Small medical instruments repair

STATEMENT OF WORK (SOW)
as of updated 2/26/2019
1. Program Manager
Name:
Shawn P. Huelsman
Section:
Sterile Processing Service; Patient Care Services
Address:
10701 East Blvd; Cleveland, Ohio 44106
Phone Number:
216-791-3800 ext. 5296
Fax Number:
E-Mail Address:
Shawn.Huelsman@va.gov
2. Contract Title.
SURGICAL AND CLINICAL INSTRUMENTATION MAINTENANCE AND REPAIR SERVICES
3. Background/Regulatory Information:
Per Centers for Medicare and Medicaid Services memorandum dated December 20, 2013,
Hospital Facilities, supplies and equipment must be maintained to ensure an acceptable level of safety and quality
A hospital may adjust its maintenance, inspection, and testing frequency and activities for facility and medical equipment from what is recommended by the manufacturer, based on a risk-based assessment by qualified personnel
Hospital electing to adjust facility or medical equipment maintenance must develop policies and procedures and maintain documentation supporting their Alternate Equipment Management (AEM) program. They must adhere strictly to the AEM activities and/or frequencies they establish.
Per Centers for Disease Control (CDC) Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008
Category II recommendation: to inspect equipment surfaces for breaks in integrity that would impair either cleaning or disinfection/sterilization. Discard or repair equipment that no longer functions as intended or cannot be properly cleaned, and disinfected or sterilized.
Category 1B recommendation: Provide comprehensive and intensive training for all staff assigned to reprocess semi-critical and critical medical/surgical instruments to ensure they understand the importance of reprocessing these instruments. To achieve and maintain competency, train each member of the staff that reprocesses semi-critical and/or critical instruments as follows:
provide hands-on training according to the institutional policy for reprocessing critical and semi-critical devices;
supervise all work until competency is documented for each reprocessing task;
conduct competency testing at beginning of employment and regularly thereafter (e.g., annually); and
review the written reprocessing instructions regularly to ensure they comply with the scientific literature and the manufacturers' instructions
3) VA National Program Office for Sterile Processing, SPS Tracer
a. There is a process or established program in place for sharpening and repairs of instruments VHA Directive 1116, VHA Directive 2009-031
b. Independent repair maintenance contracts or in-house service agreements need to be executed in order to ensure adherence with current manufacturers maintenance and repair guidelines.
3. Scope.
VAMC Cleveland is requesting the following:
Work shall be accomplished on weekdays between the hours of 0700-1530 in order to facilitate patient care.
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.
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).
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 of instrumentation that has been repaired from off-site lab. This allows proper tracking and accountability to ensure repaired instrumentation arrives undamaged.
Mobile On-Site services will be provided a minimum of once per week. Additional on-site services may be needed based on demand.
Operating Room Service trays will be rotated every week in order to meet the needs of every service based on the OR Block Schedule. Current block schedule from 11/3/2016 is listed below, but is subject to change by the VAMC Surgical Service.
Wade Park Operating Room
OR Priority Schedule
Room
Monday
Tuesday
Wednesday
Thursday
Friday
First
1
CT
CT
CT
Thoracic
CT
2
PV
Ortho
PV
PV
PV
3
CT
GU
Ortho
Ortho
Ortho
4
Spine
General
Eye
OPEN
OPEN
5
Podiatry
Plastics: AM/GU:PM
GU
Podiatry
PV
6
OPEN
General
General
Ortho
Ortho
7
ENT
ENT
GU (robot)
ENT
ENT
8
General
General
General
GU
General
Â
9
General
GYN
Podiatry
GU
GU (robot)
Second
1
CT
CT
CT
Thoracic
CT
2
PV
Ortho
PV
PV
PV
3
Podiatry
GU
Ortho
Ortho
Ortho
4
OPEN
OPEN
Podiatry
OPEN
GYN (robot)
5
Spine
General
Pain: AM/GU:PM
Podiatry
OPEN
6
General
General
General
Ortho
Ortho
7
ENT
ENT
ENT
ENT
ENT
8
General
General
General (robot)
GU
General
Â
9
PV
GYN
OPEN
GU
PV
Third
1
CT
CT
CT
Thoracic
CT
2
PV
Ortho
PV
PV
PV
3
CT
GU
Ortho
Ortho
Ortho
4
Spine
General
Eye
OPEN
OPEN
5
Podiatry
Plastics: AM/GU:PM
GU
Podiatry
General
6
OPEN
General
General
Ortho
Ortho
7
ENT
ENT
GU (robot)
ENT
ENT
8
General
General
General
GU
General
Â
9
General
GYN
Podiatry
GU
PV
Fourth
1
CT
CT
CT
Thoracic
CT
2
PV
Ortho
PV
PV
PV
3
Podiatry
GU
Ortho
Ortho
Ortho
4
OPEN
OPEN
Podiatry
OPEN
GYN (robot)
5
Plastic
General
GU
Podiatry
PV
6
General
General
General
Ortho
Ortho
7
ENT
ENT
ENT
ENT
ENT
8
General
General
General (robot)
GU
General
Â
9
Spine
GYN
OPEN
GU
OPEN
Fifth
1
CT
CT
CT
Thoracic
CT
2
PV
Ortho
PV
PV
PV
3
PV
GU
Ortho
Ortho
Ortho
4
OPEN
General
Podiatry
OPEN
OPEN
5
Podiatry
Plastics: AM/GU:PM
GU
Podiatry
Pain
6
Ortho
General
General
Ortho
Ortho
7
ENT
ENT
GU
ENT
ENT
8
General
General
General
GU
General
9
Spine
GYN
OPEN
GU
General
Outpatient Surgery Center
ASC Day Priority Schedule: August 2016
1
2
3
Week 1
Monday
Eye
Eye
Plastics
Tuesday
Eye
General
OPEN
Wednesday
Eye
General
GI
Thursday
Eye
Eye
GI
Friday
Eye
Eye
GI
Â
Â
Â
Â
Week 2
Monday
Eye
Urology
Plastics
Tuesday
Eye
General
AM: Plastics
-----------------------------------
PM: OPEN
Wednesday
Eye
General
GI
Thursday
Eye
Eye
GI
Friday
Eye
Eye
GI
Â
Â
Â
Â
Week 3
Monday
Eye
Eye
Plastics
Tuesday
Eye
Podiatry
General
Wednesday
Eye
AM: Podiatry
-----------------------------------
PM: General
GI
Thursday
Eye
Eye
GI
Friday
Eye
Eye
GI
Â
Â
Â
Â
Week 4
Monday
Eye
Urology
OPEN
Tuesday
Eye
Podiatry
Plastics
Wednesday
Eye
AM: Podiatry
-----------------------------------
PM: General
GI
Thursday
Eye
Eye
GI
Friday
Eye
Eye
GI
Â
Â
Â
Â
Week 5
Monday
Eye
Urology
Plastics
Tuesday
Eye
General
AM: Plastics
-----------------------------------
PM: OPEN
Wednesday
Eye
General
GI
Thursday
Eye
Eye
GI
Friday
Eye
General
GI
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.
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.
Vendor will provide preventative maintenance, specialty repair and services to include but not limited to the following devices:
Power Equipment (Drills, Saws, Micro-Drills, Dental Drills)
Phaco and Ophthalmic Equipment Repair and renewal
Cardiac and Vascular micro-instrumentation repair and renewal
ENT micro-instrument repair and renewal
Repair of endoscopic devices like cameras, light cords, arthroscopy shavers, laparoscopic instrumentation, and scope/larngoscopy holding devices.
Large retractor systems (i.e. Bookwalter, Thompson)
General Surgical Instrumentation
All repairs will follow all approved recommendations in regards to third party surgical instrument repair as set forth by the following:
Food and Drug Administration (FDA)
Centers for Medicare/Medicaid Services (CMS)
Centers for Disease Control (CDC)
Association for the Advancement of Medical Instrumentation (AAMI),
International Association of Healthcare Central Service Materials Management (IAHCSMM)
Association of per-Operative Registered Nurses (AORN)
Association of Professionals in Infection Control (APIC)
Department of Veterans Affairs, Veterans Health Administration (VHA) Directives
Vendor must provide documentation of Quality Assurance per VHA Directive 1116 that includes but is not limited to the following:
Verification of Complete instruments and Sets
Verification that instruments are in proper working order
Magnified Visual Inspection of all surgical instrumentation being maintained/repaired
Proactive maintenance to maximize performance of instrumentation and provide for patient safety.
Renewal of damaged surgical instrumentation to include but not limited to:
Replacement of worn, missing or broken parts, Sharpening, alignment, adjustment, tightening, Carbide-insert replacement, and general renewal.
Ultrasonic cleaning and revitalization
Buffing
Satin or mirror refinishing
Refurbishment of gold plating
Insulation-integrity testing and replacement of compromised insulation to ensure safety of the patient and surgical team
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.
Vendor will provide a total quality report of all trays reviewed and instruments repaired weekly to SPS Chief and COR.
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.
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.
Vendor must provide documentation and continued education to SPS staff that includes but is not limited to the following:
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
Provide at no additional cost to the government, Targeted staff education based on repair trends and departmental issues
Provide at no additional cost to the government, Competency validations, with proof of competency provided for individual training records
Provide at no additional cost to the government, In-service education to SPS staff on issues such as cleaning, care and handling.
Provide at no additional cost to the government, a yearly SPS Management Seminar that includes but not limited to:
Site visit to engineering and repair facility
Discussion of repair issues and proper care and handling of rigid endoscopes, flexible endoscopes, power equipment, and phaco handpieces
Discussion of programs to enhance management and administrative effectiveness.
4. Specifications
Vendor will meet or exceed the following salient characteristics:
On-site Repairs
All on-site repairs will be performed utilizing a mobile laboratory.
On-site laboratory will handle a minimum of 600 instruments per week.
Approximately 80 percent of total workload will be performed within the mobile laboratory.
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.
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.
On-site repair services will consist of the following for all Surgical Hand Instrumentation:
Repair, alignment, adjustment, tightening and general renewal
Sharpening of all Scissors, Curettes, Punches, biopsy forceps and other Cutting instruments
Refurbishment
Ultrasonic cleaning and revitalization
Replacement of worn, missing, or broken Parts (Parts must be made of German Stainless Steel approved by the Original Equipment Manufactuer (OEM))
Satin or mirror refinishing
Refurbishment of gold plating
Color-Coding (as needed)
Tungsten Carbide insert replacement
Needle holder re-application (including diamond dusting of micro needle holders)
Brazing
Soldering
Welding and machining
Electrosurgical re-insulation and testing
Dipping of surgical instrumentation to make insulated.
Chemical markings
Surgical Milk Lubrication
Case Cart Repairs (as needed utilizing OEM parts)
Sterilizer Refurbishment and Cleaning (biyearly)
Sterilization Container Repairs (as needed utilizing OEM parts)
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.
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 .
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.
ALL SURGICAL INSTRUMENTS OFFERED MUST BE MADE OF SURGICAL GRADE STAINLESS STEEL FORGED IN EUROPE OR THE UNITED STATES
ALL SURGICAL INSTRUMENTS OFFERED MUST BE ASSEMBLED IN A EUROPEAN NATION OR THE UNITED STATES
SURGICAL INSTRUMENTS OFFERED FROM PAKISTAN, CHINA, INDIA AND/OR ANY TAA NON-COMPLIANT COUNTRY WILL NOT BE ACCEPTED.
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.
Vendor must provide Indications for Use (IFU) for all common stock instrument replacements that are utilized.
Off-site Repairs
Approximately 20 percent of total workload will be performed at the off-site lab.
Off-Site repairs will be done as needed or if instrumentation cannot be repaired on-site.
Off-Site repair services will consist of the following for all Surgical Hand Instrumentation:
Repair, alignment, adjustment, tightening and general renewal
Sharpening
Refurbishment
Ultrasonic cleaning and revitalization
Replacement of worn, missing, or broken Parts (Parts must be made of German Stainless Steel approved by the Original Equipment Manufactuer (OEM))
Satin or mirror refinishing
Refurbishment of gold plating
Color-Coding (as needed)
Tungsten Carbide insert replacement
Needle holder re-application (including diamond dusting of micro needle holders)
Brazing
Soldering
Welding and machining
Electrosurgical re-insulation and testing
Dipping of surgical instrumentation to make insulated.
Chemical markings
Surgical Milk Lubrication
Sterilization Container Repairs (as needed utilizing OEM parts)
Off-Site repair services (as needed utilizing OEM parts) will include
Premium Instrument Set Restoration Services
Power Equipment Repair and Restoration (including but not limited to arthroscopy shavers, bone drills (electric/battery), bone saws (electric/battery))
Dental Power Equipment Repair and Restoration
Endoscopic Camera and Light cord Repair and Restoration.
Surgical Hand Instrumentation not able to be repaired on-site.
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
Verification of Complete instruments and Sets
Verification that instruments are in proper working order
Magnified Visual Inspection of all surgical instrumentation being maintained/repaired
Proactive maintenance to maximize performance of instrumentation and provide for patient safety.
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.
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.
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
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
Provide at no additional cost to the government, Targeted staff education based on repair trends and departmental issues
Provide at no additional cost to the government, Competency validations, with proof of competency provided for individual training records
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)
Provide at no additional cost to the government, a yearly SPS Management Seminar that includes but not limited to:
Site visit to engineering and repair facility
Discussion of repair issues and proper care and handling of rigid endoscopes, flexible endoscopes, power equipment, and phaco handpieces
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.
5. 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.
6. 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.
7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).
Government will furnish a complete list of surgical instrument trays that are currently in inventory in order to properly set up a rotation schedule.
Other Pertinent Information or Special Considerations.
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.
Identification of Potential Conflicts of Interest (COI). None
Identification of Non-Disclosure Requirements. No Proprietary Information to be given
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.
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.
9. 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.
10. 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
11. Period of Performance.
10-1-2019 to 9-30-2020 with the option to continue services up to 5 years based on quality of vendor.
12. Delivery Schedule.
Instruments repaired off site will be hand delivered to SPS department once repairs are completed..