Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF AUGUST 21, 2021 SAM #7203
SOURCES SOUGHT

J -- Surgical Instrument Maintenance Service

Notice Date

8/19/2021 12:25:54 PM
 

Notice Type

Sources Sought
 

NAICS

811219 — Other Electronic and Precision Equipment Repair and Maintenance
 

Contracting Office

242-NETWORK CONTRACT OFFICE 02 (36C242) ALBANY NY 12208 USA
 

ZIP Code

12208
 

Solicitation Number

36C24221Q1362
 

Response Due

8/27/2021 7:00:00 AM
 

Archive Date

10/26/2021
 

Point of Contact

Janice Brooks Campbell, Contracting Officer, Phone: (718) 584-9000 x6096
 

E-Mail Address

Janice.Brooks@va.gov
(Janice.Brooks@va.gov)
 

Awardee

null
 

Description

Synopsis: Please note that this is NOT a request for quotes or proposals, the Government is seeking information for market research purposes only. Network Contracting Office (NCO) 2 of the Department of Veterans Affairs is currently conducting a market survey for qualified firms capable of providing Repair, refurbish, and assess for replacement surgical instruments for use in operating room procedures for the New York Harbor VA Healthcare System. The North American Industry Classification Systems (NAICS) is 811219. Responses to this notice must be submitting in writing (email or fax) and must be received not later than August 27th, 2021 at 10:00AM. Email: Janice.Brooks@va.gov. No telephone inquiries will be accepted. Interested parties MUST provide company/individual name, a capability statement, examples of same or similar work performed at other facilities, DUNS number and address, point of contact and social-economic. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, women owned small business, HUB Zone, 8(a), small business or large business), relative to NAICS 811219. Responses to this notice will be used by the Government to make appropriate acquisition decisions. A solicitation is not currently available. If a solicitation is issued, it will be announced on Federal Business opportunities website http://www.fbo.gov at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. STATEMENT OF WORK FOR REUSABLE MEDICAL EQUIPMENT/SURGICAL INSTRUMENT REPAIR AND REFURBISHMENT SERVICES Introduction and Scope of Work The Sterile Processing Services (SPS) at the Brooklyn and Manhattan Campuses of VA New York Harbor Healthcare System (NYHHS) are seeking a contract for surgical instrument repair and refurbishment services, as well as assessment for replacement, for instruments used in operating room procedures. Additionally, this SOW contains Section V, for instructions regarding the Annual Surgical Instrument Tray Maintenance and Inspection. Preventive maintenance (PM), scheduled repairs, refurbishment and assessment for replacement will include but is not limited to all specialty trays by service (Ortho, ENT, etc.), scissors, needle holders, curettes, hemostats, graspers, laparoscopic instruments, surgical knives, etc. (see the attached list of Manhattan and Brooklyn instrument trays currently owned by the facility). These services are periodic in nature and are required to maintain the instruments in such condition that they may be operated in accordance with the intended manufacturer s design and functional capacity with minimal incidence of malfunction or inoperative conditions. The vendor shall ensure that the repairs and service functions are performed in conformance with specifications used by the instrument manufacturer. Vendor must provide current ISO 9001 certifications specific to medical devices. The vendor will obtain the instrument trays from SPS and provide these services to include but not limited to: sharpening, repairing (i.e., adjusting, aligning, straightening, and/or replacing parts), refurbishing, calibrating, ultrasonically cleaning, stain removal, polishing, and lubricating various individual surgical instruments sets and operating room (OR) procedural instrument trays; maintaining the equipment, and conducting insulation electrical safety inspection (as required by instrument type), including all emergency calls necessary between regular repairs. Ultrasonic cleaning and lubricating/milking will be done on all instruments, not just the instruments that require repair. SPS will provide the instruments individually or as components of a specialty tray. All instruments shall be maintained in proper operating conditions as specified by the original manufacturer. Upon completion of repair, refurbishment, and testing of the submitted trays and instruments, the vendor must return the equipment to the SPS. The vendor must also provide a summary report upon delivery of processed instruments as described in Section II. Repairs will be completed either on location at each campus in a mobile repair vehicle, or offsite at the vendor s repair facility. NY Harbor Healthcare System consists of two campuses and services will be required at both campuses. Details of each campus is listed below: Sterile Processing Service Manhattan Campus 423 East 23rd Street Ground Floor New York, NY 10010 Sterile Processing Service Brooklyn Campus 800 Poly Place Basement Floor Brooklyn, NY 11209 Scope and identification of all items to be covered will be obtained from the Chief, SPS and officially confirmed with contractor before award of contract. Specific Mandatory Tasks and Associated Deliverables The vendor shall provide all necessary labor, equipment, materials, supervisor, test equipment, repair/replacement parts, travel and transportation for instrument sharpening/repair. This work will be performed monthly on site at both Brooklyn and Manhattan Campuses. The SPS departments in Brooklyn and Manhattan are two separate services, only supporting their specific campus. All Brooklyn instruments must be maintained and returned to the SPS service at the Brooklyn campus. All Manhattan instruments must be maintained and returned to the SPS service at the Manhattan campus. Instruments that cannot be repaired onsite will be sent to the vendor s repair facility. The contract includes all repairs, whether they are done onsite or offsite. The repair vendor will provide multiple levels of repair service including, but not limited to two-hour turn-around, same-day turn-around, 24-hour turn-around, weekend service, mail-in/offsite repair service, in addition to onsite repair service. All Urgent instrument repairs will have a 48-hour turnaround time. All Emergency Instrument Repairs will have a 24-hour turnaround time. The repair vendor will provide one to two (or more) technicians, depending on the site, for onsite repair so that entire services instrument trays can be repaired, refurbished. The repair vendor must be capable of repairing 15 sets per visit at a minimum, with a maximum of 30 trays per visit. The vendor will provide repairs, maintenance, and testing of surgical instruments. The vendor will return instruments in as good as new condition. The finish of the surgical instruments will be maintained to manufacturer s specifications All instruments shall be repaired and maintained in proper operating conditions as specified by the original manufacturer. The manufacturer s part numbers and catalog numbers shall be preserved on all repaired or refurbished instruments. Magnification technology must be utilized during the repair process to diagnose, document, and educate facility staff regarding repairs made for the day. Surgical instrument maintenance and repair will be handled with care. The vendor will be required to test instruments for accurate alignment, sharpness, insulation and calibration. For instance, the scissors should cut all the way through the top of the scissors without catching or snagging; the jaws of the rongeur should cut cleanly through an index card, and ¾ of the blades of the bone and pin cutters, as well as those of the nail nippers, should cut cleanly through an index card, etc.. The vendor must provide the Latex Free Scissor Test Band Rolls for use at each campus at no charge. The vendor must provide one Laparoscopic Insulation Continuity Tester per campus at no charge and provide education upon request and as necessary to SPS Technicians. The vendor must be able to demagnetize instruments that require demagnetizing, e.g., needle holders. The repair vendor will provide education regarding instrument repairs, instrument care and handling, instrument processing, power equipment repairs, laparoscopic continuity testing, and endoscopy instrument repairs. Programs must be accredited programs that offer CEU credits to SPS Technicians, Surgical Technicians, and/or Registered Nurses. Instrument repairs will be completed onsite at each New York Harbor Healthcare Campus in a mobile repair lab/vehicle or within the hospital in a designated space. 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 vendor staff. Any equipment needed to set up repair lab within the hospital must be done at the expense of the vendor. The Vendor's employee(s) shall report to the Sterile Processing Department (SPS) upon arrival at either the Brooklyn or Manhattan Campus. The vendor will retrieve instruments from and deliver them to the Sterile Processing Service (SPS) located at each campus (Brooklyn and Manhattan). Individual instrument repairs will be performed on weekends and/or Monday through Friday between the hours of 8:00am 4:00pm when necessary, excluding national holidays. Repair visits will be scheduled in advance with the respective Chief, SPS at each campus. Instruments that cannot be repaired or refurbished due to cracking, pitting, corrosion, or exceeding life expectancy will be removed, marked or tagged for replacement, and returned to the Chief, SPS at each respective campus. If an instrument needs to be sent out for third party repairs by the vendor, authorization must be obtained from the SPS Chief or designee from the campus the instrument originated from. All off site repairs shall be included in the monthly, flat-rate cost of this contract. The vendor will conduct a continuous review of the condition of the sets and make recommendations for adjusting the repair frequencies for individual sets and on-site repair visit frequency. SPS Chiefs or their designees determine which trays need review and repair by the vendor at the time of service. The vendor shall make recommendations for surgical instrument replacement which may be pertinent to meet the scope of surgical trays completion. Repair of back up instruments must take place 2 times a year. The assessment of these instruments not requiring repair will be provided at no charge. In the event of inclement weather, natural disaster, or other unforeseen circumstances preventing a scheduled on-site repair visit the SPS Chief or designee will be contacted the day of the scheduled visit. Dates available for re-scheduling the scheduled on-site will be provided to the SPS Chief within in 3 business days of the originally scheduled on-site repair visit. Documentation Requirements At the conclusion of each service visit, the vendor must provide a summary report upon delivery of repaired instruments containing the following information: date of repair, instrument type, type of repair and the next date the instrument(s) should be given preventive maintenance. The report should be in an electronic format (e.g., MS Excel spreadsheet, MS Word document, or a PDF). Documentation of extensive repairs and/or recommendations for process improvements may be included in the report, along with before and after pictures, if appropriate. All single instruments and surgical trays picked up/delivered by vendor will be properly listed on the report for accountability verification. The service report will be checked against the instruments returned after repairs. Stickers indicating the date that the tray has been serviced shall be put on all trays once the service is completed. All service documentation will be maintained by SPS and made available to the COR as needed per contracting requirements. SPS and Surgical Service Operating Room (OR) Support The VA Sterile Processing Service (SPS) will be the point of contact for all surgical instrument pickups and returns. The returned repaired instruments will be inspected in SPS. The Surgical Service Operating Room will perform a serviceable quality check of instruments and any instruments that fail will be returned to SPS for re-processing to the vendor. Annual Surgical Instrument Tray Maintenance and Inspection (By Specialty) Specialty surgical instruments maintenance and repairs should be performed in the vendor s mobile repair vehicle during the monthly service visit at each campus, or offsite, at the vendor s repair facility. All instruments that can be disassembled will be disassembled and undergo a detailed vendor inspection. Pictures will be provided. Instruments will not be altered, changed or tampered with and will be repaired following manufacturers original design specifications and in compliance with ANSI-AAMI ST-79 part 7.7. Instruments such as Kerrison, Rongeurs, Biopsy Punches, Graspers, Scissors, and Endoscopic Arthroscopic devices will be disassembled for maintenance and repaired. They will also be sharpened and aligned in accordance with the manufacturer s original specifications. Surgical Picks, Nerve Hooks, Needle Holders, etc., will be straightened or aligned as to maintain their original manufacturer s configuration. Specific custom-made instruments will be repaired in coordination with operating room surgeons (end user) specifications and in accordance with the manufacturer s original design specifications. Suction tubes (Poole, Adson, Frazier Baron, and Yankauer) will be inspected, and interior lumen flushed and inspected. All instruments will be stain-free with a finish that complies with the manufacturer s specifications. Delicate sharp, pointed eye instruments will be returned covered with appropriate tip protectors. VA Monitoring of Progress and Compliance Continuous instrument repair quality improvement monitoring and turnaround time as well as contract compliance will be progressively and jointly monitored by the Chiefs, SPS at each campus and the Contracting Officer Representative (COR). The COR will designate appropriate VA personnel to monitor vendor employee work hours/services through one or a combination of the following mechanisms: The COR jointly with the Chief, Sterile Processing Service (SPS) will monitor Vendor instrument pick-up and drop-off through written logs and schedules to ensure that services called for in the contract have been received by the VA. The vendor's employee(s) shall report to SPS upon arrival at NYHHS Campus for the pickup and return of instruments. The COR will be responsible for verifying contract compliance through the direct technical oversight by the SPS Chief. The SPS Chief will be the expert and authority for any technical issues regarding the performance of the contract. Any incidents of Vendor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer by the COR. Documentation of services performed will be reviewed by the COR prior to certifying payment. The COR will perform periodic documents checks with the using service to ensure records monitoring. VA will pay only for services actually performed at VA and at the vendor s location, and in strict accordance with the schedule of prices/costs shown in the schedule of items. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided. Vendor Requirements Contractor personnel performing under this contract shall be fully qualified and competent to provide the services required in this solicitation. Fully qualified is defined as trained and experienced to provide the services described herein. The Contractor shall provide resumes of their personnel and copies of certifications/ credentials of approved personnel technicians. Resumes shall clearly reflect the experience, list of formal education and training, expertise and any licensing or certifications required. All Contractor personnel shall have at least three years of experience in the following areas: surgical instrumentation maintenance and repair. Contract personnel will have IAHCSMM/CBSPD/CCSVP certifications. Invoicing The vendor shall provide repair service invoices to designated representative for review and approval prior to submitting invoice for billing. All corresponding invoices shall include the current contract and purchase order numbers. Billings shall be made in arrears by certified invoice. All repairs shall be completed according with all terms within this Statement of Work. This contract covers all repairs, e.g., all onsite and offsite repairs shall be included in the monthly, flat-rate cost of this contract. Monthly invoices are submitted to Financial Services Center in Austin, Texas by the vendor. The COR will verify that services were actually performed against vendors certified delivery repairs document/report. Invoices will be submitted to Chief, SPS for verification prior to invoicing. Only after verification are invoices certified for payment. IX. VA Information and Information System Security/Privacy Language Vendor shall be required to complete a security clearance with the VA Police. An ID badge will be issued by the VA Police which needs to be presented by vendor s employee at the VA entrance security check points. The issued badge is for official pickup and deliveries of surgical instruments and trays. Vendor mobile unit(s) shall be properly labeled with vendor s logo and registered with the Police Service at both NYHHS campuses. This contract does not involve any VA sensitive information disclosed to contractor. Contractor requiring access to the VA facility must sign and acknowledge the VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access or Use to VA Sensitive Information Document OR complete the an online TMS course # 20939 annually. The contractor shall provide to the COR a copy of the training certificate for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.  Failure to complete the mandatory annual training the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/8d80dad944ed4c9695816ed7893c9294/view)
 

Place of Performance

Address: NY Harbor Healthcare System, 423 East 23rd Street 10010, USA

Zip Code: 10010

Country: USA
 

Record

SN06104481-F 20210821/210821203420 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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