36C24818Q9899-003.docx

STATEMENT OF WORK

FOR RESUABLE MEDICAL EQUIPMENT/INSTRUMENT SHARPENING/REPAIR/REPLACMENT PARTS

The NF/SG VA Healthcare System is currently seeking a company that can provide the following services to repair, refurbish, and assess for replacement surgical instruments and devices for use in operating room procedures. Surgical devices can include but are not limited to power equipment, scopes, cameras, minimally invasive instruments, sterilizer chamber cleaning, case carts and other general specialty instruments.

ON-SITE INSTRUMENT MAINTENANCE/SHARPENING:

1. Scope NF/SG (Includes VAMC’s Gainesville and Lake City, and VA Outpatient Clinics at Villages, Jacksonville and Tallahassee) are requesting the following:

1. Work shall be accomplished on weekdays between the hours of 0700-1530 to facilitate patient care.

2. At least 80% of all work will be done on-site via a mobile service. 20% of all work may be done by sending complex surgical instruments to an offsite lab for repair and service. SPS will determine sending surgical instruments offsite is appropriate.

3. Vendor will provide a minimum of two technical staff members for mobile services per service vehicle.

4. Instrument Technician Training Program must be approved through the Department of Labor and you must provide certificate.

5. Technical staff must be certified by either the International Association of Healthcare Central Services Materials Management (IAHCSMM) or the Certification Board for Sterile Processing and Distribution (CBSPD).

6. Instrumentation that is to be sent off-site must be picked up within the week of the on-site service date by on-site technical staff and/or sales support staff. This includes delivery of instrumentation that has been repaired from off-site lab. This allows proper tracking and accountability to ensure repaired instrumentation arrives undamaged.

7. Reporting that tracks the Instrument trays’ barcode, specialty, service rotation (based upon its usage,) last repair date, and next due date is required. It must also easily show the trays due and current on service, which will be provided to facility prior to each on-site day.

8. Vendor must be able to service between 12-18 trays per on-site service visit.

9. Vendor must provide to the government the ability to properly maintain and track an AEM (Alternative Equipment Maintenance) program for our facility's inventories. Vendor will work with each facility to determine the volume and number of visits needed to achieve AEM compliance. Any Vendor services provided to achieve this are considered value-added. As tray utilization changes, additional on-location services may be requested based upon demand.

10. Vendor must provide to the government an all-inclusive Capitated contract or an all-inclusive day-rate for their On-Location instrument repair services.

11. All repairs will 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

12. Vendor must provide documentation of Quality Assurance per VHA Directive 1116 that includes but is not limited to the following:

a. Verification of Complete instruments and Sets

b. Verification that instruments are in proper working order

0. Magnified Visual Inspection of all surgical instrumentation being maintained/repaired

0. Proactive maintenance to maximize performance of instrumentation and provide for patient safety.

0. Renewal of damaged surgical instrumentation to include but not limited to:

2. Replacement of worn, missing or broken parts, Sharpening, alignment, adjustment, tightening, Carbide-insert replacement, and general renewal.

2. Ultrasonic cleaning and revitalization

1. For keeping instrumentation free of staining, degradation, and potential pitting.

1. Utilization of Citric acid solution in ultrasonic cleaner to do more for the instrumentation other than removing scale.

1. Citric Acid based solution will replenish the passive protection for the stainless steel.

2. Buffing

2. Satin or mirror refinishing

0. Insulation-integrity testing and replacement of compromised insulation to ensure safety of the patient and surgical team

0. Documentation reports must be provided via a web-based tool that allows the end user to schedule Preventative Maintenance and management of tray rotation for stainless and laparoscopic instrument trays. Service dates should be color coded for quick identification of trays needing service. This web-based tool must allow the end user to create customized reports based on the name of the tray, quantity of trays, the last service date, and the next service date.

13. As part of the inspection process, pictures of damaged instrumentation must be taken and uploaded to a web-based tool. These pictures will assist in documentation of work completed, and will also be utilized as a training aid to assist SPS staff to point out appropriate errors and assist in the inspection process.

14. Vendor must be able to track the quantity of non-conforming instrumentation found in instrumentation trays during inspection. Vendor must be able to state specifically, on monthly report; why the non-conforming product was a problem, what SPS could do to resolve the issue, and what the Vendor can do to assist in preventing the issue in the future.

15. All instrumentation with lumens will be visually inspected with video endoscope inspection system to check for internal cracking, rust, or other issues with lumened instrumentation. Pictures taken during endoscope inspection will be uploaded to a web-based tool. These pictures will assist in documentation of work completed, and will also be utilized as a training aid to assist SPS staff to point out appropriate errors and aid in the inspection process.

16. Vendor must provide documentation and continued education to SPS staff that includes but is not limited to the following:

a. Provide at no additional cost to the government, Departmental evaluations that identify each touch point a device encounters in its usage cycle, as well as areas for process and care-and handling improvements

b. Provide at no additional cost to the government, Targeted staff education based on repair trends and departmental issues

c. Provide at no additional cost to the government, Competency validations, with proof of competency provided for individual training records

d. Provide at no additional cost to the government, In-service education to SPS staff on issues such as cleaning, care and handling.

e. Provide at no additional cost to the government, a yearly SPS Management Seminar that includes but not limited to:

i. Site visit to engineering and repair facility

ii. Discussion of programs to enhance management and administrative effectiveness.

2. Specifications Vendor will meet or exceed the following salient characteristics:

On-site Repairs

1) All on-site repairs will be performed utilizing a mobile laboratory.

2) On-site laboratory will be able to handle a minimum of 600 instruments per day and/or 12-18 trays per service visit

3) Approximately 80 percent of total workload will be performed within the mobile laboratory.

4) Vendor must provide to the government the ability to properly maintain and track an AEM (Alternative Equipment Maintenance) program for our facility's inventories. Vendor will work with each facility to determine the volume and number of visits needed to achieve AEM compliance. Any Vendor services provided to achieve this are considered value-added. As tray utilization changes, additional on-location services may be requested based upon demand.

5) 24-48 hours prior to service, vendor will provide SPS management with a list of trays that are scheduled for maintenance. SPS will pull as many sets from this list as possible as not to jeopardize patient care.

6) On-site repair services will consist of the following for all Surgical Hand Instrumentation:

a. Repair, alignment, adjustment, tightening and general renewal

b. Sharpening of all Scissors, Curettes, Punches, biopsy forceps and other “Cutting” instruments

c. Refurbishment

d. Ultrasonic cleaning and revitalization

e. Replacement of worn, missing, or broken Parts (Parts must be made of German Stainless Steel approved by the Original Equipment Manufacturer (OEM))

f. Satin or mirror refinishing

g. Color-coding Tape (as needed)

h. Tungsten Carbide insert replacement

i. Needle holder re-application (including “diamond dusting” of micro needle holders)

j. Brazing

k. Soldering

l. Electrosurgical re-insulation and testing

m. Chemical Etching

n. Surgical Milk Lubrication

o. Sterilization Container Repairs (as needed utilizing OEM parts)

7) Tasks that cannot be performed via on-site repair may be taken to off-site lab for service.

8) Instruments that are unable to be repaired must not be placed back in the set, and will be delivered to SPS Management and clearly marked “Not able to be serviced, not for patient use”.

Off-site Repairs

0. Off-Site repairs will be recommended when instrumentation cannot be repaired on-site.

0. Off-site repairs must not account for more than 20 percent of total workload.

0. Off-Site repair services will consist of the following for all Surgical Hand Instrumentation:

0. Repair, alignment, adjustment, tightening and general renewal

0. Sharpening

0. Refurbishment

0. Ultrasonic cleaning and revitalization

0. Replacement of worn, missing, or broken Parts (Parts must be made of German Stainless Steel approved by the Original Equipment Manufacturer (OEM))

0. Satin or mirror refinishing

0. Refurbishment of gold plating

0. Color-Coding (as needed)

0. Tungsten Carbide insert replacement

0. Needle holder re-application (including “diamond dusting” of micro needle holders)

0. Brazing

0. Soldering

0. Welding and machining

0. Electrosurgical re-insulation and testing

0. Dipping of surgical instrumentation to make insulated.

0. Chemical markings

0. Surgical Milk Lubrication

0. Sterilization Container Repairs (as needed utilizing OEM parts) Documentation and Inspection

1) Verification of Complete instruments and Sets

2) Verification that instruments are in proper working order

3) Magnified Visual Inspection of all surgical instrumentation being maintained/repaired

4) Proactive maintenance to maximize performance of instrumentation and provide for patient safety.

5) Documentation reports must be provided via a web-based tool that allows the end user to schedule Preventative Maintenance and management of tray rotation for stainless and laparoscopic instrument trays. Service dates should be color coded for quick identification of trays needing service. This web-based tool must allow the end user to create customized reports based on the name of the tray, quantity of trays, the last service date, and the next service date.

6) As part of the inspection process, pictures of damaged instrumentation must be taken and uploaded to the web-based tool. These pictures will assist in documentation of work completed, and will also be utilized as a training aid to assist SPS staff to point out appropriate errors and assist in the inspection process.

7) Track the quantity of non-conforming instrumentation found in instrumentation trays during inspection. State specifically, on monthly report; why the non-conforming product was a problem, what SPS could do to resolve the issue, and what the Vendor can do to assist in preventing the issue in the future.

8) All instrumentation with lumens will be visually inspected with a video endoscope inspection system to check for internal cracking, rust, or other issues with lumened instrumentation. Pictures taken during endoscope inspection will be uploaded to the web-based tool. These pictures will assist in documentation of work completed, and will also be utilized as a training aid to assist SPS staff to point out appropriate errors and aid in the inspection process.

Education and Training

1) Provide at no additional cost to the government, Departmental evaluations that identify each touch point instruments encounters in its usage cycle, as well as areas for process and care-and handling improvements.

2) Provide at no additional cost to the government, Targeted staff education based on repair trends and departmental issues.

3) Provide at no additional cost to the government, Competency validations, with proof of competency provided for individual training records.

4) Provide at no additional cost to the government, In-service education to SPS staff on issues such as cleaning, care and handling. All Continuing education credit program must be approved through the International Association of Healthcare Central Service Material Management (IAHCSMM), Certification Board for Sterile Processing and Distribution (CBSPD), Association of Surgical Technologists (AST) and Ohio Nurses Association (ONA).

5) Provide at no additional cost to the government, a yearly SPS Management Seminar that includes but not limited to:

a. Site visit to engineering and repair facility

b. Discussion of repair issues

c. Discussion of programs to enhance management and administrative effectiveness.

CHAMBER CLEANING:

3. Scope NF/SG (Includes VAMC’s Gainesville and Lake City, and VA Outpatient Clinics at Villages, Jacksonville and Tallahassee) are requesting the following:

17. The Contractor shall provide services to schedule around peak use times, weekend and evening hours must be available in addition to standard business hours of 0700-1530 to facilitate patient care.

18. Sterilization Chambers will be professionally cleaned according to the below recommended schedule or at least once every year to meet the needs of every department based on the OR Block Schedule or SPS:

a. VAMC Gainesville: Bi-annual service

b. VAMC Lake City: Bi-annual service

c. Villages Clinic: Annual service

d. Tallahassee Clinic: Annual service

e. Jacksonville Clinic: Annual service

19. Throughout the cleaning process, before and after pictures of each Chamber cleaned must be taken and uploaded to a web-based tool. These pictures will provide documentation of work completed. They will also be utilized as a training aid to SPS staff to identify appropriate errors and assist in the inspection process.

20. Vendor must provide documentation and continued education to SPS staff that includes but is not limited to the following:

a. Provide at no additional cost to the government, Targeted staff education and in-service education based on proper usage and care & handling processes

b. Provide at no additional cost to the government, a yearly SPS Management Seminar that includes but not limited to:

i. Site visit to engineering and repair facility

ii. Discussion of cleaning issues

iii. Discussion of programs to enhance management and administrative effectiveness.

4. Specifications Vendor will meet or exceed the following salient characteristics:

On-site Chamber Cleaning

1. Vendor must use manufacturer specific and approved process to clean each chamber.

1. Vendor must provide cleaning that ensures waste from the process is environmentally friendly and responsible.

1. Vendor cannot use harsh abrasives, buffing, or glass beading to clear the surface of the chambers.

1. On-Site cleaning will be done at least annually. Additional on-site cleanings may be performed at the request of the Medical Center or as needed, with one-week notification to the Vendor.

1. 24-48 hours prior to service, vendor will provide SPS and/or Operating Room Management with a list of equipment that is scheduled for cleaning. SPS/OR Depts. will follow instructions for ensuring the Chambers are cooled enough to perform service.

Documentation and Inspection

0. Verification of Complete Sterilization Equipment

0. Verification that equipment is in proper working order upon completion of service

0. Documentation reports must be provided via a web-based tool that allows the end user to schedule and review cleanings.

0. Throughout the cleaning process, before and after pictures of each Chamber cleaned must be taken and uploaded to a web-based tool. These pictures will assist in documentation of work completed. They will also be utilized as a training aid to SPS staff to identify appropriate errors and assist in the inspection process.

Education and Training

1. Provide at no additional cost to the government, Targeted staff education and in-service education based on proper usage and care & handling processes

1. Provide at no additional cost to the government, a yearly SPS Management Seminar that includes but not limited to:

0. Site visit to engineering and repair facility

0. Discussion of cleaning issues

0. Discussion of programs to enhance management and administrative effectiveness.

0.

ROLLING STOCK/OR FURNITURE REPAIR:

5. Scope NF/SG (Includes VAMC’s Gainesville and Lake City, and VA Outpatient Clinics at Villages, Jacksonville and Tallahassee) are requesting the following:

21. The Contractor shall provide services to schedule around peak use times, weekend and evening hours must be available in addition to standard business hours of 0700-1530 to facilitate patient care.

22. All work with be done via on location lab service.

23. As part of the repair process, before and after pictures of equipment must be taken and uploaded to the web-based tool. These pictures will assist in documentation of work completed.

24. Vendor must provide documentation and continued education to SPS staff that includes but is not limited to the following:

a. Provide at no additional cost to the government, Targeted staff education and in-service education based on proper usage and care & handling processes

b. Provide at no additional cost to the government, a yearly SPS Management Seminar that includes but not limited to:

i. Site visit to engineering and repair facility

ii. Discussion of repair issues

iii. Discussion of programs to enhance management and administrative effectiveness.

25. Vendor must have a minimum of 2 repair vehicles within 200 miles to ensure the needed service level for all sites.

26. All repairs will 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

6. Specifications Vendor will meet or exceed the following salient characteristics:

Rolling Stock Repairs:

1) All Rolling Stock repairs will be performed utilizing a mobile laboratory.

2) Rolling Stock repairs will be done according to each facility’s recommended needs/inventory:

VAMC Gainesville- x1/Quarter Recommended VAMC Lake City- x2/year Recommended VA Clinics Villages, Jacksonville, Tallahassee-as needed, but at least x1/year

3) Rolling Stock repair services will consist of any of the following as needed: Stainless Steel Equipment, including: Case Cart, Back Table, Mayo Stand, IV Pole, Kick Buckets, Code Carts, Bassinettes, Linen Carts, Stools, Prep Tables, Stainless Shelves,

a. Repair/Replacement of the following: Casters, Align Doors and hinges, welding, bumper, bumper channel, door keeper, hasps, hinges, latches, Cleaning,

b. Stainless Steel welding must be done on-site

Documentation and Inspection

1) Verification of Complete Rolling Stock Equipment

2) Verification that equipment is in proper working order upon completion of service

3) Documentation reports must be provided via a web-based tool that allows the end user to schedule and review repairs.

4) As part of the repair process, pictures of damaged/dirty equipment must be taken and uploaded to the web-based tool. These pictures will assist in documentation of work completed, and will also be utilized as a training aid to assist SPS staff to point out appropriate errors and assist in the inspection process.

Education and Training

1) Provide at no additional cost to the government, Targeted staff education and in-service education based on proper usage and care & handling processes

2) Provide at no additional cost to the government, a yearly SPS Management Seminar that includes but not limited to:

i. Site visit to engineering and repair facility

ii. Discussion of cleaning issues

iii. Discussion of programs to enhance management and administrative effectiveness.