Q523--Brand Name or Equal to the American Red Cross - Autologous Transfusion Cell Saver Unrestricted | POP: 05/01/26-04/30/27 This is not a request for a Quote.

PERFORMANCE WORK STATEMENT (PWS)

Autologous Transfusion (Cell Saver) Services

SERVICE AND EQUIPMENT/SUPPLIES TO BE PROVIDED

General

The contractor shall provide all labor, equipment, management, materials, supplies, and other elements necessary to provide complete Autologous Transfusion (Cell Saver) Services for the Corporal Michael J. Crescenz VA Medical Center. Registered nurses will be fully qualified and possess direct, documented experience in the performance of the services referenced.

Services

Basic autotransfusion will be used where large blood loss is anticipated. Procedures will include but not limited to: Vascular, Trauma Orthopedics, Gynecological, ENT, SPINE, Neurosurgery, and Orthopedics. Any procedure in which medical staff determine 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.

Mini autotransfusion will be used either intra or post operatively on surgical procedures where nominal to moderate blood loss is anticipated. 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.

Equipment and Supplies

The contractor will 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 substitutions 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). The contractor shall be responsible for providing the necessary machine(s) along with the disposable bowl and reservoir. Contractor shall ensure that all equipment and supplies are in pristine condition and not expired. Maintenance and repair of the Contractor s equipment is the sole responsibility of the Contractor.

TRANSPORTATION AND TRAVEL TIME

The price of this service will include the transportation of personnel and equipment. 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 services by the authorized representative from the VA for urgent cases.

Two contractor-owned cell-saving machines shall be placed in the operating room and remain there for the duration of the contract. It is agreed that the CMC VAMC personnel shall not, at any time, set up or operate contractor equipment or machines. However, CMC VAMC personnel shall be authorized to begin all necessary operations required for emergency collection set-up when they deem necessary for appropriate patient care.

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.

When the Contractor determines equipment requires additional maintenance, they shall schedule the time with the OR nurse managers. The contractor will only be in the facility when government personnel are aware of the duration of the visit.

HOURS OF COVERAGE

The Contractor shall provide coverage twenty-four (24) hours per day, seven (7) days per week. This is a critical lifesaving 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 the American Association of Blood Banks (AABB), College of American Pathologists (CAP), Joint Commission (JC) Standards as applicable. Failure of the Contractor to ensure personnel and equipment conform to these standards shall be cause for termination of the contract.

KEY PERSONNEL AND TEMPORARY EMERGENCY SUBSTITUTIONS

CMC VAMC 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 Registered Nurse

Key Registered Nurse

Back-Up Registered Nurse

Back-Up Registered Nurse

Certified Technician

Certified Technician

Back-Up Technician

CMC VAMC shall provide a locker room 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 sterile environment (Operating Room and/or CORE)

PERSONNEL QUALIFICATIONS/TRAINING

The Contractor shall ensure all personnel are fully qualified, competent, and have the training and other 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, and experience of proposed personnel.

REPORTING REQUIREMENTS

The contractor shall provide a log report for each procedure to include the date, patient name, patient identification number, volume processed, volume returned, and name and signature of the nurse or technician.

UNUSED WHOLE BLOOD

When there is whole blood remaining at the completion of a surgical procedure the nurse operator or certified technician shall ensure proper labeling as follows. Patient name, patient assigned identification number and date & time. The operator shall inform the Operating Room staff nurse where there is remaining whole blood.

FEDERAL HOLIDAYS OBSERVED BY CMC VAMC:

NEW YEAR S DAY

MARTIN LUTHER KING JR S BIRTHDAY

WASHINGTON S BIRTHDAY

MEMORAL DAY

JUNETEENTH

INDEPENDENCE DAY

LABOR DAY

COLUMBUS DAY

VETERAN S DAY

THANKSGIVING DAY

CHRISTMAS DAY

* PLEASE NOTE THAT THIS CONTRACT IS FOR 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. CMC VAMC will not validate or make reimbursement for parking violations of the contractor under any conditions.

Smoking is prohibited inside or outside any buildings at CMC VAMC and on VA property

Possession of weapons and alcohol are prohibited

Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court

PERIOD OF PERFORMANCE

1 Year of Service.

POP: 05/01/26-04/30/27

End of Performance Work Statement (PWS).