D.1 REVISED Statement of Work.docx

Statement of Work Sharpening and Repair Contract

BACKGROUND

According to VHA Directive 1116(2), Sterile Processing Service (SPS) is required to implement a systematic plan for assessing and retiring malfunctioning surgical instruments using a certified vendor or intra-facility service. At present, the facility does not have an internal service with the necessary expertise and training to perform comprehensive inspection, sharpening, and refurbishment of surgical instruments.

SPS currently maintains a contract with an external refurbishing vendor. However, the long-term objective is to establish a service that fully aligns with the requirements of VHA Directive 1116(2). The overarching vision is to obtain expert recommendations for surgical instrument replacement, access to detailed maintenance data, and implement quality assurance monitoring. These capabilities will provide SPS with critical insights to support the development of an informed annual budget for the procurement of new and replacement instrumentation.

VISN 17 INSTRUMENT SHARPENING AND REPAIR DEPLOYMENT

The Instrument Sharpening and Repair contract will service the following sites:

NOTE: The workload and number of jobs are estimated and may increase/decrease with actual need. Invoicing shall be based on the actual number of jobs completed.

1. OBJECTIVES

The objective of this project is to establish an instrument sharpening and repair service contract, at the South Texas Veterans Healthcare Sterile Processing Service (SPS) and other satellite locations. Contractor must be a qualified vendor capable of providing comprehensive instrument maintenance services, including off-site instrument sharpening, refurbishment of Reusable Medical Devices (RMD), and off-site repairs for instruments requiring extensive service. The vendor shall perform regularly scheduled visits to inspect, sharpen, repair, and lubricate surgical instruments, ensuring all instruments remain in optimal working condition.

One (1) visit per month (12 total annually) will be conducted at each of the four (4) SPS locations: Audie L. Murphy (ALM), NWHCC 151, Datapoint Dental and Kerrville. ALM will require four (4) visits per month, resulting in a total of forty-eight (48) service visits at that location per annual term. This proactive maintenance approach will support STVHCS providers in delivering high quality care and achieving positive patient outcomes during ambulatory and surgical procedures. Furthermore, Sterile Processing Services (SPS) at Audie. L. Murphy

(ALM), NWHCC, Datapoint, and Kerrville will utilize the Censis tracking system to monitor instrumentation, maintaining full compliance with VHA Directive 1116(2).

Instruments will be collected and returned by the contractor on the same day of service. In cases where an instrument is found to have extensive damage and cannot be repaired on the same day, the contractor must obtain prior approval from the Contracting Officer Representative before proceeding with off-site repairs exceeding the same day visit. Such approval may also require secondary authorization from a clinical manager or supervisor. If off-site repairs will incur additional costs above and beyond this contract, approval must be sought from the Contracting Officer prior to proceeding with off-site repairs.

If off-site repair is approved, the contractor shall, within three (3) business days, provide a detailed report outlining the nature of the defect, available repair options, associated costs, and the estimated completion timeline. The Contracting officer or designee will then determine whether to authorize the off-site repair or have the instrument returned without repair.

2. SCOPE OF WORK

The contractor shall perform onsite services that include, but are not limited to, the following:

· Inspection of surgical instruments for damage or wear and repair of rigid sterilization containers and instrument cassettes.

· Inspection, polishing, sharpening, and repair of various stainless-steel surgical instruments, including fiberoptic retractors, and laparoscopic instruments.

· Replacement of damaged instrument components with new, medical grade parts and reporting any instruments deemed beyond repair.

· Testing and quality control to ensure instruments meet performance standards such as re-insulation of electrosurgical instruments.

· Removal of instrument identification or indicator tape as necessary.

The contractor shall coordinate the arrival time for maintenance and repairs with the Contracting Officer Representative (COR) or designee on a regular basis. All site visits will be conducted Monday through Friday, between the hours of 0730 to 1730. The workload for respective facilities:

Contacts:

SPS Contracting Officer Representative:

Anthony Donovan, (210) 996-6821, Anthony.Donovan@va.gov

Audie L. Murphy Adam Wheeler, (726) 213-0665, Adam.Wheeler2@va.gov Pedro Casias, (210) 956-0838, Pedro.Casias@va.gov

NWHCC 151

Andrew Guerra, (210) 364-3918, Andrew.Guerra@va.gov

Datapoint Dental Jose Nino, (726) 582-3615, Jose.Nino@va.gov

Kerrville Armando Ramirez, (210) 993-5627, Armando.Ramirez@va.gov

Upon completion of services, each VAMC facility shall receive documentation on a daily, weekly, or monthly basis, as determined by the contractor identifying instruments deemed non-repairable. This documentation shall include the instrument’s model number, manufacturer, description, reason for being classified as beyond useful life, and the associated set identification to facilitate quick identification of incomplete sets.

The contractor shall maintain a system for reporting these occurrences to the customer and for tracking and trending the total number of instruments classified as beyond repair. Each non-repairable device must be clearly tagged as such, with the reason for its classification documented. Additionally, a digital image of the device must be provided for facility review.

The contractor shall maintain a detailed repair history for each instrument or tray serviced, documenting all instruments repaired within each VAMC set. Comprehensive reporting capabilities must be available and exportable 24/7, and shall include, but not be limited to, repair history categorized by facility, department, equipment type, and serial number.

Upon request, the contractor shall provide real-time, up-to-date records of all work orders and repairs to the respective facilities.

Additionally, each VAMC facility shall receive a service report summarizing the work performed. The service report should be emailed to the COR within 3-5 business days. This report shall include the following:

· Before and after photographs of instruments for select repairs.

· Total number of trays serviced, categorized by specialty.

· Inventory of sharpened and inspected surgical instruments.

· Quality assurance report with each batch of instruments serviced.

3. QUALIFICATIONS

The Contractor shall ensure that all personnel performing sharpening, repair, maintenance, or lubrication of surgical instruments used in direct patient care possess current, nationally recognized sterile processing and instrument maintenance credentials.

· Must have previous experience in sharpening surgical instruments.

· Must be familiar with handling various types of surgical instruments including, but not limited to, scalpels, scissors, forceps, and rongeurs.

· Must comply with all relevant health and safety regulations.

· Must be able to provide references or proof of similar services provided in the past.

All credentials shall remain active and in good standing for the duration of the contract. The Contractor shall provide proof of certification for each technician prior to performing any work or upon request by the Government.

4. GENERAL REQUIREMENTS

The Contractor will coordinate with the Contracting Officer’s Representative (COR) for the contract regarding the dates of each facilities’ visits, and other work with the COR to ensure compliance with the terms and conditions of the contract.

4.1 PERIOD OF PERFORMANCE

Base plus 4 option year periods. 04/17/2026 to 04/16/2027 04/17/2027 to 04/16/2028 04/17/2028 to 04/16/2029 04/17/2029 to 04/16/2030 04/17/2030 to 04/16/2031

4.2 RECORD KEEPING/MONITORING PROCEDURES

The COR will be responsible for ensuring that services are provided in accordance with the terms and conditions of the contract. COR will be responsible for maintaining accurate records and monitoring procedures for instrument sharpening and repair to ensure the effectiveness, safety, and longevity of medical instruments.