C01-JOFOC to Publish 20231107_Redacted.pdf

POTS: 24-000074

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

Health and Human Services National Institutes of Health

b. Sponsoring organization.

Health and Human Services National Institutes of Health Clinical Center Purchasing and Contracts Department 6701 Democracy Blvd Bethesda, MD 20892-4874

c. Project Officer information.

Project Officer name:

Mailing address. 10 Center Drive

Building 10, Room 00003 E-mail address.

Telephone number.

2. Nature and/or description of the action being approved.

The College of American Pathologist Proficiency Testing Program Enrollment

a. Acquisition purpose and objectives.

The National Institutes of Health, Department of Laboratory Medicine has a requirement for an approved accredited contractor to supply proficiency testing materials (blind samples) and provide evaluations reports with peer comparison which are required to fulfill College of American Pathologist program requirements.

b. Project background.

The Department of Laboratory Medicine is currently accredited by the College of American Pathologists (CAP) and includes five services: Chemistry, Hematology, Immunology, Microbiology, and Phlebotomy. The department provides laboratory testing for all Clinical Center inpatients and clinic outpatients. This translates to more than 1 million test results per year. The laboratory operates 24 hours per day, 365 days per year. College of American Pathologists (CAP) Laboratory Accreditation Program is an engaging, dynamic and collaborative experience that fosters continuous improvement.

The Centers for Medicare and Medicaid Services (CMS) granted the College of American a.Project title. College of American Pathologist (CAP) to Supply Proficiency Testing Materials and Evaluation Result Services.

b. Project description.

The Department of Laboratory Medicine is focused on providing accurate and reliable diagnostic test results, continuous quality improvements, and higher standards of care for performing accurate and efficient laboratory testing. The accreditation process includes periodical audits to promote quality improvements that lead to higher standards in patient care. As part of this process, proficiency testing surveys are a method to provide the opportunity for peer group comparisons that are shared by more than 6,000 laboratories worldwide. Addition, proficiency testing materials are distributed to laboratory throughout the year to assess performance.

Further, proficiency test orders that include materials, and complete evaluation criteria the opportunities for the laboratory to access continuing education resources.

Provide the following information:

Requirement type.

Research & development (R&D) R & D support services

X- Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement X Follow-on

Other (specify): ______________________

Proposed contract/order type.

X Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee):

Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee):

Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________

Other (specify): ___________ Completion Form Term form

Acquisition identification number. 24-000074

c. Total estimated dollar value and performance/delivery period.

The estimated dollar value for this project for a base and four option years is

Period of Performance:

Base Year: 11/05/2023-11/04/2024 Option Year 1: 11/05/2024-11/04/2025 Option Year 2: 11/05/2025-11/04/2026 Option Year 3: 11/05/2026-11/04/2027 Option Year 4: 11/05/2027-11/04/2028 Total:

4. Identification of the statutory authority permitting other than full and open competition.

X This acquisition is conducted under the authority of 41 United States Code (U.S.C.)

253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302- 1.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

College of American Pathologists 325 Waukegan Road Northfield, Illinois 60093-2719

SAM UIE:

Active Registration: Expires 04/13/2024

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

College of American Pathologists is uniquely qualified and the only source that can provide a proficiency testing program and evaluation result Services that no other accreditation body ty. Other accreditation bodies offer similar proficiency testing, but none of the programs include all of the proficiency testing material (Surveys) in Table A.

In order for the Department of Laboratory Medicine to be College of American Pathologists accredited DLM must comply with all of its terms of accreditation, and one

Option Year 2: 11/05/2025-11/04/2026 $ Option Year 3: 11/05/2026-11/04/2027 Option Year 4: 11/05/2027-11/04/2028 Total: $ ficiency test materials and test evaluation services provides a benefit to the government in identify weaknesses and deficiencies in the testing standard operating procedures which in turn impact patient care. This process helps increase the efficiency and increase productivity by decreasing human errors for continuous improvement. The test results assess the laboratory facilities are complying and providing accurate and quality test results which are imperative in providing patient care. Based on a review of the co to provide proficiency survey materials and testing provides the best value and in the best interest of the Government.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research was conducted, details of which are in the market research section of this document. None of these efforts have yielded additional potential sources. There is no competition anticipated for this procurement.

9. Any other facts supporting the use of other than full and open competition.

testing program, DLM would be required to suspend testing and NIH CC patients could stand the risk of not receiving the best possible laboratory testing outcome.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

There are no sources that have expressed an interest in writing to this acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

This is an ongoing requirement. The government will continue to conduct market research to determine the availability and if the requirement can be competed.

12. Program office certification. The program officials cited shall complete the information required below and sign the certification in the blocks provided.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data for other than full and open competition, are accurate and complete.