Performance Work Statement (PWS)(R).docx

Performance Work Statement (PWS) Instrument Sharpening, Repair and Maintenance

B.4 SCOPE

Contractor shall provide on-site services as well as same day pick up and drop off for refurbishing of reusable medical equipment and if necessary, off-site repairs for instruments that require extensive repairs. These instruments shall be inspected, repaired, sharpened, lubricated, and if necessary marked unrepairable during scheduled weekly, bi-weekly, monthly or quarterly visits. All work performed on surgical equipment shall be performed in accordance with Original Equipment Manufacturers (OEM) specifications

The Period of Performance is May 1, 2022 to April 30, 2023 with a provision of four (4) option years.

B.4.1 PLACE OF PERFORMANCE

The contractor shall perform pick up services and same day repair and drop off at each facility:

Albany Stratton VA Medical Center 113 Holland Avenue, Albany, NY 12208

Buffalo VA Medical Center 3495 Bailey Avenue, NY 14215

Finger Lakes VAMC 260 Calkins Road, Rochester, NY 14623

Syracuse VA Medical Center 800 Irving Avenue, Syracuse, NY 13210

The Finger Lakes VAMC includes:

Bath VA Medical Center, 76 Veterans Avenue, Bath, NY 14810 Canandaigua VA Medical Center, 400 Fort Hill, Canandaigua, NY 14424 Rochester Outpatient Clinic, 260 Calkins Road, Rochester, NY 14623

· Note pick up and drop off will be at 260 Calkins Road for all locations of Finger Lakes.

B.4.2 HOURS OF OPERATION

Buffalo VAMC, Finger Lakes VAMC and Syracuse VAMC: All work shall be performed during regular business hours, which are Monday to Friday 8:00 am to 4:30 pm eastern standard time (EST).

*Albany VA Medical Center:

Instrument maintenance/repair work shall be performed during regular business hours, which are Monday to Thursday 8:00 am to 4:30 pm eastern standard time (EST).

The following are Federal Holidays observed by the facility and the Contractor shall not expect access to the VA Facility or VA employees on these dates. Preventive Maintenance or other services are not to be scheduled on these dates:

New Year's Day Martin Luther King, Jr. Day Washington's Birthday Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

*Any day the President declares a Federal Holiday

B.4.3 ON-SITE SERVICES

Upon arrival to the Sterile Processing Service (SPS) or designated area, the contractor will pick up trays of instruments to inspect and repair as needed.

A. The contractor shall perform onsite same day full service which will include the following:

(1) Vendor will provide onsite repair services including instrument stain removal, alignment, adjustments, pins, sharpening, inserts, laparoscopic shaft insulation, springs and manufactured parts and/or screw replacements for all clinical hand instruments in primary care and specialty etc. All handheld stainless-steel instruments will be returned to SPS after first going thru a sonic bath.

(2) Inspection and repair of rigid containers and cassettes

(3) Inspection, sharpening, and repair of various stainless-steel instruments, complete instrument trays and peel pack single instruments, power equipment repair, pneumatic equipment repair, power equipment battery service, light cables, fiberoptic retractors, phaco handpieces, dental handpieces and laparoscopic instruments

(4) Replace damaged instrument parts with new, OEM medical grade parts

(5) Replace unserviceable Reusable Medical Device (RMD), if there is an additional cost a modification will be issued, if it is within the scope of the contract.

(6) Electrosurgical instrument re-insulation

(7) Loaner equipment available while instruments are being repaired off-site

(8) Removal of instrument indicator tape

(9) Case carts shall be on a preventive maintenance program each site shall have ten (10) carts checked per month. Inspection shall include ensure wheels are cleaned and move freely, doors are aligned, knobs allow for proper opening and closing of doors, shelves are properly aligned, bumper guards are in place, and tray and count sheet holders are properly attached. In the event any items listed need repair a quote will be sent to the COR requesting repairs. COR will contact SPS chief for approval and separate P.O. will be created for stated repairs.

(10) The contractor shall coordinate specific dates for maintenance and repairs with the Point of Contact (POC) at each location. Notification and confirmation for maintenance and repairs must be coordinated one week prior to the date requested.

(1) Albany VA Medical Center: MONTHLY SERVICE (1X PER MONTH)

Refurbish approximately 10 trays and items in repair bin monthly. Repair bin may include loose instruments, cords, handpieces and laparoscopic instruments. Repairs are to be done each month.

(2) Buffalo VA Medical Center: MONTHLY SERVICE (1X PER MONTH) Refurbish approximately 10 trays and items in repair bin monthly. Repair bin may include clinic trays, loose instruments, cords, handpieces and laparoscopic instruments. Vendor will approximately service 40 trays and 4 repair bins. Vendor must provide service on Tuesdays.

(3) Finger Lakes VA Medical Centers: MONTHLY SERVICE (1X PER MONTH)

Vendor will service approximately 100 Instrument trays containing one (1) to twenty (20) instruments and 200 peel pack single instruments with a quarterly target of 100 instrument trays and 50 peel-pack instruments. Note: Finger Lakes will have more single instruments than trays. Also note we will have more dental hand pieces then other sites listed.

(4) Syracuse VA Medical Center: WEEKLY SERVICE

Vendor will service approximately 700 instrument trays and 400 peel pack instruments annually with a quarterly target of 175 instrument trays and 100 peel-pack instruments.

B. Vendor will provide immediately after service (same day), each time, an Observation and Activity Report (OAR). This will include an Activity Summary, a Beyond Repairable Summary, an Instrument Exchange List, an Offsite Repair List, an Appendix, and Before and After Pictures in Color of Extensive Repairs Done to Specific Instruments. All trays and single items will be listed by contractor for accountability. The contractor will tag or label completed trays to identify the instrument inspection date. These instruments must be labeled, marked, or separated to prevent reuse. A comprehensive maintenance report which includes a description of the instruments refurbished, price, and specific defect must be provided within 3 business days.

1. In the event that an instrument is found to be defective beyond the capabilities of the mobile service, or in the event an instrument requires repair or sharpening and cannot wait until the scheduled service period, it may become necessary for the government to ship items to the contractor for service or repair.

1. SPS staff will inspect 100% of instruments serviced using standard tools designed for the testing of surgical instrumentation. Any instruments, after testing, that are found to be of poor repair, will be documented in writing and returned to the contractor for proper repair. The contractor will not bill for items that have not been repaired to acceptable standards

C. Other than exception noted in below, Instruments will be retrieved by the contractor and returned by the contractor on the same day unless the instrument needs repairs that cannot be accomplished on site at that time. These instruments must receive approval from SPS staff before any other work is performed not outlined in the Performance Work Statement.

(1.) Dental Handpieces will be retrieved by the contractor and returned to the VA Medical facility within four (4) days. If an instrument has extensive damage, the Contracting Officer Representative (COR) must be provided within 3 business days a description of the defect, repair options, cost, and estimated time of repair. The COR will determine whether to pursue repair option, under a separate purchase or return instrument without repair. All instruments will be returned to the appropriate VA Medical Center warehouse or predetermined return location. Under no circumstance will the contractor retain VA property.

B.4.4 CONTRACTOR QUALIFICATIONS / CAPABILITES

(1) The contractor shall have the capabilities to maintain and repair delicate and micro instrumentation. These instruments may include but not be limited to such items as Ophthalmology, Ear Nose & Throat, Dental Handpieces and Vascular reusable medical equipment.

(2) The contractor shall be both ISO 9001:2015 and / or ISO 13485 certified.

(3) Repair Techs should be Certified Repair Technicians of Surgical Instruments. Certifications from a nationally recognized body and shall be provided to each medical center at the time of award.

B.4.5 GOVERNMENT-FURNISHED PROPERTY

No Government-furnished property will be provided to the contractor. This includes all Government-furnished property, such as Government-furnished material, equipment, or information. All equipment and supplies used under the terms of this contract will be the provided by and the responsibility of the contractor.

B.4.6 SECURITY

1. Contractor shall be required to complete a security clearance with the VA Police.

1. An ID badge will be issued by the VA Police which must be presented by all contractors at the respective VA entrance security check points. The issued badge is designated for official pick-up and deliveries of surgical instruments and trays. ID badge must always be worn above the waist, in front, with the face of the card visible. It is the responsibility of the contracting officer or designee to verify that the vendor has a temporary identification badge. If not, they are to be escorted to the VA Police and Security office. Once issued a temporary identification badge, the contractor will be escorted by the designee to SPS.

1. Contractor’s mobile unit/van shall be properly label with the company logo and registered with the VA Police Department and parked in designated areas for service.

1. Upon arrival to the Sterile Processing Service, The contractor will pick up trays of instruments to inspect and repair as needed.

B.4.7 ADDITIONAL INFORMATION

(1) Smoking and vaping are not permitted within or around the VA facility grounds.

(2) Transportation charges for Contractor’s service personnel will not be billed or paid under the resulting contract.

(3) The POC will be assigned for each site to oversee pick up and delivery of instruments. The COR will oversee any issues, or questions pertaining to the contract as a whole.

VHA Supplemental Contract Requirements for Combatting COVID-19

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1) If fully vaccinated, contractors shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2) If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

1. For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.