PWS Surgical Inst Serv final version 03-31-2025 (002).docx

PERFORMANCE WORK STATEMENT

1.0 BACKGROUND: The US Naval Hospital Sigonella

1. GENERAL INFORMATION:

1.1. NON-PERSONAL SERVICES. The Contractor shall provide all labor, material, personnel, and transportation necessary to provide on-location repair and maintenance services of instrument trays/peel packs which contain various instruments: surgical, dental and specialty instruments from numerous manufacturers. All instruments are to be inspected, ultrasonically cleaned and lubricated. Repairs include alignment, adjustments, pins, sharpening, inserts, laparoscopic shaft insulation, springs and manufactured parts and/or screw replacement. The contractor should include the replacement of any instrument beyond repair, provide a substitution while instruments are under repair, and provide containers. 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 as the MTF has limited resources and mission readiness is expected. On-site locations include DHA Hospital Sigonella Italy and US NMRTU Bahrain, DHA Hospital Rota Spain and DHA Hospital Naples Italy. Status of serviced instruments shall be communicated by the Contractor. This service is required at least annually. The following trays and peel packs have been identified for service: sharpening and/or repair or replacement:

Serviceable Trays: Sigonella & Bahrain: 380; Naples: 99; Rota: 517 (TOTAL: 996) High Speed Handpieces: Sigonella & Bahrain:16; Naples:20; Rota: 15 (TOTAL: 51) Exam Packs: Sigonella & Bahrain: 54; Naples: 43; Rota: 300; (TOTAL: 397) Cavitron Tips: Sigonella & Bahrain: 23; Naples: 72; Rota: 20 (TOTAL: 115) Peel Pack instruments: Sigonella & Bahrain:5115; Naples: 4651; Rota: 2325 (TOTAL: 12,131)

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, OB/GYN surgery, ortho surgery, ENT surgery, dental, laparoscopic surgery instrumentation and colonoscopes/endoscopes.

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 shall report or notify the MTF designated POC prior to commencing services. The Government will provide the Contractor with the names and telephone numbers of authorized personnel. Contractor personnel shall comply with installation access protocols.

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.

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. Publications and forms 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.

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 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)

PWS ATTACHMENT 1

PERFORMANCE REQUIREMENT SUMMARY (PRS) FOR

Sharpening and Repair Services

1.1. - Sharpen and

1.3. repair

a) Sharpen and repair handheld general, specialty, and micro-surgical instruments from numerous manufacturers and return completed items prior to the end of each work day AQL: On 98% of the items to be serviced per service event

b) Align, sharpen, tighten, lubricate surgical instruments in accordance with manufacturer's specifications and return completed instruments prior to the end of each work day AQL: On 98% of the items to be serviced per service event Positive/ Negative Performance Evaluation

2.0. Inspection, repair, refurbish, refinish, replacement.

a) Inspect, repair, refurbish and/or refinish only those instruments that require service in accordance with manufacturer's specifications.

AQL: On 97% of the items to be successfully serviced per service event Positive/ Negative Performance Evaluation

3.0. - Contractor

3.7. provided services

a) Provide laparoscopic insulation testing and re-insulation repair services.

AQL: On 100% of the laparoscopic instruments with no more than 1 customer complaint per service event

b) Provide demagnetize stainless steel handheld instruments services.

AQL: On 100% of the demagnetize stainless steel handheld instruments with no more than 1 customer complaint per service event

c) Provide acid etching for instrument identification services.

AQL: : On 100% of the instruments with no more than 1 customer complaint per service event

d) Provide power hose leakage evaluations services. AQL: : On 100% of the power driven instruments with no more than 1 customer complaint per service event

e) Provide replacement of tungsten carbide inserts in needle holders and tissue forceps.

AQL: On 100% of the needle holders and tissue forceps requiring replacement of tungsten carbide inserts with no more than 1 customer complaint per service event

f) Provide improvement plans.

AQL: On 100% of the items with no more than 1 customer complaint per service event

g) Provide training of Government personnel.

AQL: On 100% of the items with no more than 1 customer complaint per service event Positive/ Negative Performance Evaluation

(End of PWS Attachment 1)