Q523--Brand Name or Equal to the American Red Cross - Autologous Transfusion Cell Saver. POP: 03/26/2026 thru 03/25/2027. Unrestricted procurement.

Description

{"description":"Performance Work Statement (PWS)\nFor\n AUTOLOGOUS TRANSFUSION (CELL SAVER) SERVICES \n\n\nSERVICE AND EQUIPMENT/SUPPLIES TO BE PROVIDED\n\nGENERAL:\n\nThe contractor shall provide preoperative blood cell saver autologous transfusion services as needed to support the Veteran beneficiary patients in the Operating Room of the Wilmington VA Medical Center (WVAMC) located at 1600 Kirkwood Hwy, Wilmington, DE. 19805.\n\nBACKGROUND:\n\nThe WVAMC is classified with a complexity level 2 representing a medium level of volume, patient risk, teaching and research. Our operative complexity is designated as Standard to Intermediate .\n\nThe WVAMC supports saving the blood supply and unnecessary exposure to the patient to viral markers. The vendor will work in conjunction with the blood bank department in the laboratory and the Operating Room to target the patients needing Cell Savers for Preoperative and Postoperative Blood services. Research has demonstrated the importance of preventing unwanted diseases through exposure to other people s blood, when possible.\n\nPLACE OF PERFORMANCE:\n\nOperating Room (Endovascular Suite), BLDG 1 2nd Floor, Wilmington VA Medical Center\nOperating Room, BLDG 1 3rd Floor, Wilmington VA Medical Center\n\nPERIOD OF PERFORMANCE:\n\n03/26/2026 03/25/2027\n\nSCOPE:\n\nThe vendor should make available all resources necessary to accomplish the deliverables described in this Performance Work Statement (PWS), except as may otherwise be specified. Contractor provides a qualified technician, Cell Saver Elites, Carts, and disposables to provide perioperative autologous collection services. Task orders will be placed against the contract on an as needed basis to the Wilmington VA Medical Center s operating room located in building 1, 3rd floor. The quantities specified in the PERIOPERATIVE AUTOLOGOUS COLLECTIONS SERVICE AGREEMENT (PACS) are estimates only and are not purchased by this contract. The quantities represent the government s best estimate of actual quantities which may be required over the term of the contract. The Contractor will be paid, in accordance with this schedule, only for actual work performed.\n\nCode\nService Description\nPACS001\nPACS: COMPLETE SERVICE\nPACS002\nPACS: ADDITIONAL TIME - PER 15 MINUTES\nPACS003\nPACS: STAND-BY SERVICE\nPACS004\nPACS: APRP\nPACS005\nPACS: APRP ADD-ON TO COMPLETE SERVICE\nPACS006\nPACS: ANTICOAG-ASPIRATION ASSEM\nPACS011\nPACS: CANCELLATION FEE - BEFORE SET-UP\nPACS012\nPACS: PROFESSIONAL SERVICE\nPACS013\nPACS: CANCELLATION FEE - AFTER SET-UP\nPACS014\nPACS: NON-SCHEDULED CASE FEE\nPACS015\nPACS: OFF HOURS RESPONSE FEE\nPACS016\nPACS: MICRO AGGREGATE FILTER\nPACS017\nPACS: TRANSFER PACK\nPACS025\nPACS: LEUKOREDUCTION FILTER\nPACS033\nPACS: PROCESSING BOWL KIT\nPACS034\nPACS: RESERVOIR\n\n\n\nSERVICES:\n\nBasic autotransfusion will be used where large blood loss is anticipated. Procedures will include but not be limited to vascular, trauma, gynecological, and some orthopedic cases. Any procedure in which medical staff determine whether this service is required shall be covered under this contract. Basic service will include use of contractor provided equipment, disposable supplies, setup and take down of equipment, and one registered nurse operator or certified technician for approximately a four (4) hour period.\n\nMini autotransfusion will be used either intra or post operatively on surgical procedures where nominal to moderate blood loss is anticipated. Procedures will include but not be limited to: Orthopedic cases such as total knee and total hip arthroplasties, ORIF, and retropubic prostatectomy. Mini autotransfusion will include all use of contractor provided equipment, disposable supplies, setup and take down of equipment, and one registered nurse operator or certified technician for approximately a minimum of a two (2) hour period.\n\nThe contractor shall provide services in accordance with American Association of Blood Bank (AABB) standards.\n\nThe contractor shall provide all labor, equipment, management, materials, supplies, and other elements necessary to provide complete Autologous Transfusion (Cell Saver) Services for the Wilmington VA Medical Center. Registered nurses and/or technicians shall be fully qualified and possess direct, documented experience in the performance of the referenced services.\n\nUniversal precaution procedures, in accordance with CDC, OSHA, & JC guidelines, shall be adhered to for services provided under this contract.\n\nThe services to be performed by the Contractor shall be performed in accordance with WVAMC policies and procedures and the regulations of the medical staff by-laws (available upon request) of the WVAMC.\n\nThe contractor shall provide only equipment and supplies that are approved by the Food & Drug Administration (FDA) for autotransfusion. The Contractor shall obtain written approval from the Contracting Officer (CO) prior to implementing any changes or substitution of equipment/supplies during the term of this contract. An approved list of supplies shall be submitted to, and maintained by, the Contracting Officer s Representative (COR) in collaboration with OR Nursing Leadership. The contractor shall be responsible for providing the necessary machine along with the disposable bowl and reservoir. The WVAMC staff are not responsible for Contractor provided equipment/supplies and/or staff. Contractor shall ensure all equipment and supplies are in pristine condition and supplies are not expired. They shall be maintained in a condition suitable for operating room applications. No other condition is considered acceptable and shall not be used in the performance of this contract. Maintenance and repair of the Contractor s equipment is the sole responsibility of the Contractor.\n\nThe Contractor shall place two (2) contractor owned cell saver machines in the operating room area and remain there for the duration of the contract. It is agreed that WVAMC personnel shall not, at any time, set up or operate contractor equipment or machines. However, WVAMC personnel shall be authorized to begin all necessary operations required for emergency collection set-up when they deem necessary for appropriate patient care.\n\n\n\nVA REQUEST FOR CELL SAVER PROCESS:\n\nDuring normal business hours, the Surgical Resident enters a consultation requesting a cell saver.\nThe Impact Nurse makes the request and provides this information to the Inventory Management Specialist.\nInventory Management Specialist calls to order the cell saver with the following information-\nSurgeon Name\nOperating Room phone number\nType of Surgical Procedure\nPatient Name\nDate and Time of Procedure\nMalignancy Status\n\nAfter hours, Saturday, Sunday and Holidays\nEmergency Service can be ordered through the same Clinical Services phone number on a 24-hour, 7-day basis. The Surgical Resident, Nursing Supervisor, or O.R. nurse can order these services.\n\nTRANSPORTATION AND TRAVEL TIME:\n\nThe price of this service shall include the transportation of personnel and equipment/supplies. No additional charges shall be authorized for transportation.\n\nRESPONSE TIME AND QUANTITIES:\n\nThe Contractor shall provide all necessary equipment, supplies, and a registered nurse or certified technician within 30 minutes of notification of needed emergency services by the Nursing Leadership or other authorized representative as identified by the CO or COR.\nUpon arrival, the registered nurse and/or technician shall immediately report to the WVAMC circulating nurse assigned to the procedure.\nThe Contractor shall not be required to perform in excess of three (3) Basic and one (1) Mini service at any one time under this contract.\n\nHOURS OF COVERAGE:\n\nThe contractor shall provide coverage twenty-four (24) hours per day, seven (7) days per week. This is a critical life-saving component for patient care. Accordingly, Contractor shall be prepared to perform services at all times.\n\nQUALITY MANAGEMENT PROGRAM:\n\nThe Contractor shall have a quality management program in place, that ensures equipment and personnel perform in accordance with American Association of Blood Banks (AABB), College of American Pathologists (CAP), Joint Commission (JC) standards as applicable. The Contractor shall submit a detailed planned which accurately details their quality control management program to the CO prior to contract start-up. Contractor shall obtain written approval from the CO prior to implementing any changes in their approved quality management program. Failure of the Contractor to ensure personnel and equipment conform to these standards shall be cause for termination of the contract.\n\nPERFORMANCE MONITORING AND SURVEILLANCE METHODS: \n\nThe COR shall use the surveillance methods listed below in the administration of this contract.\n\nDIRECT OBSERVATION:\n\n100% surveillance: The Surgeon will observe the contract Perfusionist during each case and provide feedback to Nursing Leadership who will communicate with the COR.\n\nPERIODIC INSPECTION: \n\nInspections scheduled and reported quarterly per COR delegation or as needed. COR will ask the contract Perfusionist for licensure, certification, registration, and maintenance of certification as a perfusionist information updates each month.\n\nVALIDATED USER/CUSTOMER COMPLAINTS:\n\nThe contractor will be monitored through a variety of mechanisms, including but not limited to:\n\nQA monitors to assess the quality of care provided by the contractor.\n\nReview of medical record documentation.\n\nThe Contractor is required to meet Joint Commission standards, as applicable. These performance standards may change during the course of the contract. Any new or revised quality/performance criteria or standards will be provided to the contractor before their implementation date and renegotiated into the contract as necessary. Attachment 1 contains the Performance Metrics that will be used to monitor the contractor.\n\nMonitoring of contractor s time shall be demonstrated through sign-in/ sign-out sheets. The contractor shall be required to sign an attendance log-upon reporting to work and departing from work. The Contracting Officer s Representative (COR) is designed to be the Surgical Care Line s Administrative Team. The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.\n\n\nPERSONNEL QUALIFICATIONS/TRAINING:\n\nThe Contractor shall ensure all personnel are fully qualified, competent, and have the training, and experience to perform the services in accordance with the terms & conditions of this contract and all other applicable regulations. The Contractor shall provide documentation/certification letters of qualifications, training, licensure, and experience of proposed personnel which the Contractor anticipates utilizing to perform services under this contract. Contractor shall provide evidence their prospective personnel have received all Vaccines (with TB and COVID-19 immunization being the most critical), as well as training for safety/blood borne pathogens and HIPPA. Personnel shall not be used prior to approval by the COR. This approval shall be in writing. Information shall be provided prior to the addition of new staff members.\n\nIt is the contractor s responsibility to provide competency assessments, evaluations, credentials, licensure and/or or any other documents on its employees required to comply with the accreditation policies and standards of the Joint Commission. Employees of the contractor shall be a citizen of the United States and proficient in spoken and written English. \n\nFailure to ensure personnel meet the minimum qualification requirements shall represent grounds for contract termination. The qualifications of Contractor personnel performing under this contract are subject to review and approval by the WVAMC Chief of Staff and the WVAMC Director. Accordingly, Contractor shall supply the list of prospective employees as quickly as possible, but not later than three days after contract award, to ensure personnel are in place in an acceptable period of time. Contractor personnel will be subject to a Special Agreement Check (SAC) via electronic fingerprinting prior to or simultaneous with entry on duty to WVAMC premises. \n\nHIPPA Responsibility: Contractor agrees to comply with the requirements under the Health Insurance Portability and Accountability Act of 1996 (HIPPA). Notwithstanding anything to the contrary in this contract, all individually identifiable health information shall be treated as confidential by parties in accordance with all applicable federal, state, or local laws and regulations and official guidance promulgated there under, and the parties agree to take such additional steps and/or negotiate such amendments to this contract as may be required to ensure that the parties are and remain in compliance with the HIPAA regulations and official guidance. \n\nSecurity requirements: The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include but are not limited to Federal Information Security Management Act (FISMA), Appendix II of OMB Circular A-130, and guidance and standards, available from the Department of Commerce s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST s Web site at:\n\nhttp://www.checklists.nist.gov\n\n To ensure appropriate security controls are in place, contractors must follow the \n procedures set forth in: VA Information and Information System Security/Privacy \n Requirements for IT Contracts located at the following web site:\n\nhttp://www.iprm.oit.va.gov\n\nThe Contracting Officer or COTR will provide the details required for obtaining the VHA Privacy Policy Training. \n\nIn accordance with VHA Directive 6500, Appendix G, Department of Veteran s Affair (VA) National Rules of Behavior, each contractor must read and sign the VA National Rules of Behavior prior to gaining any access to VA information and/or information systems. Contractors must initial and date each page of the copy of the page of the VA National Rules of Behavior; they must also provide the information requested on the last page, sign and date it. \n\nContractor Employee Security and HIPPA Training: Contractor shall certify that all employees working on this contract receive VHA Privacy Training. This training can be accessed online through the VA Learning Management System (LMS). Proof of training is required. \n\nContractor Personnel Security Requirements: All contractor employees who require access to the Department of Veterans Affairs computer system shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract the contractor will be responsible for the actions of those individuals that provide or perform work for the VA.\n\nCONTRACTOR RESPONSIBILITIES:\n\nContractor shall bear the expense of obtaining background investigations\nThe contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak and understand the English language. The contractor shall provide the screening results of the VA Contracting officer prior to award and anytime new employees are hired\nThe contractor will provide to the Contracting Officer prior to award the following: (1) List of names of contract personnel. (2) Social security numbers of contractor personnel, (3) Home address of contractor personnel or the contractor address\n\n\n\nAPPROVAL OF CONTRACTOR PERSONNEL:\n\nThe WVAMC 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 cause, is considered by the Contracting Officer to be objectionable, as long as thirty (30) days written notification of unsatisfactory performance has been provided to the contractor and the problem has not been cured in the thirty (30) day period.\n\nKEY PERSONNEL AND TEMPORARY EMERGENCY SUBSTITUTIONS:\n\nThe Contractor shall assign to this contract the following key personnel:\n\nKey Registered Nurse\n \n\n\nKey Registered Nurse\n \n\n\nBack up Registered Nurse\n \nBack up Registered Nurse\n \nBack up Registered Nurse\n \nBack up Registered Nurse\n \nCertified Technician\n \n\n\nCertified Technician\n \n\nDuring 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.\n\nThe 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 people being replaced. The Contracting Officer Shall 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.\n\nFor temporary substitutions where the key person will not be reporting to work for three\n(3) consecutive workdays 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.\n\n\nREPORTING REQUIREMENTS:\n\nThe contractor shall provide a log report for each procedure to include the date, patient s name, locally assigned patient identification number, volume processed, volume returned, and name & signature of the registered nurse.\nAll records of services rendered, and supplies used shall be provided to Logistics.\n\nUNUSED WHOLE BLOOD:\n\nWhen there is whole blood remaining at the completion of a surgical procedure the nurse operator shall ensure proper labeling as follows: Patient s name, locally assigned patient identification number, and date & time. The nurse operator shall inform the Operating Room circulating nurse and Anesthesia when there is remaining whole blood.\n\nPERSONNEL POLICY:\n\nThe Contractor shall be responsible for protecting the personnel furnishing services under this contract. To conform with this policy, the Contractor shall provide the following minimum requirements:\n-worker s compensation\n\n-professional liability insurance\n\n-health examinations\n\n-income tax withholding, and\n\n-social security payments\n\nThe personnel performing under this contract shall not be considered SAVAHCS employees for any purpose and shall be considered employees of the Contractor.\n\nPERSONAL ARTICLES:\n\nThe WVAMC shall provide a locker for contractor personnel to store personal articles for safekeeping. Contractor shall be responsible for any lock they wish to utilize\n\nTo maintain environmental sanitation no personal articles shall be brought into the operating\nroom.\n\nDEFINITIONS/ACRONYMS -\n\nAABB American Association of Blood Banks\n\nCAP College of American Pathologists\nCDC Centers for Disease Control\n\nCO - Contracting Officer.\n\nCOR - Contracting Officer s Representative.\n\nJC Joint Commission.\nOSHA Occupational Safety and Health Administration\n\nWVAMC Wilmington VA Medical Center\n\n\nFEDERAL HOLIDAYS OBSERVED BY THE SAVAHCS:\n\nNew Year s Day Labor Day \nMartin Luther King Day Columbus Day \nPresident's Day Veterans Day\nMemorial Day Thanksgiving Day\nIndependence Day Christmas Day\nJune Nineteenth\n\n*Note Please ensure you understand this contract is in effect 365 days a year, 24 hours a day.\n\nIDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:\n\nIt is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The WVAMC will not invalidate or make reimbursement for parking violations of the contractor under any conditions.\n\nSmoking is prohibited inside all buildings at the WVAMC and on VA property.\n\nPossession of weapons and alcohol are prohibited.\n\nEnclosed containers shall be subject to search.\n\nViolations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.\n\n\nPRIVACY AWARENESS TRAINING:\n\nPrivacy Training: \n\nThe Contractor and their sub-contractors assigned work under the contract are required to receive annual training on patient privacy as established by HIPAA statutes. Training must meet VHA s and the Department of Health and Human Services Standards for Privacy of\nIndividually identifiable health information. Contractor shall provide documented proof to the contracting officer that all employees assigned work and/or having access to Protected Health Information have received annual training. Proof of training is to be forwarded to the Contracting Officer. Information on fulfilling the training requirement as stated in this paragraph can be found at https://www.ees-learning.net. For contractors and sub-contractors who do not have access to VHA computer systems, this requirement is met by receiving VHA National Privacy Training, other VHA approved privacy training or contractor furnished training that meets the requirements of the HHS standards.\n\nA Business Associate Agreement (BAA) may be required for any contract that requires either a SAC or a NACI or higher and that is not otherwise exempt from the requirement for a BAA. The BAA shall be attached to solicitation document for this requirement. Contractor shall supply completed BAA with their solicitation offer.\n\nORDERS:\n\nA task order shall be placed against the basic contract on an annual basis to provide funding for services. In no event shall the established limit be exceeded without prior modification by the CO. See contract documents for complete procedures and requirements.\n\n\nATTACHMENT 1 - PERFORMANCE METRICS\n\n\nTask\nPWS\n\nPara\nPerformance Measures\nAcceptable Quality Level\n\nMethod of Surveillance\nBasic Autotransfusion\n\n1.B.1\n\nAt All Times\n\n100%\nObservation and random inspection\n\nMini Autotransfusion\n\n\n1.B.2\n\n\nAt All Times\n\n\n100%\n\n\n\nObservation and random inspection\n\nEquipment and Supplies\n\n\n1.C\n\n\nAt All Times\n\n\n100%\n\n\n\nObservation and random inspection\n\n\nResponse Times\n\n\n3.\n\n\nAt All Times\n\n\n100%\n\n\n\nObservation and random inspection\n\nPersonnel Qualifications\n7,\n7.1,\n7.2 & 7.3\n\nAt all times\n\n100 %\n\nObservation and random inspection (auditing)\nReporting Requirements\n8\nAt all times\n100%\nObservation and random inspection (auditing)\n\n\n\n\n\nPrivacy Awareness\n16\nAt All Times\n100 %\nObservation and random inspection (auditing)\n\n\n\n\nPRICE/COST SCHEDULE:\n\nAll quantities listed are considered estimates.\n\n\n\n\nItem information\n\n\nItem Number\nDescription of Supplies\nEstimated Quantity\nUnit\n0001\nAutotransfusion Professional Fee\n1\nEA\n0002\nHourly charge for cases beyond 10 hours\n1\nEA\n0003\nAutrotransfusion Case Cancellation (After contractor arrives on site)\n1\nEA\n0004\nAutotransfusion Case Cancellation (Cancellation with < 3 hours notice)\n1\nEA\n0005\nEmergent Autotransfusion Fee\n1\nEA\n\n\nDisposables description\n3L Reservoir Only 150 micron filter\nBasic A&A Assembly\nProcesing Set (125ml)\nProcessing Set (225ml)\nVacuum Line\nBlood Filter 40 Micron\nBlood Filter Lipid Reduction\nBlood Filter Leucocyte Reduction\nBlood Transfer Bags\nBlood QC Sample Copuler\n\n\n\nCAPITAL EQUIPMENT\n\nDESCRIPTION\n\nHaemonetics Elite Autotransfusion Device QTY (2)\n\nVendor shall be responsible for all maintenance, including PM for the equipment.\n\n\n\n End of Performance Work Statement (PWS).\n\n\n\n\n\n\n\n\n\n"} Solicitation Number: 36C24426Q0150 Type: Presolicitation Base Type: Presolicitation NAICS: 621991 Classification Code: Q523 Response Deadline: 2025-12-19T16:00:00-05:00 Office Address: PITTSBURGH, PA Place of Performance: Wilmington,, Delaware, 19805 POC: David Santiago, david.santiago2@va.gov, 412-822-3746 {"description":"Performance Work Statement (PWS)\nFor\n AUTOLOGOUS TRANSFUSION (CELL SAVER) SERVICES \n\n\nSERVICE AND EQUIPMENT/SUPPLIES TO BE PROVIDED\n\nGENERAL:\n\nThe contractor shall provide preoperative blood cell saver autologous transfusion services as needed to support the Veteran beneficiary patients in the Operating Room of the Wilmington VA Medical Center (WVAMC) located at 1600 Kirkwood Hwy, Wilmington, DE. 19805.\n\nBACKGROUND:\n\nThe WVAMC is classified with a complexity level 2 representing a medium level of volume, patient risk, teaching and research. Our operative complexity is designated as Standard to Intermediate .\n\nThe WVAMC supports saving the blood supply and unnecessary exposure to the patient to viral markers. The vendor will work in conjunction with the blood bank department in the laboratory and the Operating Room to target the patients needing Cell Savers for Preoperative and Postoperative Blood services. Research has demonstrated the importance of preventing unwanted diseases through exposure to other people s blood, when possible.\n\nPLACE OF PERFORMANCE:\n\nOperating Room (Endovascular Suite), BLDG 1 2nd Floor, Wilmington VA Medical Center\nOperating Room, BLDG 1 3rd Floor, Wilmington VA Medical Center\n\nPERIOD OF PERFORMANCE:\n\n03/26/2026 03/25/2027\n\nSCOPE:\n\nThe vendor should make available all resources necessary to accomplish the deliverables described in this Performance Work Statement (PWS), except as may otherwise be specified. Contractor provides a qualified technician, Cell Saver Elites, Carts, and disposables to provide perioperative autologous collection services. Task orders will be placed against the contract on an as needed basis to the Wilmington VA Medical Center s operating room located in building 1, 3rd floor. The quantities specified in the PERIOPERATIVE AUTOLOGOUS COLLECTIONS SERVICE AGREEMENT (PACS) are estimates only and are not purchased by this contract. The quantities represent the government s best estimate of actual quantities which may be required over the term of the contract. The Contractor will be paid, in accordance with this schedule, only for actual work performed.\n\nCode\nService Description\nPACS001\nPACS: COMPLETE SERVICE\nPACS002\nPACS: ADDITIONAL TIME - PER 15 MINUTES\nPACS003\nPACS: STAND-BY SERVICE\nPACS004\nPACS: APRP\nPACS005\nPACS: APRP ADD-ON TO COMPLETE SERVICE\nPACS006\nPACS: ANTICOAG-ASPIRATION ASSEM\nPACS011\nPACS: CANCELLATION FEE - BEFORE SET-UP\nPACS012\nPACS: PROFESSIONAL SERVICE\nPACS013\nPACS: CANCELLATION FEE - AFTER SET-UP\nPACS014\nPACS: NON-SCHEDULED CASE FEE\nPACS015\nPACS: OFF HOURS RESPONSE FEE\nPACS016\nPACS: MICRO AGGREGATE FILTER\nPACS017\nPACS: TRANSFER PACK\nPACS025\nPACS: LEUKOREDUCTION FILTER\nPACS033\nPACS: PROCESSING BOWL KIT\nPACS034\nPACS: RESERVOIR\n\n\n\nSERVICES:\n\nBasic autotransfusion will be used where large blood loss is anticipated. Procedures will include but not be limited to vascular, trauma, gynecological, and some orthopedic cases. Any procedure in which medical staff determine whether this service is required shall be covered under this contract. Basic service will include use of contractor provided equipment, disposable supplies, setup and take down of equipment, and one registered nurse operator or certified technician for approximately a four (4) hour period.\n\nMini autotransfusion will be used either intra or post operatively on surgical procedures where nominal to moderate blood loss is anticipated. Procedures will include but not be limited to: Orthopedic cases such as total knee and total hip arthroplasties, ORIF, and retropubic prostatectomy. Mini autotransfusion will include all use of contractor provided equipment, disposable supplies, setup and take down of equipment, and one registered nurse operator or certified technician for approximately a minimum of a two (2) hour period.\n\nThe contractor shall provide services in accordance with American Association of Blood Bank (AABB) standards.\n\nThe contractor shall provide all labor, equipment, management, materials, supplies, and other elements necessary to provide complete Autologous Transfusion (Cell Saver) Services for the Wilmington VA Medical Center. Registered nurses and/or technicians shall be fully qualified and possess direct, documented experience in the performance of the referenced services.\n\nUniversal precaution procedures, in accordance with CDC, OSHA, & JC guidelines, shall be adhered to for services provided under this contract.\n\nThe services to be performed by the Contractor shall be performed in accordance with WVAMC policies and procedures and the regulations of the medical staff by-laws (available upon request) of the WVAMC.\n\nThe contractor shall provide only equipment and supplies that are approved by the Food & Drug Administration (FDA) for autotransfusion. The Contractor shall obtain written approval from the Contracting Officer (CO) prior to implementing any changes or substitution of equipment/supplies during the term of this contract. An approved list of supplies shall be submitted to, and maintained by, the Contracting Officer s Representative (COR) in collaboration with OR Nursing Leadership. The contractor shall be responsible for providing the necessary machine along with the disposable bowl and reservoir. The WVAMC staff are not responsible for Contractor provided equipment/supplies and/or staff. Contractor shall ensure all equipment and supplies are in pristine condition and supplies are not expired. They shall be maintained in a condition suitable for operating room applications. No other condition is considered acceptable and shall not be used in the performance of this contract. Maintenance and repair of the Contractor s equipment is the sole responsibility of the Contractor.\n\nThe Contractor shall place two (2) contractor owned cell saver machines in the operating room area and remain there for the duration of the contract. It is agreed that WVAMC personnel shall not, at any time, set up or operate contractor equipment or machines. However, WVAMC personnel shall be authorized to begin all necessary operations required for emergency collection set-up when they deem necessary for appropriate patient care.\n\n\n\nVA REQUEST FOR CELL SAVER PROCESS:\n\nDuring normal business hours, the Surgical Resident enters a consultation requesting a cell saver.\nThe Impact Nurse makes the request and provides this information to the Inventory Management Specialist.\nInventory Management Specialist calls to order the cell saver with the following information-\nSurgeon Name\nOperating Room phone number\nType of Surgical Procedure\nPatient Name\nDate and Time of Procedure\nMalignancy Status\n\nAfter hours, Saturday, Sunday and Holidays\nEmergency Service can be ordered through the same Clinical Services phone number on a 24-hour, 7-day basis. The Surgical Resident, Nursing Supervisor, or O.R. nurse can order these services.\n\nTRANSPORTATION AND TRAVEL TIME:\n\nThe price of this service shall include the transportation of personnel and equipment/supplies. No additional charges shall be authorized for transportation.\n\nRESPONSE TIME AND QUANTITIES:\n\nThe Contractor shall provide all necessary equipment, supplies, and a registered nurse or certified technician within 30 minutes of notification of needed emergency services by the Nursing Leadership or other authorized representative as identified by the CO or COR.\nUpon arrival, the registered nurse and/or technician shall immediately report to the WVAMC circulating nurse assigned to the procedure.\nThe Contractor shall not be required to perform in excess of three (3) Basic and one (1) Mini service at any one time under this contract.\n\nHOURS OF COVERAGE:\n\nThe contractor shall provide coverage twenty-four (24) hours per day, seven (7) days per week. This is a critical life-saving component for patient care. Accordingly, Contractor shall be prepared to perform services at all times.\n\nQUALITY MANAGEMENT PROGRAM:\n\nThe Contractor shall have a quality management program in place, that ensures equipment and personnel perform in accordance with American Association of Blood Banks (AABB), College of American Pathologists (CAP), Joint Commission (JC) standards as applicable. The Contractor shall submit a detailed planned which accurately details their quality control management program to the CO prior to contract start-up. Contractor shall obtain written approval from the CO prior to implementing any changes in their approved quality management program. Failure of the Contractor to ensure personnel and equipment conform to these standards shall be cause for termination of the contract.\n\nPERFORMANCE MONITORING AND SURVEILLANCE METHODS: \n\nThe COR shall use the surveillance methods listed below in the administration of this contract.\n\nDIRECT OBSERVATION:\n\n100% surveillance: The Surgeon will observe the contract Perfusionist during each case and provide feedback to Nursing Leadership who will communicate with the COR.\n\nPERIODIC INSPECTION: \n\nInspections scheduled and reported quarterly per COR delegation or as needed. COR will ask the contract Perfusionist for licensure, certification, registration, and maintenance of certification as a perfusionist information updates each month.\n\nVALIDATED USER/CUSTOMER COMPLAINTS:\n\nThe contractor will be monitored through a variety of mechanisms, including but not limited to:\n\nQA monitors to assess the quality of care provided by the contractor.\n\nReview of medical record documentation.\n\nThe Contractor is required to meet Joint Commission standards, as applicable. These performance standards may change during the course of the contract. Any new or revised quality/performance criteria or standards will be provided to the contractor before their implementation date and renegotiated into the contract as necessary. Attachment 1 contains the Performance Metrics that will be used to monitor the contractor.\n\nMonitoring of contractor s time shall be demonstrated through sign-in/ sign-out sheets. The contractor shall be required to sign an attendance log-upon reporting to work and departing from work. The Contracting Officer s Representative (COR) is designed to be the Surgical Care Line s Administrative Team. The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.\n\n\nPERSONNEL QUALIFICATIONS/TRAINING:\n\nThe Contractor shall ensure all personnel are fully qualified, competent, and have the training, and experience to perform the services in accordance with the terms & conditions of this contract and all other applicable regulations. The Contractor shall provide documentation/certification letters of qualifications, training, licensure, and experience of proposed personnel which the Contractor anticipates utilizing to perform services under this contract. Contractor shall provide evidence their prospective personnel have received all Vaccines (with TB and COVID-19 immunization being the most critical), as well as training for safety/blood borne pathogens and HIPPA. Personnel shall not be used prior to approval by the COR. This approval shall be in writing. Information shall be provided prior to the addition of new staff members.\n\nIt is the contractor s responsibility to provide competency assessments, evaluations, credentials, licensure and/or or any other documents on its employees required to comply with the accreditation policies and standards of the Joint Commission. Employees of the contractor shall be a citizen of the United States and proficient in spoken and written English. \n\nFailure to ensure personnel meet the minimum qualification requirements shall represent grounds for contract termination. The qualifications of Contractor personnel performing under this contract are subject to review and approval by the WVAMC Chief of Staff and the WVAMC Director. Accordingly, Contractor shall supply the list of prospective employees as quickly as possible, but not later than three days after contract award, to ensure personnel are in place in an acceptable period of time. Contractor personnel will be subject to a Special Agreement Check (SAC) via electronic fingerprinting prior to or simultaneous with entry on duty to WVAMC premises. \n\nHIPPA Responsibility: Contractor agrees to comply with the requirements under the Health Insurance Portability and Accountability Act of 1996 (HIPPA). Notwithstanding anything to the contrary in this contract, all individually identifiable health information shall be treated as confidential by parties in accordance with all applicable federal, state, or local laws and regulations and official guidance promulgated there under, and the parties agree to take such additional steps and/or negotiate such amendments to this contract as may be required to ensure that the parties are and remain in compliance with the HIPAA regulations and official guidance. \n\nSecurity requirements: The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include but are not limited to Federal Information Security Management Act (FISMA), Appendix II of OMB Circular A-130, and guidance and standards, available from the Department of Commerce s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST s Web site at:\n\nhttp://www.checklists.nist.gov\n\n To ensure appropriate security controls are in place, contractors must follow the \n procedures set forth in: VA Information and Information System Security/Privacy \n Requirements for IT Contracts located at the following web site:\n\nhttp://www.iprm.oit.va.gov\n\nThe Contracting Officer or COTR will provide the details required for obtaining the VHA Privacy Policy Training. \n\nIn accordance with VHA Directive 6500, Appendix G, Department of Veteran s Affair (VA) National Rules of Behavior, each contractor must read and sign the VA National Rules of Behavior prior to gaining any access to VA information and/or information systems. Contractors must initial and date each page of the copy of the page of the VA National Rules of Behavior; they must also provide the information requested on the last page, sign and date it. \n\nContractor Employee Security and HIPPA Training: Contractor shall certify that all employees working on this contract receive VHA Privacy Training. This training can be accessed online through the VA Learning Management System (LMS). Proof of training is required. \n\nContractor Personnel Security Requirements: All contractor employees who require access to the Department of Veterans Affairs computer system shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract the contractor will be responsible for the actions of those individuals that provide or perform work for the VA.\n\nCONTRACTOR RESPONSIBILITIES:\n\nContractor shall bear the expense of obtaining background investigations\nThe contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak and understand the English language. The contractor shall provide the screening results of the VA Contracting officer prior to award and anytime new employees are hired\nThe contractor will provide to the Contracting Officer prior to award the following: (1) List of names of contract personnel. (2) Social security numbers of contractor personnel, (3) Home address of contractor personnel or the contractor address\n\n\n\nAPPROVAL OF CONTRACTOR PERSONNEL:\n\nThe WVAMC 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 cause, is considered by the Contracting Officer to be objectionable, as long as thirty (30) days written notification of unsatisfactory performance has been provided to the contractor and the problem has not been cured in the thirty (30) day period.\n\nKEY PERSONNEL AND TEMPORARY EMERGENCY SUBSTITUTIONS:\n\nThe Contractor shall assign to this contract the following key personnel:\n\nKey Registered Nurse\n \n\n\nKey Registered Nurse\n \n\n\nBack up Registered Nurse\n \nBack up Registered Nurse\n \nBack up Registered Nurse\n \nBack up Registered Nurse\n \nCertified Technician\n \n\n\nCertified Technician\n \n\nDuring 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.\n\nThe 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 people being replaced. The Contracting Officer Shall 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.\n\nFor temporary substitutions where the key person will not be reporting to work for three\n(3) consecutive workdays 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.\n\n\nREPORTING REQUIREMENTS:\n\nThe contractor shall provide a log report for each procedure to include the date, patient s name, locally assigned patient identification number, volume processed, volume returned, and name & signature of the registered nurse.\nAll records of services rendered, and supplies used shall be provided to Logistics.\n\nUNUSED WHOLE BLOOD:\n\nWhen there is whole blood remaining at the completion of a surgical procedure the nurse operator shall ensure proper labeling as follows: Patient s name, locally assigned patient identification number, and date & time. The nurse operator shall inform the Operating Room circulating nurse and Anesthesia when there is remaining whole blood.\n\nPERSONNEL POLICY:\n\nThe Contractor shall be responsible for protecting the personnel furnishing services under this contract. To conform with this policy, the Contractor shall provide the following minimum requirements:\n-worker s compensation\n\n-professional liability insurance\n\n-health examinations\n\n-income tax withholding, and\n\n-social security payments\n\nThe personnel performing under this contract shall not be considered SAVAHCS employees for any purpose and shall be considered employees of the Contractor.\n\nPERSONAL ARTICLES:\n\nThe WVAMC shall provide a locker for contractor personnel to store personal articles for safekeeping. Contractor shall be responsible for any lock they wish to utilize\n\nTo maintain environmental sanitation no personal articles shall be brought into the operating\nroom.\n\nDEFINITIONS/ACRONYMS -\n\nAABB American Association of Blood Banks\n\nCAP College of American Pathologists\nCDC Centers for Disease Control\n\nCO - Contracting Officer.\n\nCOR - Contracting Officer s Representative.\n\nJC Joint Commission.\nOSHA Occupational Safety and Health Administration\n\nWVAMC Wilmington VA Medical Center\n\n\nFEDERAL HOLIDAYS OBSERVED BY THE SAVAHCS:\n\nNew Year s Day Labor Day \nMartin Luther King Day Columbus Day \nPresident's Day Veterans Day\nMemorial Day Thanksgiving Day\nIndependence Day Christmas Day\nJune Nineteenth\n\n*Note Please ensure you understand this contract is in effect 365 days a year, 24 hours a day.\n\nIDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:\n\nIt is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The WVAMC will not invalidate or make reimbursement for parking violations of the contractor under any conditions.\n\nSmoking is prohibited inside all buildings at the WVAMC and on VA property.\n\nPossession of weapons and alcohol are prohibited.\n\nEnclosed containers shall be subject to search.\n\nViolations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.\n\n\nPRIVACY AWARENESS TRAINING:\n\nPrivacy Training: \n\nThe Contractor and their sub-contractors assigned work under the contract are required to receive annual training on patient privacy as established by HIPAA statutes. Training must meet VHA s and the Department of Health and Human Services Standards for Privacy of\nIndividually identifiable health information. Contractor shall provide documented proof to the contracting officer that all employees assigned work and/or having access to Protected Health Information have received annual training. Proof of training is to be forwarded to the Contracting Officer. Information on fulfilling the training requirement as stated in this paragraph can be found at https://www.ees-learning.net. For contractors and sub-contractors who do not have access to VHA computer systems, this requirement is met by receiving VHA National Privacy Training, other VHA approved privacy training or contractor furnished training that meets the requirements of the HHS standards.\n\nA Business Associate Agreement (BAA) may be required for any contract that requires either a SAC or a NACI or higher and that is not otherwise exempt from the requirement for a BAA. The BAA shall be attached to solicitation document for this requirement. Contractor shall supply completed BAA with their solicitation offer.\n\nORDERS:\n\nA task order shall be placed against the basic contract on an annual basis to provide funding for services. In no event shall the established limit be exceeded without prior modification by the CO. See contract documents for complete procedures and requirements.\n\n\nATTACHMENT 1 - PERFORMANCE METRICS\n\n\nTask\nPWS\n\nPara\nPerformance Measures\nAcceptable Quality Level\n\nMethod of Surveillance\nBasic Autotransfusion\n\n1.B.1\n\nAt All Times\n\n100%\nObservation and random inspection\n\nMini Autotransfusion\n\n\n1.B.2\n\n\nAt All Times\n\n\n100%\n\n\n\nObservation and random inspection\n\nEquipment and Supplies\n\n\n1.C\n\n\nAt All Times\n\n\n100%\n\n\n\nObservation and random inspection\n\n\nResponse Times\n\n\n3.\n\n\nAt All Times\n\n\n100%\n\n\n\nObservation and random inspection\n\nPersonnel Qualifications\n7,\n7.1,\n7.2 & 7.3\n\nAt all times\n\n100 %\n\nObservation and random inspection (auditing)\nReporting Requirements\n8\nAt all times\n100%\nObservation and random inspection (auditing)\n\n\n\n\n\nPrivacy Awareness\n16\nAt All Times\n100 %\nObservation and random inspection (auditing)\n\n\n\n\nPRICE/COST SCHEDULE:\n\nAll quantities listed are considered estimates.\n\n\n\n\nItem information\n\n\nItem Number\nDescription of Supplies\nEstimated Quantity\nUnit\n0001\nAutotransfusion Professional Fee\n1\nEA\n0002\nHourly charge for cases beyond 10 hours\n1\nEA\n0003\nAutrotransfusion Case Cancellation (After contractor arrives on site)\n1\nEA\n0004\nAutotransfusion Case Cancellation (Cancellation with < 3 hours notice)\n1\nEA\n0005\nEmergent Autotransfusion Fee\n1\nEA\n\n\nDisposables description\n3L Reservoir Only 150 micron filter\nBasic A&A Assembly\nProcesing Set (125ml)\nProcessing Set (225ml)\nVacuum Line\nBlood Filter 40 Micron\nBlood Filter Lipid Reduction\nBlood Filter Leucocyte Reduction\nBlood Transfer Bags\nBlood QC Sample Copuler\n\n\n\nCAPITAL EQUIPMENT\n\nDESCRIPTION\n\nHaemonetics Elite Autotransfusion Device QTY (2)\n\nVendor shall be responsible for all maintenance, including PM for the equipment.\n\n\n\n End of Performance Work Statement (PWS).\n\n\n\n\n\n\n\n\n\n"}