A13. PR98161 - Justification for Sole Source - TW CO Signed.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

National Institute for Occupational Safety and Health Respiratory Health Division Surveillance Branch Coal Workers' Health Surveillance Program 1095 Willowdale Road Morgantown, WV 26505

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch Room 3000 2920 Brandywine Road Atlanta, GA 30341

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: The purpose of this sole source justification is to procure B Reader classifications services for the chest radiographs taken for all components of the Coal Workers’ Health Surveillance Program (CWHSP) includes Enhanced, Expanded and Special Studies Base Year: 06/1/2026-05/31/2027 4 Option Years – Full POP: 6/1/2027-5/31/2031

b. Procurement Request (PR) Number (if available): 00HCCHD-2026-98161

Rev. 5/14/19

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor:

Dr. Mannachanallur R. Ramakrishnan 1745 Valley View Dr Big Stone Gap VA, 24219 276-973-8505 ramaradiologist@gmail.com

b. Estimated Procurement Amount: Total $139,000 Base Year: $28,000 Option Year 1: $27,500 Option Year 2: $28,000 Option Year 3: $27,500 Option Year 4: $28,000

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No

If yes, provide schedule number: Click here to enter text.

D. Justification:

1. The justification for this non-competitive action is:

This is a B Reader that has been chosen to classify chest radiographs for the Coal Workers’ Health Surveillance Program (CWHSP). The CWHSP is a federally-mandated program that requires in-depth knowledge of the ILO Classification System. In order to achieve confident and integrity of the classifications provided by the B Readers chosen to participate in the CWHSP, they are required to meet a set of stringent criteria prior to their participation. This criteria includes making a higher than average score on the B Reader Examination as well as achieving a designated score on the small opacity and inconsistency indices sections on the Examination. They also must be board certified in their specialty. This physician meets all of the required criteria so we can confident of continuing a high standard of classifications and thus preserving the integrity of the Program.

☒ In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

☐ Urgency ☐ Exclusive licensing agreements/Proprietary data ☐ Brand name required ☐ Industrial mobilization ☒ Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

☐ In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required mailto:ramaradiologist@gmail.com because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

☐ Urgency ☐ Only One Source ☐ Logical Follow Up ☐ Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

The CWHSP is a federally-mandated Program that was originally authorized under the 1969 Federal Coal Mine Health and Safety Act and is currently authorized under the 1977 Federal Mine Safety and Health Act and its subsequent amendments (the Act). The CWHSP is administered by RHD in Morgantown, WV. The primary objective of the Program is to screen miners for coal workers' pneumoconiosis (CWP). Miners who show signs of CWP on their chest radiographs are offered the option to transfer to an area of the mine where the concentration of dust is continuously maintained at or below the applicable standard as specified in Title 30, Part 90.100 (Part 90 Transfer Rights). Radiographs are interpreted by physicians who are certified by NIOSH as proficient in use of the International Labour Office (ILO) system for classifying radiographs of the pneumoconiosis - B Readers. B Readers interpreting rad iographs for the CWHSP are external to the CWHSP (not Federal government employees) in order to protect them from conflict of interest issues. Each film is seen by at least two readers, and a consensus rule is used to reach a final determination for each radiograph. The CWHSP is unique as a federally- mandated occupational health screening program. It is an important program which requires in-depth knowledge of the ILO Classification System, and requires confidence in the results obtained to maintain the integrity of the Program.

b. What other products/services were considered and why did they not meet the need?

None. In order to achieve confidence and integrity of the classifications provided by the B Readers chosen to participate in the CWHSP, they are required to meet a set of stringent criteria prior to their participation. These criteria include making a higher than average score on the 8 Reader Examination, as well as achieving a designated score on the small opacity and inconsistency indices sections on the Examination.

They also must be board certified in their specialty. This physician meets all of the required criteria so we can be confident of continuing a high standard of film classifications and thus preserving the integrity of the Program.

3. Program Office efforts to seek potential offerors:

B Readers for the CWHSP are selected using the following criteria: 1) Checked "YES" on the Interpreting Physician Certification Document (CDC/NIOSH(M)2.12) under, "Would you be interested in participating as a B Reader for the CWHSP?"; 2) Overall score on the most recent B Reader Exam of 75 or above; 3) Active in reading at least 50 x-rays per month as indicated on the CDC/NIOSH(M)2.12 form .; 4) Small opacity score on the most recent 8 Reader Exam of 12 or above; 5) Inconsistency index score on the most recent B Reader Exam of 20 or above; 6) Board certification in radiology (RA), pulmonary (PU) or occupational medicine (OM); 7) Holds an academic appointment.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title: Tia McClelland/COR/Assistant Heath Services Officer

Center/Institute/Office COR/Program Official Signature:

Certification Date: June 16, 2026

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Timothy Williams

Contracting Officer Signature:

Certification Date: June 16, 2026