Statement of Work.pdf

Statement of Work

1. On-Site Preventative Maintenance Program for Reusable Medical Devices (Instrument

Sharpening and Repair) Contractor shall be able to repair and sharpen instruments the same day reusable medical instruments are identified for service. Services that are required are inspecting, sharpening, adjusting, repairing, cleaning, lubricating, and refurbishing. Contractor shall provide their own workspace (truck or van). Two pre-scheduled visits per month (every other week).

The Contractor shall ensure that the repairs and service functions are performed in conformance with the American National Standards Institute (ANSI) and the Advancement of Medical Instrumentation (AAMI). ANSI-AAMI ST-79 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities), ANSI-AAMI ST-91(Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities), Center for Disease Control (CDC) regulations, Healthcare Sterile Processing Association (HSPA) standards, Association of Peri Operative Registered Nurses (AORN) standards, Association for Professionals in Infection Control and Epidemiology (APIC) and manufacturer's specifications.

2. Scope of Work On-Site services shall include but not limited to: sterilization container repair, general sharpening, spring replacement, ophthalmic instruments, arthroscopic instruments, align and sharpen Laparoscopic instruments, micro instruments, refurbishing and reinsulating shafts as needed, diamond dusting of forceps and needle holders, repair and sharpening of minimally invasive instruments, ratchet repair, bipolar repairs, power/pneumatic, phaco handpieces, graspers, dissectors, all surgical instruments, light cables, rigid and flexible scope servicing and repair, specialized instrumentation and retractors. This shall include all surgical services instrumentation.

Surgical instruments include but is not limited to those used in: General practice and surgery, Ophthalmology, ENT, Plastics, Gynecology, Neurology, Orthopedics, Urology, Laparoscopic, Anesthesiology, Oral Maxillofacial, Vascular and Cardiothoracic.

See VA OWNED INSTRUMENTS below.

The contractor shall identify instruments that are defective and that show excessive wear and tear.

Instruments shall be clearly marked and labeled with description of the problem.

Items being sent out for repair shall be cleared through the Chief of Sterile Processing Service (SPS) or designee.

3. Contractor Requirements Contractor shall be compliant with relevant VA Policies and with AAMI/ANSI standards.

4. Specific Mandatory Tasks and Associated Deliverables Instruments and instrument sets are to be retrieved from the Sterile Processing Service of each facility and returned once repair and sharpening is completed on the same day.

All single instruments and instrument sets picked up/delivered by the contractor shall be properly listed for accountability verification.

The contractor shall tag the equipment with the appropriate labels to identify instrument repair inspection date.

The contractor shall test instruments for accurate alignment, sharpness, insulation, and calibration.

If the instrument needs to be sent out to the lab for repairs, the contractor shall obtain the verbal approval of the VA Medical Center (VAMC) Chief of SPS or their designee prior to doing so.

The contractor shall provide a summary document upon delivery of processed instruments containing the following information: date of repair, instrument type, type of repair, and cost.

Documentation/Reports: Inventory provided at end of Period of Performance, will include all sets, and instruments sharpened and repaired.

5. Quality Assurance Chief of SPS or designee will inspect instrumentation as it is returned from repair and sharpening.

The following items may be observed, tracked, and continually evaluated during the contract period.

a. Overall, Contractor Performance

b. Inspect appearance: instruments shall be free of nicks, pitting, rust corrosion, burrs, pitting and cracks.

c. Inspect for function: tips of instruments for ratcheted instruments will meet, proper jaw alignment, proper tension, freely moving box locks, screws tightened as needed, freely moving hinges on scissors or other multi-jointed instruments.

d. Technically skilled personnel: P ersonnel shall be technically proficient in repair and sharpening of instruments.

The method of surveillance that will be used to verify the quality of the contractor's performance is 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.

6. Security Clearance Contractor shall be required to complete a security clearance with the VA Police.

An 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's mobile unit(s) shall be properly labeled with contractor's logo and registered with the VA Police Department and park in designated areas for service.

Contractor shall comply with all VA Handbook 6500 requirements and any other security measure put in place by the individual.

The C&A requirements do not apply, and a Security Accreditation Package is not required.

7. Schedule for Services Two visits per month (every other week). The actual times and day(s) will be agreed upon by each designated facility. The Chief of SPS, or designee and contractor must all agree.

Hours of Coverage: Normal hours of coverage are Monday through Friday from 8:00 a.m. to 5:00 p.m., excluding the federal holidays listed as follows: New Year's Day; Memorial Day; Columbus Day;

Christmas Day; Dr. Martin Luther King Jr's Birthday; Independence Day; Veterans Day;

Juneteenth Day; Presidents' Day Labor Day; Thanksgiving Day.

Any other day specifically declared a National Holiday by the President of the United States. When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by US Government Agencies.

8. Place of Performance VA New Jersey Healthcare System - East Orange VAMC located at 385 Tremont Avenue East Orange, N.J. 07018

9. Period of Performance Award will be made for the base year, with the provision for four 12-month option years.

a. Base Year: 09/01/2024 – 08/31/2025

b. Option Year 1: 09/01/2025 – 08/31/2026

c. Option Year 2: 09/01/2026 – 08/31/2027

d. Option Year 3: 09/01/2027 – 08/31/2028

e. Option Year 4: 09/01/2028 – 08/31/2029

10. Contract Type Firm Fixed Price.

VA OWNED INSTRUMENTS (INCLUDE BUT NOT LIMITED TO):

General Scissors: Metz Scissors, Mayo Scissors, Cast/Bandage Scissors, Iris Scissors, Suture Scissors, Serrated Scissors, Delicate Scissors, Osteotomes: Total Joint Osteotomes, Podiatry Osteotomes and ENT Osteotomes Curettes: Total Joint, Curettes, D & C Curettes, Adenoid Curettes Elevators: Periosteal Elevators, Cobb Elevators, Key Elevators, Freer Elevators, DIE Elevators Gouges: Total Hip Gouges Small Knives: Amputation Knives, Cartilage Knives, Meniscus Knives, Knife Handles Ronguers: AB Ronguers, Pituitary Ronguers, Kerrison Ronguers, Kerrison Punches, Dermal Punches Cutters: Bone Cutters, Wire Cutters, Pin Cutters, Rib Cutting Forceps Forceps/Clamps: Artery Forceps, Sponge Forceps, Kelly Forceps, Adson Forceps, A1lis Forceps Tissue Forceps, Mosquito Forceps, Biopsy Forceps, Hemostats, Clip Appliers Kocher Clamps, Towel Clips/Clamps, Bone Clamps

MISCELLANEOUS INSTRUMENTS

Reamers, Total Hip Cup Graters, Cranial Burrs, Enlarging Burr, Retractors, Balfour Retractor, Hand Retractors, Dental Instruments and Hand Pieces Perforating Twist/Spinal Drill’s, Chisels, Tonsillectomies, Adenotomes, Trocars, Skin Hooks, Skin Rakes, Suction Tips/Tubes, Dissectors, Rasps Mouth Gags, Saw Blades, Specu1ums, Dilators, Dental Instruments, all needle holders, Acetabular Cutters, Dental

OPHTHALMIC INSTRUMENTS

Speculums Retractors, Knives (not diamond) Spuds; Spoons, Punches, Spatulas, Manipulators, Loops, Hooks Markers Calipers, Scissors, Forceps

ARTHROSCOPIC INSTRUMENTS

Punches, Shavers, Scissors, Intra-Articular Hooks, Intra-Articular Knives, Intra-Articular Graspers, Forceps

ALIGN/SHARPEN LAPAROSCOPIC INSTRUMENTS

Laparoscopic Punches, Laparoscopic Shavers, Laparoscopic Scissors Laparoscopic Hooks, Laparoscopic Knives, Laparoscopic Graspers Laparoscopic Forceps

MICRO INSTRUMENTS

Verres Needles, Biopsy Needles, Corneal Scissors, Urethrotomes, Micro Rongeurs, Micro Forceps Micro Scissors

REINSULATION

Shaft Reinsulating Total Reinsulating - Sharpen, Realign, Refurbish & Re-insulate Scissors & Graspers

BI-POLAR REPAIRS

Standard Bipolar (Align, adjust, refurbish) Irrigating Bipolar (Align, adjust, straighten, clean and clear channel) Standard Bipolar (Replace cap, repot, refurbish, reinsulate) Irrigating Bipolar (Replace cap, repot, refurbish, reinsulate)

STERILIZATION CONTAINER REPAIR Including, but not limited to MEDLINE, AESCULAP, GENESIS, MEDTRONIC

MISCELLANEOUS, including but not limited to:

Gasket Replacement Baffle, Inner and Outer Latch Assembly, Single Action Latch Assembly, Upper Latch Plate Replacement, Lower Latch Replacement, Single Action Latch Replacement, Single Action Latch Sheer Block Replacement, Single Action Latch (w/o handle) Replacement, Double Action Latch (w/o handle) Replacement, Retention Plate Replacement, Retention Plate Repair, Handle Replacement, E-Clip Replacement, Hex Nut Replacement, Stud Nut Replacement, Instrument Holding Pin Replacement, Nut Plate Replacement, Screw Replacement for End Plates, Fastener Replacement, Tag Replacement General Repair: Bent Container, Burr Removal, Dent Removal Miscellaneous Repair: Basket Handle Replacement

DIAMOND DUSTING

Tissue Forceps, Needle Holders Micro, Needle Holders Standard, Needle holder Jaw Application

MINIMALLY INVASIVE INSTRUMENTS

Rebuilds/Minor, Rebuilds/Major, Align & adjust jaws, Align & adjust handles, Bovie clip adaptor, Control rod, Control rod ball, Control rod insulator, Frozen control rod, J-hooks - re insulate handle, hinges, jaws, jaw pins, screws shaft, sharpen & hone, straighten & remove dents from sheath.

ENDOSCOPIC & LAPAROSCOPIC INSTRUMENTS (Modular and non-modular) All applicable graspers, dissectors, scissors, clamps, biopsy instruments and forceps (to include with or without ratchets). This will include all manufacturers.

DIAMOND KNIVES

Rehone/Repair: Single Edge Micrometer Knives, Double Edge Micrometer Knives, Axe Blade Micrometer Knives, Two-Step Enhancement Micrometer Knives, Tri Square/15 Degree Arcuate Micrometer Knives, Phaco Cataract Freehand, Trifacet Cataract Freehand, Clear Corneal Cataract Freehand, Tapered Clear Corneal Freehand, Crescent 1.5mm and 2.0mm Cataract Freehand, Phaco Chisel Blade 2 sides Cataract Freehand, Simplicity Blade, 4 sides Cataract Freehand, Buck 1.0mm, Cataract Freehand.

POWER/PNEUMATIC

Basic Repair - Includes disassembly, internal cleaning and lubrication, minor adjustment, reseal test.

All power equipment to include but not limited to:

Stryker, Medtronic, Zimmer, DePuy Synthes small and large power, Micro & Heavy-Duty Air Hose 10 Ft. (Standard Repair), Battery Pack Refurbish, Misc. Power Equipment, Electric Power Equipment

PHACO HANDPIECES

All Phaco handpieces to include but not limited to:

Alcon, Chiron (Interoptics), Star, Mentor, Storz Millenium, AMO (Allergan, OMS Minor Repair)

LIGHT CABLES and Adaptors to fit all manufacturers.

Light Cable 3mm x 6 ft w/2 adaptors Light Cable 3mm x 8 ft w/2 adaptors Light Cable 4mm x 6 ft w/2 adaptors Light Cable 5mm x 6 ft w/2 adaptors Light Cable 5mm x 8 ft w/2 adaptors

RIGID, SEMI RIGID AND FLEXIBLE SCOPES

Rigid- Thorough diagnostic testing, exterior cleaning of scope, diamond polishing of lens tip, fiber optic light connection prebonding & polishing, comprehensive leak & shock test.

Disassembly & cleaning of optical system, Disassembly & cleaning of optical system, replacement of rod lens, optical system plus replacement of objective lens, replacement of distal or proximal window, replacement of eyepiece, replacement of prism, complete rebuilds included.

Semi Rigid Fiber Ureteroscope Repair, Semi Rigid Fiber Ureteroscope Rebuild All repairs include Thorough diagnostic testing, opening and testing of interior optical system, removal of minor dents, realignment of insertion tube, functional testing of all mechanical parts, video/laser adjustment of optical system & ocular lens, fine focus, hermetic sealing of scope, comprehensive leak and shock test.

Flexible- Inspection, air/water clog repair & nozzle replacement, Clear Air/water or suction channel, replace air/water nozzle, replace bending sheath, adjust angulation / elevator adjustment, Replace light guide cover lens, leak test.

Minor/ Major fluid invasion, Replace Suction Channel, replace forceps channel (includes bending sheath), Replace forceps channel (includes bending sheath), Angulation system overhaul, Insertion tube re-coating/ major patch repair, Light guide tube replacement (includes suction channel and re-wire), Bending mesh replacement, Suction cylinder replacement, includes suction channel, Stain removal from image bundle, Insertion Tube Replacement/ Overhaul.

VIDEO EQUIPMENT REPAIR

All Manufacturers: Video Coupler Repair, Minor Leaking or Fogging, External Mechanics Major Leakage/Fluid Invasion, Major Mechanical Damage Beam Sp1itters Video Camera Repair cameras and Flexible Endoscope Light Sources.