Medical Physicts to Test Bio-Med Diagnostic Equip
Added: Jun 26, 2012 2:34 pm DESCRIPTION: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Proposals are requested and a written solicitation will not be issued. Solicitation VA-250-12-R-0391 is issued is a Request for Proposal (RFP). The solicitation document and incorporated provisions and clauses are that in effect tough Federal Acquisition Circular 2005-54.This synopsis is a streamlined solicitation of offers for commercial items for use where appropriate. The intent of these is to simplify the process of preparing and issuing solicitations/synopsis for evaluating offers for commercial items and services consistent with commercial practices. Only written requests received directly from the requester are acceptable. Pricing can be submitted in a excel spread sheet format. Introduction The intent is to award a firm fixed price contract; performance period will be from Date of Award tough May 31 2013, with four one-year option periods; June 1, 2013 tu May 31, 2014, June 1, 2014 tu May 31, 2015 June 1, 2015 tu May 31, 2016 June 1, 2016 tu May 31, 2017 A successful bidder awarded this contract will perform physics testing of diagnostic radiology equipment used at the Louis Stokes Cleveland Veterans Administration Medical Center (LSCVAMC). The successful bidder shall provide documentation of an American Board of Radiology (ABR) lead Medical Physicist certified in diagnostic radiology. The lead Medical Physicist shall oversee testing of diagnostic radiology equipment at LSCVAMC, and sign physics reports documenting the required tests. This SOW lists the necessary measurements, tolerance and testing performed in accordance with Ohio Administrative Code (OAC) 3701:1-66, Radiation Generating Equipment Requirements and Quality Assurance Standards. Results of testing shall be documented on a physics report listing the acceptability of the testing, test results, discrepancies, out of tolerance measurements and recommendations. The Medical Physicist shall notify the LSCVAMC Radiation Safety Officer and/or Biomedical Engineering of any deficiencies and issues of noncompliance at the time of the physics testing. A written physics report, signed by the lead Medical Physicist, shall be provided to LSCVAMC within 30 days of performing tests. Deliverables: o Medical Physicist shall perform physics testing at the LSCVAMC, and affiliated Community Based Outpatient Clinics (CBOCs). o Physics testing shall be performed annually on General Radiographic, Dental, CT, Bone Density, Fluoroscopy and MRI units. o Additional physics testing shall be performed upon request for newly purchased equipment and following the change of an x-ray tube or major repair/alteration. These physics tests shall be performed within tee working days of the time notice is given for the testing. o The successful bid shall include the cost for performing annual testing and the cost for testing additional equipment as requested by LSCVAMC. o The successful bidder is encouraged to provide recommendations which may be used to reduce patient dose, improve image resolution, and diagnostic radiology effectiveness. Additional Testing The following testing/reporting is required in addition to testing prescribed by OAC 3701:1-66. Fluoroscopy: o Measure Air Kerma accuracy when it is displayed by fluoroscopic equipment. 21 CFR1020.32 (d) o Measure Skin Entrance Exposure (SEE) for standard adult and maximum output of all clinically used modes. o Evaluate resolution for high and low contrast modes of operation. CT: o Measure standard adult CTDI(Vol) for protocols listed by LSCVAMC 3701:1-66-10 (D)(6) o Measure accuracy of CTDI(Vol) displayed by the CT. o Verify QA/QC recommended by manufacturer including contrast scale (CT#s) and noise using the manufacturer's recommended phantom. CT phantom used for QA/QC will be provided by LSVAMC. General Radiographic: 3701:1-66-02 (H)(8) o Measure SEE for exposures listed on the technique charts provided by LSCVAMC. Bone Density: 3701:1-66-11 (C)(1) o Verify QA/QC recommended by manufacturer. MRI: o Verify QA/QC recommended by manufacturer. The successful candidate shall provide a brief description of the necessary protocols/procedures for performing the above additional testing along with their bid. This description shall including a list of the following: o Attenuators and/or phantoms used for testing. o Geometry and positioning of measurement instruments. o Calibration of detector used for measuring Air Kerma Rates, exposure and/or dose. o Description of grid pattern, and criteria for measuring fluoroscopy contrast resolution. o Statement of CT criteria for QA/QC and acceptance using manufacturer recommendations. o Statement of Bone Density criteria for QA/QC and acceptance using manufacturer recommendations. The successful bidder is encouraged to provide a statement of their unique insight, accomplishments and perspectives on how their services will assist LSCVAMC in providing the best standard of care for veterans while reducing patient radiation dose. The technical component for a successful bid will be evaluated along with cost. Annual Physics Testing All Radiology Equipment Standard: All warning lights, switches, and controls shall be properly working. Beam "on" indicators include audible and visual alarms and timers shall be operational. Deliverable: All discrepancies shall be noted on the physics report. General Radiographic Equipment Technique Chart Skin Entrance Exposure (SEE) 3701:1-66-2(H)(8) Standard: Technique charts will be provided by LSCVAMC for each X-ray machine. The Technique charts will list programmed or manual technique factors including kVP, mAs or mA and time, source-to-image distance (SID), and filters or grid (if used). Deliverable: Record measured SEE and technique (KVP and mAs) for each standard adult procedure listed on the technique charts, and provide recommendations for optimum exposures. Exposure Linearity (mr/mAs) 3701:1-66-05(A)(15) Standard: Measure mr/mAs for > 2 typical procedures on the technique chart. Deliverable: Record exposure technique and measured mr/mAs on physics report. Action Level: For any two consecutive readings the difference shall be Kilovoltage (kVP) Accuracy 3701:1-66-05 (A)(12) Standard: kVp accuracy shall be measured in 10 kVp increments between 50 - 120 kVp using typical exposure technique. Deliverable: Record exposure technique, measured kVp and accuracy on physics report. Action Level: kVP error shall be Timer Accuracy (3701:1-66 05 (A)(10)) Standard: Measure timer accuracy for > 2 typical exposure techniques. Deliverable: Record exposure technique and measured time on the physics report. Action Level: Error shall be Reproducibility (Coefficient of Variance) 3701:1-66-05 (A)(13) Standard: Perform > 4 repeat measurements of a typical exposure technique. Deliverable: Record on the physics report the exposure technique and the following: o kVp measured o Times measured o Radiation exposure Action Level: Coefficient of variation (CV) shall be Beam Quality 3701:1-66-02 (G)(3) Standard: Measure half value layer (HVL) in mm Al for > 1 typical technique. Deliverable: Record the exposure technique, and HVL (mm Al) on physics report. Stationary Radiographic Equipment 3701:1-66-05 (A)(3) Standard: Measure accuracy of: o Center of X-ray field o Source to Image Distance (SID) o Beam limiting device Action Level: Error shall be FLUOROSCOPIC EQUIPMENT Skin Entrance Exposure (SEE) 21 CFR 1020.32 (d) Standard: Measure SEE (R/min) of 'standard adult' and maximum output for all clinically used modes. o Under table fluoroscopy shall be measured 1 cm above tabletop with image receptor 30 cm from table top. o Over table fluoroscopy shall be measured at 30 cm above the tabletop. o Mobile C-arm fluoroscopy shall be measured at 30 cm from the image receptor. o Fixed C-arms shall be measured at 30 cm from the image receptor. Deliverable: Record on the physics report the kVp, mA, and measured Air Kerma Rates for each clinically used mode. Action Level: SEE shall be Contrast Resolution (per ACR recommendations) Standard: Evaluate fluoroscopy contrast resolution for high and low contrast modes of operation using the protocol; grid pattern(s), and criteria provided with the bid. Deliverable: Document any discrepancies, nonconformance and recommendations regarding fluoroscopy contrast resolution. Exposure Timer 3701:1-66-07 (A)(5) Standard: Verify proper operation of fluoroscopy timer including 5-minute alarm. Deliverable: Document discrepancies on physics report. Air Kerma Meter 21 CFR 1020.32 (d) Standard: Measure Air Kerma meter accuracy using the protocol provided with the bid Deliverable: Record the Air Kerma meter measurements, SEE measurements, accuracy and discrepancies on physics report. Fluoroscopic Field Limitation Standard: Evaluate field limitations according to specifications in 3701:1-66-07(A)(4). Deliverable: Record any discrepancies on the physics report. COMPUTED TOMOGRAPHY (CT) Operability 3701:1-66-10(D)(1) Standard: Evaluate safety features, location/positioning measurements, and operability according to manufacturer's recommendations, State of Ohio and Department of Health and Human Services requirements. Deliverable: Record any discrepancies on the physics report. CTDI(Vol) 3701:1-66-10(D)(6) Standard: Perform CTDI(Vol) measurements for standard adult protocols provided by LSCVAMC. Deliverable: Record on the physics report the measured CTDI(Vol) for each standard adult protocol, and recommendations for optimum exposures. . CT QC/QA 3701:1-66-10 (D)(1) Standard: Evaluate QA/QC recommended by manufacturer, using the phantom provided by LSCVAMC. Evaluation shall include contrast scale (CT#s) and noise evaluated according to criteria provided with the bid. Deliverable: Document QA/QC acceptability and all discrepancies, nonconformance and recommendations on the physics report. DENTISTRY 3701:1-66-06 Dental equipment shall be tested according to requirements of General Radiographic except for the requirements of stationary radiographic equipment. Panoramic machines do not require testing for timer accuracy. Bone Density 3701:1-66-11 Operability Standard: Evaluate QA/QC, safety features and operability according to manufacturer's recommendations, State of Ohio and Department of Health and Human Services requirements. Deliverable: Document QA/QC acceptability and all discrepancies on the physics report. MRI Operability Standard: Evaluate QA/QC, safety features and operability according to manufacturer's recommendations, State of Ohio and Department of Health and Human Services requirements. Deliverable: Document QA/QC acceptability and all discrepancies on the physics report. LOCATION OF TESTING All equipment listed on the attached spreadsheet is located at the following addresses: Louis Stokes Cleveland VA Medical Center 10701 East Blvd Cleveland, OH 44106 Community Based Outpatient Clinics (CBOC) including o Youngstown, Ohio o Canton, Ohio o Akron, Ohio o Parma, Ohio o Lorain, Ohio Other CBOCs and equipment may be added during subsequent option years. SCHEDULING OF TESTING All scheduling for testing equipment will be coordinated with Greg Zmina (with the exception of Cardiology - to be arranged with the Radiation Safety Officer). Special Contract Requirements: The services covered by this contract shall be furnished by the Contractor as defined herein. The contractor will not be required, except in case of emergency, to furnish such services during off-duty hours as described below. (1) Work hours: Monday tough Friday, 8:00 am to 4:30 pm. (2) National Holidays: The 10 Holidays observed by the Federal Government are, or any holiday deemed by the President of the U.S.: New Years Day Martin Luther King's Birthday Presidents Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Cistmas Personnel Policy The Contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the Contractor shall provide the following for these personnel. o Workers compensation o Professional Liability insurance o Income Tax Withholding, and o Social Security Payments. Parties agree the Contractor, its employees, agents and subcontractors shall not be considered VA employees for any purpose. Information Security The medical physics contractor may have access to sensitive patient information displayed on the control panel of X-ray equipment. However, contractor owned IT devices (such as laptop computer) shall not interface with any VA internet trusted (i.e., non-public) network. Therefore, the certification and accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required. Security Training All contractor employees and subcontractors under this contract or order are required to complete the VA's on-line Security Awareness Training Course and the Privacy Awareness Training Course annually. Contractors must provide signed certifications of completion to the CO during each year of the contract. This requirement is in addition to any other training that may be required of the contractor and subcontractor(s). Contractor Personnel Security All contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security and Investigations Center (07C). The level of background security investigation will be in accordance with VA Directive 0710 dated September 10, 2004 and is available at: http://www.va.gov/pubs/asp/edsdirec.asp (VA Handbook 0710, Appendix A, Tables 1 - 3). Appropriate Background Investigation (BI) forms will be provided upon contract (or task order) award, and are to be completed and returned to the VA Security and Investigations Center (07C) within 30 days for processing. Contractors will be notified by 07C when the BI has been completed and adjudicated. These requirements are applicable to all subcontractor personnel requiring the same access. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed, but the contractor will be responsible for the actions of those individuals they provide to perform work for the VA. In the event that damage arises from work performed by contractor personnel, under the auspices of the contract, the contractor will be responsible for resources necessary to remedy the incident. The investigative history for contractor personnel working under this contract must be maintained in the databases of either the Office of Personnel Management (OPM) or the Defense Industrial Security Clearance Organization (DISCO). Should the contractor use a vendor other than OPM or Defense Security Service (DSS) to conduct investigations, the investigative company must be certified by OPM/DSS to conduct contractor investigations. Contractor Responsibilities a. The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM) tough the VA, the contractor shall reimburse the VA within 30 days. b. Background investigations from investigating agencies other than OPM are permitted if the agencies possess an OPM and Defense Security Service certification. The Vendor Cage Code number must be provided to the Security and Investigations Center (07C), which will verify the information and advise the contracting officer whether access to the computer systems can be authorized. c. The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak and understand the English language. d. After contract award and prior to contract performance, the contractor shall provide the following information, using Attachment B, to the CO: (1) List of names of contractor personnel. (2) Social Security Number of contractor personnel. (3) Home address of contractor personnel or the contractor's address. e. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract. f. Failure to comply with the contractor personnel security requirements may result in termination of the contract for default. g. Further, the contractor will be responsible for the actions of all individuals provided to work for the VA under this contract. In the event that damages arise from work performed by contractor provided personnel, under the auspices of this contract, the contractor will be responsible for all resources necessary to remedy the incident." 6. QUALITY CONTROL 3.8.1. Quality Assurance Surveillance Plan The Quality Assurance Surveillance Plan (QASP) has been developed to evaluate Contractor actions in accordance with the Performance Work Statement (PWS). It is designed to provide an effective surveillance method of monitoring contractor performance for each listed objective in the Performance Work Statement. The QASP provides a systematic method to evaluate the service quality that the Contractor is required to furnish. This QASP is based on the premise that the Government desire to maintain high quality standards within the service contract. To provide the best means of achieving that objective, the Contractor, and not the Government, is responsible for management and quality control actions to meet the terms of the contract. Objective: The purpose of this plan is to provide a quality surveillance plan for Radiology Testing services. This plan provides a basis for the Contracting Officer's Representative (COR) to evaluate the quality of the Contractor's performance. The oversight provided in this plan will help to ensure that service levels reach and maintain the required levels toughout the contract term. Further, this plan provides the COR with a proactive way to avoid unacceptable or deficient performance, and provides verifiable input for the required annual past performance evaluations. 1. Surveillance: The COR will evaluate the performance objectives tough quarterly assessments as to the quality and effectiveness of the contract services provided. 2. Standards: The contractor shall perform all work required in a satisfactory manner in accordance with the appropriate section. 3. Procedures: The COR will inspect all performance objectives to ensure compliance with the appropriate paragraphs of the Performance Work Statement (PWS). Record results of inspection; notify the Contractor of the deficiencies for correction. The COR shall not consider the services complete until all deficiencies have been corrected. If deficiencies are not corrected within the required time frame, the COR should notify the Contracting Officer for action. Task ID Indicator Standard Acceptable Quality Level Method of Surveillance Incentive Medical Physics (MP) Testing of Diagnostic X-ray Equipment 1 Perform MP measurements according to requirements in Ohio Department of Health Rules OAC 3701:1-66 Perform annual MP measurements not to exceed 1 year + 30 days from previous MP measurement date. 100% Documentation and recording of MP measurements / results and submitting a printed report to COTR within 30 days. Positive and negative performance will be documented in past performance reports that are reported in the CPARS Past Performance Database 2 Report failure of any MP Test parameter. Notify responsible VA staff within 24 hours of measurement or discovery. 100% Documentation and recording of MP measurements / results and submitting a printed report to COTR within 30 days. Positive and negative performance will be documented in past performance reports that are reported in the CPARS Past Performance Database 3 Perform MP testing upon notification for newly installed X-ray equipment or after major repair. Perform measurements within 3 working days upon notification of newly installed X-ray equipment or a major repair. 100% Documentation and recording of MP measurements / results and submitting a printed report to COTR within 30 days. Positive and negative performance will be documented in past performance reports that are reported in the CPARS Past Performance Database. Quality Control Program The role of the Government is to monitor quality assurance to ensure contract standards are achieved. In this contract the Quality Control Program (QCP) is the driver for quality services. The Contractor is required to develop a comprehensive program of inspections and monitoring actions. The first major step is to ensuring a "self-correcting" contract. This objective is to ensure that the Quality Control Program approved at the beginning of the contract provides the measures needed to lead the Contractor to success. Contractor is required to provide Contracting Officer a Quality Control Plan which shall outline an approach to complete required tasks. Include copies of Contractor's state, local, and federal permits and licenses. Once the Quality Control Program is approved, careful application of the process and standards presented in the remainder of this document will ensure a robust Quality Assurance Program. This request is a Total 100% Small Businesses set aside IAW FAR 19.502-2(a) NAICS code assigned to this procurement is 541690 (Other Scientific and Technical Consulting Services) with a size standard of $7 million. Offerors should submit quotes based on the work requirements specified herein. Service Disabled Veteran Owned small businesses are encouraged to contact their nearest Procurement Technical Assistance Center (PTAC) if assistance is required in preparing their quote. The web site address for the location of the nearest PTAC is http://www.sellingtothegovernment.nct. Offerors shall thoroughly review the specifications and include a delivery time for specified requirements. Offerors responding to this synopsis shall also provide information included in the Federal Acquisition Regulation (Far 52.212.2 Evaluation - Commercial Items) all offerors please include a completed copy of the provision at 52.212-3, Offeror Represesentations and Certifications-(ORCA) Commercial Items, with your offer. NOTE: The Government reserves the right to award at BEST VALUE 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 used to evaluate offers: Technical capability of the services offered to meet the Government requirement, Price, Past Performance. The relative order of importance of the evaluation factors are in ascending order of importance. Technical Capability and Past Performance, when combined, are greater than Price. Evaluations may be made without discussions with offeror(s). Federal Acquisition Regulations require that all contractors submitting offers/bids to obtain contracts with agencies of the Federal Government; including the Department of Veterans Affairs, must be registered at; Central Contractor Registration (CCR) database prior to receiving an award. Registration in CCR must be maintained during performance and tough final payment of any contract or award resulting from a solicitation. You may register easily and quickly on-line at https://www.ccr.gov. Payments are to be sent to the address indicated in the quote under this contract. PROVISIONS AND CLAUSES The full text of a FAR provision or clause is available for access electronically at http://www.acquisition.gov/far/index.html. The Veterans Administration (VAAR) clauses and provisions can be accessed at, http://www.va.gov/oal/library/vaar/ The clause at 52.212-4 - Feb 2012 Contract Terms and Conditions-Commercial Items, applies to this acquisition, along with 52.212-5 - May 2012 Contract Terms and Conditions Required To Implement Statutes Or Executive order-Commercial Items, applies to this acquisition. The following FAR and VAAR clauses and provisions shall apply to this acquisition: 52.212-1, Instructions to Offerors Commercial Items; Feb 2012 Addendum 52.212.-1 52.212-3, Offeror Representations and Certifications - Commercial Items, April 2012 52.204-7 Central Contractor Registration; Feb 2012 52.212-2 Evaluation - Commercial Items Jan 1999 52.203-5 Covenant Against Contingent Fees Apr 1984 52.203-7 Anti-Kickback Procedures Oct 2012 52.217-5 Evaluation of Options July 1990 52.217-8 Option to Extend Services Nov 1999 52.217-9 Option to Extend the Term of the Contract Mar 2000 52.219 Small business Program Representations Apr 2012 52.219-6 Notice of Total Small Business Set-Aside Nov 2011 52.233-2 Service of Protest AUG 2006 52.237-1 Site Visit Apr 1984 52.237-2 Protection of Government Building, Equipment and Vegetation Apr 1984 52.237-3 Continuity of Services Jan 1991 52.237-7 Indemnification and Medical Liability Insurance Jan 1997 852.237-70 Contractor Responsibilities APR 1984 852.270-1 Representative of Contracting Officers JAN 2008 852-271-70 Nondiscrimination in Service Provided Beneficiaries APR 1984 52.219-6 Notice of Total Small Business Set-Aside Nov 2011 52.222-26, Equal Opportunity; Mar 2007 52.222-36, Affirmative Action for Workers with Disabilities; Oct 2010 52.222-41 Service Contract Act of 1965, Nov 2007 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving Aug 2011 52.225-13 Restriction on Certain Foreign Purchases Jun 2008 52.232-33, Payment by Electronic Funds Transfer--Central Contractor Registration. Department of Commerce Agency-Level Protest Procedures Level above the Contracting Officer is also incorporated and available for download at www.nist.gov/admin/od/contract/agency.htm Quotes are due no later than 9:00 a.m., EST local time, June 29, 2012. Submit questions to Maladean E. Hudson via e-mail at maladean.hudson@va.gov, or by facsimile at (216) 447-8310.
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