FILE | Q | Mobile Lithotripsy 603 - Attachment

FBO DAILY ISSUE OF OCTOBER 20, 2012 FBO #3983
DOCUMENT

Q -- Mobile Lithotripsy 603 - Attachment

Notice Date: 10/18/2012
Notice Type: Attachment
NAICS: 621999 — All Other Miscellaneous Ambulatory Health Care Services
Contracting Office: Department of Veterans Affairs;Network Contracting Office 9;1639 Medical Center Parkway;Suite 400;Murfreesboro TN 37129
ZIP Code: 37129
Solicitation Number: VA24913R0020
Response Due: 11/7/2012
Archive Date: 2/5/2013
Point of Contact: Monica Thompson
Small Business Set-Aside: Total Small Business
Description: COMBINED SYNOPSIS/SOLICITATION for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) This solicitation is issued as a request for proposal (RFP). Submit a written proposal on RFP reference number VA249-13-R-0020. The Government requires that all Contractors doing business with this office be registered with System for Award Management (SAM). No award can be made to a company not registered in SAM. For additional information and to register in SAM, please access the following web site: https://www.sam.gov/. Please ensure that the representations and certifications are completed to allow Contracting Officers to be able to determine your business size and any additional socio economic categories, if applicable. In order to register, all firms must have a Dunn & Bradstreet Number. A Dunn & Bradstreet number may be acquired free of charge by accessing the Dunn & Bradstreet website at https://iupdate.dnb.com/iUpdate/newUserLogin.htm or by phone at (800) 234-3867. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005-61A. (iv) The associated North American Industrial Classification System (NAICS) code for this procurement is 621999 with a small business size standard of $10m. This requirement is a Small Business set-aside and only qualified offerors may submit proposals. (v) This combined synopsis/solicitation is for the following commercial service: CLIN 0001- Contractor shall provide mobile lithotripsy services in accordance with the Statement of Work (SOW). Base Period - Period of Performance: December 1, 2012 through September 30, 2013 CLIN 0001- Contractor shall provide mobile lithotripsy services in accordance with the Statement of Work (SOW). Base Period - Period of Performance: December 1, 2012 through September 30, 2013 CLIN 0002- Contractor shall provide mobile lithotripsy services in accordance with the Statement of Work (SOW). Option Year 1 - Period of Performance: October 1, 2013 through September 30, 2014 CLIN 0003- Contractor shall provide mobile lithotripsy services in accordance with the Statement of Work (SOW). Option Year 2 - Period of Performance: October 1, 2014 through September 30, 2015 CLIN 0004- Contractor shall provide mobile lithotripsy services in accordance with the Statement of Work (SOW). Option Year 3 - Period of Performance: October 1, 2015 through September 30, 2016 CLIN 0005- Contractor shall provide mobile lithotripsy services in accordance with the Statement of Work (SOW). Option Year 4 - Period of Performance: October 1, 2016 through September 30, 2017 The Government anticipates making a single contract award in the aggregate. The mobile lithotripsy services are to be performed and paid at an established rate per procedure and based priced accordingly to the procedure level and type. The quantities are estimated at three (3) Cases (CS) per month totaling thirty-six (36) CS per year. The Minimum order during the entire term of this contract is 1; and maximum order limits is 45. (vi) A description of the requirements is as follows: The Robley Rex Veterans Affairs Medical Center has a requirement for mobile lithotripsy services per the following Performance Work Statement. (vii) The anticipated Period of Performance is December 1, 2012 through September 30, 2012 for the base period with four (4) option years. Performance will take place at the Robley Rex Veterans Affairs Medical Center, 800 Zorn Avenue, Louisville, Kentucky 40206. (viii) FAR 52.212-1, Instructions to Offerors - Commercial Commercial Items (Jun 2008), applies o this acquisition. Addenda: Offers may submit in any format that the offeror desires as long as it contains all the required information contained in section b of this provision. (ix) (ix) FAR 52.212-2, Evaluation -- Commercial Items (Jan 1999), applies to this acquisition. (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, 2.Past Performance, 3.Price Technical and past performance, when combined, are more important than 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. (End of Provision) TECHNICAL ACCEPTABLE/UACCEPTABLE RATING The purpose of the technical factor is to assess whether the offeror's proposal will satisfy the Government's minimum requirements. Some of the aspects affecting an offeror's ability to meet the solicitation requirements may include technical approach, key personnel and qualifications, facilities, and others. The Government shall evaluate the offeror's proposal against the requirements of the Statement of Work (SOW) contained in this solicitation to determine whether the proposal is acceptable or unacceptable. A proposal is acceptable in that it clearly meets the minimum requirements of the solicitation, or unacceptable in that the proposal clearly does not meet the minimum requirements of the solicitation. PAST PERFORMANCE EVALUATION CRITERIA: In accordance with FAR 15.305(a)(2)(ii): "The Government shall consider this information, as well as information obtained from any other sources, when evaluating the offeror's past performance. The source selection authority shall determine the relevance of similar past performance information. In accordance with FAR 15.305 and (a)(2)(iv): "In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available, the offer may not be evaluated favorably or unfavorably on past performance." Therefore, the offeror shall be determined to have unknown past performance. In the context of acceptability/unacceptability, "unknown" shall be considered "acceptable." Offerors shall submit the following information, as applicable, with their proposal: (1)The Past Performance Evaluation form is to be completed by no more than three (3) evaluators representing different contracts within the past three years. The completed form must be submitted by the evaluator to: Monica Thompson, Contracting Officer, email: monica.thompson@va.gov, fax: 615-225-3452, no later than Wednesday, November 7, 2012 3:00PM CST. (2)List all past or pending litigation for your company, your company under previous names, and your parent company. List contract terminations, in the past 24 months, under your current name, previous names, and parent company. Provide information on problems encountered on the identified contracts and your company's corrective actions. PRICE The Government will evaluate the offeror's proposed price. (x) FAR 52.212-3, Offeror Representations and Certifications -- Commercial Items (Apr 2012) An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via the SAM website at https://www.sam.gov/portal/public/SAM/. If an offeror has not completed the annual representations and certifications electronically at the SAM website https://www.sam.gov/portal/public/SAM/ the offeror shall complete only paragraphs (c) through (o) of this provision. (xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition; as well as the following addenda: N/A, no addenda to subject clause. (xii) The clause at FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Order-Commercial Items (Deviation), applies to this acquisition. (xiii) The following additional contract requirement(s) or terms and conditions apply to this acquisition: FAR 52.204-7, Central Contractor Registration; 52.204-9 Personal Identity Verification of Contractor Personnel; FAR 52.209-6; 52.217-5 Evaluation of Options; 52.217-8 Option to Extend Services within 60 days before the contract is set to expire; 52.217-9 Option to Extend Term of the Contract 30 days prior to expiration of the current performance period; FAR 52.222-3, Convict Labor; FAR 52.222-19, Child Labor-Cooperation with Authorities and Remedies; FAR 52.222.21, Prohibition of Segregated Facilities; FAR 52.222-22, Previous Contracts and Compliance Reports; FAR 52.222-25, Affirmative Action Compliance; Department of Labor Wage Determination 94-2079 Rev 30 Applies, 52.222-42 Statement of Equivalent Rates for Federal Hires; FAR 52.225-18, Place of Manufacture; FAR 52.232-28, FAR 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration; FAR 52.233-3, Protest After Award; FAR 52.233-4, Applicable Law for Breach of Contract Claim; FAR 52.246-1, Contractor Inspection Requirements; FAR 52.247-34, F.O.B. Destination; FAR 52.252-1,FAR 52.253-1, Computer Generated Forms. 52.216-18 Ordering 52.216-19 Order Limitation 52.216-19 Indefinite Quantity 52.217-8 Option to Extend Services 52.217-9 Option to Extend the Term of the Contract 52.228-5 Insurance - Work On A Government Installation CL-120 Supplemental Insurance Requirements 52.232-19 Availability OF Funds For The Next Fiscal Year VAAR 852.203-70 Commercial Advertising VAAR 852.216-70 Estimated Quantities VAAR 852.237-7 Indemnification And Medical Liability Insurance VAAR 852.203-70 Contractor Responsibilities VAAR 852.273-76 Electronic Invoice Submission 52.224-1 Privacy Act Notification 52.224-2 Privacy Act 52.232-18 Availability of Funds 52.216-1 Type of Contract 52.225-25 Prohibition On Contracting With Entities Engaging In Sanctioned Activities Relating to Iran - Representation and Certification 52.233-2 Service of Protest VAAR 852.211-72 Technical Industry Standards VAAR 852.233-70 Protest Content/Alternative Dispute Resolution VAAR 852.233-71 Alternate Protest Procedure (xiv) The following Defense Priorities and Allocations System (DPAS) rating applies: N/A (xv) The date, time, and place for submission of proposals are as follows: November 7, 2012, 3:00PM Central Time. ORAL OFFERS WILL NOT BE ACCEPTED. Submit written offers via mail, email or fax. Monica Thompson -Contract Specialist, Department of Veterans Affairs, Network Contracting Office 9, 1639 Medical Center Parkway, Suite 400 Murfreesboro, TN 37129; e-mail: monica.thompson@va.gov Proposal Questions: Interested offerors must submit any questions concerning the solicitation by Thursday, October 25, 2012, 3:00PM, CST. Questions not received by the due date may not be considered. The Government reserves the right to make award without discussions. Statement of Work (SOW) Mobile Lithotripsy Services Robley Rex Veterans Affairs Medical Center Louisville, Kentucky I. STATEMENT OF WORK A. SCOPE 1. The Contractor shall furnish certified and trained employees to provide Mobile Lithotripsy Services and operation of the equipment in accordance with the specifications contained herein to beneficiaries of the Department of Veterans Affairs (VA) and the Robley Rex VA Medical Center (603), 800 Zorn Avenue, Louisville, KY 40206. Mobile Lithotripsy services would include, but not limited to: "providing portable, state-of-the-art, digital Mobile Lithotripsy equipment; "assisting in a timely manner the Attending Urologist(s) and other physicians in providing Mobile Lithotripsy services; "operating the Mobile Lithotripsy equipment; "maintaining the equipment to ensure it is in the highest level of functioning condition; " obtaining all licenses, approvals, permits and be in compliance with all Federal state and local laws and regulations applicable to the equipment and delivery of Mobile Lithotripsy related services; "completing all applicable annual mandatory VA training; and "delivery of all reports, digital film and file records of all procedures performed with the equipment to the Contracting Officer's Representative (COR) on the same day services are performed. 2. It is understood that the quantities presented for bid are good faith estimates and that the actual numbers may be greater or less than those stated. 3. The Authority for this procurement extends from Public Law 104-262 and Title 38 U.S.C., Section 8151-8153. The solicitation is for a contract for a base period of ten months and four one-year options to renew. Mobile Lithotripsy services will be paid at an established rate per procedure. All Mobile Lithotripsy procedures will be done at the Robley Rex VA Medical Center. B. SERVICES 1. The Contractor is to provide Mobile Lithotripsy equipment and related technical personnel and support to and at the VA Medical Center (VAMC), Louisville, Kentucky, in accordance with a regularly scheduled day per month to be mutually agreed upon between the parties. This monthly schedule will be coordinated with the VA Urology Advanced Practice Registered Nurse to ensure patients are scheduled and the Contractor is available to provide Lithotripsy services. This schedule is subject to increase by mutual agreement between the VAMC and Contractor. The VA anticipates that an average of three (3) Veterans will be treated monthly per regularly scheduled visit. The per-procedure pricing shall include single stone and multiple stone procedures per unilateral or bilateral episode. The equipment must be prepared to perform the first procedure of the day at a mutually agreed upon time and continue to perform procedures until the VAMC's schedule for the day is completed. 2. The Contractor's technical personnel shall be certified and trained in Mobile Lithotripsy services and operation of the equipment. The Technologist will assist the Attending Urologist and other physicians in the operation of the equipment. The Technologist may be required to operate the equipment and any related imaging equipment during procedures. 3. The Contractor shall be responsible for providing the following: a. Provide portable, state of the art, digital equipment that can be easily moved into the Operating Room Suite at the Louisville VAMC. Equipment must meet or exceed the following criteria: (1) Treats all stones anywhere in the urinary tract; (2) Has a large focal point to allow for better positioning; (3) Has a greater than 80% success rate, based on FDA clinical study data; (4) Is modular and can treat patients in the operating room; (5) Has the ability to do endo-urologic procedures before and after Lithotripsy without moving the patient; and (6) Will accommodate patients up to 400 pounds; b. Such additional materials and supplies, including consumables (i.e., electrodes), as are necessary to conduct Lithotripsy procedures with the equipment. c. Maintenance of the equipment to include service and preventative maintenance to ensure that the equipment is in the highest level of functioning condition. d. Assist in the education of medical center personnel as it relates to Lithotripsy. e. Be responsible for obtaining all necessary licenses, approvals, permits and be in compliance with all Federal, state and local laws and regulations applicable to the equipment and delivery of Lithotripsy related services provided for under the terms of this contract. f. Delivery of all reports, digital, film and file records of all procedures performed with the equipment to the Contracting Officer's Representative (COR) located in the Surgical Service Administrative Office, Room A453, on the day the services are provided. These medical records shall be the property of the VA Medical Center, Louisville, Kentucky. g. Contractor shall perform all services under this agreement in accordance with any and all regulatory and accreditation standards applicable to the facility, including without limitations, those requirements imposed by the Joint Commission of Accreditation of Healthcare Organizations (JC). Contractor shall provide consultation, if requested, in the development of protocols, utilization review, peer review and risk management as required by JC and other regulatory bodies. h. Contractor will perform services within the policies, procedures and regulations (such as the medical staff by-laws and professional standards board) governing the VA Medical Center, Louisville, Kentucky. 4. TIMELINESS: Timeliness is an essential component of this contract and the Contractor must adhere to established timeframes for the provision of service. Failure to provide the documentation required by this agreement or to provide documentation to support the charges being assessed will be seen as incomplete services and will result in delayed processing of invoices. 5. The VA Medical Center, Louisville, Kentucky, will provide the following: a. Suitable electric service to operate the equipment; b. Provide a secure room for the equipment while located on the premises; c. Physician(s) to perform the procedure and appropriate personnel to administer any required anesthesia; d. Scheduling of patients for Lithotripsy procedures and coordinating the scheduling of in-service relating to the equipment for facility staff; e. Provide the pre-operative preparation of patients for Lithotripsy, obtain written patient consent forms and provide patients with the necessary services relating to post-procedure recovery. Facility shall be responsible for providing emergency service personnel, physicians, facilities and supplies necessary to provide patients with emergency medical care as may be required, as well as physicians, facilities and supplies necessary to provide patients with inpatient or outpatient post-procedure care. f. Any pharmaceuticals required for the procedures; g. Take all actions reasonably necessary to assist Contractor in achieving compliance with Federal, state and local laws and regulations as provided in item 3.e. h. Shall be responsible for the collection and disposal of infectious waste and sharps related to the Lithotripsy procedures. 6. INSPECTION: The VA Biomedical Engineering staff will inspect the Lithotripsy equipment upon each set up in the Operating Room Suite, prior to the first procedure. 7. RETREATMENT: If a Veteran must undergo an additional treatment within 90 days from their initial procedure due to continued problems with the stone(s); i.e., stone(s) was not broken down small enough to pass or fragments of the stone(s) remain; the Contractor will provide the treatment at 50% of the contract cost. 8. INFECTION CONTROL COMPLIANCE: Contractor and staff must be in training compliance with the Bloodborne Pathogens Standards, 29 CFR Part 1910.1030 and provide written certification to that effect to the Contracting Officer's Representative (COR) upon request. 9. The Contractor shall provide both a clinical and administrative point of contact at the Contractor's facility to coordinate services and billing within five (5) days of award of contract. C. MEDICAL EQUIPMENT 1. The Contractor will maintain a system of notification of equipment hazards, defects, and recalls and will maintain an effective, written recall plan. 2. The Contractor will have written equipment preventive maintenance policies and procedures and will maintain a system for tracking all preventive maintenance by serial number. All preventive maintenance will be performed by trained personnel and in accordance with manufacturer's guidelines. 3. The Contractor is required to maintain medical equipment records that document the following: a. Inventory; b. Historical documentation of incoming inspection prior to use and ongoing inspection, testing and maintenance; c. Monitoring and acting on hazard notices and recalls; d. Participation in the Safe Medical Device Act of 1990; e. A medical equipment education program that addresses: (1) Capabilities, limitations and special applications of equipment (users); (2) Basic operation and safety features (users); (3) Emergency procedures in the event of equipment failure (users); (4) Information and skills necessary to perform maintenance (maintainers); (5) Process for reporting failures (users and maintainers); (6) Annual chemical testing and monthly biological testing of water quality used in renal dialysis equipment (dialysis patients only); and (7) Performance testing of sterilizers. 4. CONTRACTOR RECALL AND SAFETY PLAN AND PROCESS NOTIFICATION TO FACILITIES: All Contractors shall take immediate action to notify the facility Contracting Officer's Technical Representative and Contracting Officer whenever a product, piece of equipment or item is recalled or considered dangerous, hazardous or unsafe in order to remove such products, equipment or items from use. This notification process also applies to safety alerts. The Contractor recall and safety notification plan and process is necessary so that proper notification to individuals who have received or individuals who may utilize such products, equipment or items can be made in as expedient and efficient manner as possible. The Contractor shall provide to the facility Contracting Officer's Technical Representative their plan for this safety notification process and also maintain a record system in order to document any safety incident issues by their date, time, and description of the recall or safety alert issue provided to the facility Contracting Officer's Technical Representative. D. SPECIAL CONTRACT REQUIREMENTS Under the authority of 38 USC 8153, the contractor agrees to provide Health Care Resources in accordance with the terms and conditions stated herein, to furnish to and at the Department of Veterans Affairs Medical Center, 800 Zorn Avenue, Louisville, Kentucky, the services and prices specified in this contract. 1. SERVICES a. The services specified in the Sections entitled Schedule of Services and Costs and Special Contract Requirements may be changed by written modification to this contract. The modification will be prepared by the VA Contracting Officer. b. Other necessary personnel for the operation of the services contracted for at the VA will be provided by the Contractor at levels mutually agreed upon which are compatible with the safety of the patient and personnel and with quality medical care programming. Other personnel assigned to provide services under the contract will be subject to the same qualification requirements. c. The services and documentation to be performed by the Contractor will be performed in accordance with VA policies and procedures and the regulations of the medical staff By-laws of the VA facility, Code of Ethics, Medical Center Memorandums, American Medical Association and JC. Contracted provider will comply with Joint Commission (JC) and Department of Veterans Affairs (DVA) requirements pertaining to patient treatment and documentation; the VAMC quality assurance requirements; locally accepted tenets of standards of care; the Network Performance VISN Plan; and Mission of the VA. d. Contractor must provide proof of evidence of negative PPD skin test for tuberculosis screening to the Contracting Officer's Representative (COR) for all Contractor employees providing contract services on VA property, prior to providing contract service, or the Contractor employees must accept the administration of a PPD skin test by the VA Employee Health Service. A PPD skin test is required annually thereafter. e. Annual Training - Contractors shall complete annual training, provided by the Contracting Officer's Representative (COR), required in accordance with contract services provided. Training includes, but is not limited to, HIPAA and Privacy Policies, Safety, and Infection Control. f. The services to be performed by the Contractor will be reviewed by the Chief, Surgical Service, Associate Chief Nurse, Surgical Service and/or Operating Room Supervisor, who will provide monitoring of patient care activities. This will be accomplished by utilizing clinical review and provider specific profiling. g. Contractor personnel providing services on VA property shall be electronically fingerprinted. h. All medical records pertaining to Robley Rex VAMC beneficiaries are and shall remain the property of the Department of Veterans Affairs and the Contractor IS PROHIBITED to release any information contained in the VA system of records. Any use or disclosure of information contained in these records must be in accordance with the Health Insurance Portability and Accountability Act (HIPAA), the Privacy Act, and all other applicable state and federal statutes governing the use or disclosure of individually identifiable health information. Neither the Contractor nor anyone working on his/her behalf may use, disclose, or otherwise release any information contained in their system of records on VA beneficiaries referred under this contract without the express, written consent of the patient or his/her legal guardian. At no time shall the Contractor access or permit access to the electronic medical record of any VA beneficiary not referred to the Contractor under the terms of this agreement. Inappropriate access to VA patient data shall result in termination of access privileges and may result in criminal charges, penalties, fines or any combination thereof, and shall be considered grounds for immediate termination of this agreement. i. Contractor's staff will actively participate in the educational and quality assurance programs of Surgical Service. II. DEFINITIONS A. Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the definitions and other sections of this contract, the language in this section shall govern. 1. Contracting Officer (CO) - The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings. 2. Contracting Officer's Representative (COR) - A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken. 3. Credentialing - Is the systematic process of screening and evaluation qualification and other credentials, including licensure, required education, relevant training and experience, and current competence and health status. 4. Privileging (Clinical Privileging) - Is the process by which a practitioner, licensed for independent practice (i.e., without supervision, direction, required sponsor, preceptor, mandatory collaboration, etc.), is permitted by law and the facility to practice independently, to provide specific medical or other patient care services within the scope of the individual's license, base upon the individual's clinical competence as determined by peer references, professional experience, health status, education, training, and licensure. Clinical privileges must be facility-specific and provider-specific. 5. Veterans Health Administration (VHA) - The central office for administration of the VA medical centers throughout the United States. The VHA is located in Washington, DC. 6. Veterans Integrated Services Network (VISN) - The regional oversight for the VA Medical Centers in Memphis, TN, Tennessee Valley Healthcare System (Murfreesboro and Nashville), Louisville, KY, Lexington, KY, Huntington, West Virginia and Mt. Home, TN. The VISN office is located at 1801 West End Avenue, Suite 1100, Nashville, TN 37203. 7. VISTA - Veterans Integrated Systems Technology Architecture. A PC based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient's medical record and with the hospital information system. 8. CPRS - Computerized Patient Record System (CPRS): Electronic patient charting system that houses all pertinent healthcare records (i.e., laboratory and radiology results, doctor's orders, progress notes, surgery reports, etc.). III. CREDENTIAL REVIEWS/PRIVILEGING Not Applicable. IV. QUALITY REQUIREMENTS A. Personnel assigned by the Contractor to perform the services covered by this contract shall be certified and/or licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All certifications and/or licenses held by the personnel working on this contract shall be full and unrestricted licenses to practice the individual profession. The qualifications of such personnel may also be subject to review by the VA Chief of Staff and approval by the VA Facility Director. B. Contractor payment for services may be withheld if service is provided or authorized by uncertified and/or unlicensed personnel, without regard to whether such services were medically necessary and appropriate. The VAMC, Louisville, Kentucky, shall not approve of subcontracts with uncertified and/or unlicensed individual or group providers. C. The Contractor will be responsible, through written policies and procedures regarding staff credentials, to ensure that Contractor employees providing work on this contract are fully trained and completely competent to perform the required work. D. The Contractor shall be in compliance with the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Public Law 104-191 also addresses pertinent issues related to security and confidentiality of individually identifiable health information and records that include protected health information. It is the responsibility of the Contractor to assure that patient records are protected against any anticipated threats or hazards to their security or integrity which could result in substantial harm, embarrassment, inconvenience, or unfairness to any individual for whom information is maintained. E. Offers will be considered only from Offerors who are regularly established in the business and who are, in the judgment of the Contracting Officer, financially responsible. Upon request of the Government, Offerors shall be able to show evidence of their reliability, ability, experience, equipment, facilities and personnel directly employed or supervised by them to render prompt and satisfactory service in the volume called for under this contract. F. The VA reserves the right to thoroughly inspect and investigate the establishment, facilities, equipment, business reputation, and other qualifications of any Offeror, and to reject any offer irrespective of price, that shall be administratively determined lacking in any of the essentials necessary to assure acceptable standards of performance. G. Upon request of the Government, the Offeror must be able to show evidence of his/her reliability, ability and experience by furnishing (a) a list of personnel who will perform under the contract showing the length and type of experience of such personnel, and (b) the names and addresses of other concerns and/or Government agencies for which this type of service was rendered by the Offeror. H. The Contractor shall make available, upon request, copies of certificates, training, licensure or other information as requested by the Contracting Officer or the Contracting Officer's Representative (COR) as evidence of the qualifications and/or experience of personnel providing services under this contract. I. The Contractor must be financially responsible and able to show evidence of their responsibility, ability, experience, equipment, facilities, and personnel directly employed or supervised by them to render prompt and satisfactory service in the volume required for all items under this contract. By execution of this contract, the Contractor is certifying that all requirements of Federal, state, or local laws, codes, and/or regulations regarding the operation of this type of service will be met. J. Personnel providing services under this contract having direct patient-care responsibility must speak and write English proficiently in accordance with Public Law 95-201. K. Any subcontractor utilized by the Contractor for the provision of services required under this contract must meet the same qualifications specified herein for the Contractor. The Contractor must obtain approval from the Contracting Officer for any subcontractor to be utilized for the provision of services required under this contract. L. Quality Management: Personnel providing service under this contract are required to actively participate in quality management activities as follows: 1. The contractor will be required to demonstrate compliance with Joint Commission standards and/or other medical credentialing/oversight bodies and supply the VA with a copy of their accreditation letter. The contractor must provide the VA with documentation resulting from any inspections that occur during the term of this contract, such as OSHA, NRC, etc., and must inform the VA of any citations received from any oversight or reviewing entity. Documentation of any reviews, citations, etc., is to be provided to the VA COR within seven (7) days of receipt. 2. The Contractor shall involve the patient and his/her family in the decision making process and education. 3. The Contractor will have an operational performance improvement process including data collection, measurement, assessment and improvement. Data will be required on processes, outcomes, patient satisfaction, and quality control. Appropriate statistical quality control techniques must be utilized. Results of performance improvement activities must be reported quarterly to the COR/Administrative Officer, Surgical Service through the Chief, Surgical Service. 4. Policies and procedures must be established in collaboration with associated departments. 5. Contractor will ensure that all Robley Rex VAMC mandatory training including the national training in Security Awareness and Privacy Policies, Safety and Infection Control are completed during each fiscal year. V. KEY PERSONNEL A. The Contractor shall assign to this contract the following key personnel: staff who are certified and trained in Mobile Lithotripsy services and operation of the equipment. The Contractors shall assign to this contract only those persons whose resumes, personnel data forms, or personnel qualification statements were submitted and approved as required. No substitution of personnel shall be made except as follows: 1. During the first ninety (90) days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the Contracting Officer, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required by paragraph (c) below. After the initial 90-day period of the contract, the Contractor shall submit the information required by paragraph (c) to the Contracting Officer at least 15 days prior to making any permanent substitutions. 2. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The Contracting Officer will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel. 3. For temporary substitutions where the key person will not be reporting to work for three (3) consecutive work days or more, the Contractor will provide a qualified replacement for the key person. This substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above. B. The VA reserves the right to refuse approval under this contract or require dismissal from contract work of any Contractor or subcontractor personnel who, by reason of unsatisfactory performance or for any other valid reason, is considered by the Contracting Officer or Contracting Officer's Technical Representative to be objectionable. C. The Contractor will designate one person who can be contacted for any problems or issues that arise in the performance of this contract to the Robley Rex VAMC with a phone number. The Robley Rex VAMC will also designate a contact person. D. The Contractor must identify key personnel proposed to provide the required services and their qualifications upon award of contract and on an annual basis thereafter. The Contractor cannot change key personnel without VAMC approval. E. 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: oWorkers compensation oProfessional liability insurance oHealth examinations oIncome tax withholding, and oSocial security payments. F. The parties agree that the contractor, its employees, agents and subcontractors shall not be considered VA employees for any purpose. The payment for any leave, including holiday pay, sick leave or annual leave is the responsibility of the contractor and is included in the contract price. VI. PATIENT RIGHTS AND SAFETY A. The Contractor will validate the patient's written consent prior to service which documents understanding of patient's rights and responsibilities. At the initial contact or assessment, the Contractor will coordinate services with the Urology Attending, and be aware of his/her responsibilities and any other requirements of Joint Commission or other accrediting bodies. As directed, the Contractor will provide all necessary education of medical center personnel as it relates to Mobile Lithotripsy to provide the required, safe service to the Veteran patient. B. The Robley Rex VAMC is not responsible or liable for any unsafe condition caused by the Contractor or Veteran. Contractor shall be responsible for identifying safety hazards and clearly verbalize same to the Urology Attending for documentation in the patient's electronic patient record. C. The Contractor will have evidence of implementation of the Joint Commission National Patient Safety Goals as applicable. Patient's Rights and Responsibilities A. RESPECT AND NONDISCRIMINATION 1. You will be treated with dignity, compassion, and respect as an individual. Your privacy will be protected. You will receive care in a safe environment. We will seek to honor your personal and religious values. 2. Treatment will respect your personal freedoms. 3. In order to provide a safe treatment environment for all patients or residents and staff, you are expected to respect other patients, residents and staff and to follow the facility's rules. Avoid unsafe acts that place others at risk for accidents or injuries. Please immediately report any condition you believe to be unsafe. B. INFORMATION DISCLOSURE AND CONFIDENTIALITY 1. You will be given information about the health benefits you can receive. The information will be provided in a way you can understand. 2. You will receive information about the costs of your care, if any, before you are treated. You are responsible for paying your portion of any costs associated with your care. 3. Your medical record will be kept confidential. Information about you will not be released without your consent unless authorized by law (an example of this is State public health reporting). You have the right to information in your medical record and may request a copy of your medical records. This will be provided except in rare situations when your VA physician feels the information will be harmful to you. In that case, you have the right to have this discussed with you by your VA provider. 4. You will be informed of all outcomes of care, including any potential injuries. You will be informed about how to request compensation for any injuries. C. PARTICIPATION IN TREATMENT DECISIONS 1. You, and any persons you choose, will be involved in all decisions about your care. You will be given information you can understand about the benefits and risks of treatment. You will be given other options. You can agree to or refuse treatment. You will be told what is likely to happen to you if you refuse treatment. Refusing treatment will not affect your rights to future care but you take responsibility for the possible results to your health. 2. Tell your provider about your current condition, medicines (including over-the-counter and herbals), and medical history. Also, share any other information that affects your health. You should ask questions when you do not understand something about your care. Being involved is very important for you to get the best possible results. 3. You will be given, in writing, the name and title of the provider in charge of your care. As our partner in healthcare, you have the right to be involved in choosing your provider. You also have the right to know the names and titles of those who provide you care. This includes students, residents and trainees. Providers will properly introduce themselves when they take part in your care. 4. You will be educated about your role and responsibilities as a patient or resident. This includes your participation in decision making and care at the end of life. 5. If you believe you cannot follow the treatment plan, you have a responsibility to notify your provider or treatment team. 6. You have the right to have your pain assessed and to receive treatment to manage your pain. You and your treatment team will develop a pain management plan together. You are expected to help the treatment team by telling them if you have pain and if the treatment is working. 7. As an inpatient you will be provided any transportation necessary for your treatment plan. You have the right to choose whether you will participate in any research project. Any research will be clearly identified. Potential risks of the research will be identified and there will be no pressure on you to participate. You will be included in resolving any ethical issues about your care. You may consult with the Medical Center's Ethics Consultation Service and/or other staff knowledgeable about healthcare ethics. D. If you or the Medical Center believes that you have been neglected, abused or exploited, you will receive help. VII. CONTINUUM OF CARE A. All medical records pertaining to VA beneficiaries are and shall remain the property of the Department of Veterans Affairs and the contractor IS PROHIBITED to release any information contained in the VA system of records. Any use or disclosure of information contained in these records must be in accordance with the Health Insurance Portability and Accountability Act (HIPAA), the Privacy Act, and all other applicable state and federal statutes governing the use or disclosure of individually identifiable health information. Neither the contractor nor anyone working on his/her behalf may use, disclose, or otherwise release any information on VA beneficiaries without the express, written consent of the patient or his/her legal guardian. At no time will the contractor access or permit access to the electronic medical record of any VA beneficiary under the terms of this agreement. Inappropriate access to VA patient data will result in termination of access privileges and may result in criminal charges, penalties, fines or any combination thereof, and will be considered grounds for immediate termination of this agreement. B. All Mobile Lithotripsy treatment and/or services provided by the Contractor shall be appropriately documented via the APPROPRIATE method; i.e., electronic via CPRS or via hardcopy. Any special incidents involving VA beneficiaries receiving treatment at the VAMC will be appropriately documented. Should specific Mobile Lithotripsy incidents occur that are deemed to be adverse or sentinel events during the administration and/or treatment of VA beneficiaries that warrant communication to a higher level, the Chief, Surgical Service and Associate Chief Nurse for Surgical Service will be informed as soon as possible for their completion of the electronic patient incident report (ePIR). VIII. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) A. The Contractor will be required to demonstrate compliance with Joint Commission standards and/or other medical credentialing/oversight bodies by providing evidence that all services provided by contracted individuals will be within the scope of contract guidelines. B. The VAMC shall monitor the following specific data to ensure contract compliance (see Attachment J). C. The Contractor will provide statistical, quality assurance, and performance data in accordance with schedules established by VAMC. On a quarterly basis, the Contractor will provide the following: 1. Dates of service, number of cases per month; 2. Names of physicians with whom they worked; 3. Validation of technologist's timely arrival; 4. Validation of discussions with physicians regarding treatment site; and 5. Validation of equipment check and inspection. D. This data will be provided to the Chief, Surgical Service on a quarterly basis, by the seventh (7th) workday of the month following the end of the quarter; i.e., 1st Quarter (October, November and December) submit by 7th workday in January; 2nd Quarter (January, February and March) submit by 7th workday in April; 3rd Quarter (April, May and June) submit by 7th workday in July; and 4th Quarter (July, August and September) submit by 7th workday in October. This information will be used for contract audit review documentation conducted at the VAMC on a quarterly basis. E. HEALTH & HUMAN SERVICES (HHS) OFFICE OF INSPECTOR GENERAL (OIG) EXCLUSION LIST The contractor is to ensure that individuals do not appear on the current Office of Inspector General's Exclusionary List from participation in Medicare, Medicaid and other Federal Health Care Programs http://epls.gov or http://exclusions.oig.hhs.gov. IX. ENVIRONMENT OF CARE A. The Government will schedule and provide an initial orientation which all Contract staff shall attend prior to working in the VAMC. B. The VAMC will provide all other ancillary personnel services required for performing services, including but not limited to nursing personnel, x-ray technologists, medical assistants and laboratory technicians. C. The Government will provide an identification badge to each Contract personnel during facility orientation. The Contract personnel shall wear the identification badge on the front of the outer clothing at all times when providing services under this contract. D. The Government shall provide space for consultations, conferences, study, telephone conversations and privacy. X.INFECTION CONTROL The overall goal of the Infection Control Program is to prevent, identify, and control infections in patients, employees, volunteers, students, and visitors in all areas of the medical center and outpatient programs that are within the Robley Rex VA Medical Center (LVAMC) catchment area. This is accomplished through utilization of a risk assessment and action plans that identify specific measurable goals and measurable expected outcomes. Infection control and prevention is an integral part of all services; and prevention and control of infection is a primary responsibility of all healthcare workers. The Contractor shall adhere to all applicable infection control guidelines associated with working in an Operating Room Suite and throughout the Robley Rex VA Medical Center. XI.FACILITY REQUIREMENTS 1. The VA reserves the right to refuse employment under this contract or require dismissal from contract work of any Contractor employee or subcontractor employee who, by reason of previous unsatisfactory performance at the VA or for any other reasonable reason, is considered by the Contracting Officer to be objectionable. In these instances, the Contracting Officer will contact the Contractor and request a plan of correction to be returned within ten working days. If the plan of correction is accepted, the Contractor will be provided a period of time, that is mutually agreed upon, to carry out the correction. 2. In the event of patient safety violations, the Contractor will be immediately suspended pending an investigation of which the Contractor will be a full participant. XII. CLINICAL TASK TO BE PERFORMED/PROVIDED See Statement of Work. XIII. ADMINISTRATIVE TASKS/TIME AND CLINICAL TASK/TIME See Statement of Work. XIV. REQUIREMENTS AND HOW THEY WILL BE BILLED A. Invoices shall be submitted in arrears 1. Payments made to the Contractor by the Department of Veterans Affairs under this contract shall be for the total cost of services provided. The Contractor hereby agrees, that in no event shall the Contractor or his agents bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against the beneficiary, the beneficiary's family, private insurer, Medicare, or any other entity acting on the beneficiary's behalf, for services provided pursuant to this contract. When properly invoiced and processed, VA payment for services provided to VA beneficiaries under the terms of this agreement shall constitute payment in full. 2. Reimbursement for VA beneficiaries presented prior to the expiration of this agreement shall be made at the contract rate in effect at the time of patient referral. 3. The documentation on each individual patient on whom Mobile Lithotripsy services are provided will be provided at the end of the treatment day to the Contracting Officers Representative (COR) located in the Surgical Service Administrative Office, Room A453. This documentation will validate the treatment of services provided. 4. There is no minimum or maximum number of patients established for this contract. The numbers used at the beginning of this solicitation are good faith estimates based on actual clinical data for a specified period of time. The cost for the estimated number of cases is based upon the CPT code(s) used in the performance of Mobile Lithotripsy services. 5. The Associate Chief Nurse for Surgical Service or designee is the technical Contracting Officer's Representative (COR). The Associate Chief Nurse for Surgical Service or designee is the Contractor's clinical point of contact at the VA for the purposes of answering clinical questions and requests for documentation. She/he or the designee will be notified if a patient does not show for treatment or if the patient's medical condition changes and medical treatment or hospitalization is required. This individual or designee will be responsible for coordinating VA resources to assist in the continuity of care for VA patients when necessary and informing the Contractor who the appropriate contact person is in each situation. In the absence of the Associate Chief Nurse for Surgical Service, the Contractor should contact the designee, referring physician or the VA Chief of Surgery for assistance. 6. The Administrative Officer for Surgical Service will serve as the administrative COR for purposes of receiving patient reports, processing invoices and answering contract questions for Mobile Lithotripsy services performed within the VA facility. 7. The Robley Rex VAMC will not be responsible for services provided outside the normal course of treatment unless prior scheduling is coordinated with the Urology Advanced Practice Registered Nurse as outlined earlier in this proposal. 8. Contractor shall submit invoices monthly, in arrears, for services, consultations, or upon completion of treatment. - For services provided at the Robley Rex VA Medical Center, invoices shall be forwarded to Austin Finance Center as follows: For FedEx: FMS-VA-2 (603) 1615 WOODWARD ST AUSTIN, TX 78772 For Standard Mail: FMS-VA-2 (603) P.O. BOX 149971 AUSTIN, TX 78714 For Fax: (512) 460-5540 NOTE: Invoices submitted by the vendor will only be submitted with the agreed upon contract price. At no time will invoices be submitted with amounts that may be greater than the agreed upon rates. Should any invoices be submitted with amounts that are higher than the agreed upon rates which results in an overpayment, reimbursement will be requested from the vendor. 9. The Department of Veterans Affairs (VA Financial Service Center FSC) is the designated agency office for invoice receipt in accordance with the Prompt Payment Act (5 CSF Part 1315). FSC or its designated representative may contact the vendor to provide specific instructions for electronic submission of invoices. The vendor will be responsible for any associated expenses. FSC may utilize third-party contractors to facilitate invoice processing. Prior to contact by FSC or its designated representative for electronic invoicing submissions, the vendor shall continue to submit all invoices to the FSC at the addressed noted above. 10. In addition to the requirements in FAR clause 52.212-4, paragraph (g), invoices shall contain the following information: the Contractor's full name, address and telephone number, the Contractor's Tax ID number; the veterans complete name and social security number; dates of treatment or service; diagnosis or condition treated; description of services rendered; appropriate ICD-9-CM and CPT-4 codes (modifiers, if required); fees at the contracted rate, VA contract number and current fiscal year VA assigned purchase order number. All documentation must be electronically entered into CPRS prior to the invoice being paid. The Robley Rex VAMC will review the invoice against its records and notify the Contractor of invoice discrepancies. Upon resolution of the discrepancies, the Robley Rex VAMC will approve the invoice and make payment to the Contractor. XV. IF ON SITE VA- CLEAR DESCRIPTION OF DUTY HOURS A. TIMELINESS 1. Timeliness is an essential component of this contract and the contractor must adhere to established timeframes for the provision of service. Failure to provide the documentation required by this agreement or to provide documentation to support the charges being assessed will be seen as incomplete services and will result in delayed processing of invoices. 2. Written documentation associated with each patient procedure must be provided, on the day services are provided, to the Contracting Officers Representative (COR), located in the Surgical Service Administrative Office, Room A453. B. WORK HOURS 1. The services covered by this contract shall be furnished by the Contractor as defined herein. The Contractor may be required to furnish such services during off-duty hours or national holidays as described below. 2. The following terms have the following meanings: a. Work hours: A mutually agreed upon scheduled day(s) per month, selected from Monday through Friday, 7:00 a.m. - 3:30 p.m. b. National Holidays: The ten (10) holidays observed by the Federal Government are: New Years Day Martin Luther King's Birthday Presidents Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Christmas AND any other day specifically declared by the President of the United States to be a national holiday. c. Off-Duty hours: Friday through Monday, 3:30 p.m. - 7:00 a.m. and weekends, Saturday through Sunday, 12 midnight to 12 midnight. d. In the case where Mobile Lithotripsy services may have to be provided on an urgent or emergent basis during off-duty hours or national holidays, the Contractor is required to respond telephonically within 15 minutes of receiving the call and must be in-house within two (2) hours of the original page or telephone call to provide Mobile Lithotripsy services at the VAMC. C. DEDUCTION SCHEDULE The VA will track delays or cancellations of Mobile Lithotripsy due to lack of Contractor's personnel. Invoice adjustments shall be made for any delays or cancellations due to unavailability of the Contractor's personnel. The following is a deduction schedule: 1. Delays: Information regarding delays will be collected from the nursing staff/surgeons and Urologists by the Administrative Officer, Surgical Service who is the COR. The COR/Administrative Officer will discuss the information with the Chief of Surgery, who will then investigate the issue through discussions with the nursing staff/surgeons and Urologists. This information will then be provided to the Contracting Officer for a determination of delay and penalty to be assessed. In the event, the Contractor's personnel is unavailable to ensure the Lithotripsy procedure begins at the assigned time, the Contractor's monthly invoice shall be reduced $500.00 per delay. 2. Cancellations: In the event of each cancelled Mobile Lithotripsy procedure by the Contractor's personnel for medical or non-medical reasons, the Contractor's monthly invoice shall be reduced $1,000.00 per cancellation. 3. Documentation: In the event of delays or non-existent medical documentation, the Contractor's monthly invoice shall be declined until such documentation has been provided to the COR 4. Quality Improvement Data: In the event of non-receipt of delay in receipt of quality improvement data, the Contractor's monthly invoice shall be reduced $500.00 per instance of non-receipt of data.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/VA/NaVAMC/VAMCCO80220/VA24913R0020/listing.html)
Document(s): Attachment; File Name: VA249-13-R-0020 VA249-13-R-0020_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=502394&FileName=VA249-13-R-0020-000.docx); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=502394&FileName=VA249-13-R-0020-000.docx; File Name: VA249-13-R-0020 DOL Wage Determination Mobile Lithotripsy 10-3-12.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=502395&FileName=VA249-13-R-0020-001.docx); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=502395&FileName=VA249-13-R-0020-001.docx; File Name: VA249-13-R-0020 Past Performance Evaluation VA249-13-R-0020 Mobile Lithotripsy CPARS.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=502396&FileName=VA249-13-R-0020-002.docx); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=502396&FileName=VA249-13-R-0020-002.docx; Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
Place of Performance: Address: Robley Rex VA Medical Center;800 Zorn Avenue;Louisville, Kentucky; Zip Code: 40206
Record: SN02916128-W 20121020/121018234558-980b9156118659386b1a2c60d1156cda (fbodaily.com)
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Q -- Mobile Lithotripsy 603 - Attachment