36C25019Q0795-003.docx

FedBizOpps Amendment to a Previous Combined Solicitation

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* = Required Field FedBizOpps Amendment to a Previous Combined Solicitation Rev. March 2010 J Medical Instrument Repair and Maintenance Service 44131 36C25019Q0795 08-30-2019 N 811219 Department of Veterans Affairs Network Contracting Office (NCO) 10 6150 Oak Tree Blvd., Suite 300 Independence OH 44131 Harvey J. McGowan harvey.mcgowan@va.gov Louis Stokes Cleveland VA Medical Center Description of Services: The Louis Stokes Cleveland VA Medical Center in Cleveland, Ohio, Engineering Service, requires the following services:

Statement of Work (revised):

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 at VAMC Cleveland via a mobile service. 20% of all work may be done by sending complex surgical instruments and Powered items to an offsite lab for repair and service.

3. Vendor will provide a minimum of two technical staff members for mobile services. 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).

4. Instrumentation that is to be sent offsite must be picked up twice a week by on-site technical staff and/or sales support staff. This includes dropping off instrumentation that has been repaired from off-site lab. This allows proper tracking and accountability to ensure repaired instrumentation arrives undamaged.

5. Mobile On-Site services will be provided a minimum of once per week. Additional on-site services may be needed based on demand.

6. Operating Room Service trays will be rotated every week to meet the needs of every service based on the OR Block Schedule. Current block schedule is listed below, but is subject to change by the VAMC Surgical Service.

Wade Park Operating Room OR Priority Schedule

Outpatient Surgery Center

ASC Day Priority Schedule:

PM: OPEN

PM: General

GI

PM: General

GI

PM: OPEN

7. Vendor will provide replacement of common stock instrumentation for instruments that can no longer be sharpened or repaired (i.e. Hemostats, needle holders, forceps, scissors. Vendor must provide IFU for instrumentation that is substituted and must provide a detail report to state why common stock replacement was utilized.

8. All Surgical instrumentation trays (including powered surgical instrumentation) that are utilized for Wade Park Surgery and Outpatient Surgery Center will be placed on a quarterly rotation program to ensure that all instrumentation is properly maintained and sharpened. Instrumentation for internal clinics (including dental), Community Based Outpatient Clinics (CBOCS), and other areas that may utilize reusable medical equipment (RME), will be performed on an as needed basis. Instruments needing this service will be placed in an appropriately marked bin inside the Sterile Processing Service, and will be picked up during the regularly scheduled visit.

9. Vendor will provide preventative maintenance, specialty repair and services to include but not limited to the following devices:

a. Power Equipment (Drills, Saws, Micro-Drills, Dental Drills)

b. Phaco and Ophthalmic Equipment Repair and renewal

c. Cardiac and Vascular micro-instrumentation repair and renewal

d. ENT micro-instrument repair and renewal

e. Repair of endoscopic devices like cameras, light cords, arthroscopy shavers, laparoscopic instrumentation, and scope/larngoscopy holding devices.

f. Large retractor systems (i.e. Bookwalter, Thompson)

g. General Surgical Instrumentation

10. All repairs will follow all approved recommendations in regards to third party surgical instrument repair as set forth by the following:

h. Food and Drug Administration (FDA)

i. Centers for Medicare/Medicaid Services (CMS)

j. Centers for Disease Control (CDC)

k. Association for the Advancement of Medical Instrumentation (AAMI),

l. International Association of Healthcare Central Service Materials Management (IAHCSMM)

m. Association of per-Operative Registered Nurses (AORN)

n. Association of Professionals in Infection Control (APIC)

o. Department of Veterans Affairs, Veterans Health Administration (VHA) Directives

11. 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

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

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

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

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

ii. Ultrasonic cleaning and revitalization

iii. Buffing

iv. Satin or mirror refinishing

i. Refurbishment of gold plating

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

f. 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.

g. Vendor will provide a total quality report of all trays reviewed and instruments repaired weekly to SPS Chief and COR.

12. Vendor must be able to perform Closed container repair on Wagner/Medline Steriset Full Size, Half Size, ¾ size, and “Tasket” containers. This includes performing repairs that include but not limited to

a. Gasket Replacement

b. Latch Replacement/Repair

c. Adjustment and Replacement

d. Handle Replacement

e. Handle Color Coding

f. Inner Tray Repair

g. Pin Replacement

h. Nut replacement

i. Burr and dent removal

13. Vendor must be able to perform small repairs to Steris Sterilization/washer/cart washer racks, Pedigo Revolution Case Cart, and other wire/non wire carts used within the SPS department. Repairs include but are not limited to:

j. Caster Replacement

k. Welding

l. Bumper replacement

m. Door Repair

n. Latch Assemblies,

o. Hinge repair

p. Repair of door hinges, racks, and shelf brackets

q. Repair of the cart body (including dent removal/sticker removal)

14. 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.

15. 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.

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

r. 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

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

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

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

v. 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 and proper care and handling of rigid endoscopes, flexible endoscopes, power equipment, and phaco handpieces

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

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 handle a minimum of 600 instruments per week.

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

4) On-Site repairs will be done weekly. Additional on-site repairs may be performed at the request of the medical center with one week notification to the Vendor.

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. Refurbishment of gold plating

h. Color-Coding (as needed)

i. Tungsten Carbide insert replacement

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

k. Brazing

l. Soldering

m. Welding and machining

n. Electrosurgical re-insulation and testing

o. Dipping of surgical instrumentation to make insulated.

p. Chemical markings

q. Surgical Milk Lubrication

r. Case Cart Repairs (as needed utilizing OEM parts)

s. Sterilizer Refurbishment and Cleaning (biyearly)

t. 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. Items must be hand delivered back to VAMC Cleveland, SPS personnel.

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

9) Instruments that are considered “common stock” items will be replaced into the trays at the current VA rate. These instruments must meet the following requirements.

a. ALL SURGICAL INSTRUMENTS OFFERED MUST BE MADE OF SURGICAL GRADE STAINLESS STEEL FORGED IN EUROPE OR THE UNITED STATES

b. ALL SURGICAL INSTRUMENTS OFFERED MUST BE ASSEMBLED IN A EUROPEAN NATION OR THE UNITED STATES

c. SURGICAL INSTRUMENTS OFFERED FROM PAKISTAN, CHINA, INDIA AND/OR ANY TAA NON-COMPLIANT COUNTRY WILL NOT BE ACCEPTED.

d. VAMC CLEVELAND REQUESTS THAT ALL SURGICAL INSTRUMENTS ARE 2D MARKED WITH CENSITRAC MARKINGS. VAMC CLEVELAND REQUESTS THAT ALL INSTRUMENTS ARE ENTERED INTO THE CENSITRAC INSTRUMENT DATABASE FOR HOSPITAL ID # 1207. THIS INCLUDES USING APPROVED VA NORMENCLATURE. VAMC CLEVELAND REQUESTS PICTURES OF SURGICAL INSTRUMENTS BE LOADED INTO THE CENSITRAC INSTRUMENT DATABASE.

e. Vendor must provide Indications for Use (IFU) for all common stock instrument replacements that are utilized.

Off-site Repairs

1) Approximately 20 percent of total workload will be performed at the off-site lab.

2) Off-Site repairs will be done as needed or if instrumentation cannot be repaired on-site.

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

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

b. Sharpening

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 Manufactuer (OEM))

f. Satin or mirror refinishing

g. Refurbishment of gold plating

h. Color-Coding (as needed)

i. Tungsten Carbide insert replacement

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

k. Brazing

l. Soldering

m. Welding and machining

n. Electrosurgical re-insulation and testing

o. Dipping of surgical instrumentation to make insulated.

p. Chemical markings

q. Surgical Milk Lubrication

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

4) Off-Site repair services (as needed utilizing OEM parts) will include

b. Premium Instrument Set Restoration Services

c. Power Equipment Repair and Restoration (including but not limited to arthroscopy shavers, bone drills (electric/battery), bone saws (electric/battery))

d. Dental Power Equipment Repair and Restoration

e. Endoscopic Camera and Light cord Repair and Restoration.

f. Surgical Hand Instrumentation not able to be repaired on-site.

g. Sterilization Container Repairs not able to be repaired on-site

Complete list of surgical trays changes frequently. The complete list of surgical instrument trays will be provided to vendor at time of award.

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) 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 a device 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 and proper care and handling of rigid endoscopes, flexible endoscopes, power equipment, and phaco handpieces

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

Billing and Performance:

A copy of all billing statements will be forwarded to Logistics and to SPS. Statements will be inspected to ensure correct date of service, and to ensure that services billed were services rendered. SPS will review the billing statements for accuracy and insure that work billed was completed. SPS then will inform Logistics to move forward on the billing statement.

Performance Monitoring The Government is required to monitor contractor performance and certify the work was done in accordance with the contract. This monitoring is done by the COR in coordination with the SPS Assistant Chief or designate. Quality will be assured by routine inspections, and discussion between SPS staff, Operating Room Staff, and Clinical Staff. SPS staff will inspect approximately 10 percent of all work performed on-site weekly and all instrumentation that is repaired off-site. Potential quality issues will be documented in the Censitrac Quality database and will be presented to the vendor quarterly.

Security Requirements The contractor will need to be granted physical access to room W-117, W-122, W-103 and outpatient surgery center to pick up and drop off trays and instrumentation. There are no Information Security elements related to this procurement. At least 24-hour notice prior to requiring access must be given by SPS Management to ensure access is not delayed.

Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

Government will furnish a complete list of surgical instrument trays that are currently in inventory to properly set up a rotation schedule.

Other Pertinent Information or Special Considerations.

a. Identification of Possible Follow-on Work. Government is requesting that this contract is executed with the option to renew the contract up to 5 years based on the quality of the Vendor’s work.

b. Identification of Potential Conflicts of Interest (COI). None

c. Identification of Non-Disclosure Requirements. No Proprietary Information to be given

d. Packaging, Packing and Shipping Instructions. Vendor will perform 80% of work on site. 20 % of work will be done offsite, but offsite work will be hand delivered to VAMC Cleveland SPS Department once it has been repaired.

e. Inspection and Acceptance Criteria. Craftsmanship of repairs will be reviewed by SPS Management and will be reported directly to the COR and to the vendor when issues are identified.

Risk Control Vendor must wear appropriate Personal Protective Equipment (PPE) when entering SPS areas. This may include a disposable containment suit, head cover, shoe covers, and beard covers when applicable.

Place of Performance.

Sterile Processing Service Room 117,122,103 Louis Stokes VA Medical Center 10701 East Blvd Cleveland, Ohio 44106

Outpatient Surgery Center 8901 Superior Ave Cleveland, Ohio 44106

Period of Performance.

10-1-2019 to 9-30-2020 with four (4) one year options to continue services up to 5 years based on quality of vendor service.

Delivery Schedule.

Instruments repaired off site will be hand delivered to SPS department once repairs are completed.