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Performance Work Statement (PWS) For AUTOLOGOUS TRANSFUSION (CELL SAVER) SERVICES SERVICE AND EQUIPMENT/SUPPLIES TO BE PROVIDED GENERAL: The contractor shall provide preoperative blood cell saver auto... Performance Work Statement (PWS) For AUTOLOGOUS TRANSFUSION (CELL SAVER) SERVICES SERVICE AND EQUIPMENT/SUPPLIES TO BE PROVIDED GENERAL: The 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. BACKGROUND: The 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 . The 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. PLACE OF PERFORMANCE: Operating Room (Endovascular Suite), BLDG 1 2nd Floor, Wilmington VA Medical Center Operating Room, BLDG 1 3rd Floor, Wilmington VA Medical Center PERIOD OF PERFORMANCE: 03/26/2026 03/25/2027 SCOPE: The 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. Code Service Description PACS001 PACS: COMPLETE SERVICE PACS002 PACS: ADDITIONAL TIME - PER 15 MINUTES PACS003 PACS: STAND-BY SERVICE PACS004 PACS: APRP PACS005 PACS: APRP ADD-ON TO COMPLETE SERVICE PACS006 PACS: ANTICOAG-ASPIRATION ASSEM PACS011 PACS: CANCELLATION FEE - BEFORE SET-UP PACS012 PACS: PROFESSIONAL SERVICE PACS013 PACS: CANCELLATION FEE - AFTER SET-UP PACS014 PACS: NON-SCHEDULED CASE FEE PACS015 PACS: OFF HOURS RESPONSE FEE PACS016 PACS: MICRO AGGREGATE FILTER PACS017 PACS: TRANSFER PACK PACS025 PACS: LEUKOREDUCTION FILTER PACS033 PACS: PROCESSING BOWL KIT PACS034 PACS: RESERVOIR SERVICES: Basic 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. Mini 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. The contractor shall provide services in accordance with American Association of Blood Bank (AABB) standards. The 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. Universal precaution procedures, in accordance with CDC, OSHA, & JC guidelines, shall be adhered to for services provided under this contract. The 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. The 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. The 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. VA REQUEST FOR CELL SAVER PROCESS: During normal business hours, the Surgical Resident enters a consultation requesting a cell saver. The Impact Nurse makes the request and provides this information to the Inventory Management Specialist. Inventory Management Specialist calls to order the cell saver with the following information- Surgeon Name Operating Room phone number Type of Surgical Procedure Patient Name Date and Time of Procedure Malignancy Status After hours, Saturday, Sunday and Holidays Emergency 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. TRANSPORTATION AND TRAVEL TIME: The price of this service shall include the transportation of personnel and equipment/supplies. No additional charges shall be authorized for transportation. RESPONSE TIME AND QUANTITIES: The 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. Upon arrival, the registered nurse and/or technician shall immediately report to the WVAMC circulating nurse assigned to the procedure. The 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. HOURS OF COVERAGE: The 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. QUALITY MANAGEMENT PROGRAM: The 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. PERFORMANCE MONITORING AND SURVEILLANCE METHODS: The COR shall use the surveillance methods listed below in the administration of this contract. DIRECT OBSERVATION: 100% surveillance: The Surgeon will observe the contract Perfusionist during each case and provide feedback to Nursing Leadership who will communicate with the COR. PERIODIC INSPECTION: Inspections 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. VALIDATED USER/CUSTOMER COMPLAINTS: The contractor will be monitored through a variety of mechanisms, including but not limited to: QA monitors to assess the quality of care provided by the contractor. Review of medical record documentation. The 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. Monitoring 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. PERSONNEL QUALIFICATIONS/TRAINING: The 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. It 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. Failure 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. HIPPA 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. Security 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: http://www.checklists.nist.gov To ensure appropriate security controls are in place, contractors must follow the procedures set forth in: VA Information and Information System Security/Privacy Requirements for IT Contracts located at the following web site: http://www.iprm.oit.va.gov The Contracting Officer or COTR will provide the details required for obtaining the VHA Privacy Policy Training. In 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. Contractor 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. Contractor 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. CONTRACTOR RESPONSIBILITIES: Contractor shall bear the expense of obtaining background investigations The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak and understand the English language. The contractor shall provide the screening results of the VA Contracting officer prior to award and anytime new employees are hired The 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 APPROVAL OF CONTRACTOR PERSONNEL: The 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. KEY PERSONNEL AND TEMPORARY EMERGENCY SUBSTITUTIONS: The Contractor shall assign to this contract the following key personnel: Key Registered Nurse Key Registered Nurse Back up Registered Nurse Back up Registered Nurse Back up Registered Nurse Back up Registered Nurse Certified Technician Certified Technician During the first ninety (90) days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the Contracting Officer, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required by paragraph (c) below. After the initial 90-day period of the contract, the Contractor shall submit the information required by paragraph (c) to the Contracting Officer at least 15 days prior to making any permanent substitutions. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the 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. For temporary substitutions where the key person will not be reporting to work for three (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. REPORTING REQUIREMENTS: The 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. All records of services rendered, and supplies used shall be provided to Logistics. UNUSED WHOLE BLOOD: When 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. PERSONNEL POLICY: The 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: -worker s compensation -professional liability insurance -health examinations -income tax withholding, and -social security payments The personnel performing under this contract shall not be considered SAVAHCS employees for any purpose and shall be considered employees of the Contractor. PERSONAL ARTICLES: The 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 To maintain environmental sanitation no personal articles shall be brought into the operating room. DEFINITIONS/ACRONYMS - AABB American Association of Blood Banks CAP College of American Pathologists CDC Centers for Disease Control CO - Contracting Officer. COR - Contracting Officer s Representative. JC Joint Commission. OSHA Occupational Safety and Health Administration WVAMC Wilmington VA Medical Center FEDERAL HOLIDAYS OBSERVED BY THE SAVAHCS: New Year s Day Labor Day Martin Luther King Day Columbus Day President's Day Veterans Day Memorial Day Thanksgiving Day Independence Day Christmas Day June Nineteenth *Note Please ensure you understand this contract is in effect 365 days a year, 24 hours a day. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: It 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. Smoking is prohibited inside all buildings at the WVAMC and on VA property. Possession of weapons and alcohol are prohibited. Enclosed containers shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court. PRIVACY AWARENESS TRAINING: Privacy Training: The 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 Individually 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. A 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. ORDERS: A 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. ATTACHMENT 1 - PERFORMANCE METRICS Task PWS Para Performance Measures Acceptable Quality Level Method of Surveillance Basic Autotransfusion 1.B.1 At All Times 100% Observation and random inspection Mini Autotransfusion 1.B.2 At All Times 100% Observation and random inspection Equipment and Supplies 1.C At All Times 100% Observation and random inspection Response Times 3. At All Times 100% Observation and random inspection Personnel Qualifications 7, 7.1, 7.2 & 7.3 At all times 100 % Observation and random inspection (auditing) Reporting Requirements 8 At all times 100% Observation and random inspection (auditing) Privacy Awareness 16 At All Times 100 % Observation and random inspection (auditing) PRICE/COST SCHEDULE: All quantities listed are considered estimates. Item information Item Number Description of Supplies Estimated Quantity Unit 0001 Autotransfusion Professional Fee 1 EA 0002 Hourly charge for cases beyond 10 hours 1 EA 0003 Autrotransfusion Case Cancellation (After contractor arrives on site) 1 EA 0004 Autotransfusion Case Cancellation (Cancellation with < 3 hours notice) 1 EA 0005 Emergent Autotransfusion Fee 1 EA Disposables description 3L Reservoir Only 150 micron filter Basic A&A Assembly Procesing Set (125ml) Processing Set (225ml) Vacuum Line Blood Filter 40 Micron Blood Filter Lipid Reduction Blood Filter Leucocyte Reduction Blood Transfer Bags Blood QC Sample Copuler CAPITAL EQUIPMENT DESCRIPTION Haemonetics Elite Autotransfusion Device QTY (2) Vendor shall be responsible for all maintenance, including PM for the equipment. End of Performance Work Statement (PWS).