36C24523Q0544_1.docx

Presolicitation Notice Presolicitation Notice

GENERAL INFORMATION

SET-ASIDE

PLACE OF PERFORMANCE

120(+) Specifically Identified VA Medical Centers

Pathology and Laboratory Medicine (11DIAG2)

VA Central Office.

POSTAL CODE

COUNTRY

CONTACT INFORMATION

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs VA Maryland Health Care System Network Contracting Office 05 P.O. Box 1000, Bldg. 101, Room 26 Perry Point MD 21902

POINT OF CONTACT*

Contracting Officer Robert O'Keefe Jr robert.okeefejr@va.gov **email only**

ADDITIONAL INFORMATION

AGENCY’S URL

https://www.va.gov/maryland-health-care/

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

The Department of Veterans Affairs, Pathology and Laboratory Medicine (11DIAG2), VA Central Office has an acquisition need for tissue and transfusion laboratory accreditation, education, and professional membership as a follow-on firm-fixed price contract. The Department of Pathology Laboratory Medicine intends for this requirement to be purchased in accordance with FAR 6.302-1 Only one responsible source will satisfy the agency requirements.

Objective — The objective of this requirement is to have on-site assessment and continuous monitoring services for accreditation for specified VHA clinical laboratories. Bi-annual on-site assessments are a requirement of maintaining laboratory accreditation required by Clinical Laboratory Improvement Amendment (CLIA). Educational offerings shall allow VA laboratory staff current guidelines and information on emerging technologies in blood bank/transfusion service. Professional membership allows for VHA staff to collaborate with the larger blood bank community to share resources and knowledge.

Unique Qualifications — Vendor must be CLIA deemed as a laboratory accreditation organization. Accreditation shall be based on the AABB standards for Blood Banks and Transfusion Services and cellular therapies. The American Assoc Of Blood Banks AABB accreditation program is based on the AABB standards for Blood Banks and Transfusion Services and has been designated as the industries best practice for the blood bank/transfusion service. AABB Standards allow for interim and emergent guidance when new scientific evidence supports additional requirements for patient safety. VHA Transfusion and Tissue Services would be able to follow the standards to incorporate a quality management system based on internationally accepted concepts for quality using evidence- based decision-making processes. Current professional industry standards and guidelines are essential for VHA Pathology and Laboratory Medicine Services to sustain its mission to provide critical patient care and diagnostic testing that meets accreditation and regulatory requirements Administration’s (VHA) Pathology and Laboratory Medicine (PLM) Program Office is responsible for providing guidance, standards, and policy for the administration, accreditation, staffing, and functioning of clinical and anatomic pathology laboratories in the Department of Veteran Affairs (VA) facilities or facilities managed by VA. A Congressional inquiry into the way biologics (tissue) is procured, stored, issued, and tracked in VHA brought about the necessity for improved education, training, and oversight of the processes. AABB membership and accreditation is the service needed for the VHA Transfusion and Tissue Services to align with industry standards in transfusion medicine and other disciplines such as: tissue, hematopoietic, cellular and gene therapies, transplantation, and relationship testing. The AABB accreditations support high standards for medical, technical, and administrative performance, scientific investigation, clinical application, and education. The use of AABB standards and accreditation services will assist in closing those identified gaps.

AABB transfusion service accreditation is based on standards developed by and agreed on by laboratory community experts and manufacturers. American Assoc Of Blood Banks AABB is an international, not-for-profit voluntary, professional, scientific, and educational association representing individuals and institutions involved in the field of transfusion services tissue banking therapies. AABB is the only CLIA deemed laboratory accreditation organization that specializes in tissue and transfusion medicine and is the gold standard source for tissue and transfusion accreditation nationally by private and public transfusion services. While there are other sources for full laboratory accreditation, they do not offer the breadth or specialized expertise needed by VHA transfusion services. AABB offers comprehensive accreditation standards that are developed by the industry, most used by the industry, and cited by the industry as best in breed.

Federal regulations limit the available vendors for this requirement. These are limited by the Centers for Medicare and Medicaid Services (CMS) and must be a CLIA deemed organization to provide laboratory accreditation service. The identified organizations websites and public resources were reviewed to determine if they would be able to meet the need. None other than AABB were found to specialize in tissue and transfusion accreditation service.

Award information – Solicitation No. 36C24523Q0544 is a lowest price technically acceptable (LPTA) firm-fixed- price requirement. The Government anticipates the Independent Cost Estimate to be comparable with the follow-on Contract No 36C24518C0228 to justify fair and reasonable pricing. The period of performance shall be for one base period and four, 12-month option periods. Option periods are exercised as required and are not guaranteed. The Period of Performance reads as follows:

If anyone requests additional information or would like to obtain a copy of the solicitation, please contact: Robert O’Keefe Jr. – Robert.Okeefejr@va.gov

Presolicitation Notice