P03 SSJ JA OVER SAT -36C24E-23-AP-0496 Parkinsons Disease Research - signed.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C24E-23-AP-0496

1. Contracting Activity:

Department of Veterans Affairs Regional Procurement Office (RPO) – East 1010 Delafield Road. Bldg. 32, Suite 1A111 Pittsburgh, PA 15212

Requesting Activity:

Department of Veterans Affairs Corporal Michael J. Crescenz VAMC 3900 Woodland Ave.

Philadelphia, PA 19104

2237 Number 642-23-3-905-0068

2. Nature and/or Description of the Action Being Processed:

Corporal Michael J. Crescenz VAMC, Parkinson’s Disease Research, Education and Clinical Center (PADRECC) intends to negotiate on a sole source basis a new firm fixed price contract with the University of Pennsylvania, Biostatistics Analysis Center (BAC) its primary academic affiliate, to support the US Department of Veterans Affairs’ (VA) aim to incorporate a process to improve clinical decision-making and care, inform patients, evaluate their program, and inform VA policymaking pertaining to Parkinson’s disease and related disorders. The PADRECC requires BAC services to abstract and validate VA data; develop and manage an analytic database; and analyze VA data to evaluate the structure, processes, access to and outcomes of care, including issues of patient safety and equity.

PADRECC is required by law to collect continuous data to conduct effective evaluations of the centers activities and for the collection of data on health services delivered to veterans seeking care for neurodegenerative diseases, including Parkinson’s Disease and other movement disorders (AUTHORITY: 38 U.S.C. §7329)

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This proposed action is to support the PADRECC with data analysis to abstract and validate VA data;

develop and manage an analytic database; and analyze VA data to evaluate the structure, processes, access to and outcomes of care, including issues of patient safety and equity.

Services to be provided:

a. Utilization of VA data focused primarily on care provided through the PADRECCs and for persons with Parkinson Disease, parkinsonism, and related neurodegenerative disease care.

b. Data cleaning and validation

c. Analytic database development

d. Preparing descriptive statistical analyses

e. Preparing model-based statistical analyses (both cross-sectional and longitudinal)

f. Provide quarterly reports

36C24E-23-AP-0496 Parkinson’s Disease Research

g. Assistance with drafting and reviewing methods for grant submissions

h. Abstract support

i. Manuscript support (such as the following)

i. Writing the statistical methods section(s)

ii. Assistance in preparing the results section(s) and any applicable figures/tables

iii. Reviewing the draft manuscript(s) prior to submission

iv. Assistance with responses to any applicable reviewer questions

j. Any necessary programming needed to accomplish the aforementioned tasks.

k. The BAC will attend meetings with Dr. Willis as necessary.

The anticipated value of this requirement for one year with no option periods is $625,000.

The Period of Performance is from 9/1/23-8/31/2024.

PUBLIC LAW

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4. Statutory Authority Permitting Other than Full and Open Competition:

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR

6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

(X) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The Biostatistics Analysis Center (BAC) is a highly specialized service offered by the Center for Clinical Epidemiology and Biostatistics (CCEB), which provides biostatistical and epidemiological consulting services to the University of Pennsylvania Health System community. The BAC is staffed by highly specialized, professionally trained biostatisticians and biostatistical programmers. The BAC is currently providing services for programs within the VA Health System. Their employees have a without compensation (WOC) appointment and have access to VA data. The BAC will provide critical services to evaluate programs and provide relevant data to central office. It is important for the vendor to currently have the ability to access VA data and have employees who have a WOC appointment to prevent unacceptable delays in fulfilling this requirement.

The PADRECC has reached out to data programs within VA but either they did not have the bandwidth to accept further projects, or their funding was siloed and not able to accept clinical dollars.

Due to their precise expertise required by the VA, proximity, and existing affiliate relationship, the University of Pennsylvania is the only vendor practical without experiencing substantial duplication in costs or delays to VA research. Furthermore, since the University is an academic affiliate, the VA is authorized to procure these services pursuant to 38 U.S.C.

8153 described below.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

FAR 6.302(a)(2)(i) states, full and open competition need not be provided when a statue expressly authorizes or requires that the acquisition be made through another agency or from a specified source. In accordance with 38 U.S.C. 8153 (a)(3)(A):

If the healthcare resource required is a commercial service, the use of medical equipment or space, or research, and is to be acquired from an institution affiliated with the Department in accordance with section 7302 of this title, including medical practice groups and other entities associated with affiliated institutions, blood banks, organ banks, or research centers, the Secretary may make arrangements for acquisition of the resource without regard to any law or regulation (including any Executive order, circular, or other administrative pol cy) that would otherwise require the use of competitive procedure for acquiring the resource."

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The University of Pennsylvania, is a not-for- profit organization affiliated with the VA. Previous contracts have demonstrated that the anticipated cost to the government will be fair and reasonable. The Contracting Officer anticipates the price noted in #3 above to be fair and reasonable; however, price negotiations may be conducted if the CO determines this is necessary.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

A search was conducted in the VA’s VIP database using NAICS code 541720, PSC code AN41, and keywords Parkinson’s Disease Research, which resulted in 0 SDVOSB’s and no VOSB available to meet this requirement. A search was also conducted in the Small Business Administration Dynamic Small Business Search (SBA DSBS) using NAICS code 541720 with keywords Parkinson’s Disease Research, which resulted in no small businesses available to meet this requirement.

Two SDVOSBs responded to a request for information put out by the PADRECC VA Parkinson's Disease Consortium research team. The two SDVOSBs are Social Sciences Innovations and Stonewall Analytics. Although, SSIC and Stonewall presented capabilities showing data science they do not have the experience working with VA data or the VA systems that is critically needed for this requirement. There are no other potential sources for this requirement.

This is a collaborative research project with the affiliated practice group the University of Pennsylvania Health System, no other vendors can be considered. This study involves the University’s uniquely qualified and experienced personnel who work closely with the Chief of Neurology, at the Corporal Michael J. Crescenz VAMC. The University of Pennsylvania Health System is a key partner in utilizing specific VA data research and performing extensive analyses related to Parkinson’s disease.

38 U.S.C. 8153 allows for sole source awards related to research with VA academic affiliates. In this case, the University of Pennsylvania is the primary academic affiliate of the Corporal Michael J. Crescenz VAMC and has several groups that tie in with the Center’s specific areas of expertise. The recommendation is to sole source this requirement to the University of Pennsylvania, a non-profit educational facility.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The mission of the VA is to discover knowledge and create innovation that advances healthcare for our Veterans and the nation. VHA is the country’s largest integrated healthcare system and as such, it embraces close ties to its academic affiliates by partnering on common research interests and leveraging resources. The Corporal Michael J. Crescenz VAMC and the University of Pennsylvania are one of many examples of this strategic academic affiliate partnership recognized by the Secretary of the VA.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

University of Pennsylvania Biostatistics Analysis Center (BAC) 5th Floor Blockley Hall 423 Guardian Drive Philadelphia, PA 19104-6021 Main Phone: 215-573-4594

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: None, this is a collaborative research project with the affiliated practice group the University of Pennsylvania Health System, no other vendors can be considered.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Name: Dawn McHal Date Title: Program Specialist Facility: CMC VAMC, Sta 642

DAWN MCHALE

Digitally signed by

DAWN MCHALE

ate: 2023.07.25 08:45:06 -04'00'

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Ann Marie Stewart Date Contracting Officer Regional Procurement Office-East R&D

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Seth Custer Date Division Chief Regional Procurement Office - East

ANN MARIE

STEWART

Digitally signed by ANN

MARIE STEWART

Date: 2023.07.25 10:50:49 -04'00'

VHALEBCUSTES

Typewritten Text 7/27/2023