Sources Sought Notice - Denver Apheresis.pdf

SUBJECT* Therapeutic Apheresis Treatment Services - Equipment and Staffing)

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 80111

SOLICITATION NUMBER* 36C25923Q0494

RESPONSE DATE/TIME/ZONE 05-15-2023 1200 PM MOUNTAIN TIME, DENVER, USA

ARCHIVE 60 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE

PRODUCT SERVICE CODE* Q508

NAICS CODE* 621991

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

POINT OF CONTACT*

Jim Lewis Contract Specialist james.lewis114fbb@va.gov

PLACE OF PERFORMANCE

ADDRESS Rocky Mountain Regional VA Medical Center 1700 N. Wheeling St.

Aurora, CO 80045

DESCRIPTION

SOURCES SOUGHT SYNOPSIS ONLY

1. The Department of Veterans Affairs, Network Contracting Office 19, is seeking sources for a potential agreement to provide Inpatient Therapeutic Apheresis Treatments in the Rocky Mountain Regional VA Medical Center (RMR VAMC), Aurora, CO. See the attached abridged Performance Work Statement (PWS) for more details.

2. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification (HUBZone, 8(a), small, small disadvantage, service-disabled veteran owned small business, veteran owned small business or large business) relative to NAICS 621991 – Blood and Organ Banks ($40 Million size standard). Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this Sources Sought synopsis, a solicitation announcement may be published on Contract Opportunities or GSA. Responses to this Sources Sought synopsis are not considered adequate responses to the solicitation announcement.

3. Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM) located at https://sam.gov. Additionally, all Service-Disabled Veteran Owned Small Businesses or Veteran Owned Small Businesses who respond must be registered with the U.S Small Business Administration VetCert Registry located at https://veterans.certify.sba.gov.

4. This is a Sources Sought announcement ONLY and is NOT a request for proposals or quotes.

5. In response to this announcement, please provide the following information:

Company Name:

Address:

GSA/FSS contract number:

SAM Unique Entity ID Number:

Contact Name:

Phone No.:

Email:

Business Size Information (select all that apply):

� Small Business � Emerging Small Business � Small Disadvantaged Business � Certified under Section 8(a) of the Small Business Act � HUBZone � Woman Owned � Certified Service-Disabled Veteran Owned Small Business � Veteran Owned Small Business � Large Business

6. This notice is neither a request for competitive proposal nor solicitation of offerors. This notice is to assist the VA in determining sources only and a solicitation is not currently available. If a solicitation is issued it will be announced later, and all interested parties must respond to that solicitation announcement separately from this response. Responses to this Sources Sought is not a request to be added to a prospective bidders list or to receive a copy of the solicitation. Information received as a result of this notice will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This notice does not represent a commitment by the Government to pay for costs incurred in the preparation and submission of information or any other costs incurred as a response to this announcement. Inquiries will only be accepted in writing via email to james.lewis114fbb@va.gov on or before May 15, 2023 by 12:00 pm MDT.

mailto:james.lewis114fbb@va.gov

PERFORMANCE WORK STATEMENT

B.3 PERFORMANCE WORK STATEMENT (PWS)

B.3.1 Overview

B.3.1.1 Contractor shall provide all material, supplies (except replacement fluids (albumin or plasma), equipment, personnel, and qualified supervision that are required to provide routine and urgent On-Site Therapeutic Apheresis services at the Rocky Mountain Regional Veterans Affairs Medical Center, 1700 N Wheeling St Aurora CO 80045. The vendor will be in full compliance with current FDA and American Association of Blood Banks regulatory Compliance standards. Vendor will maintain full training and competency documents on their staff performing apheresis.

Vendor will participate in a quality assurance monitoring program and provide quarterly reports in a timely manner to the Medical Service COR. When required by Accrediting agencies, vendor will ensure that training documents on staff will be available for review. Vendor will maintain compliance with Quality System Essentials.

The company will provide duly licensed and qualified nurses trained in therapeutic apheresis treatment as applicable to the service described in accordance with the relevant state license requirements. Qualified nursing staff will be responsible for completing credentialing and the mandatory security and HIPPAA training prior to providing services within the Department of Veterans Affairs Medical Center.

The following services, equipment and supplies are required:

1. Therapeutic plasma exchange with fresh frozen plasma (approx. 25 per year)

2. Therapeutic plasma exchange with albumin (approx. 25 per year)

The following disposable supplies and capital equipment is required:

1. Blood cell separator tubing set

2. Blood warmer tubing set

3. Microaggregate blood filters (procedures with fresh frozen plasma)

4. AV fistula needles (as needed for peripheral access)

5. Anticoagulatant ACD-A

6. Syringes

7. Hypodermic needles

8. Iodine swabsticks and alcohol swabs

9. Tape

10. Gauze pads, 2x2, 4x4, sterile and non-sterile

11. Normal saline

12. Treatment saline

13. Apheresis system

14. Blood warmer

15. Photopheresis set/system

B.3.2 Therapeutic Apheresis Procedures

B.3.3.1 The Contractor’s therapeutic apheresis staff’s responsibilities shall include, but are not limited to the following:

B.3.3.1.1 The Contractor shall establish an appropriate clinical relationship with the patient to be treated, including answering questions the patient or patient’s family may have.

B.3.3.1.2 The Contractor shall create and complete a written record of each therapeutic apheresis procedure performed.

B.3.3.1.3 The Contractor shall set up the apheresis equipment and assure proper function prior to beginning the therapeutic apheresis.

B.3.3.1.4 The Contractor shall assess the patient just prior to therapeutic apheresis, to assure adequate hematocrit, vital signs, and overall clinical stability.

B.3.3.1.5 The Contractor shall establish vascular access and obtain any required samples

B.3.3.1.6 The Contractor shall perform the requested therapeutic apheresis procedure and maintain fluid balance as required

B.3.3.1.7 The Contractor shall monitor the patient clinically during the therapeutic apheresis.

This should include periodic recording of vital signs and monitoring for adverse effects of the therapeutic apheresis (e.g. citrate toxicity) and transfusion reactions. Reporting of adverse events during the procedure will be coordinated through risk management office at the VAECHCS and Medical Service.

B.3.3.1.8 The Contractor shall monitor equipment function, respond to alarms, and maintain vigilance for malfunctions (i.e. lead, return site hematoma) that may not trigger alarms.

B.3.3.1.9 The Contractor shall take corrective action for detected adverse effect or malfunctions to the extent qualified or call for VA staff assistance if needed.

B.3.4 Administrative Support

B.3.4.1 The Contractor shall provide an Administrative Coordinator to provide oversight responsibilities to ensure that qualified, competent personnel are performing the on-site apheresis services in a timely and professional manner.

B.3.5 Scheduling

B.3.5.1 The Contractor shall provide on-demand apheresis services 24 hours per day, seven days per week, including National and Contractor-honored holidays.

B.3.5.2 The Contractor will be contacted by the Rocky Mountain Regional VA personnel;

Medical Service- Renal/Hematology Oncology/Neurology/General Medicine requesting to schedule a therapeutic apheresis procedure.

B.3.5.3 The Contractor shall receive telephone notification by the authorized Government personnel.

B.3.5.4 The Contractor may only perform the therapeutic apheresis only after receiving the telephone request by the Rocky Mountain Regional VA personnel as identified in B.3.5.2.

B.3.5.5 The Contractor shall notify the authorizing personnel of schedule all routine therapeutic apheresis service appointments within 2 hours following receipt of request at a time that is mutually agreeable with both parties.

B.3.5.6 The contractor shall arrive at the station within two hours of the agreed upon schedule appointment. The Contractor shall notify the Government immediately of any delay or missed appointments.

B.3.5.7 The Contractor shall arrive on-site to perform urgent therapeutic apheresis (patients who need to initiate therapy without any delay) services within four hours of receipt of the telephone notification.

B.3.6 Contractor Equipment

B.3.6.1 Contractor shall maintain its equipment in good working order and in accordance with the specifications of the manufacturer and in compliance with applicable safety regulations.

Equipment quality assurance/calibration shall also be performed in accordance with manufacturer's specifications. Records of equipment quality assurance/calibration activities shall be made available to VA for review upon request.

B.3.6.2 Contractor shall notify the Government (COR and CO) within 48 hours when equipment is unavailable. Upon notification, Contractor shall provide the Government with a written corrective action plan/alternate source plan for the delivery of services during the equipment down-time.

B.3.7 Qualifications of Personnel

B.3.7.1 Medical Director

B.3.7.1.1 Medical Director assigned by the Contractor to perform the services covered by this purchase order shall possess a M.D. or D.O. degree.

B.3.7.1.2 The Medical Director shall be Board Certified in clinical pathology and licensed in the State, Territory, or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the Rocky Mountain Regional VAMC Chiefs of Staff and approved by the Rocky Mountain Regional VAMC Facility Directors.

The Contracting Officer will be notified prior to any changes in personnel. VA reserves the right to approve the assignment of individual personnel furnished by the contractor to perform the functions specified in the contact.

B.3.7.2 Therapeutic Apheresis Staff

B.3.7.2.1 Registered Nurse(s) or equivalently trained and certified allied health professionals assigned to perform services shall hold a current unrestricted license in the State of Colorado (as applicable) and shall be trained in therapeutic apheresis techniques and must possess the following qualifications:

B.3.7.2.1.1 Operational knowledge with specific instruments used by the Contractor through documented training and competency records.

B.3.7.2.1.2 Knowledge of the basic principle of separation

B.3.7.2.1.3 Knowledge of transfusion of blood components and the requirements of fluid replacement after removal or exchange

B.3.7.2.1.4 Expertise in the management of adverse effects of therapeutic apheresis and transfusions

B.3.7.3 Contractor’s employees performing services under this contract shall maintain current Basic Life Support (BLS) or Advanced Cardiac Life Support (ACLS) certification and provide a copy of the certification upon renewal.

B.3.7.4 Contractor’s employees assigned to the contract shall agree to accept the professional obligations delineated in the Rocky Mountain Regional VAMC Medical Staff bylaws, rules, and regulations.

B.3.7.5 Personnel assigned by the contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402).

B.3.7.6 Any new requirements for mandatory education and/or competency reassessment, which occur during the purchase order period, must be completed by the individual contractor employee(s) within established timeframes.

B.3.7.7 The Contractor shall identify their contact person, who shall serve as liaison between the Contractor and the Rocky Mountain Regional VAMC, and who shall ensure that the Contractor performs services in accordance with contract specifications. The Contractor’s contact person(s) shall be available during the VA’s administrative tour of duty from 8:00 a.m. to 4:30 p.m., Monday through Friday.

B.3.7.8 The Contractor will designate a physician who will serve as the Medical Director. The Medical Director is responsible for the oversight of the services provided and the staff providing those services. The Medical Director or his/her designee must be available to the Rocky Mountain Regional VAMC’s medical staff 24 hours a day / 7 days a week should issues arise that need attention.

B.3.7.9 The Contractor will designate one person who can be contacted for any problems or issues that arise in the performance of this contract. The Rocky Mountain Regional VAMC will also designate a contact person. Telephone numbers of both individuals will be provided to the other party.

B.3.7.10 Any subcontractor used by the Contractor for the provision of services required under this contract must meet the same qualifications herein for the Contractor. The Contractor must obtain approval from the VA Contracting Officer to utilize any Subcontractors for the provision of services required under this contract.

B.3.8 Customer Service

B.3.8.1 Contractor shall provide customer service between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday that is accessible by telephone to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this purchase order.

[End of Performance Work Statement]