P09 - PWS Instrument Sharpening Repair.pdf

Attachment 1

Performance Work Statement

Surgical Instruments Sharpening, Repair, Testing, and Inspection

A. Contracting Officer’s Representative (COR).

Name: Malonda Frison

Section: Sterile Processing Service

Address: 2495 Shreveport Hwy 71, Pineville, LA 71360

Phone Number: 318-466-2188

Fax Number: 318-483-5120

E-Mail Address: Malonda.Frison@va.gov

B. Background.

1. The Alexandria VA Health Care System, Pineville, LA is currently seeking a vendor to provide services for sharpening, repair, test, inspect, and assessment of surgical instruments used in the operating rooms and in clinical procedures. Surgical instruments need to be sharpened and maintained for optimal performance.

C. Scope

1. Contractor shall provide all necessary on-site labor, materials, supervision, test equipment, replacement parts, travel, and transportation to provide services that include, but are not limited to, sharpening, adjusting, aligning, straightening, refurbishing, calibrating, cleaning, extensive stain removal, polishing, lubricating, adjusting, chemical etching, and replacing parts of various individual surgical instruments sets and operating room (OR) procedural instrument trays for government owned items listed in Appendix A- Equipment List.

2. Instruments shall be provided individually or as components of a specialty tray. All instruments shall be maintained in proper operating conditions as specified by the original manufacturer and in compliance with American National Standards Institute (ANSl)-Association for the Advancement of Medical Instrumentation (AAMI) - (ANSI- AAMI ST-79 part 7.7).

3. Instruments are to be retrieved from and delivered to the Sterile Processing Service

(SPS), located at the Alexandria VA Medical Center, Sterile Processing-Department, 2495 Shreveport Hwy 71, Pineville, Louisiana 71360.

4. All repairs shall follow all approved recommendations regarding third party surgical instrument repair as set forth by the following:

a) Food and Drug Administration (FDA)

b) Centers for Medicare/Medicaid Services (CMS)

c) Centers for Disease Control (CDC)

d) Association for the Advancement of Medical Instrumentation (AAMI),

e) International Association of Healthcare Central Service Materials

Management(IAHCSMM)

f) Association of per-Operative Registered Nurses (AORN)

g) Association of Professionals in Infection Control (APIC)

h) Department of Veterans Affairs, Veterans Health Administration (VHA)

Directives

D. Specific Tasks

1. Instruments are to be retrieved from and delivered to the Sterile Processing Service

(SPS) located Sterile Processing- Department located at 2495 Shreveport Hwy 71, Pineville, Louisiana 71360.

2. The Contractor's employee(s) shall report to the Sterile Processing· Service

(SPS) upon arrival at the Alexandria VAMC for the pickup and return of instruments.

3. If instruments cannot be repaired, they must be marked or tagged with set name, number, and returned to SPS.

4. The repair contractor shall provide multiple levels of repair service including, but not limited to, same-day turn-around, 24-hour turn-around, weekend service, mail-in repair service, and onsite repair service.

5. All urgent instrument repairs shall have a 48-hour turnaround time.

6. All emergency instrument repairs shall have a 24-hour turnaround time. Urgent and

Emergency status shall be determined by the using service and/or SPS.

7. Instrument sets and trays must be returned throughout the day when work is completed, not all at the end of a workday.

8. If instruments need to be sent out for third party repairs by the contractor, authorization must be obtained from the Contracting Officer Representative (COR) and/or SPS Chief.

9. Surgical instrument maintenance and repair shall be handled with care. The contractor shall be required to test instruments for accurate alignment, sharpness, insulation, and calibration. The contractor shall return instruments in new like condition. All instruments shall be repaired and maintained in proper operating conditions as specified by the original manufacturer.

a) New, original manufactured instruments and parts shall be used.

b) The contractor shall not use Gray Market items for any work associated with this service. Instrument repairs shall be completed onsite at the Alexandria VA Medical Center in a mobile repair lab/vehicle that is self-sustained with electrical power, air compressor, tools, etc., or within the hospital in a designated space.

c) The manufacturer's part number and catalog number shall be preserved on all repaired or refurbished instruments. All single instrument and surgical trays picked up/delivered by the contractor shall be properly listed for accountability verification.

d) Specific custom-made instruments shall be repaired in coordination with operating room surgeons (end user) specifications.

e) Instruments shall not be altered, changed, or tampered with and shall be repaired following manufacturers' original design specifications.

f) All instruments that can be disassembled shall be disassembled for maintenance and repair. They shall also be sharpened and aligned in accordance with the manufacturer's original specifications. Any bio burden found once disassembled, should be photographed, and submitted as part of the service documentation for that visit.

g) Instruments shall undergo appropriate extensive cleaning, and processes to result in a stain-free finish that complies with the manufacture's specifications.

All instruments must be in working order after any chemicals that may be used on them. The contractor shall be responsible for returning within 24 hours to fix any instruments found to be in non-working order after the use of chemicals.

h) Any etches should not interfere with instrument tracking barcodes. The manufacturer's part numbers, and catalog numbers shall be preserved on all repaired or refurbished instruments, as well. If that is not possible, the information should be chemically etched on to a different part of the instrument (i.e.- shaft or main component of the instrument).

i) Instruments that cannot be repaired or refurbished due to cracking, pitting, corrosion, or exceeding life expectancy shall be tagged or marked for removal and/or replacement. Information should include the reason for removal, and which instrument set the instrument was removed from. A list of all items removed from service should be provided after each visit.

j) The contractor shall not repair any surgical instruments that are on the "DO

NOT USE" list. These instruments should be pulled from service. The list shall be provided to the contractor at the initial visit, and new copies shall be provided as the list is updated.

k) No labels and/or stickers should be placed on instruments and/or sterilization containers. Only chemical etching is allowed. Any tape found on instruments needing service should be removed.

l) Shipping containers and materials shall be provided for offsite repairs and are to be included in the overall price of the visit.

m) Pre-paid shipping labels and transportation insurance shall be provided for offsite repairs. Contractor shall be responsible for return shipping costs as well.

n) Case cart and push-cart repair services should be available, including, but not limited to, wheel replacement, hinge replacement, bumper replacement, and rust removal.

o) The contractor shall remove from the facility all excess materials, trash, debris, and barriers generated as a result of their services.

E. Reporting/Documentation

1. All documentation should be completed within the VA SPS Facility’s Instrument tracking system. The contractor is responsible for identifying which instruments need to be pulled for sharpening and completing records within the instrument tracking system to monitor maintenance of each set.

2. Instruments are to be handled with care to avoid further damage. While instruments are in the contractor's possession, the contractor take full responsibility and accountability for all instruments removed from the VA facility. Contractor shall provide an inventory of instruments and instrument sets removed from and returned to the facility that are to be serviced or repaired.

3. The contractor shall provide a summary document upon delivery of processed instruments containing information showing date of repair, instrument tray, instrument type, type of repair, and cost.

4. The contractor shall provide a written or emailed summary of all items removed from service and the instrument tray name and number from which it was removed within one (1) business day.

5. The contractor shall contact the Alexandria VAMC SPS Office to review all instruments that require offsite repair and the instrument tray name and number from which it was removed.

Alexandria VAMC SPS Department must provide written approval prior to removal of any and all instruments that require offsite repair.

6. Items that have been repaired for the last time before replacement is needed shall be reported after every visit. Additionally, any instrument nearing the end of useful life shall be noted for replacement prior to being removed so that the service can replace the instrument prior to removal. Included in this replacement & end of useful life report shall include the instrument name, catalog number, instrument set it is being removed from and a brief description as to why it is near its end of useful life.

7. The contractor shall provide education regarding instrument repairs, instrument care and handling, instrument testing, instrument processing, laparoscopic continuity testing, and endoscopy instrument repairs. An electronic presentation that details issues, problems, bioburden, etc., should be provided after every visit.

8. Repaired instruments returned to SPS will be on a detailed list document provided by the contractor containing the following information: date of repair, instrument type, type of repair, and cost.

F. Requirements

1. Repairs shall be completed either on location at the Alexandria VAMC located at 2495 Shreveport Hwy 71, Pineville, Louisiana 71360 in a mobile repair vehicle, or offsite at the contractor's repair facility.

2. IS09001 and IS013485 (medical device) certifications must be obtained by the repair contractor.

3. Employees of the contractor responsible for repairing surgical instruments must be ASQ (American Society for Quality) certification and receive CQI (Certified Quality Inspector) training.

4. The contractor shall provide enough technicians for onsite service to be completed in one business day.

5. Individual instrument repairs conducted on-site shall be performed Monday through Friday between the hours of 8:00am-4:00pm, central station time (CST) excluding weekends and federal holidays (New Year's Day, Martin Luther King Jr's Birthday, Washington's Birthday, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veteran's Day, Thanksgiving Day, Christmas Day).

6. In the event of inclement weather, natural disaster, or other unforeseen circumstances preventing a scheduled on-site repair visit, the contractor shall notify the SPS Chief or COR. Dates available for re-scheduling the scheduled on-site service shall be provided to the SPS Chief and COR within 3 business days of the originally scheduled on-site visit.

7. Instrument repairs completed onsite at in a mobile repair lab/vehicle must be repaired in a vehicle that is clearly labeled with the contractor's name and permit numbers. The mobile repair vehicle should be self-sustained with electrical power, air compressor, tools, etc. Safety cones must be utilized around the perimeter of the mobile repair vehicle to ensure the safety of hospital and contractor staff. The vehicle must be parked in a pre-determined area, to be determined by the Warehouse.

8. Services are to be completed once monthly with five additional optional visits as may be necessary at the discretion of the Sterile Processing Department Chief.

9. Visits should be 2 days with a 3rd if necessary, per month. Any repairs outside the scope of this contract require a Purchase Order prior to performing any additional work.

10. Continued instrument repairs quality improvement monitoring and turnaround time as well as contract compliance shall be progressively jointly monitored by Sterile Processing Service (SPS) Chief/or Supervisor.

11. Sterile Processing Chief shall designate appropriate VA personnel to monitor contractor employee work hours/services through one or a combination of the following mechanisms: Overall Performance, Appearance of instruments, Function of Instruments, Provide technically skilled personal.

12. The COR jointly with the Chief, Sterile Processing Service (SPS) shall monitor

Contractor instrument pick-up and drop-off. This shall be accomplished by the contractor's employee(s) reporting to SPS upon arrival at the facility, and again before departure.

13. On-line access to account should be made available to SPS.

a) The contracting Officer's Representative (COR) jointly with the Chief, Sterile

Processing Service shall be responsible for verifying contract compliance. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer by the COR.

14. Documentation of services performed shall be reviewed by the COR jointly with Chief of Sterile Process Service prior to certifying payment. Both shall perform periodic documents checks with the using service to ensure records monitoring. VA shall pay only for services actually performed at VA and at the contractor's location, and in strict accordance with the schedule of prices/costs shown in the schedule of items.

Contract monitoring and recordkeeping procedures shall be sufficient to ensure proper payment and allow audit verification that services were provided.

G. Period of Performance:

1. Base plus four (4) year option year.

H. Security and General Requirements

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

2. Upon arrival report to Building 7 and check in with Sterile Processing (SPS). A member with SPS will accompany contractor to the police station for badging.

3. A contractor ID badge shall be issued by the VA Police which needs to be presented by contractor's employee at the VA entrance security check points. The issued badge is for official pickup and deliveries of surgical instruments and trays.

4. Contractor mobile unit(s) shall be registered with the Alexandria VAMC Police

Department and Security Department.

5. ISO Requirements: Equipment does not require Network Access or Sensitive Material.

I. Appendix A- Equipment List.

Sharpening

Instruments and Repair.pdf