Inactive

Draft Statement of Work A. GENERAL GUIDANCE Title: Full Service and Maintenance of VA Pittsburgh Medical Center owned Sterrad 100NX Sterilizers Scope of Work: The contractor shall provide full service... Draft Statement of Work A. GENERAL GUIDANCE Title: Full Service and Maintenance of VA Pittsburgh Medical Center owned Sterrad 100NX Sterilizers Scope of Work: The contractor shall provide full service and maintenance for government owned Sterrad Sterilizers required by the requirements stated herein. The facility is located at: VA Pittsburgh Healthcare System University Drive Campus University Drive Pittsburgh, PA 15240 Background: This contract is issued to ensure the continuous reliability of two Sterrad Sterilizers identified in this SOW. The units require repair and maintenance by trained personnel using manufacturer approved parts and specifications. These units are critical for continuous sterilization of reusable medical equipment by the Sterile Processing Department (SPD) at the VA Pittsburgh Medical Center. The reliable and accurate operation of this equipment at all times is considered critical to the health of patients. Type of Contract: Firm-fixed-price. B. GENERAL REQUIREMENTS This agreement includes all preventative maintenance and corrective maintenance repairs to the Sterrad Sterilizers for continuous reliability. Equipment to be Serviced: Each of the following items are to be serviced in accordance with the specifications, terms and conditions of this contract. Line item Manufacturer Model Serial No. Location 1. Sterrad 100NX 1047180314 AA106-1-UD 2. Sterrad 100NX 1047180257 AA106-1-UD Corrective Maintenance: The Contractor and Biomedical Engineering shall maintain the equipment in accordance with Section D Conformance Standards. Service for corrective maintenance will be provided per hours of coverage defined in Section B.1g. Contractor shall provide unlimited telephone technical support, labor, travel and parts, unless specifically excluded. Service calls to the Contractor requesting service are only authorized when they are received from the COR, CO, or designated alternates. Outside of the Contract s hours of coverage, emergency on-site services require authorization by the COR. The COR or a Biomedical Engineering Staff Member shall initiate these calls. If VA staff other than the COR or a Biomedical Engineering Staff Member place calls requesting services, the Contractor shall contact Biomedical Engineering services and verify the request. Service responses on calls from unauthorized personnel can result in nonpayment. The VA Administrative Officer of the Day is an authorized caller and can also be contacted for verification. Uncorrected deficiencies or unfavorable histories of downtime can result in the termination of this contract under the Termination for Default clauses of the Federal Acquisition Regulations. Preventative Maintenance: The Contractor shall perform preventative maintenance (PM) service to ensure that equipment listed in Section B.1a performs in accordance with Section D Conformance Standards. Any exceptions to the PM schedule shall be arranged and approved in advance with the COR and provided in writing to the CO. The Contractor shall provide complete and original documentation indicating PM work performed, referencing the procedures followed, actual tests and/or evaluation results obtained to the COR at the completion of the PM service. Parts, travel, and labor necessary for PM are provided by awarded contractor at no additional customer cost. Any charges for materials such as lubricants, fluids, cleaning supplies, services, manuals, or tools required for the Contractor to successfully complete scheduled PM shall be provided by the Contractor and are included within this contract, and its agreed upon price. Preventative maintenance will be provided at a scheduled time and must be scheduled at least one week in advance to minimize the impact to patient scheduling. All exceptions to the preventative maintenance schedule and procedure shall be addressed and approved in advanced with the COR. A designated staff member will accompany the Contractor as an observer during the inspection. The inspection shall be thorough and shall conform to manufacturer and Industry Standards for the equipment. Sufficient time shall be allowed to permit a thorough inspection and test of each device comprising the overall system. Maintenance work and inspections may be combined at the approval of the COR or alternate COR if downtime is not considered significant. The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and COR, (in writing), of the existence or the development of any defects in, or repairs required to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs. Parts and Software The contract shall include all parts with the exception of consumable or expendable items. All parts supplied shall be OEM or equivalent and fully compatible with existing equipment. Used parts (or refurbished), those removed from another system, shall not be installed without approval by the COR. The contractor is required to install VA supplied parts when said parts are determined to be fully compatible. The determination of compatibility is at the discretion of the COR. All defective parts replaced become the property of the Contractor, unless otherwise specified by the CO, COR, or Alt COR. Any software patches and quality updates are included under the terms of this contract and shall be applied in accordance with manufacturer specifications. Remote Service The contractor must be able to provide remote support as needed by phone for the equipment owned by VA Pittsburgh. Personnel with OEM equipment training will respond by phone within 1 hour of the call for service. If situations are responded to by phone and do not resolve the service issue, OEM trained personnel will be required for an on-site visit within 4 hours after receipt of initial notification unless otherwise agreed upon, in writing, by the COR or Biomedical Engineering personnel. Full resolution is expected within 48 hours of initial call. If the contractor cannot remediate the issues within this timeframe, the COR or Alt COR shall be notified immediately and provided an estimated time for resolution. Hours of Coverage: The contractor will provide all required services within the normal business hours (8:00 AM to 5:00 PM (EST) M-F), excluding holidays. All services shall be performed during these normal hours of coverage unless one of the following conditions exists: The contractor wishes to furnish services at a time that is outside of the normal hours of coverage, at no additional cost to the Government, the contractor submits a request to the COR prior to the proposed start of the work, and the request is approved in writing by the COR before work is begun. The COR directs that the services be furnished at a time that is outside the normal hours of coverage and the additional cost is recommended by the COR and authorized by the CO. Customer service shall respond to service request calls 24 hours a day, 7 days a week and all holidays. Work performed outside the normal hours of coverage must be preapproved by the CO, COR or Alt COR. The Contractor will provide a written estimate of the charges prior to approval of the work. Work performed outside the normal hours of coverage at the request of FSE/contractor shall be considered service performed during normal hours of coverage. There will be no additional charge for time spent waiting at the site during or after the normal hours of coverage for delivery of parts Note: Any hardware/software update/upgrade installations shall be scheduled and performed during normal hours of coverage at no additional charge to the government. Federal Holidays Observed by the VA Medical Center: New Year s Day, Martin Luther King, Jr. Day, President s Day (Washington s birthday), Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically designated by the President of the United States. Customer Notification: Contractor shall notify Biomedical Engineering and the Police service when they arrive on site. Contractor will schedule all preventative maintenance with Biomedical Engineering. When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s) per Section E. The FSE shall be required to check out with the Biomedical Engineering Department and submit the ESR(s) to the COR. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature." If the COR is unavailable, a signed accepted copy of the ESR will be sent to the COR within five business days of work completion. FAILURE TO COMPLY, EITHER IN WHOLE OR IN PART, WITH EITHER THE NOTIFICATION OR ESR REQUIREMENTS WILL BE DEEMED SIGNIFICANT NON-COMPLIANCE WITH THE CONTRACT AND MAY BE JUSTIFICATION FOR TERMINATION OF THE CONTRACT. C. DEFINITIONS/ACRONYMS: Biomedical Engineering - Supervisor or designee, Phone Number (412) 360-3780 CO - Contracting Officer. COR - Contracting Officer's Representative. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or operative conditions. Service shall consist of calibration and testing in accordance with the manufacturer s latest established service procedures to ensure operation of equipment within manufacturer s or VA s performance specifications, whichever is the most rigorous. PM includes cleaning, inspecting lubricating and testing all equipment. All equipment shall be operated at least one complete operating cycle at the end of each PM. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VA Medical Center premises. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract. Acceptance Signature - VAPHS employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR. Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR. NFPA - National Fire Protection Association. CDRH - Center for Devices and Radiological Health. VAPHS - Department of Veterans Affairs Pittsburgh Healthcare System. OEM - Original Equipment Manufacturer D. CONFORMANCE STANDARDS: Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, JC, NEC, OSHA, HIPAA, Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA. E. DOCUMENTATION/REPORTS: The documentation will include equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards. In addition, each ESR must at a minimum document the following data legibly and in complete detail: Name of Contractor Name of FSE who performed services. Contractor Service ESR Number/Log Number. Date, Time (starting and ending), Hours-On-Site for service call. VA Purchase Order Number(s) (if any) covering the call, if outside normal working hours. Description of Problem Reported by COR/User. Identification of Equipment to be serviced to include the following: Equipment ID # or EE# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers. Itemized Description of Service(s) Performed (including Costs associated with after normal working hour services), including: Labor and Travel, Parts (with part numbers) and Materials and Circuit Location of problem/corrective action. Total Cost to be billed. Signatures from the following: FSE performing services described. VA Employee who witnessed service described. Equipment downtime calculated in accordance with Conformance Standards. Note: Any additional charges claimed must be approved by the COR before service is started. F. SCHEDULE FOR DELIVERABLES Draft copies of deliverables shall be provided to Biomedical Engineering staff at VAPHS before the contractor leaves the facility at each visit. If a final copy can be provided at that time then a draft copy is not necessary, final copies must be provided within 5 business days of the time of each deliverable. G. CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor. H. SERVICE MANUALS/TOOLS/EQUIPMENT VAPHS shall not provide service manuals or service diagnostic software to the contractor for use in providing services under this contract. 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. Prior to commencement of work on this contract, the contractor shall make available if requested a copy of the current calibration certification of all test equipment that is to be used by the contractor in performing work under the contract. This certification shall also be provided on a periodic basis when requested by VAPHS. Test equipment calibration shall be traceable to a national standard. I. CONDITION OF EQUIPMENT: The contractor accepts responsibility for the equipment described in this scope of work, in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract. J. CONTRACTOR EXPERIENCE REQUIREMENTS Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) shall have successfully completed a formalized training program, for the equipment or similar equipment identified in Section B.1a. For field experience, the FSE(s) shall have a minimum of two years of experience, with respect to scheduled and unscheduled preventive and remedial maintenance on equipment. The FSE(s) shall be authorized by the contractor to perform the maintenance services as required. 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 VAPHS. The CO may authenticate the training requirements, request copies of training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VAPHS equipment. The CO and/or the COR specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the VAPHS equipment. Any Contractor personnel must provide a copy of: 1) Tuberculosis (Tb) vaccination documentation, 2) flu vaccination documentation and 3) copy of HIPAA compliance training certificate. K. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD: The contractor shall comply with the Federal/California OSHA Bloodborne Pathogens Standard. The contractor shall: Have methods by which all employees are educated as to risks associated with bloodborne pathogens. Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract. L. INFLUENZA PREVENTION PROGRAM: VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Healthcare personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. Those HCP unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation: Documentation of vaccination, e.g., signed record of immunization from a healthcare provider or pharmacy, or a copy of medical records documenting the vaccination. Completed Healthcare Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine. The contractor is required to submit annual certification to the Contracting Officer s Representative (COR) that all contract staff performing services at VA facilities are in compliance with the VHA Directive 1192. Please complete form below: September 26, 2017 VHA DIRECTIVE 1192 APPENDIX B HEALTH CARE PERSONNEL INFLUENZA VACCINATION FORM I received the seasonal influenza vaccine this flu season (required documentation is attached.) I decline to receive seasonal influenza vaccine at this time for the following reason: Select the single answer that best fits your reason: I do not like needles. I have a philosophical or religious reason for not receiving the vaccine. I have an allergy to the vaccine or one of its components. I am concerned about the side effects/safety of the vaccine. I have never had the flu and don t think I will this season. I have another reason. (Please explain) I acknowledge that VHA policy requires health care personnel to receive the influenza vaccine every year. I understand that if I decline to receive the vaccine and/or to provide proof of vaccination by November 30 or within two weeks of beginning employment if after November 30, I must wear a face mask according to requirements and guidelines within the Directive 1192, Seasonal Influenza Prevention Program. I have read and fully understand the information on this form and have been given the opportunity to have my questions answered. Signature: Date: Name (print): Last 4 SS# Contractor Name: B-1 M. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. N. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS: The contractor's FSE shall wear visible identification at all times while on the premises of VAPHS. Identification shall include, as a minimum, the employee s name, position, and the contractor s trade name. 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. VAPHS will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings and on premise at VAPHS. This covers all smoking and tobacco products, including but not limited to: Cigarettes Cigars Pipes Any other combustion of tobacco Electronic nicotine delivery systems (ENDS), including but not limited to electronic or e-cigarettes, vape pens, or e-cigars. Chewing tobacco 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. O. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS This language is still in draft form. The OI Service Center is reviewing alternative sources for background investigations. The language included in this draft is based on last year s contract. Language must be updated to match App A for 646-20-2-068-0071 signed by ISOs. Contractor may not have access to the VA network or any VA sensitive information under this contract. Contractor owned computer equipment including laptops are not permitted to be connected to the VA network. Any removable storage device used in medical equipment must be scanned by Biomed or OIT. The following language from VA Handbook 6500.6 is required in this contract: Appendix C: Paragraphs #3a, #5h, #6a, #7a, #7d, #9 (All) See below: MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX C VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE VA INFORMATION CUSTODIAL LANGUAGE Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data -General, FAR 52.227-14(d) (1). INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: Vendor must accept the system without the drive; VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; (a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and (b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract. (c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. SECURITY INCIDENT INVESTIGATION The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. LIQUIDATED DAMAGES FOR DATA BREACH Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $___37.50___ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: Notification; One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; Data breach analysis; Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. TRAINING All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior 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 and sign the Rules of Behavior annually, within 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. [ End of Statement of Work ]