Sources Sought

SOURCES SOUGHT SYNOPSIS (Not a Notice of Solicitation) The United States Air Force, AFLCMC/PZIO Operational Contracting Branch, Wright-Patterson AFB, Ohio is seeking capabilities packages of potential sources including Small Business (SB), 8(a), HUBZone, and Service-Disabled Veteran-Owned Small Business (SDVOSB) concerns. This Sources Sought Synopsis is published for market research purposes only, to identify potential sources capable of providing an automated chemistry testing platform that is fully automated, walk away, fully integrated, and provides a random access platform capable of high throughput for the Clinical Laboratory at Wright-Patterson Air Force Base hospital for instrumentation, reagents, consumables and support to perform, on a single platform in accordance with the requirements of industry standards and applicable local, state, and Federal laws. Specifically, the Government is seeking reagents, consumables, and support to perform automated clinical chemistry and immunochemistry testing that must be compatible with the existing Cobas 6000 single platform analyzers. TECHNICAL REQUIREMENTS and SALIENT CHARACTERISTICS The automated chemistry testing platform must provide instrumentation, reagents, consumables, and support to perform, on a single platform: 1. Acetaminophen 2. Alanine Amino Transferase (ALT) 3. Albumin (ALB) 4. Alkaline Phosphatase (ALKP) 5. Amylase (AMY) 6. Ammonia 7. Amphetamines 8. Aspartate Amino Transferase (AST) 9. Vitamin B12 10. Barbituates 11. Benzodiazepine 12. Blood Urea Nitrogen (BUN) 13. N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) 14. Calcium (CA) 15. Carbamazepine 16. Carbon Dioxide (CO2) 17. Cerebral Spinal Fluid (CSF) a. Glucose b. Protein 18. Chloride (CL) 19. Cholesterol (CHOL) 20. Cocaine 21. Cortisol 22. C-Reactive Protein (CRP) 23. C-Reactive Protein High Sensitivity (CRP HS) 24. Creatinine (CREA) 25. Creatinine Kinase (CK) 26. Creatinine Kinase MB (CK-MB) 27. Digoxin 28. Direct Bilirubin (DBIL) 29. Estradiol 30. Ethanol 31. Ferritin 32. Folate 33. Follicle Stimulating Hormone (FSH) 34. Free Thyroxine (FT4) 35. Gamma-Glutamyl Transpeptidase (GGT) 36. Gentamicin 37. Glucose 38. Hemoglobin A1c (HbA1c) 39. High Density Lipoprotein (HDL) 40. Human Chorionic Gonadotropin (HCG), STAT 41. Iron (FE) 42. Iron Binding Capacity (TIBC) 43. Lactate Dehydrogenase (LD) 44. Lactic Acid (LA) 45. Lipase 46. Lithium (LIT) 47. Luthenizing Hormone (LH) 48. Magnesium (MG) 49. Methadone (METH) 50. Opiates 51. Parathyroid Hormone (PTH) 52. Phencyclidine (PCP) 53. Phenobarbitol 54. Phenytoin 55. Phosphorus (PHOS) 56. Potassium (K) 57. Procalcitonin 58. Progesterone (PROG) 59. Prolactin 60. Prostate Specific Antigen (PSA) 61. Salicylate 62. Sodium (NA) 63. Testosterine 64. Tetrahydrocannabinol (THC) 65. Theophylline 66. Thyroid Stimulating Hormone (TSH) 67. Total Bilirubin (TBIL) 68. Total Protein (TP) 69. Triiodothyronine (T3) 70. Thyroxine (T4) 71. Triglycerides (TRIG) 72. Troponin 73. Uric Acid 74. Valproate 75. Vancomycin 76. Microalbumin 77. Urine chemistry a) Na b) K c) Cl d) Creat e) Ca f) Phos g) Ua h) Protein i) Urine nitrogen j) Amylase Additionally, the automated chemistry testing platform must fulfill the following specifications: A. Must be capable for high throughput of at least 100-150 tests per hour. The contractor will provide enough instrumentation, reagent and consumables to complete an average daily test load within a 24 hour window. Without the use of additional middle-ware, the instrumentation must prompt the user when quality control (QC) is expired and/or about to expire on all analytes/reagents. The analyzer will not perform testing on expired calibrations or reagent. (The daily workload can be estimated from the anticipated annual workload and factoring in MON - FRI testing, including all down days, weekends and federal holidays; see Table 1). B. The system shall come equipped to perform statistical analysis of Quality Control data including QC lot numbers, means, ranges, SD, and CVs%. C. The application shall validate QC results by checking them against user selected rules and automatically alert the operator when a rule violation has occurred. D. The QC software shall provide the capability to write user defined Westgard QC Rules. E. The QC software shall have a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics - all available to user. F. The analyzer system shall include a data management system for control of the operation of the analyzer system, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer for the production of hard copy patient reports and other reports generated via the analyzer system's data management system. G. Must have a bidirectional computer interface that is compatible with Composite Health Care System (CHCS). H. Must sample directly from primary patient tube. I. Must have the capability of reloading sample, reagent and supplies without interruption from sample processing J. Must detect if primary patient sample has inadequate volume for required testing. H. Must automatically dilute patient sample if initial testing is outside the reportable range. I. Must have automatic clot detection. J. Must have continuous specimen loading capability. K. Must have automatic test reflex capability that is programmable by the user. L. Must indicate the hemolysis, icterus, and lipemia level in plasma and/or serum samples. M. Each analyzer shall come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer, to include the data management system for 15 to 20 minutes. N. If the system requires a water source, the water source must not be external and must be internal to the instrument platform. The contractor shall provide the following: I. INSTRUMENT INSTALL AND TRAINING SUPPORT: A. Must provide instrument transportation, delivery, and installation, to include calibration and test and system validation support within 90 calendar days after the contract award. B. The Contractor shall provide initial on-site operator training to all technicians assigned to the Government site (Wright-Patterson Lab Staff) prior to initiation of use of the analyzer for patient testing. C. Must provide training to include: onsite training and vendor specific to cover training that is not covered at onsite training. Offsite training will be a minimum of two per year and will be available over the length of this contract. The contractor will provide, all expenses to include but not limited to travel, lodging, meals and any additional expense that are training specific. D. The Contractor shall provide on-site training for 10-15 technicians annually at no additional cost to the Government or individual trainee. E. The laboratory will have patient testing and resulting capability into the Composite Healthcare System (CHCS) on all required analytes by 120 calendar days after the contract award. II. INSTRUMENT REPAIR AND MAINTENANCE: At a minimum, the contractor will provide the following maintenance and repair services: A. Must provide onsite maintenance (monthly, quarterly, annually, etc.) in accordance with manufactures guidelines. B. Must provide all required tools, parts and labor as necessary to keep the instrument operational. C. Must provide over the phone, instrument technical support during all duty hours (24 hours a day, 7 days a week). D. The contractor will monitor equipment to ensure instrument downtime will not exceed 24 hours for a single occurrence. E. In the event of an instrument failure, the contractor will provide onsite technical support with a response time of <12 hours. The contractor is responsible for all tools, parts, travel/lodging and labor that are necessary to bring the instrumentation back online in <24 hours from service call. F. In the case of both instruments simultaneously failing contractor will provide onsite technical support in <8 hours. The contractor is responsible for all tools, parts, travel/lodging and labor that are necessary to bring at least one instrumentation back online in <24 hours from service call. G. Scheduled routine services shall be performed between 0730-1630 Monday-Friday, excluding Federal Holidays. H. During any period when the analyzers are inoperable, the Contractor shall pay all costs associated with the provision of alternative testing, including those for delivery of hardcopy patient results by express courier, directly to the laboratory, for as long as the analyzers remain inoperable. I. The Contractor shall be responsible for the collection and transportation of equipment upon termination of the contract. J. The Contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for the analyzer failure at no additional cost. K. The Contractor shall replace all reagents, calibrators, controls and any other materials used by the Government to trouble shoot the instrument failure prior to notification of the contractor. L. Within one working day after completion of a repair, the Contractor's representative shall provide one copy of a service report for all services performed. M. When required, the Contractor shall comply with the Occupational Safety and Health Administration lockout and tagout procedures while performing maintenance on electrical equipment. N. The Contractor shall provide all material to verify analytical measurement range. O. All analyzers and associated parts and accessories shall be new. No used, refurbished, - grey market', or like-new equipment shall be provided in support of this contract at any time. P. If the instrument requires a water source all repair of the water source will be covered by the contractor IAW with the aforementioned repair timelines. III: MINIMUM REAGNET REQUIREMENTS: At a minimum, the contractor will provide the following maintenance and repair services: A. The Contractor shall provide the reagents and shall coordinate exact quantities and shipment schedule prior to shipment. B. The minimum shelf life of the reagents will be three (3) months after the date of delivery. C. All reagent kits must be FDA approved and will exhibit at least 95% sensitivity and 95% specificity. D. Upon request, sufficient reagents shall be provided by the vendor for in-house evaluation of each analyte. E. Following evaluation, each test kit shall exhibit at least 95% agreement with test kits currently in use. F. The vendor will be the sole manufacturer and distributor of the test kits with the exception of TDM reagents. G. The vendor shall comply with all FDA regulations, the College of American Pathologist (CAP) checklist; current edition. H. All reagent kits must come from the specific manufacturer that produces the analyzer. The reagents will be analyzer specific, and not outsourced from other companies with the exception of Therapeutic Drug Monitoring (TDM). The TDM assays may be a manufacturer validated assay not made by the vendor. IV: UPGRADE OF EQUIPMENT A. Subject to mutual agreement between the Government and the Contractor, instrumentation may be upgraded within the specifications of the contract as new technology may become available. B. Additionally, the Government will add reagents through the life of this contract as a result of advances in technology or changes to clinical practice standards. Any such change to the reagents shall be mutually agreed upon by the contractor and the Government through a bilateral modification. V: CONTRACTOR PERSONNEL: A. Contractor Employees. The Contractor shall not employ persons for work on this contract if such employee is identified to the Contractor by the Contracting Officer as a potential threat to the health, safety, security, general well- being or operational mission of the installations and their population. B. Contractor employees shall present a neat appearance. Contractor personnel shall either wear a distinguishable uniform or badge on the exterior of their clothing while performing any service at any Government facility. C. The Contractor shall not employ any person who is an employee of the Department of Defense, either military or civilian, unless such person seeks and receives approval according to DOD 5500.7R, "Joint Ethics Regulation". VI: CONSERVATION OF UTILITIES: A. Lights shall be used only in areas where work is actually being performed. B. Employees shall not adjust mechanical equipment controls for heating, ventilation, and air conditioning systems. C. Water faucets or valves shall be turned off when not in use. D. Environmental and Hazardous Materials Handling. If the disposal of any waste or byproduct of the analyzers cannot be safely dumped into the facility's drain system, the Contractor must provide guidelines for safely disposing these wastes or byproducts in accordance with local and national guidelines. As a reminder, these are draft salient characteristics and technical requirements which are subject to be changed. The North American Industry Classification System (NAICS) code for this requirement is 334516 -Analytical Laboratory Instrument Manufacturing, with a size standard of 1,000 employees. The Government reserves the right to consider a small business set-aside based upon responses hereto for any subsequent action. All prospective contractors must be registered in the System for Award Management (SAM) database to be awarded a DoD contract. No set-aside decision has been made. Note that a key factor in determining an acquisition to be a Small Business Set Aside is that small business prime contractors must perform at least 50% of the effort, as defined in Federal Acquisition Regulation (FAR) clause 52.219-14. The Air Force anticipates an acquisition for a Firm Fixed Price contract. Any information submitted by respondents to this sources sought synopsis is voluntary. This sources sought notice is not to be construed as a commitment by the Government, nor will the Government reimburse any costs associated with the submission of information in response to this notice. Respondents will not be individually notified of the results of any Government assessments. The Government's assessment of the capability statements received will factor into whether any forthcoming solicitation will be conducted as a full and open competition or as a set-aside for small businesses, or any particular small business program. INSTRUCTIONS: 1. The information below provides a "Contractor Capability Survey" to allow you to document your company's capabilities in meeting these requirements. 2. If, after reviewing these documents, you desire to participate in the market research, please complete and return the Contractor Capability Survey below. Response format and due date information is specified at the bottom portion of this notice. Failure to provide a complete response may result in the Government being unable to adequately assess your capabilities. If you lack sufficient experience in a particular area, please provide details explaining how you would overcome the lack of experience/capabilities in order to perform that portion of the requirement (i.e., teaming, subcontracting, etc.) 3. Both large and small businesses are encouraged to participate in this Market Research. Joint ventures or teaming arrangements are encouraged. Questions relative to this market survey should be addressed via email to Ms. Kelsie Cooley, AFLCMC/PZIOA, at kelsie.cooley@us.af.mil. CONTRACTOR CAPABILITY SURVEY: Part I. Business Information: Please provide the following business information for your firm: ? Company/Institute Name: ? Address: ? Point of Contact: ? CAGE Code: ? Phone Number: ? Email Address: ? Web Page URL: Based on North American Industry Classification System (NAICS) code 334516 -Analytical Laboratory Instrument Manufacturing, with a size standard of 1,000 employees, please circle Yes or No as to whether your company is: ? Small Business (Yes / No) ? Small Disadvantaged Business (Yes / No) ? 8(a) Certified (Graduation Date: _______________) (Yes / No) ? HUBZone Certified (Yes / No) ? Veteran-Owned Small Business (Yes / No) ? Service-Disabled Veteran-Owned Small Business (Yes / No) ? Women-Owned (WO) (Yes / No) ? Economically Disadvantaged Women-Owned Small Business (Yes / No) ? Please indicate if your company is domestic or foreign owned (if foreign, please indicate the country of ownership). ? Indicate if you are the manufacturer or provide the name and size of the manufacturer of the product(s) you will be supplying. ? Please provide a statement that the respondent will allow or will not allow the Government to release proprietary data. The Air Force will handle proprietary items in accordance with FAR 2.101 and 3.104. ? Please provide information about the firm's standard warranty. ? Please provide recent sales history to commercial companies in order to determine commerciality. ? Please provide a statement to acceptability of the following proposed provisions and clauses, as they are determined to be consistent with customary commercial practice. At this time the following non-commercial clauses are being considered for inclusion in the solicitation package: FAR 52.203-6 Alt I, Restrictions on Subcontractor Sales to the Government FAR 52.204-4, Printed or Copied Double-Sided on Postconsumer Fiber Content Paper FAR 52.204-7, System for Award Management FAR 52.204-13, System for Award Management Maintenance FAR 52.204-16, Commercial and Government Entity Code Reporting FAR 52.204-18, Commercial and Government Entity Code Maintenance FAR 52.215-20, Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data FAR 52.228-5, Insurance-Work on a Government Installation FAR 52.229-3, Federal, State, and Local Taxes FAR 52.232-39, Unenforceability of Unauthorized Obligations FAR 52.233-2, Service of Protest FAR 52.242-13, Bankruptcy FAR 52.252-1, Solicitation Provisions Incorporated by Reference FAR 52.252-2, Clauses Incorporated by Reference FAR 52.252-5, Authorized Deviations in Provisions FAR 52.252-6, Authorized Deviations in Clauses DFARS 252.203-7002, Requirement to Inform Employees of Whistleblower Rights DFARS 252.204-7003, Control of Government Personnel Work Product DFARS 252.209-7004, Subcontracting with Firms that are Owned or Controlled by the Government of a Country that is a State Sponsor of Terrorism DFARS 252.225-7002, Qualifying Country Sources as Subcontractors DFARS 252.225-7048, Export-Controlled Items DFARS 252.243-7001, Pricing of Contract Modifications AFFARS 5352.201-9101, Ombudsman AFFARS 5352.223-9000, Elimination of Use of Class I Ozone Depleting Substances (ODS) Attention: Small business respondents who are interested in submitting a proposal as the prime contractor for this effort: The acquisition strategy for this requirement has not been decided; however, the Air Force is contemplating setting this acquisition aside for small businesses if there is sufficient demonstrated interest and capability. Note that a key factor in determining an acquisition to be a Small Business Set Aside is that two or more small business prime contractors must be capable of providing at least 50% of the entire scope of providing the automated chemistry testing platform, as defined in Federal Acquisition Regulation (FAR) clause 52.219-14, Limitations on Subcontracting. Provide specific details and rationale as to how compliance with FAR clause 52.219-14 would be achieved, including specific details regarding teaming arrangements, etc. If subcontracts are to be used, provide anticipated percentage of effort to be subcontracted and whether small or large businesses will be used. Teaming and/or subcontracting arrangements should be clearly delineated and previous experience in teaming must be provided. Attention All potential respondents: If this acquisition is not set aside for small business, it is anticipated that the contract may contain a small business utilization requirement. Please provide feedback on what areas of this requirement are likely candidates for small business subcontracting. Part II. Capability Survey Questions: 1. Name of country where the components of the automated chemistry testing platform are manufactured. 2. Describe briefly the capabilities of your facility and the nature of the services you provide. Include a description of your staff composition and management structure. 3. Describe your company's past experience on previous projects similar in complexity to this requirement. Include contract number and date, a brief description, agency/organization supported, and point of contact name and telephone number. 4. Are there specific requirements in the documentation that we provide that would currently preclude your product/service from being a viable solution to our requirement? 5. Are there established market prices for our requirement? If you offer this product and/or service to both U.S. Government and commercial sources, is the same workforce used for both the U.S. Government and general public? Is our requirement offered to both under similar terms and conditions? Briefly describe any differences. 6. Describe your standard warranty and return process for goods and services furnished to the Government for items similar in nature to this requirement. CAPABILITIES PACKAGE: All interested firms shall submit a response demonstrating their capabilities to provide the requested items to the primary point of contact listed below. Any information submitted by respondents to this sources sought synopsis is voluntary. As stipulated in Federal Acquisition Regulation 15.201, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Any information submitted by respondents to this sources sought synopsis is voluntary and will not be returned. The Government will not reimburse any costs incurred or associated with the submission of information in response to this notice. The decision to solicit for a contract shall be solely within the Government's discretion. Responses are limited to 5 pages and may be submitted electronically to the following email address: kelsie.cooley@us.af.mil in a Microsoft Word compatible format or mailed to AFLCMC/PZIOA POC: Ms. Kelsie Cooley, 1940 Allbrook Drive, Building 1 Room 109, Wright-Patterson AFB, OH 45433-5344 to be received no later than 12:00 p.m., EST, Wednesday, November 16, 2016. Direct all questions concerning this acquisition to Ms. Kelsie Cooley at kelsie.cooley@us.af.mil or 937-522-4556. The Government's assessment of the capability statements received will factor into whether any forthcoming solicitation will be solicited as full and open or set-aside for small business, or any particular small business program (e.g. SDVOSB, EDWOSB, HUBZone, 8(a), etc.). Be advised that all correspondence sent via e-mail shall contain a subject line that reads "Automated Chemistry Testing Platform." If this subject line is not included, the e-mail may not get through e-mail filters at Wright-Patterson AFB. Filters are designed to delete emails without subject lines or with suspicious subject lines or contents. Attachments with files ending in .zip or .exe are not allowable and will be deleted. Ensure only .pdf, .doc, or .xls documents are attached to email.