P01 PWS for SPS Sharpening contract Updated.docx

General Information

On-site Preventative Maintenance Program for Reusable Medical Equipment (RME) (Instrument Sharpening, Repair and Preventative Maintenance)

Period of Performance:

The period of performance: March 1st, 2025 through February 28th, 2026 (base year) with four (4) option years.

Places of Performance:

· Department of Veterans Affairs Nebraska-Western Iowa Health Care System Omaha 4101 Woolworth Ave, Omaha, NE 68105

· Department of Veterans Affairs Nebraska-Western Iowa Health Care System-Grand Island 2201 N Broadwell Ave, Grand Island, NE 68803

· Department of Veterans Affairs – Iowa City VA Medical Center 601 Highway 6 West Iowa City, IA 52246-2209

Scope of Work

All repairs will follow all approved recommendations regarding surgical instrument repair as set forth by the following:

• Food and Drug Administration (FDA)

• Centers for Medicare/Medicaid Services (CMS)

• Centers for Disease Control (CDC)

• Association for the Advancement of Medical Instrumentation (AAMI)

• Healthcare Sterile Processing Association (HSPA) Standards

• American National Standards Institute (ANSI)

• Association of per-Operative Registered Nurses (AORN)

• Association of Professionals in Infection Control (APIC)

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

• Manufacturer Instructions (MFI)

All services are required twice per month in Grand Island, Nebraska approximately 24 visits per year. Additional visits may be added via modification from the contracting officer on an as needed basis to ensure that we have the safest and most reliable instruments on hand to use on our Veteran patients.

All services are required once per week in Omaha, NE approximately 52 visits per year. Additional visits may be added via modification from the contracting officer on an as needed basis to ensure that we have the safest and most reliable instruments on hand to use on our Veteran patients.

All services are required 3 times per month in Iowa City, Iowa approximately 36 visits per year. Additional visits may be added via modification from the contracting officer on an as needed basis to ensure that we have the safest and most reliable instruments on hand to use on our Veteran patients.

Each surgical set shall be inspected, repaired, and refurbished at least twice annually.

Instruments and instrument sets are to be retrieved from Sterile Processing Services (SPS) of each facility and returned once repairs 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 provide a summary document upon delivery of processed instruments containing the date of repair, instrument type, and type of repair completed.

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

Contractor will meet or exceed the following:

The contractor shall provide all labor, materials, and equipment necessary for maintenance, inspection, and repairs of several types of surgical instruments that are contained in various instrument sets, the refurbishment of containers and lids and case carts. All surgical instruments and sets shall also be inspected and evaluated for continued best practice performance and restored to like new condition.

All on-site servicing repairs will be performed utilizing a fully equipped mobile laboratory for services including but not limited to the following:

· Complete entire set inspection and evaluation of all general and micro instruments

· Inspection, repair, alignment, adjustment, tightening, cleaning, lubricating, and general renewal

· Perform all furnishing to include labor, parts to perform all refurbishment, maintenance and repair on instrumentation listed to guarantee the proper functionality of the instrument according to manufacturer's specifications.

· Sharpening of all Scissors, Curettes, Punches, biopsy forceps and other “Cutting” instruments

· Replacement of worn, missing, or broken Parts (Parts must be approved by the Original Equipment Manufacturer (OEM))

· Disassembly when applicable

· Refurbishment

· Refinish as needed

· Cleaning/oiling as needed

· Align and sharpen laparoscopic instruments

· Align and adjust as required for optimal performance

· Spring replacements

· Inspecting tape and identification of defective or damaged tape

· Ultrasonic cleaning and revitalization

· Satin or mirror refinishing

· Tungsten Carbide insert replacement

· Needle holder re-application (including “diamond dusting” of micro needle holders and forceps)

· Repair ratchet, jaw and shank as required

· Bipolar repairs: Align, Adjust, Refurbish, Replace Cap, Reinsulate

· Irrigating Bipolar repairs: Align, Adjust, Straighten, Clean and Clear Channel

· Re-insulation

· Brazing

· Buffing

· Soldering

· Power/pneumatic

· General sharpening

· Electrosurgical re-insulation and testing

· Chemical Etching

· Surgical Milk Lubrication

· Sterilization Container Repairs (as needed utilizing OEM parts)

· Case cart repairs to include: doors, hinges, latches, wheels, and minor welding

· Instruments that are damaged or broken during refurbishment will be repaired

· Trays serviced according to case volume and maintenance scheduling

Additionally, Contractor shall include service for the following instruments and services but not limited to:

· Ophthalmic instruments: Speculums Retractors, Knives, Spoons, Punches, Spatulas, Manipulators, Loops, Hooks Markers Calipers, Scissors, and Forceps in various lengths, sizes and shapes.

· Arthroscopic instruments: Punches, Shavers, Scissors, Intra-Articular Knives and Graspers, and Forceps in various lengths, sizes, and shapes.

· Laparoscopic Instruments: Cleaning, Sharpening, Resetting, Alignment, New Flush Port, Straightening, Repair/replacement of cautery posts, Thumb screws, Inner stem resetting, skirts, Repair/replacement of shaft insulation, Repair/replacement of ratchet assemblies, Repair/replacement of valves, Repair/replacement of springs, Repair/replacement and resealing of handles, New Needles/hooks/spatulas, On-site laparoscopic insulation testing, Complete rebuilding or replacement of laparoscopic instrument components including replacement of all parts as necessary.

· Micro Instruments: Verres Biopsy Needle, Corneal Scissors, Urethrotomes, Micro Rongeurs, and Forceps and Scissors in various lengths, sizes and shapes.

· Reinsulation: Shaft Reinsulation, Total Reinsulation- Sharpen, realign, refurbish & re-insulate Scissors and Graspers in various lengths, sizes and shapes

· Sterilization Container inspection and repairs: As needed preventative maintenance utilizing OEM replacement parts as well as Gasket Replacement, Inner and Outer Latches, Single Action Latch Assembly, Upper and Lower Single Action Latch Plate Replacement, Single Action Latch Sheer Block Replacement, Single Action (w/o handle) Replacement, Double Action Latch (w/o handle) Replacement, Retention Plate Replacement or Repair, Handle 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, Basket Handle Bracket, and Basket Handle Leg Bracket.

· This shall include all surgical services instrumentation including all Dental instruments and hand pieces. General practice including Podiatry and Cardiology, Surgery, Ophthalmology, Ear Nose & Throat (ENT), Plastics, Gynecology, Neurology, Orthopedics, Urology, Laparoscopic including minimally invasive surgery, Anesthesiology, Oral Maxillofacial, Vascular, and Dental. General Stainless-Steel Instruments, Curettes, Elevators, General Scissors, Osteotomes Gouges, Total Hip Gouges in various lengths, sizes and shapes, Knives and Knife Handles in various lengths, sizes and shapes, Rongeurs, Dermal Punches, and All Single and Double Action Ronguers in various lengths, sizes and shapes, Cutters for Bone, Wire, Pin, and Rib Cutting Forceps in various lengths, sizes and shapes. Forceps for Artery, Sponge, Kelly, Adson, Allis, Tissue, Mosquito, and Biopsy Forceps in various lengths, sizes and shapes, Clamps, Hemostats, Clip Appliers, Kocher, Towel Clips/Clamps, and Bone Clamps in various lengths, sizes and shapes, Reamers, Total Hip Graters, Acetabular Cutters, Cranial Burrs, Enlarging Burrs, Retractors, Balfour Retractor, Bookwalters, Hand Retractors, Dental Instruments and Hand Pieces, Perforating Twist/Spinal Drills, Chisels, Tonsillectomies, Adenotomes, Trocars, Skin Hooks and Rakes, Suction Tips/Tubes, Dissectors, Rasps, Mouth gags, Speculums, Dilators, All Delicate, Fine and Regular Needle Holders. Micro instruments, refurbishing and reinsulating shafts as needed, repair and sharpening of minimally invasive instruments, power/pneumatic, graspers, dissectors, and specialized instrumentation.

The contractor shall identify instruments that are defective and that show excessive wear and tear or unrepairable damage. Instruments shall be clearly marked and labeled with specific description of the problem and what set the instrument came from. Instruments that are unable to be repaired must not be placed back in the set and will be delivered to SPS Leadership and clearly marked “Not able to be serviced, not for patient use”.

Items required to be sent off site for repair shall be cleared through SPS Chief, SPS Assistant Chief, OR Manager or designee.

Ability to work harmoniously with SPS automated Instrument Tracking Systems (ITS). Contractor will preserve the integrity of the Instrument Tracking System (ITS) marking. If the repair process damages or removes the ITS mark the contractor will remark or will repair in a way that will not remove or have negative impact to the ITS marking. Contractor will provide own workspace (truck or van) for each visit to include ability to repair case carts.

Prior to commencing work on hospital instruments, the contractor shall conduct a set evaluation to determine specific needs of the facility and coordinate a proper schedule for routine maintenance, refurbishing and replacement. Generally, instrument sets should be scheduled for sharpening every 3-4 months. Contractor shall provide the required service approximately 8 to 12 sets in a day depending upon the size, type of trays and service required. Certain sets may take longer than others. But on average, a tray can be serviced in about 45 minutes. Instrument sets shall be opened and repaired one at a time to keep instruments together.

As instruments are removed from the container, they shall be counted and separated. Hemostats and ring handled instruments shall be checked for alignment, box lock tension and fractures. Tissue forceps checked for alignment, proper spring tension and fractures. Special attention shall be focused on delicate instruments and teeth alignment. All sharps shall be checked for use.

For example: Scissors shall be tested using latex material, rongeurs and Kerrison's should snap card stock, osteotomes, elevators and curettes should dig into a plastic dowel rod. Other instruments shall be tested and checked for fractures, proper tension, loose, or missing screws, alignment, etc.

The repair vans shall carry an assortment of springs, screws, and other OEM replacement parts to ensure a cost-effective same day repair. Before sharpening, the instruments shall be refurbished by bead blasting. After sharpening and repair, all stainless instruments shall be placed into the ultrasonic cleaner which removes debris and oxidation. The instruments shall be rinsed with clean water, counted again, and placed back into the container where attention is given to protect the sharps.

After repair is completed, a computer printed work order shall be provided by the contractor on the same day of repair, showing the work performed, line-items and trays serviced. Pricing on this order shall be predetermined by the existing contract. Contractor shall require a signature from Lead or Supervisor in SPS and the repair technician shall provide a copy of the work order to the Assistant Chief or SPS Chief for record keeping.

Education: the repair technician shall organize a care and handling in service with hospital staff and show how they can test instruments for sharpness/functionality. This knowledge is especially helpful while SPS technicians assemble trays for surgery. The contractor shall schedule with the Education Coordinator, SPS Chief, or SPS Assistant Chief, for in-service. In-services shall be provided at least twice per year in Omaha and twice per year in Grand Island and Iowa City.

The contractors mobile repair van shall always maintain an open-door policy to hospital staff and full access to the repair specialist. The contractor shall be committed to meeting the instrument repair needs of the customers. Satisfaction repair surveys shall be provided to the contractor at the end of period of performance to help ensure that hospitals are getting the best service possible from the contractor's trained technicians.

The contractor shall provide at minimum, a computer spreadsheet database for tracking purposes. This can be accomplished with an electronic tracking system and/or web based online database. This database will provide invoices and generate preventive maintenance schedules, maintenance completed instruments not repairable and repair history reports. Instruments damaged beyond repair, will be tagged non-repairable with an explanation and then bagged with the instrument count sheet attached so the hospital can identify what tray the instrument came from for re-ordering. The contractor shall submit reports of trays completed, repair history, etc. to the Chief of SPS on a weekly basis. Instruments requiring additional work or off-site repair shall be repaired within 72 hours at no additional cost to the Government.

After repairs are completed, a computer printed document shall be provided by the contractor on the same day of repairs, showing the work performed, line items, and trays serviced. Pricing on this order shall be predetermined by the existing contract. Contractor shall require a signature from an SPS Lead, SPS Assistant Chief, SPS Chief, or designee and the repair technician shall provide a copy of the work order to the Assistant Chief or SPS Chief for record keeping.

Contractor must provide SPS Leadership annual evidence/documentation that all servicing technicians have documented training for all services.

1. Schedule of Services Hours of Coverage: Normal hours of coverage are Monday thru Friday from 8:00am to 5:00pm, excluding Federal Holidays or any other day specifically declared a National Holiday by the President of the Unite States.

When a Federal Holiday falls on a Sunday, the following Monday will be the observed legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a Federal holiday by U.S. Government Agencies.

The actual times and day(s) will be agreed upon by each designated facility. The SPS Chief or designee and the contractor must all agree.

Overtime shall not be authorized under any circumstance. Any holiday pay that may be entitled to the Contractor personnel performing under this contract shall be the sole responsibility of the Contractor and shall not be billed to nor reimbursed by the Government.

2. Contractor Requirements The contractor performing the repairs, sharpening and preventative maintenance of surgical instruments shall be ISO-9000 certified.

Contractor shall be complaint with relevant VA Policies.

Security Clearance

All vendors requiring access to the Omaha VA Medical Center, Grand Island VA medical Center and the Iowa City VA medical must be registered and obtain a badge from O.R. TRAX

Please register at: https://app.ortrax.com O.R. TRAX will provide the credentialing services of all VA Medical Center vendors, service technicians, equipment installers, consultants, service reps, delivery reps, sales reps, etc. O.R. TRAX will provide digital badges that can be tracked through the ORX system. We encourage you to register 7-10 days prior to arriving to ensure that you will receive your badge before you begin working on site.

· Clocking In:

Upon arriving at the facility, you will need to clock-in by scanning the QR Code on the OR Trax Sign Kiosk. They will be located at several entrances to the hospital and service departments. To do so, simply open your mobile phone, scan the QR Code to login. (you do not need to take a picture or download a QR Code Scanner app). Follow the prompts on your phone to complete access to the facility.

· Please note that if you do not have an approved O.R. TRAX badge, you will NOT be granted access at any of the facilities in VISN 23.

· If you have any questions, please contact O.R. TRAX Support Team at (813)444-8729.

Contractor's mobile unit(s) shall be properly labeled with contractor's logo 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 VA.

Quality Assurance

SPS Lead, SPS Quality Nurse, SPS Assistant Chief, SPS Chief or designee will inspect instrumentation as it is returned from repair, sharpening and preventative maintenance.

All items will be observed, tracked, and continually evaluated during the contract period.

Overall contractor Performance Inspection appearance: instruments shall be free of nicks, pitting, rust, etching, corrosion, burrs, and cracks.

Inspection for function: tips of ratcheted instruments will meet, proper jaw alignment, proper tension, freely moving box locks, screws tightened as needed, freely moving hinges on scissors or the 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 specific 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 Checklist, Exhibit A in Section D.

· Quality Assurance Surveillance Plan

Exhibit A Surveillance Inspection Checklist

Evaluation Area: Omaha Grand Island

Overall Performance

Appearance of Instruments

Function of Instruments

Provide Technically skilled Personnel

Assessment Elements

4. Function of Instruments: instruments shall be repaired and sharpened and preventative maintenance per manufacturer's instructions.

5. Technically skilled personnel: personnel shall have appropriate training and certification to provide quality service.

Rating Definitions:

Exceptional: Performance meets contractual requirements and exceeds many to the Government's benefit. The contractual performance of the element or sub-element being assessed was accomplished with few minor problems for which corrective actions taken by the contactor were highly effective.

Very Good: Performance meets contractual requirements and exceeds some to the Government's benefit. The contractual performance of the element or sub-element being assessed was accomplished with some minor problems for which corrective actions taken by the Contractor were effective.

Satisfactory: Performance meets contractual requirements. The contractual performance of the element or sub-element contains some minor problems for which corrective actions taken by the Contractor appear to be or were satisfactory.

Marginal: Performance does not meet contractual requirements. The contractual performance of the element or sub-element being assessed reflects a serious problem for which the contractor has not yet identified corrective actions. The Contactor's proposed actions appear only marginally effective or were not fully implemented.

Unsatisfactory: Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The contractual performance of the element or sub-element contains serious problem(s) for which Contractor's corrective actions appear or were ineffective.

Records Management

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. [VA Nebraska-Western Iowa Health Care System] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [VA Nebraska-Western Iowa Health Care System] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [VA Nebraska-Western Iowa Health Care System]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [VA Nebraska-Western Iowa Health Care System] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [VA Nebraska-Western Iowa Health Care System] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [VA Nebraska-Western Iowa Health Care System] policy.

8. The Contractor shall not create or maintain any records containing any non-public [VA Nebraska-Western Iowa Health Care System] information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The [VA Nebraska-Western Iowa Health Care System] owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [VA Nebraska-Western Iowa Health Care System] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flowdown of requirements to Subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.