65--CHLAMYDIA/GONORRHEA COST PER TEST

ADMENDMENT: The purpose of this admendment is to extend the closing date FROM: 2:00 PM EST 3 September 2014 TO: 2:00 PM EST 8 September 2014. SALIENT CHARACTERISTICS Automated Molecular Platform Features/Benefits The System Must: Be FDA cleared and approved Not exceed 80 x 90 x 36 dimension in inches (H x W x D) including computer or any other integrated equipment Be supplied with UPS system Be an integrated nucleic acid testing system that fully automates all steps necessary to perform the assays from sample processing through amplification Detect Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, Human Papilloma High Risk genotypes, Human Papilloma genotype 16 and 18,45 specifically with FDA approved kits Be able to process for GC/CT testing: male and female urine specimens, male urethra swab, female endocervical or vaginal swabs collected in FDA approved devices. Be able to process cervical cells collected in ThinPrep PreservCyt Solution for HPV High Risk and HPV genotype 16 and 18,45 Allow test menu expansion for lab growth Have on-board documentation and help functions Have all waste contained within the system. Not allow sample and or reagent carryover Be able to provide more than 250 patient results per 8- hour shift using 1 technician Be self-monitoring and alert operators to prompt action, avoiding testing delays Include an integrated software system that performs all required calculations as needed for a final result and is fully compatible with the Composite Health Care System (CHCS) use by all military health care centers. Have no off board plumbing, drains, floor vents and offer self-contained on-board liquid waste management. Have a printer for the production of hard copy patient, QC, and other reports generated Meet 220V electrical requirements The solicitation number W81K00-14-R-0039 for purchase request GFEBS 0010524424 is issued as a Request for Proposal (RFP). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-76. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516. Size standard is 500. This RFP is being issued as Firm Fixed Price, UNRESTRICTED. All responsible sources may submit a quotation which shall be considered by the agency. Responses due date: SEPTEMBER 3, 2014 The requirements of this solicitation are for contractor owned analyzer, reagents, training for contractor owned analyzer, tools and material required daily operation on a cost per test basis for the period of 1 October 2014 through 30 September 2017 for Eisenhower Army Medical Center, Fort Gordon, GA. Initial Ordering Period: I October 2014 through 30 September 2015. Item No. 0001. AUTOMATED CT/GC ANALYZER FFP AUTOMATED CT/GC ANALYZER FFP PLATFORM INCLUDES (A) ANALYZER , (B) COMPUTER WORK STATION (CPU & SOFTWARE), (C) UPS LOCATED AT DWIGHT DAVID EISENHOWER ARMY MEDICAL CENTER (DDEAMC), FORT GORDON, GA. ORDERING PERIOD: 01OCT14-30SEP15. PAYMENT TO BE MADE IN ARREARS. Item No. 0001AA CT/GC TEST REAGENTS QTY: 30 Kit; UNIT PRICE: $___________ TOTAL AMOUNT: $____________ Item No. 0001AB TRICHOMONAS TEST REAGENTS QTY: 1,000 EACH; UNIT PRICE: $___________ TOTAL AMOUNT: $____________ Total Base Period: ___________________ Item No. 1001. AUTOMATED CT/GC ANALYZER FFP AUTOMATED CT/GC ANALYZER FFP PLATFORM INCLUDES (A) ANALYZER , (B) COMPUTER WORK STATION (CPU & SOFTWARE), (C) UPS LOCATED AT DWIGHT DAVID EISENHOWER ARMY MEDICAL CENTER (DDEAMC), FORT GORDON, GA. ORDERING PERIOD: 01OCT15-30SEP16. PAYMENT TO BE MADE IN ARREARS. Item No. 1001AA CT/GC TEST REAGENTS QTY: 30 Kit; UNIT PRICE: $___________ TOTAL AMOUNT: $____________ Item No. 1001AB TRICHOMONAS TEST REAGENTS QTY: 1,000 EACH; UNIT PRICE: $___________ TOTAL AMOUNT: $____________ Option Year 1: ___________________ Item No. 2001. AUTOMATED CT/GC ANALYZER FFP AUTOMATED CT/GC ANALYZER FFP PLATFORM INCLUDES (A) ANALYZER , (B) COMPUTER WORK STATION (CPU & SOFTWARE), (C) UPS LOCATED AT DWIGHT DAVID EISENHOWER ARMY MEDICAL CENTER (DDEAMC), FORT GORDON, GA. ORDERING PERIOD: 01OCT16-30SEP17. PAYMENT TO BE MADE IN ARREARS. Item No. 2001AA CT/GC TEST REAGENTS QTY: 30 Kit; UNIT PRICE: $___________ TOTAL AMOUNT: $____________ Item No. 2001AB TRICHOMONAS TEST REAGENTS QTY: 1,000 EACH; UNIT PRICE: $___________ TOTAL AMOUNT: $____________ Option Year 2: ___________________ Item No. 3001. AUTOMATED CT/GC ANALYZER FFP AUTOMATED CT/GC ANALYZER FFP PLATFORM INCLUDES (A) ANALYZER , (B) COMPUTER WORK STATION (CPU & SOFTWARE), (C) UPS LOCATED AT DWIGHT DAVID EISENHOWER ARMY MEDICAL CENTER (DDEAMC), FORT GORDON, GA. ORDERING PERIOD: 01OCT17-30SEP18. PAYMENT TO BE MADE IN ARREARS. Item No. 3001AA CT/GC TEST REAGENTS QTY: 30 Kit; UNIT PRICE: $___________ TOTAL AMOUNT: $____________ Item No. 3001AB TRICHOMONAS TEST REAGENTS QTY: 1,000 EACH; UNIT PRICE: $___________ TOTAL AMOUNT: $____________ Option Year 3: ___________________ Item No. 4001. AUTOMATED CT/GC ANALYZER FFP AUTOMATED CT/GC ANALYZER FFP PLATFORM INCLUDES (A) ANALYZER , (B) COMPUTER WORK STATION (CPU & SOFTWARE), (C) UPS LOCATED AT DWIGHT DAVID EISENHOWER ARMY MEDICAL CENTER (DDEAMC), FORT GORDON, GA. ORDERING PERIOD: 01OCT18-30SEP19. PAYMENT TO BE MADE IN ARREARS. Item No. 4001AA CT/GC TEST REAGENTS QTY: 30 Kit; UNIT PRICE: $___________ TOTAL AMOUNT: $____________ Item No. 4001AB TRICHOMONAS TEST REAGENTS QTY: 1,000 EACH; UNIT PRICE: $___________ TOTAL AMOUNT: $____________ Option Year 4: ___________________ Place of Performance: Eisenhower Army Medical Center 300 East Hospital Road Fort Gordon, GA 30905 UNITED STATES The following FAR and DFARS provisions and clauses apply to this solicitation: The full text of a FAR provision or clause may be accessed electronically at www.farsite.hill.af.mil. The following provision at 52.212-1, Instructions to Offeror - Commercial Items (FEB 2012). Addendum to 52.212-1: (m) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and MEDCOM provisions included herein are incorporated into this solicitation. Offerors must address the salient characteristics in the combined synsposis solicitation. See provision 52.252-1 for locations where full text can be obtained. 52.212-2, Evaluation - Commercial Items (JAN 1999). ADDENDUM TO 52.212-2 (a) is hereby replaced with the following: 52.212-2 EVALUATION--COMMERCIAL ITEMS (JAN 1999) (a) The Government will issue a single order to the responsible contractor whose proposal, conforming to the solicitation, is the Lowest Priced, Technically Acceptable (LPTA). Award is on an all or none basis. The following factors will be used to evaluate quotes: Technical acceptability and price. 1. Technical Acceptability. Technical capability ratings reflect the Government's confidence in each vendor's item, as demonstrated in its submission, to meet the salient characteristics set forth in the solicitation. The Government will make an independent judgment of the acceptability. To receive consideration for award, a rating of no less than Acceptable must be achieved in technical acceptability. Prospective contractors shall demonstrate that the items offered complies with the technical requirements described by submission of a written capability statement with their offer. This written capability statement must be submitted with offer and not exceed 10 pages. The following adjectival ratings will be used in evaluating each written technical capability proposal: Acceptable - To receive this rating, the vendor's items shall meet the salient characteristics set forth in the solicitation. Unacceptable - An unacceptable rating will be assessed on any vendor that presents items that demonstrate any of the following: 1. Failure to meet the salient characteristics set forth herein (see page 14). 1a. Failure to provide sufficient detail for the Government to determine whether the items satisfactorily meet the requirements of this solicitation. Explain how your company will meet the terms of the solicitation for Microcuvette Reagents of the items as specified in the solicitation. Prospective contractors shall demonstrate that the items offered complies with the technical requirements described by submission of a written capability statement with their offer. This written capability statement must be submitted with offer and not exceed 10 pages. 2. Price. The offeror shall submit pricing for all CLINs identified in the combined synopsis/ solicitation, unless otherwise noted. Pricing will be evaluated to the extent to which it is fair and reasonable in term of the Government's equipment. 3. Evaluation Process: Except for communications conducted for the purpose of minor clarification, the Government intends to issue an award without discussions. The government reserves the right to enter into discussions if an unacceptable technical proposal can be made acceptable. Potential contractors must be registered in the System Award management (SAM) to be eligible for award. The SAM internet web site is http://www.sam.gov. IAW 52.212-3 Offeror Representations and Certifications- Commercial Items. Offeror must complete annual representations and certifications on-line at http://orca.bpn.gov. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (End of provision) Offers are due by September 3, 2014, 2:00 PM, Eastern Standard Time. Submit offers via email to contact@example.gov, facsimile +1 (555) 000-0000 or mail. Contracting Office Address: Southern Region Contracting Office (SRCO) 39706 40th Street Fort Gordon, GA 30905 Point of Contact: Valerie DeVeaux, Contract Specialist, +1 (555) 000-0000 The following stand alone discretionary FAR and DFARS provisions are necesssary: 52.204-5 - Women-Owned Business Other Than Small Business (MAY 1999). 52.211-6 - Brand Name Or Equal (AUG 1999) 52.225-25 - Prohibition On Engaging In Sanctioned Activities Relating To Iran-Certification (DEC 2012) 52.203-2 - Certificate Of Independent Price Determination (APR 1985) 52.209-7 - Information Regarding Responsibility Matters (JUL 2013) 52.215-20 - Requirements For Certified Cost Or Pricing Data And Data Other Than Certified Cost Or Pricing Data (OCT 2010) 52.216-1 - Type Of Contract (APR 1984) 52.233-2 - Service Of Protest (SEP 2006) 52.252-1 - Solicitation Provisions Incorporated by Reference (FEB 1998). 52.252-5 - Authorized Deviations in Provisions (APR 1984), (b) DoD Far Supplement (48 CFR Chapter 2). 252.203-7005 - Representation Relating To Compensation Of Former DoD Officials (NOV 2011). 252.204-7011 - Alternative Line-Item Structure (SEP 2011) 252.209-7001 - Disclosure Of Ownership Or Control By The Government Of A Terrorist Country (JAN 2009) 252.215-7007 - Notice Of Intent To Resolicit (JUN 2012) 252.215-7008 - Only One Offer (OCT 2013) 252.225-7020 - Trade Agreements Certificate (JAN 2005) 252.247-7022 - Representation Of Extent Of Transportation By Sea (AUG 1992) 52.212-4 -- Contract Terms and Conditions - Commercial Items, applies to this acquisition (JUN 2010) and Addendum to 52.212-4--(u) The non-FAR Part 12 discretionay FAR, DFARS, AFARS, and LOCAL clauses included herein are incorporated into this either by reference or in full text. If incorporated by reference, see clause 52.252-2 herein for locations where full text can be found. 52.203-3 - Gratuities (APR 1984). 52.203-6 - Restrictions On Subcontractor Sales To The Government (SEP 2006). 52.203-12 - Limitation On Payments To Influence Certain Federal Transactions (OCT 2010). 52.203-17 - Contractor Employee Whistleblower Rights And Requirement To Inform Employees Of Whistleblower Rights (APR 2014) 52.204-4 - Printed Or Copied Double-Sided On Postconsumer Feber Content Paper (MAY 2011). 52.204-10 -- Reporting Executive Compensation and First-Tier Subcontract Awards (JUL 2013) 52.209-6 -- Protecting the Government's Interest When Subcontracting with Contractors Debarred, suspended, or proposed for Debarment (AUG 2013). 52.219-8 - Utilization Of Small Business Concerns (JAN 2011). 52.219-9 - Small Business Subcontracting Plan (JUL 2013) 52.219-16 - Liquidated Damages - Subcontracting Plan (JAN 1999) 52.222-19 - Child Labor-Cooperation With Authorities And Remedies (JAN 2014) 52.222-50 -- Combat Trafficking in Persons (FEB 2009). 52.223-3 - Hazardous Material Identification And Material Safety Data (JAN 1997) 52.223-5 - Pollution Prevention and Right-To-Know Information (MAY 2011) 52.223-18 - Contractor Policy to Ban Text Messaging While Driving (AUG 2011). 52.225-13 - Restrictions on Certain Foreign Purchases (JUN 2008). 52.228-5 - Insurance - Work On A Government Installation (JAN 1997). 52.232-18 - Availability Of Funds (APR 1984) 52.232-33 -- Payment by Electronic Funds Transfer -- Central Contractor Registration (OCT 2003). 52.232-39 - Unenforceability Of Unauthorized Obligatiojns (JUN 2013) 52.232-40 - Providing Accelerated Payments To Small Business Subcontractors (DEC 2013) 52.233-3 - Protest After Award (AUG 1996). 52.233-4 - Applicable Law for Breach of Contract Clalim (OCT 2004). 52.237-2 - Protection of Government Buildings, Equipment, And Vegetation (APR 1984). 52.237-3 - Continuity Of Services (JAN 1991) 52.242-13 - Bankruptcy (JUL 1995). 252.203-7000 -- Requirements Relating to Compensation of Former DoD Officials (SEP 2011). 252.203-7002 - Requirement to Inform Employees of Whistleblower Rights (SEP 2013). 252.204-7003 - Control of Government Personnel Work Product (APR 1992). 252.205-7000 - Provision Of Information To Cooperative Agreement Holders (DEC 1991) 252.209-7004 - Subcontracting With Firms That Are Owned Or Controlled By The Government Of A Terrorist Country (MAR 2014) 252.225-7012 - Preference For Certain Domestic Commodities (FEB 2013) 252.225-7021 - Trade Agreements (OCT 2013) 252.225-7048 - Export Controlled Items (JUN 2013) 252.232-7003 - Electronic Submission of Payment Requests and Receiving Reports (JUN 2012). 252.232-7010 - Levies on Contract Payments (DEC 2006). 52.217-6 - Option For Increased Quantity (MAR 1989) 52.217-9 - Option to Extend the Term of the Contract (MAR 2000). 52.219-28 - Post-Award Small Business Program Representation (APR 2012). 52.252-2 - Clauses Incorporated by Reference (FEB 1998). 52.252-6 -- Authorized Deviations in Provisions (APR 1984). quote mark DoD FAR Supplement (48 CFR Chapter 2). quote mark 252.204-7012 - Safeguarding Of Unclassified Controlled Technical Information (NOV 2013) 252.244-7000 - Subcontracts For Commercial Items And Commercial Components (JUN 2013) INVOICING INFORMATION: All prospective offeror must be registered in the Wide Area Work Flow (WAWF) System. For registration go to https://wawf.eb.mil/ and follow the registration instructions. The payment on invoices will be made quarterly invoices as a 2-in-1 invoice via the internet using the Government provided Wide Area Work Flow (WAWF) Receiving/Acceptance System at https://wawf.eb.mil (reference clause 252.232-7003). Web Base Training is available at www.wawftraining.com and for more information go to www.dod.mil/dfas and click the e-commerce link. STATEMENT OF OBJECTIVES (SOO) FOR AUTOMATED CHLAMYDIA/GONORRHEA AMPLIFICATION DETECTION INSTRUMENT 1. GENERAL REQUIREMENTS: 1.1. SCOPE OF WORK: The contractor shall provide non-personal services to include, but not limited to, tools, materials, reagents, items required for the proper operation of its' contractor owned equipment, training, and other items necessary to provide a Food and Drug Administration (FDA) approved (for the youngest possible age group) Automated Chlamydia/Gonorrhea/Trichomonas Amplification Detection Instrument and Processor system. Additional FDA approved testing would be preferable. The analyzer will be located at the Dwight David Eisenhower Army Medical Center (DDEAMC). The productivity and efficiency will include greater than 250 results/8-hour shift using 1 technician (~30,000 samples per year for Chlamydia/Gonorrhea and 1,000 samples per year for Trichomonas), ultra-high reliability, robotic pipetting, specimen tracking, easily learned upgrades, an enclosed testing area, pipettor travel lanes, fluid transfer verification, absent/defective tip detection, enclosed, segregated area for biohazardous waste and UL certification. The system must include an integrated software system that performs all required calculations as needed for a final result and is fully compatible with CHCS. The contractor shall comply to the standards of this Statement Of Objectives. The contractor shall provide local support for equipment failures. 1.2. CONTRACTOR POINT OF CONTACT: 1.2.1. Contract Manager. The contractor shall provide a contract manager who shall be the point of contract for deliveries. The name of this person, and an alternate or alternates, who shall act for the contractor when the manager is absent, shall be designated in writing to the contracting officer. 1.2.1.1. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. 1.2.1.2. The contract manager or alternate shall be available during normal duty hours (0730-1630 Eastern Standard Time Zone (EST). After normal duty hours, the manager or alternate shall be available within 48 hours. 1.2.2. 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. 1.2.2.1. Contractor personnel shall present a neat, business-like appearance and be easily recognized as contractor employees. Contractor personnel shall either wear a distinguishable uniform or badge on the exterior of their clothing while at any U.S. Government facility. 1.2.2.2. The contractor shall make sure employees have the following current and valid professional certifications before starting work under this contract. The Trainers and Product Specialists shall have a 2 or 4 year certification in Medical Technology or Clinical Laboratory Sciences or similar European certification. 1.2.2.3. The contractor shall not employ any person who is an employee of the U.S. Government if employing that person would create a conflict of interest. Additionally, 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, quote mark Joint Ethics Regulation quote mark . The contractor shall not employ any person who is an employee of the Department of Defense if such employment would be contrary to local policies. 1.2.2.4. The contractor is cautioned that off-duty active military personnel hired under this contract may be subject to permanent change of station, change in duty hours, or deployment. Military Reservists and National Guard members may be subject to recall to active duty. The abrupt absence of these personnel could adversely affect the contractor's ability to perform; however, their absence at any time shall not constitute an excuse for nonperformance under this contract. 1.2.3. Security Requirements. 1.2.3.1 Access and General Protection/Security and Procedures. This standard language text is for contractor employees with an area of performance within an Army controlled installation, facility or area. Contractor and all associated sub-contractors employees shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative). Contractor workforce must comply with all personal identity verification requirements directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes. 1.4. QUALITY ASSURANCE N/A 1.5. HOURS OF OPERATION: 1.5.1. Normal Hours of Operation. Deliveries required under this contract during the following hours: Monday through Friday between the hours of 0730 - 1630 EST. 1.5.2. The contractor shall neither deliver reagents on U.S. holidays. 1.5.3. The Contractor shall deliver reagents during normal business hours. 1.5.4. Holidays. 1.5.4.1. The following is a list of legal U.S. Federal holidays: New Year's Day, January 1st Martin Luther King's Birthday, 3rd Monday in January President's Day, 3rd Monday in February Memorial Day, Last Monday in May Independence Day, July 4th Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran's Day, November 11th Thanksgiving Day, 4th Thursday in November Christmas Day, December 25th NOTE: Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday 1.6. CONSERVATION OF UTILITIES. 1.6.1. Environmental and Hazardous Materials Handling. If the disposal of any waste or byproduct of the analyzer cannot be safely disposed of into the facility's drain system, the contractor shall provide guidelines for safely disposing these wastes or byproducts in accordance with local national guidelines. 1.7. RECORDS. If requested by the U.S. Government, the contractor shall provide the original record or a reproducible copy of any such record within 5 working days of receipt of the request. 2. DEFINITIONS/ACRONYMS. 2.1. DEFINITIONS. Following is a list of basic definitions. 2.1.1. CONTRACTING OFFICER: A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings. 2.1.2. QUALITY CONTROL. Those actions taken by a contractor to control the delivery of supplies to ensure that they meet the requirements of the contract. 2.1.3. QUALITY IMPROVEMENT (QI): Those actions taken by the U.S. Government, in accordance with AR 40-68, to assure supplies meet the requirements of the Statement of Objective (SOO). 2.2. ACRONYMS/ABBREVIATIONS. Following is a list of basic acronyms/abbreviations used in the contract. AR Army Regulation CAP - College of American Pathologists DoD CLIP - Department of Defense Clinical Laboratory Improvement Program MAS Minimal Acceptable Standards MEDCOM Medical Command OSHA Occupational Safety and Health Administration PRS - Performance requirements summary SOO - Statement of Objectives 3. U.S. GOVERNMENT FURNISHED FACILITIES, EQUIPMENT, MATERIAL, AND SERVICES 3.1. GENERAL. The U.S. Government will provide, without cost to the Contractor, the facilities, equipment, materials, and services listed below. 3.1.1. FACILITIES. The U.S. Government will furnish the facilities for set-up and operation of the analyzers as indicated in paragraph 5.6 of the SOO. The Contractor shall not alter the facilities without written approval of the Contracting Officer. The Contractor shall return the facilities to the U.S. Government in the same condition as received, fair wear and tear and approved modifications excepted. These facilities shall be used for this contract only. 3.1.2. EQUIPMENT. No equipment will be provided 3.2. MATERIALS. No materials will be provided. 3.3. GOVERNMENT SERVICES. The U.S. Government will provide the following services at no cost to the Contractor: 3.3.1. UTILITIES. The U.S. Government will provide the standard range of utilities, electricity, water, heating, refuse collection, etc., as is provided other personnel as required. 3.3.2. Security Police and Fire Protection, as is provided by DDEAMC. 3.3.3. Emergency Healthcare for Contractor employees. The MTF will provide emergency healthcare for injuries occurring while on duty. The contractor shall reimburse the U.S. Government for medical attention. 4. CONTRACTOR FURNISHED PROPERTY. 4.1. General. Except for those U.S. Government furnished items specified in section 3, the Contractor shall furnish all items required under this contract. 4.2. Transportation. Transportation is the responsibility of the Contractor. The U.S. Government will not provide transportation. 4.3. Nametags. The contractor shall furnish a nametag to each contract employee. The nametag will contain the name of the company and the employee. 5. SPECIFIC TASKS: 5.1. DESCRIPTION: The contractor shall provide equipment, reagents, training, supplies, consumables/disposable items parts, accessories and any other items required for the proper operation of its' contractor owned FDA approved automated Chlamydia/Gonorrhea Amplification Detection Instrument and Processor. The analyzer will be located at the DDEAMC, building 300 Room 1F-08, 30905 Fort Gordon, GA. Use of this equipment shall include delivery, installation, reagents, and materials necessary to perform the specified assays, initial Method Validations per CLIA/NCCLS guidelines and analyzer removal at the termination of the contract. 5.1.1. Method Validation (Correlation Studies) will include parallel runs with existing equipment if possible. Specificity and Sensitivity shall be equal to or exceed 96.6% and 90.7%, respectively for Chlamydia and 98.5% and 95.8% respectively for Gonorrhea. Before the validation begins the contractor shall present a validation plan to the Ordering POC of the contract. The contractor shall perform the validation and ensure all requirements are met. The contractor shall also provide all reagents and Materials for validation at no cost to the government. Validation of the LIS and compatibility with CHCS will be completed by the start of the contact. 5.1.3. The Contractor shall provide one (1) paper copy and one (1) CD copy of the Operator's and Maintenance manuals and a statement of the warranty terms in the English language. 5.1.4 The Contractor shall provide the reagents as outlined in the Schedule of Supplies. 5.1.5. The contractor shall be responsible for the collection, decontamination, packing and transportation of equipment upon termination of contract period. 5.1.6 The electrical requirement for this equipment shall be 110V. 5.2. ANALYZERS. 5.2.1. The analyzer shall provide for all Chlamydia and Gonorrhea test menu capabilities. An integrated printer for the production of hard copy patient reports and other reports generated shall also be provided. Additional FDA approved testing such as; HSV 1/2, HPV, and Trichomonas vaginalis would be preferable. 5.2.2. The analyzer will be able to perform Chlamydia/Gonorrhea testing for both swab and urine specimens. The instrument will use collection containers with pierceable caps and all specimen types must be treated in the same manner (No special handling for any samples). 5.2.3 The analyzer system shall be equipped with an un-interruptible power supply capable of providing all necessary electrical power to the analyzer system for 15 to 20 minutes to allow salvaging of the current batch of specimens in the analyzer. 5.2.4. The analyzer system will utilize reagents that are FDA approved. The analyzer to include all associated parts and accessories will be new. No used, refurbished, or like-new equipment will be provided in support of this contract at any time. 5.2.5 The system must include an integrated software system that performs all required calculations as needed for a final result and is fully compatible with CHCS. 5.3. REAGENTS. 5.3.1. All assays will be FDA approved. 5.3.2. The Contractor shall provide an estimate of the yearly quantities of reagent and quality control materials required to perform the volume of tests indicated annually (approximately 30,000 specimens per year); 5.3.3. Reagents shall have a minimum shelf life of six (6) months upon receipt by the U.S. Government, or, if this shelf life requirement cannot be met, the Contractor shall identify the guaranteed shelf life after receipt. 5.3.4. The manufacturer shall provide the required quality control materials and test reagents and ensure that there is minimal change in lot numbers during the contract year. 5.3.5. All reagents and quality control material will: 5.3.5.1. Include an package insert. 5.3.5.2. Be provided by the manufacturer of the equipment. 5.3.5.3. Be marked with the required storage temperature and expiration dates. 5.3.5.4. Be maintained at the proper storage temperature during transportation from the Contractor's storage facility to the U.S. Government acceptance site and be delivered on time at the appropriate storage temperature. 5.3.6. The Contractor shall provide the reagents and quality control material as outlined in the Schedule of Supplies/Services. 5.3.7. Deliveries of required items will be called in to the Contractor by the designated Contracting Officer's Representatives. Orders will be delivered within five (5) business days of requested date of delivery. 5.3.8. Emergency orders will be delivered as soon as possible, but not less than five (5) business days. 5.3.9. Preservation and packing - Preservation and packing shall be performed in accordance with the best commercial practices and in such a manner to afford adequate protection against any damage during shipment from source to destination. 5.3.10. If the company is unable to deliver reagents agreed upon in the contract due to production, supply shortages, recalls, or quality control failures within five (5) business days of the order, the contractor shall notify the Ordering POC, in writing, as to the reason(s) for non-compliance. During the period of unavailability, the Contractor shall arrange the pickup and delivery of specimens to a College of American Pathologists accredited clinical laboratory of the Governments choice within the United States of America. The selected laboratory shall provide patient reports and shall include the testing laboratory's reference range for the test being performed. The Contractor shall be responsible for all costs associated with the provision of this service, including those for delivery of hardcopy patient results by DHL or other express courier, for as long as the analyzer remain inoperable. 5.4. EQUIPMENT 5.4.1. Upon notification of equipment failure, the Contractor shall respond to telephonic requests for unscheduled repair within one (1) business day for all sites. Should the analyzer at DDEAMC become inoperable, the Contractor's Repair Service Engineer shall be on-site within two (2) business days of initial notification for routine/emergency failures. If the equipment is out of service for longer than five (5) business days (from the time of service technician's arrival on site), the contractor shall notify the Ordering POC, in writing, as to the reason(s) (i.e. non-availability of parts, etc.) for non-compliance. If the equipment cannot be repaired, a replacement instrument will be provided within five (5) business days. If the equipment cannot be replaced within five (5) business days, the Government may seek remedies for damages during the period when the analyzer is inoperable. The Contractor shall arrange the pickup and delivery of specimens to a College of American Pathologists accredited clinical laboratory of the Governments choice with...