36C25525Q0264 0001.docx

5. PROJECT NUMBER (if applicable)

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Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

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is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

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Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

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Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

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Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

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(SEE ITEM 11)

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13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

03-25-2025

None 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048 To all Offerors/Bidders

36C25525Q0264

X

Surgical Instrument Maintenance - Kansas City VAMC

The purpose of this amendment is to:

1) Provide an updated Performance Work Statement changes will be highlighted.

2) Answer questions in reference to RFQ 36C255Q0264.

No other questions will be accepted at this time.

Betty Flores Contracting Officer

PERFORMANCE WORK STATEMENT (PWS)

Surgical Instrument Repairs, Testing, and Inspection

Part 1

General Information

1. GENERAL: This is a non-personal services contract to provide Surgical Instrument Repairs, Testing, and Inspection. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1 Description of Services/Introduction: The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform Surgical Instrument Repairs, Testing, and Inspection as defined in this Performance Work Statement (PWS), section 5 except for those items specified as government furnished property and services. The Contractor shall perform to the standards in this contract.

1.2 Background: The Kansas City VA Medical Center (589), Surgery Service (112) is currently seeking a vendor that can provide services related to a Preventative Maintenance (PM) program for surgical instrumentation used in the operating room and in clinical procedures which includes repair, refurbishing and assessment for replacement.

1.3 Objectives: Required services are to be complete four (4) times per month (weekly) and will be conducted on 10 trays per visit (i.e. 40 trays per month). The expected performance period is a base year of twelve (12) months with four (4) option years. Each option year is twelve (12) months.

1.4 Scope:

1.4.1 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.

1.4.2 Surgical instruments include but are not limited to those used in: Anesthesiology, Bariatrics, Cardiothoracic, General Surgery, Gynecology, Laparoscopic, Neurosurgery, Ophthalmology, Oral Maxillofacial, Orthopedics, Otolaryngology, Plastics, Podiatry, Urology, and Vascular.

1.4.3 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.

1.4.4 Items being sent out for repair shall be cleared through COR or designee either in writing or through email.

1.5 Period of Performance: Required services are to be complete two (4) times per month (weekly) and will be conducted on 10 trays per visit (i.e. 40 trays per month). The expected performance period is a base year of twelve (12) months with four (4) option years. Each option year is twelve (12) months.

1.6 General Information:

1.6.1 Federal Observed Holidays: Contractor is not required to report or work on Holidays as listed below or any other day specifically declared by the President of the United States to be a national holiday.

Independence Day

When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When one of the above designated legal holidays falls on a Saturday, the preceding Friday is observed as a holiday.

1.6.2 Hours of Operation: The Contractor is responsible for conducting business, between the hours of 6:00 am to 3:30 pm Monday through Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The Contractor must, at all times, maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.6.3 Emergency Points of Contact: All after hours emergencies should be reported to the Kansas City VA Police: (816)922-2875.

1.6.4 Place of Performance: The work to be performed under this contract will be performed at:

Kansas City VA Medical Center 4801 E Linwood Blvd.

Kansas City, MO 64128

1.6.5 Quality Assurance: The government shall evaluate the contractor's performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.6.6 Type of Contract: The Government will award a single award firm fixed priced contract

1.6.7 Special Qualifications: The contractor performing the repairs and sharpening of surgical instruments shall be ISO-9000 certified at time of award. 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).

1.6.8 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation (FAR) Subpart 42.5. The CO and Contracting Officer’s Representative (COR) shall meet periodically with the contractor to review the contractor's performance. At these meetings the CO will apprise the Contractor of how the Government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues.

1.6.9 Contracting Officer’s Representative (COR): The COR Management System Tool (eCOR File)- for nomination, tracking, documentation, and management of CORs will be used. The COR will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: Assure that the Contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the Contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, and specifications; monitor Contractor's performance and notifies both the CO and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.6.10 Key Personnel: The following personnel are considered key personnel by the Government: Contract Manager, Alternate Contract Manager, and Instrument Technician. The Contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract.

1.6.11 Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations where their Contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed. Contractor personnel are required to obtain and wear appropriate credentials (badge) while onsite at the facility.

1.6.12 Facility Access:

1.6.12.1 Contractor shall be required to complete a security clearance with the Kansas City VA Medical Center Police Department

1.6.12.2 An ID badge will be issued by the VA Police which must be presented by the contractor’s employee at all VA entrances and check points. The issued badge is for official pickup, repairs, and deliveries of surgical instruments and trays.

1.6.12.3 Contractors mobile units (Vehicles) shall be properly labeled with the contractor’s logo and are required to utilize only authorized parking while on site.

1.6.12.4 Contractor shall comply with all VA Handbook 6500 requirements and any other security measure instituted at the Kansas City VA Medical Center

1.6.13 Contractor Personnel Conduct: Contractor personnel’s conduct shall not reflect discredit upon the Government. The Contractor shall ensure that personnel present a professional appearance. The Contractor’s employees shall observe and comply with all local policies and procedures concerning fire, safety, environmental protection, sanitation, security, and possession of firearms or other lethal or illegal weapons or substance. The Contractor is responsible for ensuring that any contractor employees providing services under this contract conduct themselves and perform services in a professional, safe, and responsible manner. The Contractor shall remove from the job site any employee for reasons of misconduct or security. The Contractor employees must avoid improperly influenced in the execution of their duties under the contract. Particular attention should be paid to acceptance of gifts/ gratuities, and on non-disclosure of sensitive or classified information. The Contractor shall ensure employee conduct complies with 41 U.S. C 423 relative to release of acquisition related information or actions or discussions which may prejudice future competitions. The Contractor shall ensure no contractor employees conduct political related activities or events on U.S Government facilities.

1.6.14 Organizational Conflict of Interest: Contractor and subcontractor personnel performing work under this contract may receive, have access to, or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.), or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the CO immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the CO to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the CO, and in the event the CO unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the CO may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

1.6.15 Contractor Employees Who Require Specialized Training outlined in VA form 6500.6. All contractor employees that require specialized training; i.e. Privacy, HIPPA must be registered in TMS (Talent Management System) at commencement of services, and must successfully complete the required classes and provide the COR and CO a copy of the certificates of completion.

1.6.16 Incident Reporting

1.6.16.1 The Contractor shall have competent personnel trained and capable of dealing with minor personnel injuries. The Contractor or their employees shall immediately notify their supervisor of any accident requiring emergency medical treatment. The Contractor will, in turn, notify the CO or COR within 30 minutes of the incident.

1.6.16.2 Emergency medical treatment and services for Contractor personnel is the responsibility of the Contractor.

PART 2

SPECIFIC TASKS

2. SPECIFIC TASKS: Preventive Maintenance services and Instrumentation described herein consist of the following.

2.1 Basic Services:

2.1.1 Clinic Repair Services: Consists of instrumentation tasks that can be performed/completed on site

2.1.2 Laboratory Repair Services: Consists of repairs needed on instruments that must be done in the laboratory and which cannot be performed on site.

2.1.3 Repair Bin: Comprised of instruments (collected from patient care areas) that may require clinic repair services and/or laboratory repair services.

2.1.4 Preventive Maintenance: The contractor shall provide Preventative Maintenance (PM), which consists of aligning, calibrating, refurbishing, cleaning, stain removal, polishing, sharpening, oiling, straightening, adjusting, replacing parts, and maintaining the equipment. Instruments will be provided individually or as components of a specialty tray. Requested services are periodic in nature and are required to maintain the equipment in such a condition that it may be operated in accordance with its intended manufacturer’s design and functional capacity with minimal incidence of malfunction or inoperative conditions. Recommendations for replacement and/or removal of surgical instruments is also covered within the scope of PM. Preventative Maintenance also includes the following (By Specialty):

2.1.4.1 All instruments that can be disassembled, will be disassembled, and undergo a detailed contractor inspection.

2.1.4.2 Instruments will not be altered, changed, or tampered with, and will be repaired following manufacturers original design specifications and in compliance with ANSI-AAMI ST-79 part 7.7.

2.1.4.3 During preventative maintenance instruments will be sharpened, adjusted, aligned, straightened, refurbished, calibrated, cleaned, oiled, and parts replaced in accordance with the manufacturer’s original specifications and configuration, in compliance with ANSI-AAMI ST-79 part 7.7. Any stains, sharp edges and/or scratches will be removed. Instruments should have a mirror finished appearance, except for the locator barcode, on return.

2.1.4.4 The contractor shall make recommendations for surgical instrument replacement which may be pertinent to ensure all surgical trays remain fully stocked and functional.

2.1.4.5 All cannulated items will have interior lumen flushed and inspected.

2.1.4.6 Contractor will provide preventative maintenance, repairs, and testing of all surgical instruments owned by the VA. See attached listing, paragraph 2.3.

2.2 Specific Mandatory Tasks and Associated Deliverables:

2.2.1 The contractor will work with the Sterile Processing Services (SPS) to establish a preventative maintenance inspection schedule for the items identified by SPS.

2.2.2 Delicate sharp, pointed instruments will be returned covered with appropriate tip protectors.

2.2.3 Surgical instruments maintenance and repair will be handled with care. All instruments shall be repaired and maintained in proper operating conditions, as specified by the original manufacturer. The contractor will return instruments in as good as new condition.

2.2.4 The contractor will be required to test instruments for accurate alignment, sharpness, insulation, and calibration per manufacturer’s Instructions for Use (IFU). All returned, inspected, and repaired instruments will be stain-free and polished to a mirror finish while maintaining locator barcodes.

2.2.5 The contractor shall tag the equipment with the appropriate labels (not Etching) to identify instrument repair inspection date.

2.2.6 Instruments are to be retrieved from and delivered to Sterile Processing Services (SPS) located at: Kansas City VA Medical Center, SPS Preparation Area and OR Surgery Unit. Delivered to Kansas City VA Medical Center, SPS Decontamination area.

2.2.7 If the instrument needs to be sent off site for repairs, the contractor shall obtain the written or emailed approval of the COR, SPS Chief, or the OR Manager prior to doing so

2.2.8 Documentation shall be provided by the contractor for the specific work that is performed. Upon completion of services the contractor must provide a summary document/end of day report (PowerPoint or equivalent) which contains the following information: Date of repair, instrument type, tray description, department, status of instrument repair or resolution, type of repair, cost, and serial/tracking number if available. All instrumentation that are deemed unrepairable will be annotated in this log and packaged separately in a fashion to prevent intermingling of serviceable and non-serviceable equipment.

2.2.9 All single instruments and surgical trays picked up or delivered by the contractor will be properly listed for accountability verification in a records book maintained by the Chief, SPS Service

2.2.10 Documentation reports shall be submitted by the 10th of the month for the previous month and will include a description of all sets and instruments sharpened and repaired by serial number when applicable.

2.2.11 Kansas City VA Medical Center instruments will have their locator barcodes verified at each inspection and re-etched if necessary. If an instrument does not have a barcode, the vendor agrees to apply one. Vendor will be asked to etch barcodes on all new instrumentation using laser marking. Bar codes and etching will be in compliance with “SensiTrack” systems.

2.2.12 Contractor will provide maintenance and repair for surgical instrument containers and systems components to ensure that all lid gasket vent devices are fully functional in accordance with manufacturer specifications.

2.2.13 All Kansas City VA Medical Center instruments will be returned to SPS decontamination area regardless of serviceability for processing.

2.3 VA Owned Instruments: Instruments include but are not limited to the following:

2.3.1 General Scissors: Metz Scissors, Mayo Scissors, Cast/Bandage Scissors, Iris Scissors, Suture Scissors, Serrated Scissors, Delicate Scissors

2.3.2 Osteotomes: Total Joint Osteotomes, Podiatry Osteotomes and ENT Osteotomes

2.3.3 Curettes: Total Joint, Curettes, D & C Curettes, Adenoid Curettes

2.3.4 Elevators: Periosteal Elevators, Cobb Elevators, Key Elevators, Freer Elevators, DIE Elevators

2.3.5 Gouges: Total Hip Gouges

2.3.6 Small Knives: Amputation Knives, Cartilage Knives, Meniscus Knives, Knife Handles

2.3.7 Rongeurs: AB Rongeurs, Pituitary Rongeurs, Kerrison Rongeurs, Kerrison Punches, Dermal Punches

2.3.8 Cutters: Bone Cutters, Wire Cutters, Pin Cutters, Rib Cutting Forceps

2.3.9 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

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

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

2.3.12 Arthroscopic Instruments: Punches, Shavers, Scissors, Intra-Articular Hooks, Intra-Articular Knives, Intra-Articular Graspers, Forceps

2.3.13 Align/Sharpen Laparoscopic Instruments: Laparoscopic Punches, Laparoscopic Shavers, Laparoscopic Scissors, Laparoscopic Hooks, Laparoscopic Knives, Laparoscopic Graspers Laparoscopic Forceps

2.3.14 Micro Instruments: Verres Needles, Biopsy Needles, Corneal Scissors, Urethra tomes, Micro Rongeurs, Micro Forceps Micro Scissors

2.3.15 Re-insulation: Shaft Re-insulation, Total Re-insulation - Sharpen, Realign, Refurbish & Re-insulate Scissors & Graspers

2.3.16 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)

2.3.17 Sterilization Container Repair: Medin, Aesculap, Bookwalter, Genesis

2.3.18 Miscellaneous Repairs: Gasket Replacement Baffle, Inner, 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), 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

2.3.19 Diamond Dusting: Tissue Forceps, Needle Holders Micro, Needle Holders Standard, Needle holder Jaw Application

2.3.20 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, handle, hinges, jaws, jaw pins, screws shaft, sharpen & hone, straighten & remove dents from sheath.

2.3.21 Endoscopic and 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.

2.3.22 Diamond Knives: 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, Simplicity Blade

2.3.23 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 Refurbish, Misc. Power Equipment, Electric Power Equipment

2.3.24 Phaco Handpieces: Alcon 10,000, Alcon Legacy, Chiron (Interoptics), Staar, Mentor, Storz Storz Millenium, AMO (Allergan, OMS Minor Repair)

2.3.25 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.

2.3.26 Rigid, Semi-Rigid, and Flexible Scopes:

2.3.26.1 Rigid: Thorough diagnostic testing, exterior cleaning of scope, diamond polishing of lens tip, fiber optic light connection re-bonding & 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.

2.3.26.2 Semi-Rigid: Fiber Ureteroscope Repair and 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.

2.3.26.3 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

2.3.27 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

PART 3

ATTACHMENT/TECHNICAL EXHIBIT LISTING

3. ATTACHEMENT/TECHNICAL EXHIBIT LIST:

3.1 Attachment 1/Technical Exhibit 1 – Performance Requirements Summary

TECHNICAL EXHIBIT 1

Performance Requirements Summary The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of

Required Services (Tasks)

Frequency

# 1.

PWS Paragraph 2.2.3, The contractor will provide all delicate, sharp, or pointed instruments with tip protectors before their return to decontamination 100% Compliance

# 2 PWS Paragraph 2.2.6, The contractor shall tag the equipment with the appropriate labels (laser marking) to identify instrument repair inspection date.

# 3 PWS Paragraph 2.2.8, If the instrument needs to be sent off site for repairs, the contractor shall obtain the written or emailed approval of the COR, SPS Chief, or the OR Manager prior to doing so

#4 PWS Paragraph 2.2.10, All single instruments and surgical trays picked up or delivered by the contractor will be properly listed for accountability

Questions and Answers

1.3 Objectives: Required services are to be complete four (4) times per month (weekly) and will be conducted on 10 trays per visit (i.e. 40 trays per month). The expected performance period is a base year of twelve (12) months with four (4) option years. Each option year is twelve (12) months.

Please see changes in Section 1.5 of the Performance Work Statement

1.5 Period of Performance: Required services are to be complete two (2) times per month (bimonthly) and will be conducted on 10 trays per visit (i.e. 20 trays per month). The expected performance period is a base year of twelve (12) months with four (4) option years. Each option year is twelve (12) months.

1.5 Period of Performance: Required services are to be complete two (4) times per month (weekly) and will be conducted on 10 trays per visit (i.e. 40 trays per month). The expected performance period is a base year of twelve (12) months with four (4) option years. Each option year is twelve (12) months.

1. Page 5., 1.2 mentions that, in addition to preventative maintenance, a one-time joint, wall-to-wall inventory of instruments is required. Considering the extensive time and resources this process entails, could you please confirm if this inventory is essential prior to beginning services? We want to ensure we meet your needs efficiently and effectively.

Please see changes in the Performance Work Statement

2. Additionally, if a one-time "wall-to-wall" inventory and barcoding of all instruments are indeed required, these two services need to be performed simultaneously, would that be acceptable?

This requirement is no longer needed and has been removed from the PWS.

3. When you refer to etching barcodes, which process is used, laser marking or chemical etching?

Laser marking

4. Page 5., 1.4.1 mentions autoclave cleaning. Could you please provide the following:

a. The number of autoclaves requiring cleaning?

b. The sizes of autoclaves (small, medium, large)?

c. The manufacturer of the autoclaves?

d. How many times per year the cleaning is required for each autoclave?

This requirement is no longer required and has been removed from PWS.

5. Page 5. 1.3 Objectives: states required services are required (4) times per month (weekly), then same page at 1.5 Period of Performance: it states services required (2) times per month (bimonthly). Could you please clarify how many days per month are needed?

Please see changes in the Performance Work Statement

6. Pages 12 and 13 refer to the repair of power/pneumatic devices, phaco power pieces, rigid and flexible scopes, and video equipment. Could you please confirm if surgical device repair is included in this service request? If so, could you provide an inventory of this equipment, including make, model, and serial number, to enable accurate pricing?

An equipment list has been attached to this amendment.

See attached document: Instrument Product Catalog.

SURGICAL INSTRUMENT MAINTENANCE