P01 SOW On-Site Surgical Instrument Service.doc

Statement of Work (SOW) On- Site Preventive Maintenance Service for Reusable Medical Equipment and Sterile Processing Services

A. GENERAL INFORMATION

Surgical instrument repair and preventive maintenance of Reusable Medical Equipment (RME) is a highly specialized vocation. Finding a contractor with a strong knowledge base of the specific instruments and equipment used at the VA Medical Center, Sterile Processing Service (SPS) is crucial. Acquiring an annual contract for this requirement ensures cost efficiency by having highly skilled technicians conduct repair services without damaging or breaking instruments and equipment; standardization using the same company for all repairs and replacements; and time saving processes from having one point of contact and consistent plans of action.

1. Performance Specifications:

This requirement is for on-site surgical instrument repair, sharpening and refurbishing or replacing as needed, repair of closed surgical case carts as needed, and cleaning of steam sterilizers biannually. There are two locations specified in this Statement of Work which require these services:

Atlanta VA Hospital SPS Department 1670 Clairmont Rd.

Decatur, GA 30033

Cobb VA North Clinic

1263 Cobb Pkwy N.

Marietta, GA 30066

2. Scope of Work:

The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified. Contractor shall provide minimum specifications contained herein. Work shall meet all applicable codes and regulations and is subject to the terms and conditions of the contract.

This requirement is for on–site preventive maintenance for all Reusable Medical Equipment (RME) including steam sterilizers in Sterile Processing Service (SPS) department. The contractor shall be able to repair and sharpen instruments the same day reusable medical equipment is identified doe service. Services that are required are inspecting, sharpening, adjusting, repairing, cleaning, lubricating and refurbishing. The contractor should be able to repair dental hand pieces, rigid scopes and anything else that may require repair. They must also be able to repair surgical case carts, and clean steam sterilizers as needed. The contractor shall ensure that the repairs and service functions are performed in conformance with the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI). ANSI-AAMI ST-59 Part I: (General Sterilization of Health Care Products), ANSI- AAMI ST- 79 Part 7.7(Servicing and repairs of Devices in the health Care Facility), ANSI- AAMI ST- 91(Flexible and Semi- Rigid Endoscope Processing in Health Care Facilities), Center for Disease Control (CDC) regulations, International Association of Healthcare Central Service Material Management (IAHCSMM) standards. Association of Peri-Operative Registered Nurses (AORN) Standards, Associate for Professionals in Infection Control and Epidemiology (APIC) and manufacturer’s Specifications.

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 ever 3-4 months while frequent use sets in a day depending upon the size, type of trays and service required. Repair specialist shall provide the required service about 15 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, in order to keep instruments together.

The repair vans shall carry replaceable instruments, 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. Instruments beyond repair or refurbishment that fall within the patterned replaceable instruments covered in Assurance Service Program will be replaced. There is no limit as to the quantity of unrepairable instruments that need to be replaced as long as the unrepairable instruments fall within the patterns listed.

The 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 contractors trained technicians.

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 reinstating shafts as needed, diamond dusting of forceps and needle holders, repair and sharpening of minimally invasive instruments, rachet repair, bipolar repairs, power/pneumatic, phaco handpieces, graspers, specialized instrumentation and retractors. This shall include all surgical services instrumentation.

Surgical instruments include, but 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. The contactor shall be able to remove marking tape from the instruments when requested or as needed. Items being sent out for repair shall be cleared through Chief of SPS or designee.

All surgical instruments and sets shall be inspected and evaluated for continued best practice performance and restored to like new condition. The repair services are required twice a month and on 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.

· Ability to work harmoniously with SPS automated instrument tracking systems

· Ability to repair surgical case carts as needed

· Cleaning of steam sterilizers annually or as needed VA Owned Instruments include but not limited to:

General Scissors: Scissors Metz, Mayo, Iris, cast/ bandage scissors, suture scissors, serrated scissors, pots scissors and other delicate scissors.

Osteotomes: Total Joint osteotomes, Podiatry osteotomes, ENT osteotomes.

Curettes: Total Joint curettes, D&C Curettes, Adenoid curettes, ortho- spine and neuro surgery curettes.

Elevators: periosteal elevators, Cobb elevators, key elevators, freer elevators, D/E elevators.

Gouges: Total Hip Gouges

Small knives: Amputation knives, cartilage knives, meniscus knives, knife handles.

Ronguers: All Ronguers, pituitary, Kerrison, Kerrison punches, Dermal punches.

Cutters: Bone cutters, wire cutters, pin cutters, rib cutting forceps, Forceps/ Clamps: artery forceps, sponge forceps, Kelly clamps, Adson, Allis, Tissue, mosquito, biopsy, Hemostats, clip appliers, Kocher clamps, towel clips, bone clamps.

Miscellaneous instruments:

Reamers, Total hip cup graters, cranial burrs, retractors, balfour retractor, other hand retractors, Dental instruments, dental hand pieces. Spinal drills, chisels, skin hooks, rakes, suction tips and tubes, dissectors, rasps, saw blades, speculums, dilators, all needle holders, Acetabular cutters.

Ophthalmic Instruments:

Speculums, Retractors, Knives (not diamond)

Spuds, spoons, punches, spatulas, Manipulators, loops, Hooks, marker 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 like Pots Reinsulation:

Shaft Reinsulation

Total Reinsulation – Sharpen, Realign, Refurbish and Re- Insulate Scissors and Graspers

Bipolar Repairs:

Standard Bipolar forceps (Align, Adjust, refurbish)

Irrigating Bipolar forceps (Align, Adjust, refurbish)

Standard Bipolar forceps (Replace cap, report, refurbish, reinsulate)

Irrigating Bipolar forceps (Replace cap, report, refurbish, reinsulate)

STERILIZATION CONTAINER REPAIR

GENESIS, AESCULAP, BOOKWALTER

MISCELLANEOUS:

Gasket Replacement, Baffle, Inner, outer latch assembly, Single Action Latch Assembly, Upper Latch place replacement, lower latch 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, Basket Handle bracket, basket handle leg bracket repair or replacement.

DIAMOND DUSTNG:

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

MINIMAALY INVASIVE INSTRUMENTS:

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

ENDOSCOPIC & LAPAROSCOPIC INSTRUMENTS (Modular and non- modular).

All applicable graspers, dissectors, clamps, biopsy instruments and forceps (to include with or without rachets). This will include all manufacturers.

DIAMOND KNIVES

Single Edge Micrometer knives, Rehone, Double Edge Micrometer Knives, Rehone, Axe blade micrometer knives, Two-step enhanced micrometer knives, Rehone, Tri square/15-degree arcuate Micrometer knives, Rehone, Phaco cataract Free hand Rehone, Trifacet Cataract Freehand Rehone, Clear Corneal Cataract Freehand Rehone, Phaco Chisel Blade 2 sides cataract Freehand Rehone, simplicity blade, 4 sides Cataract Freehand Rehone Buck 1.0mm, Cataract Freehand Rehone.

POWER/PNEUMATIC

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

All power equipment to include but not limited to:

Stryker, Conmed small and large power, Micro& Heavy-Duty Air Hose 10 ft (Standard repair), Battery pack refurbishing, Misc. Power Equipment, Electric Power Equipment.

PHACO HANDPIECES

Alcon 10,000, Alcon Legacy, Chiron (Interoptics), Staar, Mentor, Storz, Storz Millenium, AMO (Allergan, OMS Minor repairs).

LIGHT CABLES and ADAPTORS to fit all manufacturers Light Cable 3mm x 6ft w/2 adaptors

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

Light Cable 5mm x 8ft w/2 adaptors

CLEANING OF STEAM STERILIZERS BIANNUALLY

Cleaning of Three (3) Steris Steam sterilizers model # and one Getinge Steam Sterilizer model #

Services should include, preparation of work area, closing of the valves, drains and steam outlets while cleaning, cleaning of drains, cleaning of sterilizer chambers, removal of oxidation from sterilizers and polishing of the metal surfaces.

Sterilizers will have a satin polished finish upon completion of work.

SURGICAL CASE CART REPAIR

Maintenance and repair of stainless-steel surgical case carts, replacing hinges, repair or replace coasters and wheels, restore once piece wrap-around bumper as needed. Replace any stainless-steel parts as needed.

3. Specific Mandatory Tasks and Associated Deliverables Instruments and instruments sets are to be received 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, sharpens, 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 VAMC SPS chief 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 the 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 a Monday through Friday from 8:00 am to 5:00 pm., excluding the federal holidays listed as follows:

Federal Holidays:

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 the Sterile Processing Services, or Designee, 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 ST-79: 2010 Part 7.7 standards (Servicing and Repairs of Devices in the health care facility).

6. Quality Assurance Chief of Sterile Processing Services (SPS) or designee will inspect instrumentation as it is returned from repair and sharpening. Evaluation of work performed during the contract period shall consist of the following:

Overall contractor performance inspect appearance: Instruments shall bee free of nicks, pitting, rust corrosion, 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.

6. SECURITY INCIDENT INVESTIGATION

a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/ subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident or obtain injunctive relief against any third party arising from, or related to, the incident.

B. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

Description of Tasks and Associated Deliverables: The contractor shall provide the specific deliverables described below within the performance period stated in this SOW.

Deliverable Schedule

Base Year FY 25

OY1

FY26

OY2

FY27

OY3

FY28

OY4

FY29

Performance Period:

The contract Period of Performance (POP) shall be a 12-month Base Year and four 12-month Option Years. The Period of Performance shall be as follows:

Base Year: 6/01/2025 – 5/31/2026 Option Year 1: 6/01/2026 – 5/31/2027 Option Year 2: 6/01/2027 – 5/31/2028 Option Year 3: 6/01/2028 – 5/31/2029 Option Year 4: 6/01/2029 – 5/31/2030

C. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the COR. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the COR shall be borne by the contractor.

D. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

E. CONTRACTOR RULES OF BEHAVIOR

This User Agreement contains rights and authorizations regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the Department of Veterans Affairs (VA). This User Agreement covers my access to all VA data whether electronic or hard copy ("Data"), VA information systems and resources ("Systems"), and VA sites ("Sites"). This User Agreement incorporates Rules of Behavior for using VA, and other information systems and resources under the contract.

*No network access or user accounts (VISTA) will be needed by contractor, as they will not be using the Atlanta VA Sterile Processing Department, Operating Room or Community Based Outpatient Center (CBOC) computers.