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Performance Work Statement (PWS) Preventive Maintenance and Repair on Ziehm Vision RFD 3D C-ARM Department of Veterans Affairs (VA) Veterans Health Administration (VHA) PURPOSE: Veterans Affairs requi... Performance Work Statement (PWS) Preventive Maintenance and Repair on Ziehm Vision RFD 3D C-ARM Department of Veterans Affairs (VA) Veterans Health Administration (VHA) PURPOSE: Veterans Affairs requires a contractor to provide annual Preventive Maintenance (PM), and Repair Support Services, on an as-needed basis, for the Ziehm Vision RFD C-arm at the Oklahoma VA Health Care System. Services are to be performed in accordance with this PWS and to OEM standards, with the intent of ensuring the equipment operates as the original manufacturer intended, uninterrupted (95% uptime), with the latest updates, in a cost-effective, efficient manner, contributing to the VA Mission. Services are required on the government-owned equipment listed in this PWS for the period of performance and at the location outlined in this PWS. This Contract will be a non-personal services contract. The Contractor, its employees, agents and subcontractors shall not be considered government employees for any purpose. Contractor shall furnish all labor, materials, parts, equipment, tools, transportation, and supervision to provide services in accordance with this Performance Work Statement (PWS). Period of Performance: refer to the Price/Schedule or page 1 of this contract, SF 1449 Location of performance: refer to page 1 of this contract, SF 1449 BACKGROUND: Equipment: The VA owned Ziehm Vision RFD 3D C-arm is used for image guided surgery and imaging in the Operating Rooms at the VA Medical Center. The following pieces of equipment require service under this contract: Equipment Description Brand & Model Original Equipment Manufacturer (OEM) Serial Number VA PMI Number C-arm Ziehm Vision RFD 3D Ziehm 21159 68502 SUMMARY OF REQUIREMENTS Contractor shall provide OEM-trained technicians to perform OEM-standard services on equipment in this PWS. Services on the equipment include maintenance support, corrective maintenance repair, 24x7 emergency phone support, provision of parts (comprehensive parts coverage), and service and modification as required due to safety or reliability. All OEM software updates shall be included. The scheduled month for annual preventative maintenance shall be November. Tasks and Requirements Performance and Repairs: All work performed shall be in accordance with manufacturer s specifications, including but not limited to: adjustments, calibrating, cleaning, lubricating, testing, disassembly, checkout, replacement of parts, etc. required to keep the equipment in operating condition. Contractor must guarantee 95% up time for the equipment. Contractor shall guarantee that all equipment covered by this contract shall be in optimum working condition at the completion of each contracted Period of Performance. Contractor will make every attempt to maintain and repair equipment on-site within a reasonable time, unless local environment prohibits on-site attendance. Failing this, contractor will provide substitute equipment in the event a repair continues beyond the reasonable time frame. A reasonable time frame ensures the VA mission continues uninterrupted with no loss, damage or suffering to VA patients and resources. Preventive Maintenance: Contractor shall provide annual preventive maintenance service on equipment, in scheduled month of each contracted Period of all work between Standard Business Hours, weekend hours, and non-standard hours, and arranged through the COR. The contractor shall work with the COR and Surgery service to not disrupt patient care by scheduling PM visits in advance. The visits will include equipment verification by an OEM-trained technician. Before the expiration of each period of performance, the contractor shall provide the COR with a report certifying the equipment listed in this PWS has been calibrated to O.E.M. standards not less than annually during the contract period. All parts shall be O.E.M. standard or certified. Service Call: Unscheduled service should be conducted at no additional cost during standard business hours, Monday through Friday, 8:00 AM 5:00 PM. Non-emergency service (machine still able to run with no increased patient risk) should be available, with a technician onsite at location, within 48 hours notice from the COR. If support call for repair service is deemed mission-critical, contractor will be on-site performing corrective action response to service calls within 24 hours of notice from COR, barring special circumstances. 24 hour service call center support should be available to schedule corrective service calls. Technical phone support shall be available weekdays from 7:00 AM 7:00 PM at no additional charge. Software Updates: Contractor shall provide any software updates, as they become available, for all equipment, at no additional cost. All software changes made become the property of the VA. Help Desk Support: Contractor shall provide emergency telephone support during Standard Business Hours, as a minimum at no additional charge, with phone calls returned no later than 2 hours after a voice message has been left by the COR. Modifications: If contractor or external hazard assessment/notification by the FDA, NCPS, or CEOSH determines that a modification is necessary to address safety concerns or reliability, installation and modification will be performed at no additional charge. Parts: As part of the OEM-standard of service required on this contract, contractor must provide unique and/or high mortality replacement parts. All parts will be O.E.M. recommended parts. Shipment: Contractor shall be responsible for shipment of repair parts and substitute equipment at no expense to the government, with FOB destination terms applicable in these circumstances, and in favor of the VA Medical Center at this location. GOVERNMENT FURNISHED EQUIPMENT / PROPERTY (GFE / GFP) Government Property is any real property at the VAMC accessed by the Contractor in the performance of services in accordance with the PWS. Condition of Equipment The Contractor shall accept responsibility for the equipment in "as is" condition. Failure to inspect the equipment prior to contract award shall not relieve the Contractor from performance of the requirements of this contract. Storage Storage for Contractor equipment is not provided at the VAMC. The Contractor is responsible for the security of its equipment. The Government is not responsible for the security of Contractor equipment. CONTRACTOR FURNISHED EQUIPMENT / PROPERTY (CFE / CFP) Service Manuals/Tools/Equipment The VAMC shall not provide tools, (test) equipment, service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation (such as; operational and service manuals, schematics, and parts list) which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name and/or the manuals themselves shall be provided to the CO upon request. QUALITY Conformance Standards Contractor shall ensure that their services, staff and equipment used in the performance of this contract conform and comply with the latest industry service standards, information, guidance, regulations and publications of the following: AAMI-ANSI ST-79:2010 Part 7.7 standards (Servicing and Repairs of Devices in the Health Care Facility). This can be obtained at http://www.aami.org/publications/standards/st79.html IAHCSMM - International Association of Healthcare Central Service Materiel Management US FDA US Food and Drug Administration CDC Centers for Disease Control and Prevention CDRH Center for Devices and Radiological Health ISO (As a minimum: ISO 9001:2008 Certification and ISO 13485:2003 certification (medical devices)) ASQ American Society for Quality UL Underwriters Laboratories OSHA Occupational Safety and Health Administration Safety The Contractor must perform services in accordance with: local, state and federal Occupational Safety and Health guidelines and legislation, to include Occupational Safety and Health Administration (OSHA), the American National Standards Institute (ANSI) safety guidelines, and any VA Medical Center Directives; local, state and federal Fire and Safety legislation and guidelines, to include VA Medical Center directives and legislation on Fire and Safety; all other Conformance Standards identified in this PWS Medical Center Policies Each VA Medical Center has policies that are updated from time to time. The COR can provide more detailed information to the contractor of these upon commencement of the contract and throughout the term of the contract, as needed, especially policies regarding, parking, possession of weapons, cell phone use and photography as well as smoking on VA property. Violations of such policies may result in individual fines or citation answerable in the United States (Federal) District Court. Remedy or Rework Rework or Remedy is defined as performing the Service again until the Purpose of this PWS is achieved in full. This involves less than Satisfactory Service by the Contractor and as noted by the COR. Rework or Remedy must occur within 3 business days of the notice of the rework or remedy requirement from the COR and at no additional cost to the Government. Inspection and Acceptance of Services: The Government reserves the right to inspect and test services in accordance with this PWS and the Contract. The only individual authorized to officially accept services is the COR. While inspection of services may be delegated by the COR and a shared responsibility with departmental management staff, the COR is ultimately the only authorized individual to approve and accept services on behalf of the VA. DELIVERABLES (refer also to Technical Qualification and Contact Points for additional Deliverables) Service Report (SR) Contractor is responsible for providing Service Reports for every service. A Service Report is required for all: outgoing serviced equipment with an inventory of all equipment collected by the contractor, and incoming serviced equipment with an inventory of all equipment completely serviced and delivered by the contractor and with the Service Report provided to the COR at the time of delivery of serviced equipment. Such documentation shall meet the guidelines as set forth in the Conformance Standards. In addition, each Service Report shall, at a minimum, document the following data legibly and in complete detail: Name of contractor and contract number. Name of Field Technician who performed services. Contractor s Service Report number/log number. Date and time (arrival and departure) of Field Technician on-site at VA collecting and delivering equipment VA purchase order number Description of problem reported by COR. Details of Equipment serviced: Equipment set numbers Device name, instrument type Serial number Any other manufacturer's identification numbers. PMR and Service description Signatures: Field Technician performing services described. COR acceptance signature Service Reports (Engineers Service Report (ESR) or Service Report) When the service is completed, the Field Technician shall document services rendered on a legible Service Report(s). During Check In/Check Out procedures with the COR, the Field Technician must provide the COR with the Service Report(s) for that service visit. ESR can be submitted electronically to the COR, not exceeding 5mb in size, following service completion yet before the Technician departs the location to ensure the COR has an opportunity to review and provide an acceptance signature. All Service Reports shall be submitted to the COR for an "acceptance signature". If the COR is unavailable, a signed copy of the Service Report shall be sent to the Contractor after the work can be reviewed (if requested or noted on the Service Report). The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the COR (in writing) of the existence or the development of any defects in the equipment submitted for service which the Contractor considers he/she is not responsible for under the terms of the contract and where replacement is recommended. TECHNICAL QUALIFICATIONS and PERSONNEL STANDARDS Calibration of Vendor s Equipment: Contractor must provide the COR with certification attesting that all gauging and measurement equipment used to check and calibrate the subject items of equipment has been calibrated either according to the manufacturer s specifications or within the last twelve months against a standard that is traceable to the National Bureau of Standards. Contractor must provide the COR and Contracting Office with such documentation, as a minimum: Within 5 business days of contract award, Within 5 business days after renewal or extension of services in accordance with, and if permitted by applicable FAR clause, and and in advance of commencing services on equipment identified in this PWS. Qualifications of Contractor OEM-Trained Technicians: Contractor shall document, in writing, their experience in working on the identical make and model equipment listed in this PWS as well as the qualifications of individuals who will work on the equipment. Where the PWS requires OEM-trained technicians, demonstration of this will also be required in the documentation. Contractor must provide the COR and Contracting Office with such documentation, as a minimum: Within 5 business days of contract award, Within 5 business days after renewal or extension of services in accordance with, and if permitted by applicable FAR clause, and immediately, when previously assigned OEM-trained technicians have been replaced, and in advance of commencing services on equipment identified in this PWS. The contractor shall have sufficient staff to satisfactorily support this contract, including the PWS and its purpose. Contractor staff providing services on this contract must include a "fully qualified" Filed Service Engineer (FSE) and a "fully qualified" FSE who shall serve as the backup. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program, for the equipment. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance of the equipment in this contract The FSEs shall be authorized by the Contractor to perform the maintenance services. All work shall be performed by "Fully Qualified" competent FSEs. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the Contractor services at the VAMC. The CO may authenticate the training requirements, request training certificates or credentials from the Contractor at any time for any personnel who are servicing or installing any VAMC equipment. The CO and/or COR specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment. If subcontractor(s) are used, they shall be approved by the CO prior to commencement of services. The Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval. Contractor Employee s On-site At Location: At all times during performance of Services, in accordance with this PWS, the Contractor must ensure Contractor personnel: Be able to function professionally amongst the general public in a hospital and health care environment. Where possible, a warm-natured and humane approach is preferred. Be able to read, understand and apply printed rules, detailed orders, and instructions Be familiar with and compliant with this PWS and Contractual requirements. Be displaying VA Identification badges and Contractor-issued name tags, clearly visible to the general public Be directly and personally escorted by the Contractor s on-site Supervisor when Contractor personnel are not displaying VA Identification badges and Contractor-issued name tags Maintain a neat, clean, professional appearance Be properly attired in Contractor-issued uniforms which clearly display Contractor branding, keeping in accordance with VHA Dress Policies. Compliant with VA Safety and OSHA regulations throughout the VA Medical Center, as well as VA Medical Center policies. Compliant with parking requirements at the VAMC and park only in the designated parking areas as assigned by the COR. Maintain Decorum at all times. During the performance of services care and consideration must be given to VA visitors and staff. All Services must be performed with minimal disturbance or hindrance to VA Medical Center visitors and staff, specifically maintaining the requirements identified in the Overview of this PWS. Contractor shall not be considered government employees for any purpose. SECURITY PROCEDURES AND OPERATING HOURS Check In/Out Procedures Prior to commencement of services, and when visiting the VA Medical Center, the Contractor or Contractor s authorized Field Technician, must check in and out with the COR. Only individual VA Biomedical management staff, as delegated by the COR, can coordinate check in and check out procedures for the Contractor in the absence of the COR. Due to heightened security requirements, the Contractor or their authorized service representative will be required to wear an ID Badge which will be signed for upon arrival and turned in when leaving. All Badges must be worn at or above the waist and facing forward. This Badge must be turned in before leaving the premises; otherwise the person signing for it will be required to pay for the unreturned ID Badge. Standard Business Hours and Federal Holidays: Contract performance shall occur during standard business hours unless approved and arranged through the COR. Standard hospital hours are 8 AM to 5 PM. Contractor must coordinate all services with the COR. The Federal Government observes the following days as holidays. New Year s Day January 1st * Martin Luther King s Birthday Third Monday in January Presidents Day Third Monday in February Memorial Day Last Monday in May Independence Day July 4th * Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11th * Thanksgiving Day Fourth Thursday in November Christmas Day December 25th * *Holidays that fall on Saturday are observed on the preceding Friday. Holidays that fall on Sunday are observed on the following Monday. In addition to the days designated as holidays, the Government observes the following days: Any other day designated by Federal Statute Any other day designated by Executive Order Any other day designated by the President of the United States to be a Federal holiday Contractor holidays not included in the table of government holidays or other observation days listed above shall not be considered official holidays and shall be included in the contract performance as standard business days for the purposes of repairs and maintenance. CONTACT POINTS Contractor Point of Contact (POC) The Contractor shall specify an individual who shall serve as a single point of contact for all contract issues (POC). Contractor must provide the COR and Contracting Office with the POC contact details, to include business phone number or cell phone number and email, as a minimum: Within 5 business days of contract award, Within 5 business days after renewal or extension of services in accordance with, and if permitted by applicable FAR clause, and Within 5 business days prior to a change in the POC by the Contractor. The POC must be easily accessible by phone and return COR calls within 48 hours of a voice message left by the COR. Contracting Officer s Representative (COR) Upon contract commencement, the Contracting Officer will notify the Contractor in writing as to the COR assigned to this contract, and upon reassignment of a new COR, as applicable. Contractor shall only respond to requests for service from the COR or the CO. If service is requested from any source, other than the COR or the CO, the Contractor is to advise the individual of this requirement and refuse to respond. Any billing resulting from unauthorized service will not be paid by the government. The COR will evaluate the contractor s performance through review of the Contractor s Quality Control Procedures in accordance with this contract and PWS. Authority of the COR The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract. In the event the Contractor affects any changes at the direction of any person other than the Contracting Officer, the changes will be considered to have been made without authority and no adjustment will be made in the contract price or schedule to cover any increase in costs incurred as a result thereof. The Contracting Officer shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract, and/or modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer. Any invoicing or charges resulting from unauthorized service will not be paid by the government. Government Alternate Points of Contact (POC) Emergencies Only The COR will identify Alternate Points of Contact (POC) to be used only for instances of emergencies when the COR is not easily contactable. These will be individuals in supervisory or managerial roles within the Biomed department. The contractor will be provided this information within 5 days after contract award and within 48 hours of a change to this information. An Alternate POC does not replace the COR nor do they replace the Contracting Officer during the performance and administration of this contract, nor does it relinquish or diminish the Contractor s requirements in relation to the performance of this Contract. LIABILITIES AND INSURANCES Protection from Damage Contractor shall provide all labor, materials, and equipment necessary for protection of VAMC personnel, furnishings, equipment and buildings from damage, and shall replace or repair any damage due to work performed under this contract equal to its original construction and finish. Liability Insurance Contractor must provide the COR and the CO with written confirmation that Contractor has adequate insurance protection against negligent work and other forms of liability. DEFINITIONS Acceptance Signature - COR's signature; indicates COR accepts work status as stated in Service Report. Contractor Employees has the same meaning as Contractor Personnel Contractor Personnel - has the same meaning as Contractor Employees COR Contracting Officer s Representative FDA - Food and Drug Administration (U.S. Department Of Health And Human Services) Field Technician or Field Service Engineer (FSE) - a person who is authorized by the contractor to perform PMR services on VA premises. Also known as Technically Trained Personnel. ISO - International Organization for Standardization Labor refer to Technically Trained Personnel, also Field Technician O.E.M. or OEM Original Equipment Manufacturer. The actual manufacturer and point of origin of the equipment. The OEM provides schematics and standards for maintenance and repair of the equipment and equipment shall be maintained in accordance with these practices. The OEM is identified in the Background section of this PWS. OEM-trained Technicians means contractor technicians (Technically Trained Personnel, FSE, Field Technicians), be they OEM or third party provided, who are formally trained to OEM standards to satisfactorily perform services on equipment in this PWS. Where OEM-trained technicians are required in the PWS it means that services are to be performed at no less than this criteria, for the period of performance at the location, to ensure the PWS Purpose is met in order to avoid future equipment breakdowns or malfunctions which could lead to the VA being accused of malpractice or negligence. This assists the VA in meeting its Mission. Original Equipment Manufacturer - OEM OSHA Occupational Safety and Health Administration PMI - Preventive Maintenance Inspection Service Report - a documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract. Services includes Preventive Maintenance and Repair for equipment and components listed in this PWS and in accordance with this PWS SR Service Report Technically Trained Personnel are personnel and/or employees who shall be suitably knowledgeable in the field related to the services in this PWS in order to satisfactorily perform services in accordance with the PWS. The contractor shall provide personnel experienced and qualified to perform the required services in accordance with industry practices and standards. Also known as Field Technician or Field Service Engineer (FSE). For example, this could mean German-trained technicians, certified technicians etc. Technically Trained Personnel are also known as Contractor Personnel or Contractor Employees or Technicians. VAMC Veterans Affairs Medical Center Location of performance VA Medical Center 921 NE 13th. St. Oklahoma City, OK 73104-5007 IMPORTANTR NOTE: This RFI (Request for Information) is for information only; no award will be made from this RFI. Please communicate via e-mail to Mitchael.Purdom@va.gov by COB May 20, 2019 as to your company s ability to perform service per this brief Scope of Work. If interested please provide the following: Please state your company s business size Please provide DUNS number If you have a FSS/GSA contract that includes this service Provide FSS/GSA contract number if applicable