STX SPS Instrument Sharpening SOW.pdf

Statement of Work

Sharpening and Repair Contract

1 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), including the integration of laser marking capabilities. 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.

1.1 VISN 17 INSTRUMENT SHARPENING AND REPAIR DEPLOYMENT

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

Facility (VAMC/HCS) Address

South Texas HCS (San Antonio) 7400 Merton Minter Blvd, San Antonio, TX 78229

South Texas HCS (Kerrville) 3600 Memorial Blvd, Kerrville, TX 78028

South Texas HCS (San Antonio) 8410 Datapoint Rm 110, San Antonio, TX 78229

Northwest HCC (San Antonio) 9939 Texas 151 Access Rd., San Antonio, TX 78251

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.

2 OBJECTIVES

The objective of this project is to establish a contract with a qualified vendor capable of providing comprehensive instrument maintenance services, including on-site laser sharpening, refurbishment of Reusable Medical Devices (RMD), and off-site repairs for instruments requiring extensive servicing. Through regularly scheduled visits, the vendor will inspect, sharpen, repair, and lubricate surgical instruments, ensuring they remain in optimal condition.

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).

The contractor shall perform all services on-site at the designated VA Medical Center (VAMC).

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-site, the contractor must obtain prior approval from the Contracting Officer or their designee before proceeding with off-site repairs. Such approval may also require secondary authorization from a clinical manager or supervisor.

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 to have the instrument returned without repair.

3 SCOPE OF WORK

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

• Inspection and repair of rigid sterilization containers and instrument cassettes

• Inspection, sharpening, and repair of various stainless-steel surgical instruments, including power equipment repair, light cables, fiberoptic retractors, phacoemulsification handpieces, and laparoscopic instruments

• Replacement of damaged instrument components with new, medical grade parts

• 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. The workload for respective facilities:

Facility Estimated Workloads Estimated Jobs

Audie L. Murphy VA 25 to 30 trays 36

NWHCC 600 to 800 instruments 12

Datapoint Dental 410 to 430 instruments 12

Kerrville 410 to 430 instruments 12

Upon completion of services, each VAMC facility shall receive documentation on a daily, weekly, or monthly basis, as determined by the facility 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. This report shall include the following:

• Before and after photographs of instruments for select repairs

• Total number of trays serviced, categorized by specialty

• Total number of instruments inspected

• Total number of instruments repaired

4 THE SOFTWARE LICENSES

This contract does not involve the connection of any contractor owned IT equipment (e.g., laptops, remote systems) to the Department of Veterans Affairs’ internal trusted network. As a result, Certification and Accreditation (C&A) requirements are not applicable, and a Security

Accreditation Package is not required.

5 QUALIFICATIONS

a. To be determined responsible, a prospective contractor must:

ISO 9001: 2015 Certified

IAHCSMM Certified

6 GENERAL REQUIREMENTS

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

6.1 PERIOD OF PERFORMANCE

Will be one-year base with four 1-year option renewals

6.2 CONTRACT ADMINISTRATION

6.3 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.

7 SECURITY REQUIREMENTS

Information Systems Officer, Information Protection:

7.1 The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services.

If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

Privacy Officer:

7.2 The contractor will not have access to protected Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the

VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

Records Officer:

7.3 There will be no federal records created, maintained, used or dispositioned with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.]

7.4 Physical Security

a) An identification (ID) badge will be issued by VA Police and must be presented by all contractor personnel at VA entrance security checkpoints. This badge is designated specifically for the official pickup and delivery of surgical instruments and trays.

b) The ID badge must be always worn above the waist, on the front of the body, with the photo and information clearly visible.

c) It is the responsibility of the Contracting Officer’s Representative (COR) or their designee to verify that the contractor possesses a valid temporary identification badge. If the contractor does not have one, they must be escorted to the VA Police to obtain a temporary badge. Once issued, the contractor shall be escorted by the COR or designee to the Sterile Processing Service (SPS) area.

d) The contractor’s mobile unit or service van must be clearly marked with the company’s logo, registered with the VA Police, and parked only in designated areas.

e) Upon arrival at the Sterile Processing Service, the contractor is required to notify the

COR and/or the shift supervisor.