DOCUMENT
Q -- Lithotripsy Services - Attachment
- Notice Date
- 7/17/2015
- Notice Type
- Attachment
- NAICS
- 621999
— All Other Miscellaneous Ambulatory Health Care Services
- Contracting Office
- Department of Veterans Affairs;Gulf Coast Veterans Health Care System;Network Contracting Office 16;400 Veterans Avenue;Biloxi MS 39531
- ZIP Code
- 39531
- Solicitation Number
- VA25615Q0874
- Response Due
- 8/14/2015
- Archive Date
- 9/13/2015
- Point of Contact
- Rene' Impey
- Small Business Set-Aside
- N/A
- Description
- This Gulf Coast Veterans Health Care System (GCVHCS), Biloxi, MS, is issuing a combined synopsis/ solicitation for commercial services prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice in conjunction with procedures in FAR Part 13. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation is being issued. The solicitation number VA256-15-Q-0874 is issued as a Request for Quote (RFQ). This document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-81 effective April 10, 2015. The NAICS code is 621999 and the size standard is $15.0 million. This requirement is full and open, unrestricted; however, small businesses are preferred, and will be awarded as firm-fixed-price. The closing date for this notice is 3:00 p.m. EST August 14, 2015. The requirement is for the following: The Michael E. DeBakey VA Medical Center (VAMC) is seeking preferably small businesses (but will accept other than small business) capable of providing one Lithotripsy Services technician. The location of service is 2002 Holcombe Boulevard, Houston, TX 77030-4298. The contractor shall provide availability to the Michael E. DeBakey VAMC, one ESWL technician trained and certified in Lithotripsy services and operation of the equipment units. See Statement of Work (SOW) for details of services. Contractor to provide services in accordance with the terms and conditions of the contract for the period of October 1, 2015 through September 30, 2016, with two (2) - twelve (12) month option periods to be exercised at the Government's discretion. To be eligible for award of a contract, vendor must be actively registered in the SAM database (http://www.sam.gov). Vendor is also required to complete representations and certifications fund in the provision at 52.212-3, Offeror Representations and Certifications - - Commercial Items. Questions regarding this solicitation must be made in writing to the Contract Specialist, Rene' Impey, at rene.impey@va.gov, or by fax at 228-523-4324, and must include the solicitation number VA256-15-Q-0874 on the subject line or the fax cover sheet. NO TELEPHONE REQUESTS OR INQUIRIES WILL BE ACCEPTED. Submissions must be received by 3:00 p.m. EST on August 14, 2015. In order to be responsive, the firm must offer a quote on all items and total base year including all option years pricing as provided below. Base Year: 10/01/2015 - 09/30/2016 Option Year 1: 10/01/2016 - 09/30/2017 Option Year 2: 10/01/2017 - 09/30/2018 Base Year: 10/01/2015 - 9/30/2016 ITEM NOLOCATIONQTYUNITUNIT COSTTOTAL 0001ESWL procedure, unilateral episode, regularly scheduled clinic CPT Code 5059051EA TOTAL BASE YEAR Option year 1: 10/01/2016 - 9/30/2017 ITEM NOLOCATIONQTYUNITUNIT COSTTOTAL 1001ESWL procedure, unilateral episode, regularly scheduled clinic CPT Code 5059054EA TOTAL OPTION YEAR Option year 2: 10/01/2017 - 9/30/2018 ITEM NOLOCATIONQTYUNITUNIT COSTTOTAL 2001ESWL procedure, unilateral episode, regularly scheduled clinic CPT Code 5059057EA TOTAL OPTION YEAR *NOTE: Unit Cost/Price must be firm-fixed, all-inclusive. STATEMENT OF WORK 1.CONTRACTOR SPECIFIC TASKS A.The Contractor's technical personnel shall be certified and trained in ESWL Lithotripsy services and operation of the equipment units. The technician shall assist the attending Urologist and other physicians in the operating room and/or cysto suite in the operation of the equipment units. The technician may be required to operate the device. B.The contractor shall be responsible for providing the following: 1. Provide portable, state of the art, digital units that can be easily moved into the operating rooms/cysto suite in the Michael E. DeBakey VA Medical Center (VAMC), Houston, TX. The equipment must meet or exceed the following criteria: a. Treats all stones anywhere in the urinary tract. b. Has a greater than 80% success rate based on FDA clinical study data. c. Is modular and can treat patients in the operating room/cysto suite. d. Has the ability to do endourological procedures before and after ESWL without moving the patient. 2. Such additional materials and supplies, including consumables, as are necessary to conduct ESWL. 3. Maintenance of the devices to include service and preventative maintenance to insure that the devices are in the highest level of functioning condition, with, as a minimum, maintenance performed at the manufacturer's manual requirements. 4.Assist in the education of each facility's personnel as it relates to ESWL. 5.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 devices and delivery of ESWL. 6.Delivery of all reports, digital, film and file records of all procedures performed with the devices to the Contracting Officer's Representative (COR). These medical records shall be the property of the Department of Veterans Affairs, Michael E. DeBakey VAMC. 7.To the extent that this contract is subject to Section 952 of the Omnibus Reconciliation Act of 1980, 42 U.S.C. 1395(v)(1)(I), and the regulations promulgated hereunder, and the cost or the value of the services provided is $10,000 or more over a 12-month period, the contractor shall allow the Comptroller General and their duly authorized representatives to have access to the contractor's contract, books, documents and records until the expiration of four (4) years after the services are furnished under the contract. 8.The contractor shall perform all services under this contract in accordance with any and all regulatory and accreditation standards applicable to the individual VA facility, including without limitations, those required by the Joint Commission. Contractor shall provide consultation, if requested, in the development of protocols, utilization review, peer review and risk management as required by Joint Commission and other regulatory bodies. 2. GOVERNMENT FURNISHED ITEMS AND SERVICES The Michael E. DeBakey VAMC shall provide the following: A.Provide a secure room for the devices while located on the premises. B.Provide suitable electric service to operate the units. C.Shall be responsible for scheduling of patients for the procedure and coordinating the scheduling of any in-service, relating to the units for facility staff. D.Provide the pre-operative preparation of patients for ESWL. Obtain written patient consent forms and provide patients with the necessary services related 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. E.Take all actions reasonably necessary to assist contractor in achieving compliance with federal, state and local laws and regulations as required within this contract. F.Shall be responsible for the collection and disposal of infectious waste and sharps related to the ESWL procedures. G.Shall provide other necessary personnel for the operation of the services contracted for at the VA. These other necessary personnel shall be mutually agreed upon between the VA and the contractor who are compatible with the safety of the patient and are personnel with quality medical care programming. H.The services to be performed by the contractor shall be under the Chief of Urology or their designated representative. I.Record keeping: 1. The VA Healthcare Center shall establish and maintain a record keeping system that will record the procedures performed by the contractor employee(s). 2. Contractor's employees shall report to the COR or designee upon arrival at the Medical facility. 3.CONTRACTOR QUALIFICATIONS A. Contractor's employee(s) shall be fully credentialed by the Credentialing Office of the Michael E. DeBakey VAMC, Houston, TX, prior to performing any work under this contract. Use of "VetPro", VA's internet credentialing database, is mandatory for credentialing. The Contractor's employee's credentials and competency must be reviewed and approved by the Chief, Surgical Service and the Chief of Staff. B. Contractor's employee(s) shall be United States citizens and shall be technically proficient in the skills necessary to fulfill the Government's requirements, to include the ability to speak, understand, read and write English fluently. C. Contractor's employees assigned by the contractor to perform the services covered by this contract shall be licensed by the State that the services are being rendered. All licenses held by the personnel working on this contract shall be full and unrestricted licenses. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff, Chief of Surgery, Chief of Urology and other VA medical staff as required by one of more of these Chiefs and approval by the VA Facility Director. D.The trained licensed technician shall have full knowledge and experience to operate and troubleshoot the ESWL. 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: 1.Workers compensation; 2.Professional liability insurance; 3.Health examinations; 4.Income tax withholding; and 5.Social Security payments. F.The Contractor shall be prepared to perform on a long-term basis (minimum of one year) to eliminate turnover and learning curve issues that arise with the familiarization of new technicians to Michael E. DeBakey VAMC, Houston, TX, policies, procedures, and processes. G.All Continuing Education requirements shall be met to maintain professional status. A staffing plan, to include back-up coverage, position descriptions, and competency assessment tools shall be provided to the COR within fifteen (15) calendar days after award. The staffing plan shall be approved by Michael E. DeBakey VAMC, Houston, TX, prior to commencement of patient care activities. All related documentation, such as completed competency checklists or educational training records, shall be maintained by the Contractor and available for Michael E. DeBakey VAMC, Houston, TX, and review upon request. The Contractor shall maintain a culture that promotes self-development and learning, which is designed to maintain or enhance required competencies. H.All Joint Commission standards and Michael E. DeBakey VAMC policies related to anesthesia and moderate sedation will be rigorously adhered to. The moderate sedation training must completed according to policies. Moderate Sedation training may be satisfied by successful completion of moderate sedation module available on the EES intranet web site. The links to this training are: http://vaww.sites.lrn.va.gov/modsed/frame.htm and http://vaww.sites.lrn.va.gov/vacatalog/cu_detail.asp?id=22416 I.Evidence of current CPR and ACLS certification must be provided. J.Medication control, security and safety will be maintained at all times. No samples will be accepted from vendors or given to patients. K. The parties agree that that the contractor, its employees, agents and subcontractors shall not be considered VA employees for any purposes. 4. PRIVACY POLICY TRAINING A. All Contractor and Subcontractor employees performing work under this contract are required to complete an approved VHA privacy policy training course. This is a mandatory requirement. For multiple year contracts, privacy training is required annually. B.The VHA Privacy Policy Training web-based course is available at Internet site: https://www.ees-learning.net/librix/loginhtml.asp?v=librix C.Submittal: Upon completion of the web-based training options, employees will be able to print a certificate of completion. All training certificates shall be forwarded as one submittal package to the Contracting Officer within thirty (30) calendar days of award or exercise of option period. 5. ID BADGES/PARKING/SMOKING POLICY/FINGERPRINTING/ORIENTATION A.All Contractor personnel are required to wear identification (ID) badges during the entire time that they are on VA grounds. ID badges must have an identification picture, name of the individual and name of the represented company depicted on it. B.It is the responsibility of the Contractor personnel to park only in designated parking areas. Parking information is available from the VA Police Security Department. The VA will not invalidate or make reimbursement for parking violations of the Contractor's personnel. C.Smoking is not permitted within or around Michael E. DeBakey VAMC, except in designated areas. D.Finger printing and a complete background investigation which must be initiated prior to employment with the Michael E. DeBakey VAMC are required. E. Contractor personnel shall report to the Chief, Urology Service for orientation prior to commencing work under this contract. This orientation shall include applicable policies and procedures governing the medical care provided at the medical center. Contractor personnel must demonstrate an understanding of the key concepts and policies prior to commencing work. 6. INFECTION CONTROL COMPLIANCE A.Contractor shall provide written certification of training compliance with the Blood borne Pathogens Standards, 29 CFR Part 1910.1030 (copy available upon request) to the COR prior to the contractor commencing work. B.Mantoux Testing: Contractor shall provide evidence to the COR: 1. Negative PPD test within fourteen (14) calendar days prior to beginning service. If an earlier PPD test was given over twelve (12) months previously, the current test shall be a 2-step Mantoux test. 2.Medical evidence that personnel are disease free for those having a positive PPD. 3.A regular annual re-testing program for TB shall be established and maintained by the contractor. Contractor shall provide evidence of re-tests to the COR within ten (10) calendar days of the re-test. C. Hepatitis B Vaccination: Contractor shall consider the need for Hepatitis B vaccine and vaccination series within ten (10) calendar days of contract employment and follow-up if there has been an exposure incident. VA shall not provide the vaccine or vaccination series. VA Form 1 0-5549c, Information About Hepatitis B Vaccine (Recombinant), Consent Form or VA Form 1 0-549d, Hepatitis B Vaccine Declination (Mandatory) shall be submitted to the COR within thirty (30) days of waiver or completion of the first in the series of Hepatitis B Vaccine and completion of the vaccination series. D.Drug Testing: All Contractor personnel shall be subject to the VA's Drug-Free Workplace Policy. Personnel may receive a drug test and are subject to random drug testing thereafter. This includes any situation of "reasonable suspicion" and "accident or unsafe practice testing". Refusal to be tested or interfering with the process shall result in immediate termination of the contract. In addition, Contractor's personnel shall be subject to background check with local and county law officials to determine "suitability" for this sensitive position. 7. CONFIDENTIALITY OF PATIENT RECORDS A. The Contractor is a VA contractor and will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. Contractor is considered to be a VA contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the sharing agreement, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA. B. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA 's records, at VA's place of business on request during normal business hours, to inspect and review and make copies of such records. C. The Contractor is required to complete and return the Business Associate Agreement (Attachment 3) in accordance with the Health Insurance Portability and Accountability Act (HIPAA) of 1996 prior to contract award. 8.QUALITY ASSURANCE A.Preventative maintenance documents shall be available to VA Biomedical Engineering upon request. All equipment is required to be safety checked by the local VA Biomed staff each time it arrives on site before any procedures begin. 1. The VA COR shall arrange for the biomedical staff inspection with the contractor technician. B.Monitoring of the contractor's performance shall be demonstrated through sign-in and sign-out sheets as well as verification of patient records that the specified services were performed. The contractor shall be required to sign an attendance log upon reporting for scheduled procedures and upon completion of the procedures. The COR shall be the VA official responsible for verifying contract compliance. Any incidents of contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer. C.The contractor shall provide ESWL equipment with sufficient power, configuration and interface to achieve nationally acceptable stone fragmentation and clearance efficacy standards, based on stone size and location. ESWL devices must meet efficacy standards to avoid excess retreatment procedures or ancillary urological procedures to manage the urinary calculus(i). 9. CONTRACTOR PERSONNEL A.Contractor's Program Manager. The contractor shall provide a Contract Manager who shall be responsible for the performance of work. The name of this person shall be designated in writing to the Contracting Officer. The contractor's program manager shall have full authority to act for the contractor on all matters relating to daily operations of this contract. Contract Program Manager: Company Name: Address: Phone No.: Fax No.: Contact Name: Email: B.Contractor Employees. The contractor shall not employ persons for work on this contract if such employee is identified to the contractor as a potential threat to the health, safety, security, general well-being or operational mission of the installation and its population. Contractor must provide documentation to the Contracting Officer and/or the COR that background checks have been completed for all technicians. C.The contractor shall perform services in accordance with the ethical, professional and technical standards of the healthcare industry as consistent with VA Policy, Regulations and Procedures. 10. KEY PERSONNEL AND TEMPORARY EMERGENCY SUBSTITUTIONS A. The contractor shall assign to this contract the following key personnel: Company Name: Address: Phone No.: Fax No.: Technician Name: Email: D.During the first ninety (90) days of performance, the contractor shall make NO substitutions of key personnel (Contract Program Manager and Service Technician) unless the substitution is necessitated by illness, death or termination of employment. The contractor shall notify the Contracting Officer, in writing, within fifteen (15) calendar days after the occurrence of any of these events and provide the information required as in the information box of A. above. After the initial ninety (90) day period of the contract, the contractor shall submit the information required in the information box of A. above to the Contracting Officer at least 15 days prior to making any permanent substitutions. E.The contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitution; complete resumes including licenses, health clearances, and all other requirements as have been set forth in this contract and any additional information requested by the Contracting Officer for the proposed substitute. Proposed substitute shall have comparable qualifications to those of persons being replaced. The Contracting Office shall notify the contractor within fifteen (15) calendar days after receipt of all required information of the decision on the proposed substitute. The contract will be modified to reflect any approved changes of key personnel. F.For temporary substitutions where the key person will not be reporting to work for more than 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 shall require the procedure as stated above. 11. HOURS OF OPERATION A.The services covered by this contract shall be furnished by the contractor as defined herein. The contractor shall not be required, except in case of emergency, to furnish such services during non-standard workday hours as listed by each individual facility. B.Work hours are described as Monday through Friday; 8:00 a.m. to 4:30 p.m.; National Holidays excluded. Any service performed during other than normal work hours must be approved in advance by the COR. 12. INSPECTIONS A. The Government may, at its option and expense, request an unrelated third party to inspect the equipment provided by the contractor. B. The contractor shall repair, at the contractor's cost, any defects discovered by the inspection of the third party within fifteen (15) days when notified by the COR. 13. RETREATMENT AND CANCELLATIONS A.If a Veteran must undergo an additional treatment within ninety (90) days from his/her 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 price. B.On occasion (perhaps 1 to 3 times per year per facility) the scheduled procedure is needed to be cancelled. This may occur (1) when a stone passes between the time the patient was initially seen and scheduled and the actual procedure date or (2) when there is a medical emergency such as when anesthesia is administered or another medical emergency with the patient arises. 1.When a cancellation is known to the VA personnel and the contractor is notified by phone, fax or email twenty-four (24) hours prior to the contractor technician's scheduled arrival time at the VA facility, there shall be no charge for the procedure. If notification is given to the contractor in less than twenty-four (24) hours, the contractor shall be paid 50% of the contracted price for the procedure. 2.When there is a medical emergency which prevents the patient from receiving the procedure, if only one patient was scheduled with the contractor to receive the procedure on that day, the contractor shall be paid 50% of the contracted price for the procedure. When there is a medical emergency which prevents a patient from receiving the procedure, and more than one patient was scheduled with the contractor to receive a procedure on that day, the contractor shall not be paid for the cancelled procedure.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/BiVAMC/VAMCCO80220/VA25615Q0874/listing.html)
- Document(s)
- Attachment
- File Name: VA256-15-Q-0874 VA256-15-Q-0874_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2175076&FileName=VA256-15-Q-0874-000.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2175076&FileName=VA256-15-Q-0874-000.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: Department of Veterans Affairs;Michael E. DeBakey VAMC;Network Contracting Office 16;2002 Holcombe Blvd.;Houston, TX
- Zip Code: 77030-4298
- Record
- SN03801549-W 20150719/150717235302-dd0b11b54a7831df140409b6a00fbbd3 (fbodaily.com)
- Source
-
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