award Management OCT 2018 52.204-10 Reporting Executive Compensation and First-Tier

Subcontract Awards

JUN 2020

52.204-13 System for Award Management Maintenance OCT 2018 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-17 Ownership or Control of Offeror AUG 2020 52.204-18 Commercial and Government Entity Code Maintenance AUG 2020 52.204-23 Prohibition on Contracting for Hardware, Software, and

Services Developed or Provided by Kaspersky Lab and Other Covered Entities

DEC 2021

52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment

DEC 2021

52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment

DEC 2021

52.212-1 Instructions to Offerors--Commercial Products and Commercial Services

DEC 2021

CLAUSE(S) 52.212-1 - ADDENDUM TO 52.212-1

The following paragraphs are hereby amended:

Paragraph 52.212-1(a) the small business size standards and any resulting set asides or preferences do not apply to this Request for Quote.

Paragraph 52.212-1(b), the second sentence is deleted and replaced with the following: “Quotes must be submitted on the Standard Form (SF) 1449 and accompanied by all requested items elsewhere specified in the solicitation.

Paragraph 52.212-1(b)(10) is deleted and replaced by “information required to be submitted with ‘Factor 3 – Prices’ of the quote.

Paragraph 52.212-1(c), Period for acceptance of quotes is hereby replaced with the following: “Period for acceptance of quotes. The quoter agrees to hold the prices in its quote firm for 90 calendar days from the date specified for receipt of quotes, unless another time period is specified in an addendum to the solicitation.”

Paragraph 52.212-1(e) Multiple quotes does not apply to this Request for Quote.

Paragraph 52.212-1(g), the following paragraph is added to the end of the current paragraph as follows: "After evaluating quotes, if discussions are deemed necessary, the contracting officer may determine that the number of most highly rated quotes that might otherwise be included in the competitive range exceeds the number at which an efficient competition can be conducted. In this event, the contracting officer may limit the number of quotes in the competitive range to the greatest number that will permit an efficient competition among the most highly rated quotes."

Paragraph 52.212-1(h)(iii) Only one contract will be awarded from this RFQ. Award will be on an “All OR NONE” basis. Quotes for less than all items will be rejected as nonconforming and unacceptable to the RFQ.

The following paragraphs are hereby added:

Paragraph 52.212-1(m), The non-FAR Part 12 discretionary FAR and DFARS provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 herein for locations where full text can be found.

Paragraph 52.212-1(n), Organizational Conflict of Interest. For those quoters planning to engage in a teaming arrangement or to use subcontractors, a conflict of interest may be created if a company is identified as a prime quoter, teaming partner/subcontractor, or as a member of a Joint Venture on more than one quote. Each participating company shall only submit one quote. If the contracting officer concludes during quote evaluation that a potential conflict of interest exists because one or more companies have participated in more than one quote as a prime quoter, teaming partner/subcontractor, or as a member of a Joint Venture, the contracting officer reserves the right to require a conflict of interest mitigation plan from the prime quoters of those quotes. If a quoter fails to submit a plan, or submits an inadequate plan, the quoter may not be considered.

QUOTE SUBMISSION

1. INSTRUCTION

a. ELECTRONIC Quote. Quoters may submit electronic quote in response to this Request for Quote. The quote must be received by the quote due date/local time as specified in block 8 of the SF 1449 cover page to the inbox of the following email address: henningfalk.mayer-goldstein.ln@mail.mil Vendors may call Mr. Henning Mayer-Goldstein at +49 (6371) 9464 6789 to verify receipt of the quote. If the vendor chooses to email the quote, the Government will not be responsible for any failure of transmission or receipt of the quote, or any failure of the vendor to verify receipt of the emailed quote.

b. FORMAT and SIZE: Each paragraph shall be separated by at least one blank line. A standard, 12-point minimum font size applies. Margins: Top, Bottom, Left, Right – 1” Page Size, Width – 8.5” Page Size, Height – 11” or DIN A4 size. Tables and illustrations may use a reduced font size not less than 8-point and may be landscape. Page size 11x17 or DIN A3 size may be used where needed for readability, however, each printed side of an 11x17 or A3 size page will count as two pages Page limitations shall be treated as maximums. If exceeded, the excess pages will not be read or considered in the evaluation of the quote and (for paper copies) will be returned to the quoter as soon as practical. The technical quote shall address how you will comply with the requirements set forth in the PWS and must clearly explain each of the technical subfactors as shown in paragraph (4) above. The following is excluded from the page count: copies of certificates, price schedule, completed FAR 52.212-3 Quoter Representations and Certifications – Commercial Items, and acknowledgement of any amendments issued.

c. FACTORS: The quoter’s quote shall consist of the following sections:

SF 1449 (completed and signed) Factor 1 – Technical, Factor 2 – Past Performance and Factor 3 – Prices (Exhibit A - Schedule of Estimated Items)

d. QUESTIONS. Prospective quoters are strongly encouraged to submit any questions regarding this Request for Quote no later than ten (10) business days prior to the request for quote due date specified in block 8 of the SF 1449 cover page. Questions can be emailed to henningfalk.mayer-goldstein.ln@mail.mil. All questions received will be answered officially through an amendment to the Request for Quote for distribution to all prospective quoters. Questions received after the CET cut-off date/time will not be accepted by the Government.

FACTOR 1 – TECHNICAL:

Quoter shall demonstrate compliance with the requirements in the solicitation by submitting a written quote which addresses compliance with each of the following technical subfactors:

SUBFACTOR 1:

The quoter shall provide a capability statement which proves the quoter’s capability to provide a broad range of on-site surgical sharpen, repair and refurbishment services in accordance with FDA and U.S.

National standards for surgical instruments which includes the following:

Sharpening:

-Osteotomes -Chisels -Gouges -Elevators -Curettes -Bone Hooks -Trocars -All Scissors -Ronguers, to include laminectomy -Bone Cutters -Microsurgical Instruments -Pin Cutters -Biopsy Punches & Forceps -Clamps with teeth and without teeth -Reamers, Burrs -Wire Cutters, Twisters

Repair:

-Ring-Handled forceps, clamps, and clips

-Dressing and tissue forceps -Hand-held retractors, speculas, dilators, and sounds -Suction tubes and cannulas -Knives, rasps, needles -Mallets -Microsurgical instruments -Punches (nasal, biopsy arthroscopy, adenoid) -Hand-held drills -Snares -Self-retraining retractors, speculas, dilators -Tungsten carbide insert replacement -Microsurgical forceps (teeth rebuilt) -Endoscopic instruments sharpening/repair -Endoscopic instruments re-insulation -Speculum -Graspers -Obturators

SUBFACTOR 2:

The quoter shall provide a capability statement which proves the quoter’s capability to perform inspection of the instruments in order to determine which service needs to be provided.

SUBFACTOR 3:

The quoter shall provide a capability statement which proves the quoter’s capability to provide the following services:

-Laparoscopic insulation testing and re-insulation repair -Demagnetize stainless steel handheld instruments -Etching for instrument identification -Power hose leakage evaluations -Replacement of tungsten carbide inserts in needle holders and tissue forceps -Improvement plans -Training of Government personnel

SUBFACTOR 4:

The quoter shall provide proof of documented formal instrument sharpening and repair training in General Surgery, OB/GYN Surgery, Ortho Surgery, Neuro Surgery, Eye Surgery, ENT Surgery, Micro-surgery, Laparoscopic Surgery, Thoracic Surgery, Vascular Surgery, Plastic Surgery, DaVinci or Robotic Surgery instrumentation.

SUBFACTOR 5:

The quoter shall provide a capability statement which proves the quoter’s capability to provide service providers which are able to write, speak, and understand English.

FACTOR 2 – PAST PERFORMANCE:

(i) List at least three (3) references, but not more than five (5), to include Point of Contact, Email address, Telephone Number, Nature of Work, Annual Dollar Value, Contract Number, Location and Time Period involved. Past performance information should be for work performed within the past three (3) years. Any/all references received beyond the maximum number will not be evaluated.

FACTOR 3 – PRICE:

A complete pricing package shall include the information below:

(1) Quoter’s quoted prices shall be provided in electronic format on the Excel spreadsheet included in the solicitation as Exhibit A, “Schedule of Estimated Items”.

(2) The price quote shall be read only but not password protected. All formulas, lookup tables, and links shall be intact, and no links shall exist to files not included with the submission. Spreadsheets shall not contain hidden worksheets.

(3) The quoter shall limit their prices to two decimal places (example: $/€3.45).

(4) All information related to pricing shall only be included in this section of the quote and identified as pricing data.

(5) Contract Line Item Number (CLIN) pricing:

a) CLIN 0001 SURGICAL INSTRUMENT REPAIR & MAINTENANCE SERVICES.

Quoters shall provide a unit and extended price for each item to be refurbished listed in Exhibit A, Schedule of Estimated Items, as well as a total quoted amount for all items to be refurbished based on the estimated quantities. The successful quoter’s quoted prices will be incorporated into the contract award as Exhibit A, Schedule of Estimated Items, for the first 12-month ordering period.

(i) Quoters shall submit fixed pricing for all tests listed in Exhibit A. Failure to provide fixed pricing for all items to be furnished will render the quote ineligible for award.

b) CLIN 1001 SURGICAL INSTRUMENT REPAIR & MAINTENANCE SERVICES.

Exhibit A, Schedule of Estimated Items, as well as a total quoted amount for all items to be refurbished based on the estimated quantities. The successful quoter’s quoted prices the second 12-month ordering period.

c) CLIN 2001 SURGICAL INSTRUMENT REPAIR & MAINTENANCE SERVICES.

Exhibit A, Schedule of Estimated Items, as well as a total quoted amount for all items to be refurbished based on the estimated quantities. The successful quoter’s quoted prices the third 12-month ordering period.

d) CLIN 3001 SURGICAL INSTRUMENT REPAIR & MAINTENANCE SERVICES.

Exhibit A, Schedule of Estimated Items, as well as a total quoted amount for all items to be refurbished based on the estimated quantities. The successful quoter’s quoted prices the fourth 12-month ordering period.

e) CLIN 4001 SURGICAL INSTRUMENT REPAIR & MAINTENANCE SERVICES.

Exhibit A, Schedule of Estimated Items, as well as a total quoted amount for all items to be refurbished based on the estimated quantities. The successful quoter’s quoted prices the fifth 12-month ordering period.

ACQUISITION PROCEDURE

This is a commercial item under FAR Part 12 and the acquisition procedures to be used for this purchase will be in accordance with FAR Part 13.5, Simplified Procedures for Certain Commercial Products and Commercial Services.

SPECIAL NOTE: All vendors must be registered in the System for Award Management (SAM) prior to award, and lack of registration shall make a quote ineligible for award. Vendors may obtain information on registration and annual confirmation requirements by calling 1-866-606-8220 or via Internet at https://www.sam.gov.

(End of Addendum)

CLAUSES INCORPORATED BY REFERENCE

52.212-4 Contract Terms and Conditions--Commercial Products and

Commercial Services

DEC 2021

52.214-34 Submission Of Offers In The English Language APR 1991 52.216-27 Single or Multiple Awards OCT 1995 52.222-29 Notification Of Visa Denial APR 2015 52.223-2 Affirmative Procurement of Biobased Products Under Service and Construction Contracts

SEP 2013

52.223-3 Hazardous Material Identification And Material Safety Data FEB 2021 52.223-5 Pollution Prevention and Right-to-Know Information MAY 2011 52.223-10 Waste Reduction Program MAY 2011

52.223-18 Encouraging Contractor Policies To Ban Text Messaging While Driving

JUN 2020

52.225-13 Restrictions on Certain Foreign Purchases FEB 2021 52.229-6 Taxes--Foreign Fixed-Price Contracts FEB 2013 52.232-18 Availability Of Funds APR 1984 52.232-33 Payment by Electronic Funds Transfer--System for Award

Management

OCT 2018

52.232-37 Multiple Payment Arrangements MAY 1999 52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2021

52.233-1 Disputes MAY 2014 52.233-3 Protest After Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.237-1 Site Visit APR 1984 52.237-2 Protection Of Government Buildings, Equipment, And

Vegetation

APR 1984

52.242-13 Bankruptcy JUL 1995 52.242-15 Stop-Work Order AUG 1989 52.244-2 Subcontracts JUN 2020 52.244-6 Subcontracts for Commercial Products and Commercial

Services

JAN 2022

52.245-1 Government Property SEP 2021 52.246-4 Inspection Of Services--Fixed Price AUG 1996 252.201-7000 Contracting Officer's Representative DEC 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7016 Covered Defense Telecommunications Equipment or Services

-- Representation

DEC 2019

252.204-7017 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services -- Representation

MAY 2021

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services

JAN 2021

252.209-7004 Subcontracting With Firms That Are Owned or Controlled By The Government of a Country that is a State Sponsor of Terrorism

MAY 2019

252.216-7003 Economic Price Adjustment - Wage Rates or Material Prices Controlled by a Foreign Government

MAR 2012

252.222-7002 Compliance With Local Labor Laws (Overseas) JUN 1997 252.223-7006 Prohibition On Storage, Treatment, and Disposal of Toxic or

Hazardous Materials

SEP 2014

252.223-7008 Prohibition of Hexavalent Chromium JUN 2013 252.225-7005 Identification Of Expenditures In The United States JUN 2005 252.225-7021 (Dev) Trade Agreements - Basic (DEVIATION 2020-O0019) JUL 2020 252.225-7041 Correspondence in English JUN 1997 252.225-7048 Export-Controlled Items JUN 2013 252.232-7008 Assignment of Claims (Overseas) JUN 1997 252.232-7010 Levies on Contract Payments DEC 2006

252.232-7017 Accelerating Payments to Small Business Subcontractors-- Prohibition on Fees and Consideration

APR 2020

252.233-7001 Choice of Law (Overseas) JUN 1997 252.243-7001 Pricing Of Contract Modifications DEC 1991 252.243-7002 Requests for Equitable Adjustment DEC 2012

CLAUSES INCORPORATED BY FULL TEXT

52.204-19 INCORPORATION BY REFERENCE OF REPRESENTATIONS AND CERTIFICATIONS (DEC

2014)

The Contractor's representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of clause)

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services-- Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications- Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services."

(d) Representations. The Offeror represents that--

(1) It [ ___ ] will, [ ___ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that--

It [ ___ ] does, [ ___ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

(a) Definitions. As used in this provision--

Administrative proceeding means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission Administrative Proceedings, Civilian Board of Contract Appeals Proceedings, and Armed Services Board of Contract Appeals Proceedings). This includes administrative proceedings at the Federal and State level but only in connection with performance of a

Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables.

Federal contracts and grants with total value greater than $10,000,000 means--

(1) The total value of all current, active contracts and grants, including all priced options; and

(2) The total value of all current, active orders including all priced options under indefinite-delivery, indefinite-quantity, 8(a), or requirements contracts (including task and delivery and multiple-award Schedules).

Principal means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

(b) The offeror ( ) has ( ) does not have current active Federal contracts and grants with total value greater than $10,000,000.

(c) If the offeror checked “has” in paragraph (b) of this provision, the offeror represents, by submission of this offer, that the information it has entered in the Federal Awardee Performance and Integrity Information System (FAPIIS) is current, accurate, and complete as of the date of submission of this offer with regard to the following information:

(1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection with the award to or performance by the offeror of a Federal contract or grant, been the subject of a proceeding, at the Federal or State level that resulted in any of the following dispositions:

(i) In a criminal proceeding, a conviction.

(ii) In a civil proceeding, a finding of fault and liability that results in the payment of a monetary fine, penalty, reimbursement, restitution, or damages of $5,000 or more.

(iii) In an administrative proceeding, a finding of fault and liability that results in--

(A) The payment of a monetary fine or penalty of $5,000 or more; or

(B) The payment of a reimbursement, restitution, or damages in excess of $100,000.

(iv) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgment of fault by the Contractor if the proceeding could have led to any of the outcomes specified in paragraphs (c)(1)(i), (c)(1)(ii), or (c)(1)(iii) of this provision.

(2) If the offeror has been involved in the last five years in any of the occurrences listed in (c)(1) of this provision, whether the offeror has provided the requested information with regard to each occurrence.

(d) The offeror shall post the information in paragraphs (c)(1)(i) through (c)(1)(iv) of this provision in FAPIIS as required through maintaining an active registration in the System for Award Management, which can be accessed via https://www.sam.gov (see 52.204-7).

52.209-10 Prohibition on Contracting With Inverted Domestic Corporations. (NOV 2015)

(a) Definitions. As used in this clause--

Inverted domestic corporation means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Subsidiary means an entity in which more than 50 percent of the entity is owned--

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

(b) If the contractor reorganizes as an inverted domestic corporation or becomes a subsidiary of an inverted domestic corporation at any time during the period of performance of this contract, the Government may be prohibited from paying for Contractor activities performed after the date when it becomes an inverted domestic corporation or subsidiary. The Government may seek any available remedies in the event the Contractor fails to perform in accordance with the terms and conditions of the contract as a result of Government action under this clause.

(c) Exceptions to this prohibition are located at 9.108-2.

(d) In the event the Contractor becomes either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation during contract performance, the Contractor shall give written notice to the Contracting Officer within five business days from the date of the inversion event.

(End of clause)

52.212-2 EVALUATION--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) Evaluation. The Government will evaluate each quotation using Simplified Acquisition Procedures under FAR 13.5, Simplified Procedures for Certain Commercial Items, lowest price, acceptable past performance and technically acceptable quote to the Government.