66--621-13-4-037-1073 Mountain Home Laboratory Services - FIT Fecal Occult Blood Testing

2237 Transaction # or Vista Equipment Transaction #: 621-13-4-037-1073 (INSERT) This acquisition is conducted under the authority of the Multiple Award Schedule Program. The material or service listed in par. 3 below is sole source, therefore, consideration of the number of contractors required by FAR Subpart 8.4 - Federal Supply Schedules, is precluded for the reasons indicated below. Restricted to the following source: Provide original manufacturer's name for material or contractor's Name for service. (If a sole source manufacturer distributes via dealers, ALSO provide dealer information.) Manufacturer/Contractor: POLYMEDCO Cancer Diagnostic Products, LLC (V797P-5265B) Manufacturer/Contractor POC & phone number: Mr. Vince Langford, +1 (555) 000-0000/+1 (555) 000-0000 Manufacturer/Contractor address: 510 Furnace Dock Road, Cortlandt Manor, New York 10567 Dealer/Representative address/phone number: Not applicable The requested material or service represents the minimum requirement of the Government. (1) AGENCY AND CONTRACTING ACTIVITY: Department of Veterans Affairs Network-09 Contracting Office (NCO-09) Suite 400 (90) 1639 Medical Center Parkway Murfreesboro, Tennessee 37129 VISN: 09 (2) NATURE AND/OR DESCRIPTION OF ACTION BEING APPROVED: The James H. Quillen VA Medical Center, Pathology and Laboratory Medicine Service requires an Instrument that performs fecal occult blood testing for the detection of gastrointestinal bleeding associated with disorders such as colorectal cancer, polyps, and colitis that is capable of being interfaced with a computer to include user manuals, service manuals, consumable reagents, standard controls, supplies for fecal occult blood testing, and 24/7 services through a firm-fix-price (FFP) Cost Per Reportable Blanket Purchase Agreement (BPA) with an existing Federal Supply Schedule (FSS) Small Business (mandatory source) schedule holder. MAS Schedule / SIN: 66 III - Clinical Analyzers, Laboratory, Cost-Per-Test / 605-2B Low Maintenance/Complexity Analyzers (3) (a) A DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY'S NEED: CLIN DESCRIPTION OF SUPPLIES/SERVICES MANUFACTURER MANUFACTURER PART NUMBER 0001 Occult Blood Analyzer (Cost Per Reportable Test - includes equipment, preventative maintenance, training, and service) POLYMEDCO (* FSS Contract only one (1) preventative maintenance visit per year) 0002 VA-CPT1 (Estimated minimum of 1000 patients monthly - Patient Test Volume include FOBT latex reagents (1000 test), FOBT calibrator, FOBT negative control, FOBT positive control, wash solution, buffer, Cuvettes 1 x 100, calibrators cups, Estimated 12,000 patients/year (with 50% patient compliance) POLYMEDCO VA-CPT1 0003 Personal pack (1-device per mailer, 20 per box) 50 boxes per month Open Market Item OCPU-VA1 "Open Market Item" - see paragraph 8. CLIN DESCRIPTION OF SUPPLIES/SERVICES MANUFACTURER MANUFACTURER PART NUMBER 0004 4 x 50 sample bottles (200 per box) 5 boxes per month Open Market Item OCS1 "Open Market Item" - proprietary item 0005 TP5 Thermal paper (printer paper five (5) rolls per box) OPTIONAL - Dependent on VA CPT1 Price selected, cost is $900 per visit which include labor, travel, and parts 0006 Afterhours service/maintenance POLYMEDCO (b) ESTIMATED DOLLAR VALUE: $ 470,740.00 to $475,790.00 (price range) (c) REQUIRED DELIVERY DATE: September 1, 2013 (4) IDENTIFICATION OF THE JUSTIFICATION RATIONALE (SEE FAR 8.405-6), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR'S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE. (CHECK ALL THAT APPLY AND COMPLETE) X Specific characteristics of the material or service that limit the availability to a sole source (unique features, function of the item, etc.). Describe in detail why only this suggested source can furnish the requirements to the exclusion of other sources. Fully automated, 80-samples per hour, reduced testing period (eight (8) minutes per test, can run up to 10-samples per rack), closed samples (eliminates exposure to Bio-hazardous materials); patient Results are automatically updated into their records (eliminating transcription errors). Eliminates dietary and Medicinal restrictions on patients while patient requirements in collecting bowel samples. X A patent, copyright or proprietary data limits competition. This proprietary data is: (If FAR 8.405-6 (a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.) POLYMEDCO OC FIT-Check - OC-Auto Micro 80 technology detects gastrointestinal bleeding associated with disorders such as colorectal cancer, polyps, and colitis through several patents and proprietary hardware and software applications streamlining laboratory functions and verification of results. These are "direct replacements" parts/components for existing equipment. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system. The new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays. (5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.4 TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: This vendors Fecal Immunochemical Test (FIT) (traditionally referred to as fecal occult blood test) Does not impose dietary? or medicinal? restrictions on patients, reduces sample collection from three (3) samples from three (3) separate bowel movements to one (1) sample from one (1) bowel Movement. This immunoassay screening method has improved sensitivity over conventional testing procedures and improved patient compliance has the potential to reduce healthcare cost. NOTE(S): ?Conventional guaiac based tests place dietary restrictions on meat, certain vegetables, fruit, and Certain supplements (i.e. Vitamin C) three days prior to collecting samples ? Conventional guaiac based tests place medical restrictions on non-steroidal anti-inflammatory Drugs, such as ibuprofen, naproxen or aspirin one (1) week prior to collecting samples (6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED: An internet search of existing Federal Supply Schedule (VA National Acquisition Center) mandatory Schedule holders to determine if they offered an alternative product that was comparable to the POLYMEDCO OC Auto FIT-Check Micro 80 with its automated immunoassay format streamlines Laboratory functions and verification of results while reducing patient process in collecting samples (7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: (8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE: Some of the products/supplies used in performing these test may be available from other sources, or could be acquired through the stations Prime Vendor. (9) REQUIREMENTS CERTIFICATION: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor's supervisor, fund control point official, chief of service or someone with responsibility and accountability.)