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DEPARTMENT OF VETERANS AFFAIRS - NETWORK CONTRACTING OFFICE 7 (NCO 7) Description: THIS IS A SOURCES SOUGHT NOTICE ONLY. The sole purpose of this notice is to obtain information on Small Businesses in... DEPARTMENT OF VETERANS AFFAIRS - NETWORK CONTRACTING OFFICE 7 (NCO 7) Description: THIS IS A SOURCES SOUGHT NOTICE ONLY. The sole purpose of this notice is to obtain information on Small Businesses interest, capabilities and qualifications to determine if a VOSB or SDVOSB or SB set-aside is appropriate. Proposals are NOT being requested or accepted at this time. BACKGROUND: The Department of Veterans Affairs, Veterans Integrated Service Network 7 (VISN 7) has a requirement for Perfusionist Services for Birmingham VA Health Care System located at: Birmingham VA Medical Center, 700 19th St S, Birmingham, AL, 35233-1927. The Contractor shall furnish all personnel to provide services necessary to perform onsite Perfusion/Autotransfusion Services to eligible beneficiaries of the Department of Veterans Affairs Medical Center, Birmingham, AL (hereinafter referred to as VAMC). The Contractor s physician(s) care shall cover the range of Perfusion/Autotransfusion Services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by the American Board of Cardiovascular Perfusion http://www.abcp.org. The Contractor shall propose a minimum of 0.67 Perfusionists and 1.02 Perfusionist Assistants to be credentialed and be available for scheduling to meet the requirements of the contract. 4. CONTRACTOR RESPONSIBILITIES: 4.1. Clinical Personnel Required: The Contractor shall provide contract personnel (s) who are competent, qualified per this performance work statement and adequately trained to perform assigned duties. 4.1.1. Contract personnel (s) shall be responsible for signing in and out when in attendance. Time sheets will be used by the COR to confirm hours/day and services provided against the contractor s invoices. 4.2. Standards of Care: The contract personnel (s) care shall cover the range of Perfusionist/Autotransfusion services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by: 4.2.1. American Board of Cardiovascular Perfusion: http://www.abcp.org 4.2.3. VA Standards: VHA Directive 2006-041 Veterans Health Care Service Standards (expired but still in effect pending revision) https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443 4.2.4. The professional standards of The Joint Commission (TJC) http://www.jointcommission.org/standards_information/standards.aspx 4.2.5. The standards of the American Hospital Association (AHA) http://www.hpoe.org/resources?show=100&type=8 and; 4.2.6. The requirements contained in this PWS 4.3. MEDICAL RECORDS 4.3.1. Authorities: Contract personnel (s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (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), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA). 4.3.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled Patient Medical Records-VA (24VA19). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at his expense. Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date. 4.3.3. Disclosure: Contract personnel (s) may have access to patient medical records: however, Contractor shall obtain permission from the VA before disclosing any patient information. 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. The VA will provide the Contractor with a copy of VHA Handbook 1907.1, Health Information management and Health Records and VHA Directive 1605.01, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor. 4.3.4. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information Management and Health Records: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 and all guidelines provided by the VAMC. 4.3.5. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. The Contractor shall be responsible for locating and forwarding records not kept at their facility. VA Form 10-5345, Request for and Authorization to Release Medical Records or Health Information is the VHA authorization to release patient information to a third-party. Completed Release of Information requests will be forwarded to Release of Information at the following address: Release of Information - 136 Birmingham VA Health Care System 700 19th Street South Birmingham, AL 35233 4.3.6. Confidentiality - VA will provide the contract personnel (s) access to pertinent patient medical information, within the existing privacy rules and regulations, for the purpose of providing coordinated comprehensive primary care. Contract personnel (s) shall ensure the confidentiality of all patient information and shall be held liable in the event of the breach of confidentiality. 4.3.7. Personal Identity Verification (PIV) - Contract personnel (s) shall participate in computer security and documentation training as is all personnel practicing within the VA Medical Center. Contract personnel (s) shall comply with facility requirements to obtain personal security investigations, installation access and participate in the computer security and documentation training. 4.3.8. Contract personnel (s) shall provide medical record documentation in accordance with rules and regulations of the medical staff and medical staff by laws. Reference Policy Memorandum No. 136-1, Change 2 to Appendix B dated Sept. 29, 2000, Control of Medical Records and in accordance with Policy Memorandum 136-1, Change 2 to Appendix A dated September 29, 2000, Completion of Medical Records. 4.3.9. Records created by contract personnel (s) in the course of treating VA patients under this agreement are the property of the VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations. Contract personnel (s) shall maintain computer access and prepare for cases the following day by obtaining the patient information and record within the CPRS system for review. 4.3.10. Contract personnel (s) shall participate in quality improvement projects, initiatives, and reporting as requested. 4.3.10.1. VA utilizes a fully automated electronic medical record. The EMR consists of two primary components. The first is the Veterans Health Information System and Technology Architecture (VISTA), which consists of commercial hardware and software developed by the VA. VISTA is a collection of over 100 applications that make up a comprehensive hospital information system. It includes both medical records and clinical applications or packages such as order entry, progress note, laboratory, radiology, and scheduling/admission-discharge-transfer and discharge summary. The present VISTA packages combined comprise an estimated 80 percent of the information maintained in the EMR. Contract personnel (s) shall be responsible for viewing the patient record within CPRS and will not be utilizing the VISTA system. 4.3.10.2. Upon transfusion of components, the Perfusionists are responsible for completing the required information on the SF-518 form (Record of Transfusion on the Standard Form 518) to include pre-transfusion data and post-transfusion data. The completed original SF-518 shall be scanned into the patient's chart, and a copy of the SF-518 shall be placed in the designated location for return to the Blood Bank. Under no circumstances will the SF-518 be discarded. 4.3.10.3. The second component uses optical disk imaging technology to meet the remaining 20 percent of the EMR information needs such as advance directive/guardianship papers, medical record documentation from non-VA facilities and informed consents. 4.3.10.4. VA will provide the necessary training to contract personnel (s) on the proper use and operation of the computerized medical records system (Computerized Patient Recordkeeping System - VA CPRS). Contractor agrees and shall instruct their employees in signing computer security access agreements and is bound by confidentiality and release of information restrictions. For purposes of clarity, where the VA Forms reference Contracted Employee Name it shall mean Contractor s Employee Name. 4.4. Direct Patient Care: 90 % of the time involved in direct patient care. The Perfusionists and Perfusionist Assistant role will be 90% to patient care related. 4.4.1. Scope of Care: Contract personnel (s) (as appropriate and within scope of practice/privileging) shall be responsible for providing Perfusion/Autotransfusion care, including, but not limited to: 4.4.1.1. All Perfusionists shall assist the Cardio-Thoracic service with by-pass surgical cases and valve replacement of various types. The contractor shall perform onsite Perfusion/Autotransfusion Services in the treatment of care for eligible veteran beneficiaries as referred and authorized by the Birmingham VAMC. The Perfusionists are responsible for preparation, and operation of the heart and lung machines/pumps in conjunction with maintaining a sterile environment for procedures maintaining blood volume in the patients preventing shock or air embolus. Assemble supplies and equipment in preparation to accept patient on extra corporeal circulation in cases of premature cardiac arrest or failure. Other services include preparation, maintenance and operation of VA owned equipment to include the heart lung machine, auto transfusion pump, intra-aortic balloon pump, centrifugal ventricular assist device, and cell saver device. 4.4.1.2. The Autotransfusionist is responsible to check the OR schedule daily for surgical procedures requiring Autotransfusionist services; coordinate scheduled periodic preventative maintenance and repair calls for VA owned equipment and maintain a record of such; assure a minimum of four complete sets of supplies for open heart and Autotransfusion cases are available at any given time; sets up and operates Autotransfusion pump for surgical procedures other than open heart. Also, generates a record during each surgical case to include the surgical time of the procedure and the amount of autotransfused blood given to Anesthesiology for delivery to the patient and; handle breakdown of disposable within autotransfusion pump after completion of each procedure. 4.4.1.3. Reporting Information for Treatment: Access to the VA CPRS shall be provided to the perfusionists/autotransfusionist, including the ability to printout a report of those services provided by the Perfusionists/autotransfusionist. A detailed treatment plan which includes an initial assessment, recommended plan of treatment and expected outcomes will be entered in the patient's clinical record within twenty-four hours of initiating treatment and at a minimum contain the following information: § Patient s name and identification number § Treating Physician's name and telephone number for follow-up questions § Pertinent History § Physical Findings § Summary of the Recommended Treatment Plan § Date treatment was initiated or is planned § Anticipated or actual date that treatment was completed § Follow-up Recommendations/Results of the Treatment § Instructions given to the patient 4.4.1.4. It is the Perfusionists responsibility to view the patient record within CPRS prior to the surgery to review the surgeon s plan of care. 4.5. ADMINISTRATIVE: estimated 10% of time not involved in direct patient care. Administrative duties include: a) Assembly of heart lung machines for open heart surgery and adjustment as necessary. b) Keeping perfusion work area clean and orderly at all times. c) Preparing and calibrating pressure monitoring equipment. d) Cleaning and reassembling of all equipment after use. e) Calibrating heart lung machine (every day of surgery) f) Reporting Contracting Administration complications (every day of surgery as needed) g) Conducting in-service education and instructing newer contractor employee in the performance of their duties at the VAMC (as needed) 4.5.1. Quality Improvement Meetings: The Contractor s physician(s) shall participate in continuous quality improvement activities and meetings with committee participation as required by the VAMC Chief of Service, Chief of Staff, or designee. 4.5.2. Staff Meetings: The Contractor s physician(s) shall attend staff meetings as required by the VAMC Chief of Service, Chief of Staff, or designee. Contractor to communicate with COR on this requirement and report any conflicts that may interfere with compliance with this requirement. 4.5.3. QA/QI documentation: The Contractor s physician(s) shall complete the appropriate QM/PI documentation pertaining to all procedures, complications and outcome of examinations. 4.5.4. Patient Safety Compliance and Reporting: Contractor s physician(s) shall follow all established patient safety and infection control standards of care. Contractor s physician(s) shall make every effort to prevent medication errors, falls, and patient injury caused by acts of commission or omission in the delivery of care. All events related to patient injury, medication errors, and other breeches of patient safety shall be reported to the COR VA Safety Policy. As soon as practicable (but within 24 hours) Contractors shall notify COR of incident and submit to the COR the Patient Safety Report, following up with COR as required or requested. IMPORTANT INFORMATION The information obtained through this notice will be utilized exclusively as market research for acquisition planning purposes for the future solicitation of a Firm-Fixed Price (FFP) Contract for the Surgical Service Department of the Department of Veterans Affairs. All work to be performed will be within North American Industry Classification System (NAICS) Code 621399 - Offices of All Other Miscellaneous Health Practitioners, with a Small Business Size Standard of $8M. Product Service Code is Q523 - MEDICAL- SURGERY. In order to be eligible to respond as an SDVOSB or VOSB, a firm must be Center for Veterans Enterprise (CVE) registered in VetBiz. Registration may be accomplished at http://www.vip.vetbiz.gov. An active registration in System for Awardee Management (SAM) is also required. Registration is available at www.sam.gov. Responses to this Sources Sought notice MUST contain the following information: (1) Company name and address, point of contact with phone number, email address, and DUNS number; (2) Documentation that clearly demonstrates the firm s capability of performing laboratory services with specific relevance to the description of the requirement indicated above (including references with current point of contact and phone number); (3) Proof of registration in the VA Vet Biz website and verification by VA Center for Veterans Enterprise (CVE) if applicable. Responses to this notice must be made via e-mail to Tanjia.Dotson@va.gov. Responses may be submitted as attachments, or contained in the body of the e-mail, and must be clearly marked SOURCES SOUGHT RESPONSE 1 Perfusionist and 2 Perfusionist Assistants for Birmingham VA Health Care System" in the subject line and document header. The deadline to respond is March 5, 2021 at 3:00 pm (EST). As a reminder this is a Sources Sought announcement only, evaluation letters will be not be issued to any respondent, nor will the Government be required to pay for any costs incurred for responses submitted. Interested parties are requested to submit a statement of capability outlining the capabilities related to this requirement as stated above. The statement of capability shall include: a) Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. b) Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. c) Business size for NAICS 334220 and 334290 and socio-economic category status, if any. d) DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the System for Award Management (SAM www.sam.gov) to be considered as potential sources. e) The statement of capability shall be UNCLASSIFIED. Any information provided by industry to the Government as a result of this sources sought synopsis is strictly voluntary. Responses will not be returned. No entitlements to payment of direct or indirect costs or charges to the Government will arise as a result of contractor submission of responses, or the Government's use of such information. The information obtained from industries responses to this notice may be used in the development of an acquisition strategy and a future RFP (if applicable). The company's standard format is acceptable; however, the limit for all responses is not to exceed six (6) single-sided pages. Contractors capable of providing these products should submit a Statement of Capability containing the above reference information via e-mail to Contracting Officer, Mrs. Tanjia Dotson at Tanjia.Dotson@va.gov. Each submission shall be virus scanned prior to being sent. Electronic submission (email) is required. Responses shall be received no later than March 5, 2021, 3:00 pm Eastern Time Zone. NOTE: E-mail submissions are subject to size and type restrictions (typically limited to less than 2 megabyte in size and only non-executable attachments such as .doc or .pdf files) as well as any other appropriate network security measures. It is the respondent's responsibility to verify the e-mail was received and can be viewed. All responses must address each of the above stated requirements.