Refractive Eye Surgery Equipment Maintenance

The 10th Contracting Squadron (10 CONS/PKB), United States Air Force Academy (USAFA) intends to award on Sole Source basis to the vendor, Johnson & Johnson for preventative maintenance and repair services on Abbott Medical Optics, Inc. (now Johnson & Johnson Vision) manufactured refractive surgical equipment. This notice document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005-100, effective 22 August 2018. 10th Medical Group currently has refractive surgical equipment that requires semiannual preventative maintenance and unscheduled repair services. Equipment includes one (1) IntraLase FS Laser System, one (1) Visx Star S4 Laser System, and two (2) Wavescan Measurement Systems. Period of Performance is one (1) year. Johnson & Johnson is the only authorized service provider and parts supplier for the Abbott Medical Optics Inc. manufactured equipment. This procurement is for the acquisition of a sole source commercial item using simplified procedures in accordance with FAR Parts 12 & 13. The North American Industry Classification System Code (NAICS) is 811219 and the business size standard is $20.5M. 1. Only one responsible source, and no other, will satisfy current USAFA requirements. 2. Comprehensive preventative maintenance on the refractive surgical equipment is required. Services must be in accordance with (IAW) manufacturer's preventive maintenance procedures. Repairs must be performed IAW manufacturer requirements on all unscheduled repair service calls. All parts used during maintenance and repair services should be original equipment manufacturer parts. All personnel, software updates, parts, tools, materials, supervision, technical literature, manufacturer repair requirements/manuals, transportation and services necessary to meet the refractive surgical equipment maintenance and repair services requirement shall be provided. All services shall be conducted using manufacturer trained and authorized personnel. Maintenance of refractive surgical equipment, to include repairs shall be performed IAW manufacturer specifications. The following summarizes the justification and approval of single source from Johnson & Johnson by detailing more specifically the proprietary nature of the requirement, as well as requirements that other vendors do not meet. a. Johnson & Johnson is the manufacturer of our existing refractive surgical equipment. b. IAW AFI 41-209, Medical Logistics Support, the purchase of refurbished or used medical equipment is not authorized, and the use of refurbished components is authorized only if provided by the original equipment manufacturer (OEM), an OEM-approved source or subsidiary, or Department of Defense or VA depot services. c. In order to ensure equipment accuracy and patient safety, preventative maintenance and repairs services for Johnson & Johnson equipment can only be performed by Johnson & Johnson-trained and authorized/certified personnel. All equipment must be serviced in accordance with manufacturer specifications, any deviation from these service procedures could put medical patients at risk of injury or death. In addition to having an authorized Johnson & Johnson service technician, suitable replacement equipment parts can only be provided by the manufacturer. d. These equipment items are highly specialized, refractive eye surgery units used to measure and alter patients' eyes during surgery. Each piece of equipment item is classified, by the FDA, as a Class 2 medical device unit must adhere to rigid control standards established by the equipment manufacturer. Equipment must be maintained, tested, and inspected according to manufacturer specifications. Accreditation Association for Ambulatory Health Care requires that the hospital maintain records of equipment testing and maintenance in order to maintain accreditation. Refractive surgery units must pass daily function tests before they can be used in surgery. e. Johnson & Johnson is the only authorized service provider and parts supplier for Johnson & Johnson manufactured refractive surgical equipment. Service providers for Johnson & Johnson equipment must be Johnson & Johnson trained/certified technicians using Johnson & Johnson manufactured parts. Johnson & Johnson does not train, certify, or support independent third party providers to service their equipment or supply their parts. Johnson & Johnson trained/certified technicians and manufactured parts are required to ensure the equipment is maintained within manufacturer specifications. f. The use of an unauthorized Johnson & Johnson technician or non-manufactured Johnson & Johnson parts could lead to equipment failure or malfunction, possible patient injury or blindness, lawsuits against the hospital and potential loss of hospital accreditation. This utilization of such untrained and uncertified sources would present a significant liability and risk to the Government. Additionally, if refractive surgery equipment malfunctions, the laser eye department would not be permitted to perform surgery as scheduled, which would lead to a cancellation. Canceled surgeries result in a Government loss of $1,500 per cancellation. This synopsis is for notification purposes only and does not constitute a solicitation for bids or proposals. DO NOT submit a bid/quote at this time. Any offerors believing they can provide the preventative maintenance and repair services on Johnson & Johnson manufactured refractive surgical equipment that meets the requirements described above may provide evidence for consideration. Evidence must support the offeror's claim that they can provide these services. All qualified sources may submit a response, which if received timely, will be considered by this agency. Information received will be considered solely for the purpose of determining whether a competitive procurement can be conducted. A determination not to compete this proposed procurement based on responses to this notice is solely within the discretion of the Government. Responses must be received NLT 12:00 p.m. MDT on XX XXX 2018. Responses received after this date, will not be be considered. The Government does not intend to pay for any information provided under this announcement. Contractors must have a current registration with the System for Award Management (SAM) at http://sam.gov/. The Government intends to award a firm fixed price purchase order processed in accordance with FAR 12 and 13. Questions should be addressed to the Primary POC: Miles Montgomery, Contract Specialist, louis.montgomery.2@us.af.mil. 5352.201-9101 OMBUDSMAN (JUN 2016) (a) An ombudsman has been appointed to hear and facilitate the resolution of concerns from offerors, potential offerors, and others for this acquisition. When requested, the ombudsman will maintain strict confidentiality as to the source of the concern. The existence of the ombudsman does not affect the authority of the program manager, contracting officer, or source selection official. Further, the ombudsman does not participate in the evaluation of proposals, the source selection process, or the adjudication of protests or formal contract disputes. The ombudsman may refer the interested party to another official who can resolve the concern. (b) Before consulting with an ombudsman, interested parties must first address their concerns, issues, disagreements, and/or recommendations to the contracting officer for resolution. Consulting an ombudsman does not alter or postpone the timelines for any other processes (e.g., agency level bid protests, GAO bid protests, requests for debriefings, employee-employer actions, contests of OMB Circular A-76 competition performance decisions). (c) If resolution cannot be made by the contracting officer, the interested party may contact the ombudsman, James Anderson 8110 Industrial Drive, Ste 103 USAFA, CO 80840 Telephone number 719-333-2704 FAX 719-333-9103 Email: james.anderson.72@us.af.mil Concerns, issues, disagreements, and recommendations that cannot be resolved at the Center/MAJCOM/DRU/SMC ombudsman level, may be brought by the interested party for further consideration to the Air Force ombudsman, Associate Deputy Assistant Secretary (ADAS) (Contracting), SAF/AQC, 1060 Air Force Pentagon, Washington DC 20330-1060, phone number (571) 256-2395, facsimile number (571) 256-2431. (d) The ombudsman has no authority to render a decision that binds the agency. (e) Do not contact the ombudsman to request copies of the solicitation, verify offer due date, or clarify technical requirements. Such inquiries shall be directed to the Contracting Officer. (End of clause)