D -- AAO MDT Unit - digital mammography & ultrasound image service

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This procurement is being conducted under Simplified Acquisition procedures pursuant to the authority of FAR Subpart 13.5, Test Program for Certain Commercial Items (10 U.S.C. 2304(g) and 2305 and 41 U.S.C. 253(g) and 253a and 253b), FAR Part 12, Acquisition of Commercial Items (Title VII of the Federal acquisition Streamlining Act of 1994 (Public Law 103-355)), FAR 37.104, and FAR Subpart 37.6, Performance-Based Acquisition. This announcement constitutes the only solicitation; therefore, a written solicitation will not be issued. The Aberdeen Area Indian Health Service (IHS) intends to award a firm fixed-price, performance-based, commercial item contract in response to Request for Quotation (RFQ) RFQ-COM-06-13. The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-11. PRICE SCHEDULE CONTRACT LINE ITEM NUMBER (CLIN) ONE: DIGITAL ULTRASOUND: BASE PERIOD: 2,000 studies @ $_____ per study = $_____; OPTION ONE: 2,000 studies @ $_____ per study = $_____; OPTION TWO: 2,000 studies @ $_____ per study = $_____. CLIN TWO: DIGITAL MAMMOGRAMS: BASE PERIOD: 8,500 studies @ $_____ per study = $_____; OPTION ONE: 8,500 studies @ $_____ per study = $_____; OPTION TWO: 8,500 studies @ $_____ per study = $_____. BACKGROUND: The Aberdeen Area Indian Health Service (AAIHS) is establishing a mobile women's health clinic with broadband telemedicine capabilities to provide quality health care to Native American women in eight underserved communities in the area. The Mobile Digital Telemammography (MDT) Project Aberdeen Area has been designed to offer mammography and breast ultrasound examinations, cervical cancer screenings, and other health assessments and education services to Native American women. The broadband satellite telecommunications capability on the mobile unit will transmit digital images to a contracted reading center for immediate interpretation. The use of digital imaging in combination with broadband satellite communications will allow radiologists to read mammograms while the patients are still at the clinic. With this broadband link, the mobile clinic can go anywhere that is convenient for the patients in the widespread rural areas of North and South Dakota, and Nebraska. A distant radiology department equipped with digital mammography reading equipment will interpret images and transmit reports back to the mobile clinic while the patient is still there. This innovative approach is intended to reduce the patient anxiety that comes while waiting for the results of a mammogram. Such anxiety sometimes causes patients to defer screenings until serious problems occur. Digital mammography offers numerous technical advantages over screen-film, including faster image acquisition, image enhancement capability, and better storage and transmission for archiving and consultation. But its full potential can be met only through soft-copy display and interpretation. Success is highly dependent on a range of factors that include workstation design, efficient use of personnel, data management between digital acquisition and display systems, and determining the best way to review film priors alongside soft-copy images. The purpose of this contract is for the provision of immediate interpretation services of digital, telemammography images. Workflow on the mobile unit has been planned to provide care to 15 - 20 patients per day. A mammography examination will be followed by the other women's health services, keeping patients productively occupied while the images are transmitted and interpreted by remote radiologists. PROFESSIONAL QUALIFICATIONS: The Contractor's attending radiology physicians shall be: A. Board certified by the American College of Radiology (ACR); B. State-licensed to practice radiology, without restrictions, within the state where the contractor is located; and C. Credentialed and privileged by a JCAHO-accredited institution to perform radiology study interpretations via teleradiology. Contractor's attending physicians will also meet the - Qualifications and Responsibilities of Personnel in the America College of Radiology Technical Specification for Teleradiology Section III, A, Physician. INTERPRETATION REQUIREMENTS: A. Report turnaround time shall be as specified in section C-5 following receipt of electronic images Tuesday through Thursday during mobile unit hours of operation, 7:00 A.M. to 3:00 P.M. (Central-Standard Time). B. The Contractor shall provide immediate telephone consultation with ordering clinicians to report abnormal findings for any radiology study that could alter the treatment and care of the patient. COMMUNICATION NETWORK INTERFACE/REQUIREMENTS: To be compatible with equipment on board the mobile unit, the Contractor shall: A. Use a teleradiology system/PACS or Reading Work Station that is DICOM 3.0 part 10 compliant and is current with ACR/NEMA Image Data Format. B. Provide equipment quality control policies and certifications to the contact person identified by the Aberdeen Area Indian Health Service. C. Establish local network firewalls and procedures to ensure patient confidentiality and security are consistent with HIPAA regulations and ACR guidelines. D. Provide a Reading Work Station that: 1. Has FDA approval to read mammography images acquired from a GE Senographe 2000D. 2. Is capable of displaying the DICOM standard Sigmoind LUT (Not Linear LUT). 3. Is capable of applying the - Premium View image processing algorithm. 4. Has the ability to display mammography images acquired from a GE Senographe 2000D in the appropriate hanging protocols. 5. Has FDA approval and the ability to display the RTSS CAD markers for R2 and iCAD. The Aberdeen Area utilizes a GE Senographe 2000D digital mammography acquisition system for current mammography images and will utilize a mammography film digitizer to provide prior patient mammography images, when available. The recommended systems are the: GE RWS or GE Seno Advantage workstations. VOLUME OF MEDICAL IMAGING EXAMINATION PER YEAR BY CATEGORY AND REPORTING TIMEFRAMES: The following totals are estimated for mammograms. Multiple films for standard radiographic exam procedures will be forwarded to the Contractor for interpretation. A. Digital Mammography = 2,500/year; Real-time interpretation available Monday to Friday, 7:00 A.M. to 3:00 P.M (Central Standard Time). Interpretation of screening digital mammography should be within 60 minutes from study receipt. Interpretation of diagnostic digital mammography studies should be within 30 minutes from study receipt. The estimated minimum of 1,300 mammograms per year. B. Routine breast ultrasounds = 500/year; Interpretation to be returned to mobile unit by noon the following business day. Ultrasounds are planned for FY2007 but may not be implemented until late in the Fiscal Year. DISCUSSION OF PERFORMANCE OBJECTIVES: Radiologist reading requirements contained in this Performance Work Statement are considered performance based, focusing on the Aberdeen Area's desired results and outcomes. The Contractor shall be responsible for determining the most effective means by which these requirements will be fulfilled. Success is highly dependent on a range of factors that include workstation design, efficient use of personnel, data management between digital acquisition and display systems, and determining the best way to review film priors alongside soft-copy images. In order to fulfill the requirements, the Contractor shall implement a recruitment and placement process and systems that will deliver the required services in a manner that will best meet the IHS's performance objectives. These performance based requirements represent a challenge to the Contractor to develop and apply innovative and efficient approaches for achieving results and meeting or exceeding the performance objectives and measures described in the PWS. The Indian Health Service will monitor the Contractor's performance in accordance with the Quality Assurance Surveillance Plan (See Attachment 1). In cases where performance objectives and acceptable quality levels are not being met, the Contractor will make every effort to immediately correct the problem to ensure customer satisfaction If the problem is systemic, the Contractor will submit a plan of corrective action to the Project Officer and Contracting Officer. PERFORMANCE OBJECTIVES: Performance Objective 1 - Technical Approach and Management Plan. During the 12-month contract performance period, the Contractor shall define a functional, supportive, and efficient system of diagnostic electronic image interpretation and electronic report capability for approximately 3,000 mammography examinations performed on the mobile unit. Interpretation shall be required for approximately 600 digitized images of prior mammography examinations. The technical approach shall integrate contract management and contract performance activities to meet performance objectives in the provision of digital image interpretation services for the Aberdeen Area MDT Project. The Contractor shall implement quality checks and related reporting in accordance with MQSA requirements. Contractor shall communicate possible quality issues to the Project Coordinator immediately and assist in resolving quality issues. Through September 30, 2007, the Contractor shall provide all personnel, equipment, materials, supervision, and other items and services necessary to perform the work and provide support as defined in this performance work statement (PWS). The Contractor shall perform to the standards in the Quality Assurance Surveillance Plan (See Attachment 1). A tentative schedule for Calendar Year 2007 is attached (See Attachment 2). A. Contractor Responsibilities. The Contractor's work and responsibility shall include, but not be limited to the recruitment, credentialing/licensure, and placement of Radiologists to assure all services and operations are conducted in accordance with the terms and conditions of this PWS. B. Contractor shall maintain processes to manage the digital images for reading for efficiency and maintain archive of all digital images. C. Contractor will ensure there is a mechanism in place to ensure appropriate updates of computer hardware/software. D. Fully cooperate with the Government and the contracted staff of the MDT Unit. E. The contractor shall participate in meetings and/or conference calls in which procedures and activities are discussed. Contract personnel shall speak, understand, read, and write English fluently and communicate with sufficient clarity to be understood by Aberdeen Area Indian Health Service personnel and patients. Contract personnel shall possess sufficient initiative, interpersonal relationship skills, and social sensitivity such that they can relate constructively to patients from the Native American community. Contractor Qualifications: The Contractor shall furnish in writing not later than (NLT) 30 calendar days prior to start of each contract performance month, a list of employees who will perform under this PBWS. The Contractor shall notify in writing, of any addition, deletion, or change within five working days of such change. This list shall include each employee's name, work assignment, certification, qualifications, and experience. Performance Objective 2 - Peer Review Activities. Contractor shall randomly select and submit for peer review a minimum of ten (10) routine/priority examinations during each quarter. In addition to the random selection, the Indian Health Service may, at its option, request review of specific cases prior to the end of the quarter. The results of the peer review shall be submitted within thirty (30) days after the end of each quarter. Reports shall be directed to the Project Officer in the Aberdeen Area Office. The Aberdeen Area Indian Health Service considers a negative peer review report to require additional follow-up, therefore the Contractor shall provide a root cause analysis for all those cases that are deemed missed or incorrect. The analysis shall be completed and included in the quarterly report. Additional follow-up action will be taken as indicated. PERFORMANCE SURVEILLANCE ACTIVITIES: Performance surveillance activities will be monitored by the project officer to ensure compliance with Indian Health Service regulations and other regulatory body requirements. SUBMISSION OF WORKLOAD INFORMATION AND INVOICES: The Contractor shall establish a reporting and invoicing process for each calendar month identified in this task order. Each invoice shall contain workload information for each service unit or Tribal community served by the MDT unit for the invoice period. In order to monitor contract performance and provide benchmarking data to participating service units or communities, a standardized report is requested on a quarterly basis. This report shall provide contract performance data used to monitor performance metrics critical to the performance based service contract evaluative process. The contractor shall submit a workload report electronically to the project officer. The reports shall contain cumulative data for Calendar Year 2006, 2007 and shall be submitted electronically to the Project Officer in the Aberdeen Area Office. PERIOD OF PERFORMANCE: Date of Award (projected start date is September 29) through September 28, 2007, with two 12-month options. GOVERNMENT FURNISHED PROPERTY: The IHS shall provide all necessary equipment and supplies. The MDT unit will be responsible for getting the Contractor access and clearance to all pertinent ARMS; intranet, internet, and computer services necessary to carry out his/her duties. COMPUTER SECURITY: All Federal agencies are required by the Federal Information Security Management Act of 2002 (FISMA) to complete a course in Computer Security Awareness Training (CSAT). Within HHS, there is a requirement for this training to be completed annually by all employees including all contractors, volunteers, students, summer externs, etc. CONTRACTING OFFICER AUTHORITY: Authority to negotiate changes in the terms, conditions or amounts cited in this contract is reserved for the Contracting Officer. PROJECT OFFICER: The project officer shall be responsible for: (1) Monitoring the Contractors technical progress, including surveillance and assessment of performance and recommending technical changes: (2) Interpreting the Statement of Work; (3) Technical evaluation as required; (4) Technical inspections and acceptance; and (5) Assisting the Contractor in the resolution of technical problems encountered during performance of this contract. INVOICE SUBMISSION AND PAYMENT: The Contractor shall submit its invoice to the Project Officer at the Aberdeen Area Indian Health Service, 115 4th Ave SE, Room 309 Federal Building, Aberdeen, South Dakota 57401. The Contractor agrees to include the following information on each invoice: (1) Contractors named, address; (2) Contract Number; (3) Invoice number and date; (4) Cost or price; (5) Dates of Service including the number of hours worked; and (6) Remit to address. Payment shall be made by the Aberdeen Area Financial Management Branch, 115 4th Ave SE, Room 309 Federal Building, Aberdeen, South Dakota 57401. SPECIAL CONTRACT REQUIREMENTS: Contractors cannot serve as expert witnesses in any suit against the Federal Government. Many of the IHS patients receiving services may only speak a native language and/or reside on a Native American Reservation, therefore, the Contractor must demonstrate sensitivity to cross-cultural and language differences. The Privacy Act of 1974 mandates that the Contractor maintain complete confidentiality of all administrative, medical and personnel records, and all other pertinent information that comes to his/her attention or knowledge. The Privacy Act carries both civil and criminal penalties for unlawful disclosure of records. Violation of such confidentiality shall be cause for adverse action. The IHS shall provide training on the Freedom of Information Act and the Privacy Act. All IHS regulations and policies applicable to these Acts shall be enforced. The Contractor shall comply with IHS facility infection control and safety procedures, practices, and standards PROVISIONS AND CLAUSES: The following provisions and clauses apply to this acquisition. The FAR provision 52.212-1 Instructions to Offerors Commercial Items; and 52.212-3 Offeror Representations and Certifications Commercial Items are incorporated by reference. The provision at 52.212-2 applies to the acquisition and is provided in full test. FAR 52.212-2 EVALUATION - COMMERCIAL ITEMS (JAN 1999): (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: (1) Technical Capabilities = 50 POINTS: The technical capabilities evaluation factor will assess the depth and breadth of the offeror's experience in locating, credentialing, and placing medical providers in rural, isolated health care environments similar to the 10 Aberdeen Area locations identified in the PWS. In assessing the offeror's placement capabilities, the proposal will be judged solely on the written material provided by the offeror. In evaluating technical capabilities, the offeror's approach to address the staffing requirements for the MDT mobile unit will be assessed. To assist in the valuation of this criteria, the offeror shall provide a staffing plan to assure the availability of qualified and experienced staff to met PWS requirements during the contract performance period. The offeror shall document that they have the necessary technical capacity to complete staffing requirements in a timely, comprehensive, and successful manner. (2) Past Performance and Experience = 50 POINTS: This evaluation factor will assess the relevance and breadth of the offeror's experience and the quality of the offeror's past performance on task orders consistent in scope and complexity with the MDT Project. This will be assed on task orders or contracts completed during the past three years and all task orders currently in progress which are consistent in scope and complexity with the MDT Project. The offeror's technical proposal shall include a listing of other task orders or contracts awarded to the offeror in other rural or IHS facilitates to at least include task order number, type, value, description and contact information. The task orders must be similar in scope and complexity as the requirements outlined in the PWS. The offeror must demonstrate its record of successful performance in past rural or IHS task orders each offeror will be evaluated on its performance under existing and prior task orders and for similar services. At a minimum it shall include the one task order you consider to be most successful and why, evidence of timely and acceptable performance, evidence indicating customer satisfaction for similar services outlined in the PWS, and evidence of concern for cost control and budgetary considerations. Technical and past performance, when combined, are considered higher than cost or price. (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). (c) 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. The following FAR and Health and Human Services Acquisition Regulation (HHSAR) clauses are applicable: 52.204-4, 52.204-7, 52.204-9, 52.212-4, 52.212-5 with Alternate I, 52.217-8, 52.21709, 52.223-5, 52.223-6, 52.224-1, 52.224-2, 52.229-3, 52.232-18, 52.233-4, 52.237-2, 52.237-3, 52.239-1, 52.242-15, 52.242-17, 52.243-1, 52.245-1, 52.245-1, 52.249-2, 52.249-8, 352-202-1, 352-215-1, 352.215-70, 352.223-70, 352.232-9, 352-270-2, 352.270-3, 352.270-4, 352.270-6, and 352.270-7. The following FAR clauses cited in 52.212-5 are applicable to the acquisition: 52.204-6 with Alternate I, 52.222-3, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-39, 52.225-13, and 52.232-33. Upon request, the Contracting Officer will provide full text copies of the FAR and HHSAR provisions and clauses. The provisions and clauses may also be accessed electronically at http://acquisition.gov/far/index.html and http://www.hhs.gov/oamp/dap/hhsar.html. CONTRACTORS INTENDING TO CONDUCT BUSINESS WITH THE FEDERAL GOVERNMENT MUST REGISTER WITH THE DEPARTMENT OF DEFENSE CENTRAL CONTRACTOR REGISTRATION (CCR) DATABASE. THE CCR IS THE PRIMARY GOVERNMENT REPOSITORY, WHICH RETAINS INFORMATION ON GOVERNMENT CONTRACTORS. YOU MAY REGISTER VIA THE INTERNET AT HTTP://WWW.CCR.GOV OR BY CALLING +1 (555) 000-0000. PROPOSAL SUBMISSION INSTRUCTIONS: The Contractor shall submit a written response to, the technical evaluation factors in FAR 52.212-2. In addition, the Contractor shall submit a completed copy of FAR 52.212-3 with its offer. Attachment 1 & 2 can be obtained by contacting the contract specialist identified in the synopsis/solicitation. All responsible offerors may submit a proposal, which shall be considered by the Agency. Offers shall be submitted to the Aberdeen Area Indian Health Service, 115 4th Ave SE, Room 309, Federal Building, Aberdeen, South Dakota 57401, no later than 3:00 p.m. on August 21, 2006. The offer must be submitted in a sealed envelope, addressed to this office, showing the time specified for receipt, the solicitation number, and your name and address. ACCEPTANCE PERIOD: Your proposal must stipulate that it is predicated upon all the terms and conditions of this RFQ. In addition, it must contain a statement to the effect that it is firm for a period of at least 60 days from the date of receipt by the Government.