P01 - SOW VISN Instrument Repair and Sharpening 02.docx

Statement of Work

1. On-Site Preventative Maintenance Program for Reusable Medical Devices (Instrument Sharpening and Repair)

VISN 19

Veterans Affairs (VA) Veteran Integrated Service Network (VISN) 19 consists of the Eastern Colorado Health Care System, 1700 N. Wheeling Street, Aurora, Colorado 80045; the Grand Junction Health Care System, 2121 North Avenue, Grand Junction, Colorado 81501; the Cheyenne VA Medical Center, 2360 E. Pershing Blvd, Cheyenne Wyoming, 82001; the Salt Lake City Health Care System, 500 Foothill Drive, Salt Lake City, UT 84148; the Montana Health Care System, 3687 Veterans Drive, Fort Harrison, MT 59636; the Eastern Oklahoma VA Health Care System, 1011 Honor Heights Drive, Muskogee, OK 74401 and the VA Oklahoma City Health Care System, 921 N.E. 13th Street, Oklahoma City, OK 73104. VISN 19 is currently undergoing a reorganization which may impact this requirement in the future via modifications to either add additional locations or remove locations. VISN 19 has a requirement for on-site preventative maintenance for all reusable medical devices (RMD).

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).

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.

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.

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

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 Reinsulation Total Reinsulation - 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), Staar, 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.

3. 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 (not etching) 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 verba1 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 de1ivery 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.

4. Schedule for Services Hours of Coverage: Normal hours of coverage are Monday through Friday from 8:00 a.m. to 5:00 p.m., exc1uding the federal holidays listed as follows: Federal Holidays:

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.

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.

5. Contractor Requirements

The contractor performing the repairs and sharpening of surgical instruments shall be ISO-9000 certified.

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

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

7. 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.

Overall Contractor Performance:

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

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.

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

1. 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. See Surveillance Inspection Form Checklist, Exhibit A in Section D.

8. VISN 19 Facilities Locations:

6.1 Colorado

6.1.1 VA Eastern Colorado Health Care System

Rocky Mountain Regional VA Medical Center 1700 N. Wheeling St.

Aurora, CO 80045

6.1.2 VA Western Colorado Health Care System

Grand Junction VA Medical Center 2121 North Avenue Grand Junction, CO 81501

6.2 Montana

6.2.1 Montana VA Health Care System

6.3 Utah

6.3.1 VA Salt Lake City Health Care System

George E. Wahlen VA Medical Center 500 Foothill Dr.

Salt Lake City, UT 84148

6.4 Wyoming

6.4.1 Cheyenne VA Medical Center

VA Medical Center- Cheyenne 2360 E. Pershing Blvd.

Cheyenne, WY 82001

Northern Colorado CBOC 4575 Byrd Drive Loveland, CO

6.5 Oklahoma

6.5.1 Oklahoma City Veterans Affairs Health Care System

Oklahoma City Veterans Affairs Medical Center 921 NE 13 Street Oklahoma City, OK 73104

6.5.2 Eastern Oklahoma VA Health Care System

Jack C Montgomery VA Medical Center 1011 Honor Heights Drive Muskogee, OK 74401

Ernest Childers VA Outpatient Clinic 8921 South Mingo Road Tulsa, OK 74133

Yale Avenue VA Clinic 5110 South Yale Ave, 51 Yale Building, Suite 200 Tulsa, OK 74134