JOFOC HHSA290201100007C.pdf

HHS Template and Instructions for a Justification for Other than Full and Open Competition

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS/AHRQ

b. Sponsoring organization. CDOM

c. Project Officer information.

• Project Officer name. Fred Hellinger, Ph.D.

• Mailing address. 540 Gaither Road, Rockville, MD 20850

• E-mail address. Fred.Hellinger@ahrq.hhs.gov

• Telephone number. 301-427-1408

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

a. Acquisition purpose and objectives. The purpose of this project is to gather and analyze timely and relevant data on the utilization, quality, outcomes, and cost of health care services delivered to persons with HIV disease. Given the rapidity of changes in clinical treatment of HIV infection, it is important to have a mechanism for continual monitoring of HIV service provision. The proposed acquisition will support the HIV Research Network for an additional period of time, with the goal of collecting data in CY 2011 and in later years, and thereby extending the current longitudinal HIVRN database further in time, beyond 2010.

b. Project background. The HIV Research Network (HIVRN) has been supported since 2000 by two contracts between AHRQ and Johns Hopkins University (HHSA29020010012 and HHSA2900200600025C). The period of performance for the current contract is from September 27, 2006 through September 26, 2011.

The main focus of this project is to collect recent data on provision of health services to people with HIV infection, based on a sample that is large, diverse in terms of sociodemographic characteristics (i.e., gender, race/ethnicity, HIV transmission group, insurance), and diverse geographically. The project collects information not only on HIV patients’ background characteristics, but also on utilization of health services and relevant clinical data, such as values of CD4 and HIV-1 RNA laboratory tests. In order to assess tends over time in HIV service provision, access to and disparities in care, and outcomes of care, data are collected yearly and amalgamated into a longitudinal database. The current database includes data from 2000 through 2009, and data from 2010 will be incorporated by the end of the current contract in September, 2010.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. HIV Research Network Continuation.

b. Project description. See SOW in acquisition plan.

• Requirement type.

X Research & development (R&D) R & D support services 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. AHRQ-11-10009

c. Total estimated dollar value and performance/delivery period. $10,662,139, for the base year and 4 option years (i.e., from September 30, 2011 through September 29, 2016).

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

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). Johns Hopkins University Medical School.

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). To our knowledge, the current contractor, Johns Hopkins University School of Medicine, is the only entity that is capable of continuing the HIVRN project. One of the key strengths of this project is the prospect of timely data collection; replacing the current contractor would severely jeopardize this aspect of the project. A new contractor, beginning from scratch, would have virtually no chance of establishing relationships and procedures with multiple sites and effecting data transfers in accordance with the demanding schedule of deliverables set forth in the scope of work.

This project requires the contractor to have close contacts with clinical sites providing HIV care, and to have established procedures and protocols whereby the site transfers specific data elements from existing clinical records to the contractor.

A significant component of activity in this project consists of obtaining medical record data from HIV provider sites and working with each site to ensure that data are transmitted in (or can be put into) a uniform format. Over the past decade, Hopkins has established detailed and well functioning protocols for collecting data from medical records at HIV care provider sites participating in the HIVRN. Good working relationships have been established with the data provision sites, and protocols for abstracting, cleaning, and transmitting data have been developed. The Contractor’s staff must be in frequent contact with staff at the data provision sites, to discuss anomalies in the data and to ask for extended scrutiny of problematic data elements.

A new contractor would not be familiar with these procedures, nor would it have established smooth working relationships with staff at data provision sites. In addition, the incumbent contractor’s staff have developed an intimate familiarity with the nuances of the data, which is a prerequisite for conducting informed and appropriate data analyses.

In addition, because HIV infection is still an area of high sensitivity, data provision sites must have confidence that the entity coordinating data collection (i.e., Hopkins) will treat the data with the appropriate level of security and will have staff with the appropriate level of clinical expertise to interpret and apply results of data analyses. As Hopkins has a stellar reputation, establishing this level of trust with data provision sites was not difficult. Moreover, clinical investigators at the data provision sites work closely with clinical investigators at Hopkins to develop data analysis plans and prepare reports; this collaboration rests on shared expertise in clinical treatment of HIV infection. In addition, Institutional Review Boards at the provider sites have agreed to send data to the current Contractor. Changing the recipient of sensitive HIV-related medical data would require IRB approval from each participating site; a new contractor would also have to initiate the IRB approval process for its own activities from the beginning. The process of obtaining such approvals for a new contractor would be time-consuming and would jeopardize the project.

If a new entity were to be selected as data coordination center, working relationships and data collection protocols would have to be re-established with the other participating sites, resulting in additional inefficiencies and increased costs.

Under this scenario, it is likely that Hopkins would cease participating in the HIVRN.

As Hopkins also provides data from its own patient population, at least one site would be lost, resulting in a major loss of sample size, disrupting the longitudinal aspect of the data, and requiring costly efforts to recruit a substitute site (or sites). It is not known how many of the other HIVRN sites would cease participating if a new entity were to assume the role of Data Coordination Center.

If a new contractor were selected that would use a different set of HIV care providers to supply data in 2011 and later (i.e., not continuing the current set of participating HIVRN sites), then the longitudinal nature of the data would be lost, as the data from new sites would not necessarily be comparable to the 2000-2010 data from existing HIVRN sites. To maintain the ten-year sweep of the data, a potential new contractor would have to demonstrate that it already has data available for a ten-year period that are comparable to data that the HIVRN has collected. We know of no entity that has such data available for a similar time period, from a large sample of patients each year, from multiple clinical sites across the U.S.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A presolicitation notice was published on Federal Business Opportunities on May 26, 2011 which resulted in no responses.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The Contracting Officer will perform a cost/price analysis along with the Cost Analyst to make sure the costs are fair and reasonable.

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.

The proposed project will continue activities funded under previous contracts with Johns

Hopkins Medical School. The goal is to assemble a data set on HIV-related service utilization that satisfies several criteria:

spans the years 2000-2015;

has a large sample size each year (i.e., > 10,000 patients in care);

has a sample of patients that is diverse in terms of clinical and sociodemographic characteristics;

obtains data from multiple (i.e., > 12 at a minimum) clinical sites;

includes individual-level data on CD4 and HIV-1 RNA lab test results, outpatient visits, inpatient nights, and insurance coverage.

We have reviewed the relevant literature appearing in professional journals (such as the Journal of Acquired Immune Deficiency Syndromes, AIDS, Clinical Infectious Disease, AIDS Patient Care and STDs, HIV Medicine, Medical Care, and Health Services Research), covering the topics of HIV-related health care utilization, quality of HIV care, and disparities in HIV care. To our knowledge, there is no equivalent activity that meets the criteria listed above. Some published studies come from only one site and/or have small sample sizes. Studies based on clinical trials data typically have small sample sizes, and the samples do not represent “typical” HIV patients. The Veterans Administration has data on a large number of patients from several sites, but their samples lack sociodemographic diversity, being limited to virtually all men. HIV surveillance data collected by the CDC do not include information on health service use and quality. We are not aware of any similar activity that has collected data on HIV-related health care use for a ten-year period. If any similar activity existed, findings would have appeared in one or more of these journals in recent years.

Thus, based on this literature review, the current project is unique and there is no open market of potential alternative suppliers of the required services.

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

This project requires that some staff have detailed knowledge of current clinical practice in treating HIV infection. The project is intended to be responsive to current developments in the rapidly changing arena of clinical care of HIV infection, so that protocols for data collection can be modified to capture new variables that reflect changes and advances in clinical practice. For this reason, potential offerors must demonstrate that one or more principal participants have expertise in treating HIV-infected patients in clinical settings. While there are a number of physicians trained in Infectious Disease as a medical specialty, we are not aware of any ID specialists that have access to detailed patient-level data that satisfy the criteria listed in item 8 above, beyond the current HIVRN staff at Johns Hopkins.

Regarding item 9(b)i, in our experience with the HIVRN, one year prior to the first contract year (1999) was used as a pretest, to ascertain the feasibility of the data collection. Establishing protocols and procedures at the various data collection sites, including obtaining approval from relevant Institutional Review Boards, took well over one year. Detailed review of data from the first year of the project revealed numerous deficiencies, which required repeated interaction with the data collection sites, and revisions to site-specific protocols, before the data were of acceptable quality. Over time, the sites have become more proficient at data extraction, and they are now providing data that meet quality control standards in an efficient manner. But there was a definite learning curve at each site.

Selecting a contractor different from the incumbent would in essence put the data collection process back to square one. Based on our past experience, potentially an entire year could be lost as sites developed familiarity with different data collection protocols, sought IRB approval, and developed understanding of data quality requirements and standards. Such a delay could jeopardize an entire year’s worth of data collection and thereby introduce an interruption in the longitudinal nature of the data. Such an interruption would have a devastatingly adverse impact on the analyses of HIVRN data, creating a “hole” in any trend analyses that would be difficult, if not impossible, to rectify.

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

There were no interested sources in the 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.

At this time, we do not know of any future acquisitions for this work.

12. Program office certification.

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 verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer Fred Hellinger, Ph.D

Project Officer’s

Immediate Supervisor

Irene Fraser, Director

CDOM

Head of the Sponsoring

Program Office lkajsldjfalsdjlkajldfk

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

Gayle R. Sunde

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date

Chief of the Contracting

Office

Monica Gibson/

Annmarie Keane

Head of the Contracting

Activity

Monica Gibson/

Annmarie Keane

15. Competition Advocate signature.

Competition Advocate lakjsdlfkjaslkdfj

16. HHS Senior Procurement Executive signature.

HHS Senior Procurement

Executive lkajsdlfkjlkajsl