36C24124Q0765_2.docx
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- Attached to
- J066--Laser Marker and Etching Service Federal contract opportunity
- Solicitation number
- 36C24124Q0765
About this file
This document is a combined synopsis/solicitation for a federal contract opportunity. The Department of Veterans Affairs is seeking to purchase a laser etcher and related laser marking services for its Sterile Processing Services at the VA Boston Healthcare System. The key details are:
The solicitation number is 36C24124Q0765 and the NAICS code is 332812 - Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to Manufacturers. The contract is set-aside for Service-Disabled Veteran-Owned Small Businesses (SDVOSBs). The contract period of performance is 9/16/2024 - 9/15/2025. The required equipment includes a NuTrace NUX-20 laser unit and related accessories. The contractor must provide installation, training, and maintenance services. Proposals are due by 8/9/2024 at 4:30 PM Eastern Time. Award will be based on a comparative evaluation of technical, past performance, veterans involvement, and price factors.
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Text version
SUBJECT*
Laser Marker and Etching Service
GENERAL INFORMATION
| CONTRACTING OFFICE’S ZIP CODE* |
| 01730 |
| SOLICITATION NUMBER* |
| 36C24124Q0765 |
| RESPONSE DATE/TIME/ZONE |
| 08-09-2024 4:30 PM EASTERN TIME, NEW YORK, USA |
| ARCHIVE |
| 30 DAYS AFTER THE RESPONSE DATE |
| RECOVERY ACT FUNDS |
| N |
| SET-ASIDE |
| SDVOSBC |
| PRODUCT SERVICE CODE* |
| J066 |
| NAICS CODE* |
| 332812 |
| CONTRACTING OFFICE ADDRESS |
| Department of Veterans Affairs |
Network Contracting Office 1
1400 VFW Parkway West Roxbury, MA 02132
POINT OF CONTACT*
Contracting Specialist Manases Cabrera manases.cabrera@va.gov
PLACE OF PERFORMANCE
| ADDRESS |
| VA Boston Healthcare System Sterile Processing Ser |
1400 VFW Parkway
West Roxbury MA
| POSTAL CODE |
| 02132 |
| COUNTRY |
| USA |
ADDITIONAL INFORMATION
AGENCY’S URL
URL DESCRIPTION
| AGENCY CONTACT’S EMAIL ADDRESS |
| manases.cabrera@va.gov |
| EMAIL DESCRIPTION |
| POC Email |
DESCRIPTION
The purpose of this amendment is to update the statement of work (SOW). The new SOW adds the following task:
· Full refurbishment of up to 20,000 surgical instruments: During the laser marking process, staff will inspect and fully refurbish instruments to their original finish, removing stains to enhance the passivation layer.
This also removes two subparagraphs (g and h) from paragraph 3.
Amendment to a Previous Combined Solicitation
Amendment to a Previous Combined Solicitation
| *= Required Field |
| Amendment to a Previous Combined Solicitation |
Page 1 of
Amendment to a Previous Combined Solicitation
STATEMENT OF WORK
SCOPE OF WORK: Boston Healthcare System Sterile Processing Services will be purchasing a laser etcher. Along with purchasing this etcher, we will be buying services for Censitrac. These contractors providing service will come to the facility and gain access to Censitrac via PIV badge. Once gaining access, they will provide training on how to etch surgical instrumentation and will organize instrument reference numbers on count sheet and in the Centsitrac software. The Contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items and services necessary to perform the following:
· Installation and implementation of a fully functional NuTrace NUX-20 laser unit or equal.
· Full refurbishment of up to 20,000 surgical instruments: During the laser marking process, staff will inspect and fully refurbish instruments to original finish, removing stains to enhance the passivation layer.
1. EQUIPMENT
The following equipment shall be provided and installed by the Contractor in the space determined by the Government. All equipment installed by the Contractor shall be FDA approved for use, in new condition, and fully operational in accordance with manufacturer literature specifications. A minimum of two (2) copies of any associated operational and/or service manuals shall be provided for all equipment listed below as applicable.
NuTrace NUX-20 laser unit.
The Contractor shall provide all tools and equipment necessary to properly and safely perform the services set forth within this statement of work. This shall include, but is not limited, to all Personal Protective Equipment (PPE) which may be required for the work to be completed in a safe manner. The Contractor shall provide any equipment necessary for proper infection control measures during installation.
2. SALIENT CHARACTERISTICS
The Contractor shall provide a fully functional system that meets the following characteristics:
-20W Max power.
- 2D DataMatrix reader for code verfication.
- Computer/Laptop with Windows 10 and supporting accessories.
-Fumex Fume/Odor extractor equipment. FA1-M.
- Select & Mark templates. Different laser configurations for different instrument materials included GS1 Codes.
- Select Set of Assorted Vectors to identify surgical instruments.
-2 hours of laser safety awareness guidance online by LIA (Laser Institute of America). Two seats.
-10 hours of training on site included.
-2 pairs of 1064nm OD7+ "Clear View" safety glasses to operate the laser in class 4 mode.
-Instructional videos and manuals
2. AREAS TO BE SERVICED (one or all as necessary and appropriate to this contract) Department of Veterans Affairs VA Boston Healthcare System Sterile Processing Services (SPS) 1400 VFW Parkway West Roxbury, MA 02132 Other information:
West Roxbury – about 18,000 pieces of surgical instruments and 2000 pieces of surgical instruments in peel packs West Roxbury has 11 Workstations.
3. INSTALLATION
a) The Contractor shall provide all labor, materials, tools, equipment etc. to prepare for and complete the installation of the equipment in the space determined by the Government.
b) Project implementation meetings, if necessary, shall be coordinated with the COR.
c) Installation and implementation dates are to be coordinated in advance with the Contractor and the COR.
d) All employees of the Contractor and subcontractors shall comply with VA security management program and obtain the permission of the VA police, be identified by project and employer, and restricted from unauthorized access. Also, All Employees of the Contractor shall be OEM certificate of Authorization of necessary training to operate the NUX-20Laser System and is authorized to provide the required training to end users who have purchased this technology.
e) All installation personnel shall be trained by the manufacturer on how to properly install the equipment. Resumes and certifications shall be submitted for review upon request by the Government.
f) All installation personnel shall be trained by the manufacturer on safe and proper Personal Protective Equipment (PPE) usage and general infection control regulations and requirements relevant to the work outlined in the Scope of Work.
g) The Contractor shall be responsible for the safe removal and disposal of all packing materials and related waste generated during installation.
4. TRAINING
The Contractor shall provide a comprehensive onsite training program for the operating clinicians. This training program shall include at the minimum the following sessions: (i) Technical Training, (ii) Operational Training, (iii) Administrative Training, and (iv) Hardware and Software Troubleshooting. Training shall occur onsite during normal business hours, 7:00am-3:30pm, Monday through Friday. Competency assessments shall be provided with the training. Onsite training is to be scheduled in advance with the Boston Healthcare System through the COR.
The Contractor shall provide onsite general overview technical training for Clinical Engineering personnel as requested. Training shall include a technical overview of the mechanics, electronics, and general operations of the system. Training shall cover detailed instruction regarding the preventative maintenance, troubleshooting, and general maintenance of the equipment.
Training will also include:
• UDI Application- Surgical instruments will be marked with a unique device identifier on most instruments including stainless steel, anodized aluminum, titanium, and plastics.
• Data entry/Editing – Existing instruments already marked will be reviewed for accurate description and unnecessary duplicates will be eliminated. Any marks not being picked up and read by Tenth Medical Group scanners will be removed and reapplied using our approved Class I laser. We are certified by the OEM on using this technology and can also provide necessary training to end users for sustainability.
• Count sheet revisions - as directed by and agreed to by Tenth Medical Group Leadership, we will edit and make necessary count sheet changes to help eliminate tray picking errors.
• Identify all missing instruments - needed to make the set complete, finding replacements, then scanning them and entering them into the system.
• Quality Assurance- each tray laser marked will also be individually examined.
5. INSPECTION AND ACCEPTANCE
a) The Contractor shall conduct a joint inspection with the COR upon delivery of equipment.
b) Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s).
c) The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer.
6. WARRANTY
a) The contractor shall provide a one-year manufacturer’s warranty on all parts and labor.
b) The warranty shall include all travel and shipping costs associated with any warranty repair.
7. TASK FREQUENCY AND INSTRUCTIONS
The work set forth in the Scope of Work shall be completed in a single visit, be it a single day or multiple days as required for appropriate completion. All work is to be scheduled in advance with the COR.
Equipment delivery shall not preceed installation by more than 20 days. Installation and implementation must be immediately followed by clinical user training including “go live” support. Implementation and integration with VistA CPRS shall not exceed 90 days from date of award.
8. SPECIAL WORK REQUIREMENTS
The Contractor shall comply with any and all Infection Control Risk Assessment requirements deemed appropriate by the VA Boston Healthcare System HCS during all portions of the work set forth in the Scope of Work.
The Contractor must comply with security, privacy, and safety issues in accordance to VA standards, policies, and directives set forth at all times while providing the work outlined in the Scope of Work.
9. PROPERTY DAMAGE
The contractor shall take all necessary precautions to prevent damage to any government property. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor unless corrective action is taken. Any damaged material (e.g. trees, shrubs, lawn/turf, curbs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the government, upon approval of the Contracting Officer.
10. ATTACHMENTS
None.
11. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS
The contractor's employees shall always wear visible identification while on the premises of the VA property. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. The VA will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VA. Cellular phones and two-way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.
12. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD
| The contractor shall comply with the Federal OSHA Blood borne Pathogens Standard. The contractor shall: |
| A. Have methods by which all employees are educated as to risks associated with blood borne pathogens. |
| B. Have policies and procedures which reduce the risk of employee exposure to blood borne pathogens. |
| C. Have mechanisms for employee counseling and treatment following exposure to blood borne pathogens. |
| D. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, and mouthpieces for the employee during performance of the contract. |
13. INFORMATION SECURITY LANGUAGE
MARCH 12, 2010, VA HANDBOOK 6500.6
APPENDIX C
C-1
VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR
INCLUSION INTO CONTRACTS, AS APPROPRIATE
RECORDS MANAGEMENT OBLIGATIONS
A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.
B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.
The term Federal record:
| 1. | includes VHA records. |
| 2. | does not include personal materials. |
| 3. | applies to records created, received, or maintained by Contractors pursuant to their VHA contract. |
| 4. | may include deliverables and documentation associated with deliverables. |
C. Requirements
| 1. | Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. |
| 2. | In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. |
| 3. | In accordance with 36 CFR 1222.32, the Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. |
| 4. | VHA and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VHA or destroyed except in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the Contractor must report to VHA. The agency must report promptly to NARA in accordance with 36 CFR 1230. |
| 5. | The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records, and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records, and/or equipment is no longer required, it shall be returned to VHA control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand-carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). |
| 6. | The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material, and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VHA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. |
| 7. | The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VHA policy. |
| 8. | The Contractor shall not create or maintain any records containing any non-public VHA information that is not specifically tied to or authorized by the contract. |
| 9. | The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. |
| 10. | The VHA owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VHA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. |
| 11. | Training. All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. |
** VHA training for contractors is available in Talent Management System (TMS):
Records Management for Records Officers and Liaisons, Item #3873736 D. Flow down of requirements to subcontractors
| 1. | The Contractor shall incorporate the substance of this clause, its terms, and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same. |
| 2. | Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor. |
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