POST_JA17-0046_DoP-17-03096.pdf

Tracking#JA17-0046

Justification and Approval for Other than Full and Open Competition Sole Source Acquisition

FAR Subpart 6.3 Other Than Full and Open Competition- Sole Source

1. Identification of the agency and contracting activity: Defense Health Agency (DHA) J-4 contracting activity responsible for this action will be the Contracting Office-Falls Church (CO-FC), 7700 Arlington Boulevard, Falls Church, Virginia 22042.

2. Nature and/or Description of Action being approved: Approval is being requested for a new firm-fixed price contract.

The action to be approved is to award a Firm-Fixed-Price contract to the Institute for Safe Medication Practices (ISMP), a non-profit organization that has distributed medication safety newsletters and advisories for the DoD Patient Safety Program

The incumbent contractor is ISMP under Contract No. HT0011-13-P-0026 with a POP from 9/30/13 through 09/29/16, which included a Base plus two option years and a six month extension that ends 29 March 2017.

3. Description of Supplies/Services: The Contractor shall perform the services outlined in the Performance Work Statement (PWS). Services include distribution of Safe Medication newsletters tailored to acute care hospitals, ambulatory care centers and a patient version. These shall be distributed to a total of 186 sites each. The service is required on an ongoing basis with the need to provide the Department of Defense (DoD) with subscriptions to existing pharmaceutical publications and advisories that address the importance of patient safety and medication errors. The publications must be based upon current and valid concerns within the healthcare industry to prevent actual or potential medication errors. Moreover, the publication will be associated, accredited, or have been developed in collaboration with national institutions and national reporting on medication errors and address both the medical personnel and patients.

Medication errors account for a high percentage of all actual and near miss reported events within the MHS. These materials are provided to MTFs across the MHS as part of the comprehensive patient safety program strategy to help improve the culture of safety and quality within the MHS.

This has been a long standing requirement of the DoD Patient Safety Program going back to FY04. We are not aware of other agencies engaged in any similar market research. Past strategies included searching for potential sources (large & small businesses, 8A, Women Owned, non-profit) through Internet searches, attending various industry webinars and reviewing various patient safety literature magazines and journals to stay abreast of any new competitors that would provide similar services that might meet the Government’s requirements.

ISMP is recognized as a pharmaceutical organization that creates the national standard for pharmaceutical practices. They are the nation’s only none nonprofit organization devoted entirely to medication error prevention and safe medication use. The ISMP has 35 plus years of experience in providing healthcare practitioners with medication safety information. The contractor’s publications are recognized as a national standard among the medical community at large, including the Food and Drug Administration (FDA). ISMP provides a national benchmark; the organization is a FDA MedWatch partner and works closely with Joint Commission on Accreditation of Healthcare Organizations. It was one of the first organizations to collect, track, and analyze information on actual medication processes and errors. In addition, ISMP provides a variety of newsletter issues that cater to a specific audience and medical specialty.

The Period of Performance (POP) will be a base period and four (4) options as follows:

Base Period beginning 30 March 2017 and ending 29 March 2018 Option Period 1 beginning 30 March 2018 and ending 29 March 2019 Option Period 2 beginning 30 March 2019 and ending 29 March 2020 Option Period 3 beginning 30 March 2020 and ending 29 March 2021 Option Period 4 beginning 30 March 2021 and ending 29 March 2022

The total estimated price of the contract for the base period and all four options (including a three percent (3%) escalation every two (2) years), is $212,849.10 as shown below:

Total Cost Estimate Summary

Acute Care Subscription

Community and Ambulatory Care

Subscription

Consumer Subscription

TOTALS

Base Year (12 Month POP) Option Year One Option Year Two Option Year Three Option Year Four Grand Total (Base plus Four)

The type of funds to be used is Fiscal Year (FY) 17 Operations & Maintenance (O&M). The option periods will be funded with current fiscal year funds at the time in which the options are exercised

4. Statutory Authority Cited permitting other than full: The statutory authority permitting other than full and open competition for this acquisition is: 10 U.S.C. § 2304(d)(1)(B) and in accordance with FAR 6.302-1 (a)(2)(iii)(B) -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. For DoD, NASA, and the Coast Guard, services may be deemed to be available only from the original source in the case of follow-on contracts for the continued provision of highly specialized services when it is likely that award to any other source would result in unacceptable delays in fulfilling the agency’s requirements.

5. Reason for Authority Cited: The ISMP has provided this service on behalf of the DoD Patient Safety Program since FY04. The ISMP remains the only comprehensive source to alert hospital and clinic staff and our patient/beneficiary population of current trends and advisories for medication safety.

The subscription service must specifically include access to the following three (3) electronic medication safety alert newsletters as follows:

Pharmaceutical Acute Care Hospital Systems - Biweekly pharmaceutical newsletters addressed to medical personnel within acute care hospital systems that must provide a systems approach to implement improvements and changes within healthcare organizations and relate vital and potentially life-saving information about medications and device errors and adverse drug reactions, as well as timely notifications on emergent advisories.

Communities and Ambulatory Care - Monthly newsletters to physicians, nurses, pharmacists, pharmacy staff, and other healthcare team members that will help reduce the risk of medication errors and other adverse drug events within community and ambulatory healthcare settings, and must keep healthcare professionals up to date on actual medication errors, contributing factors, and prevention suggestions that can assist healthcare practices to avoid the occurrence of similar errors.

Consumers (Patient and Family Oriented) - Bimonthly consumer (patient and family) oriented newsletters that engage consumers to become active partners with their healthcare practitioners and take a leading role in preventing medication errors.

The requirement has the following unique requirements:

The subscription services must be a pharmaceutical newsletter published at least once a monthly basis.

The publication must be based on national standards and guidelines.

The newsletter must be in a format that may be reproduced and distributed and circulated electronically via email in whole or in part within MHS healthcare facilities

6. Efforts to Obtain Competition: CO-FC posted a Sources Sought Notice to Federal Business Opportunity (FBO) website on 7 March 2017 with a closing/response date of 10 March 2017;

results yielded no responses from interested commercial sources. An award notice will be publicized as required at FAR Subpart 5.2

Additional efforts were made to ensure full and open competition from as many potential sources as is practicable include query of past acquisition documents and survey on the Federal Data Procurement System (FDPS), the U.S. General Services Administration (GSA) Electronic Library, and the System for Award Management (SAM) government-wide databases of contracts.

Currently, the ISMP as a non-profit organization creates the national standard for pharmaceutical practices. They are the nation’s only non-nonprofit organization devoted entirely to medication error prevention and safe medication use.

If and when another national organization is established that exceeds these services, competition will be more likely.

7. Actions to Increase Competition: This is a follow-on effort of the Clinical Support Division to provide subscriptions to existing pharmaceutical publications and advisories that address the importance of patient safety and medication errors, which is a highly specialized requirement;

however in its effort to overcome barriers, the program office will continue to read the latest journals in this field, attend trade shows to stay abreast of any and all new technologies, and perform market surveillance for new companies providing the same and similar services.

In addition, Requests for Information (RFI) and Sources Sought Notices (SSN) will continue to be posted on the Federal Business Opportunity (FBO) website at the government-wide point of entry

(GPE).

8. Market Research: An independent analysis of the market research identified no other commercial sources that have the capability to provide these services. No potential small business vendors were identified in the online search or industry review. Therefore, the decision was made to acquire this commercial service on a noncompetitive basis.

Market research indicated the incumbent, ISMP, has the capability to meet this requirement.

Two (2) other sources were identified but did not meet the requirement.

(1.)Journal of the American Pharmacists Association (JAPhA)is only published bimonthly and does not offer the three different editions of safety alert newsletters, that the Government requires.

(2.)Safemedication is only an online web-based resource (administered by the American Society of Health-System Pharmacists (ASHP)) that does not issue publications that can be reproduced and distributed and circulated electronically via email. And it does not provide the newsletters, safety alerts, or in depth research on device errors or adverse medication reactions.

Market research results are summarized as follows:

Vendor Name Vendor Name Vendor Name

Institute for Safe Medication

Practices (ISMP)

American Pharmacists Association (APhA)

American Society Of Health-system

Pharmacists doing business as: ASHP

Horsham, PA

DUNS: 878225952

CAGE: 1VFP8

NAICS: 813212 Voluntary Health Organizations ISMP provides all required services with consistent superior past performance ratings.

CSD determined in an independent analysis of the incumbent conducted during market research, that ISMP has the required capabilities to perform the services required.

Birmingham, AL

DUNS: 077805992

CAGE: 95225

NAICS: 541611 Administrative Management and General Management Consulting Services; 541711 Research and Development in Biotechnology;

611430 Professional and Management Development Training; 621399 Offices of all other Miscellaneous Health Practitioners; 813920 Professional organizations

Bethesda, MD

DUNS: 072633464

CAGE: 3EPZ7

NAICS 813910 Business Associations Website administered by the American Society of Health-System Pharmacists for safe and effective drug therapy.

Vendor Name Vendor Name Vendor Name ISMP APhA ASHP

A thorough review of ISMP’s capabilities revealed past performance and capabilities in this requirement.

Their publications provide the MHS with vital and potentially life-saving information about medication and device errors and adverse drug reactions.

ISMP is exclusively dedicated to address patient safety issues, and more specifically, those that reduce the risks associated with medication errors.

The national recognized work and their safety alert newsletters focus on safe and effective medication administration.

ISMP is recognized as a pharmaceutical organization that creates the national standard for pharmaceutical practices.

ISMP is certified as a Patient Safety Organization (PSO) by the Agency for Healthcare Research and Quality.

The ISMP has 35 plus years of experience in providing healthcare practitioners with medication safety information. ISMP’s publications are recognized as a national standard among the medical community at large, including the Food and Drug Administration (FDA). ISMP provides a national benchmark; the organization is a FDA MedWatch partner and works closely with Joint Commission on Accreditation of Healthcare Organizations.

The Journal of the American Pharmacists Association is the official peer-reviewed journal of the American Pharmacists Association (APhA), providing information on pharmaceutical care, drug therapy, diseases and other health issues, trends in pharmacy practice and therapeutics, informed opinion, and original research.

This source provides some similar services but does not meet the Government’s requirements.

Although it is the official journal of the APhA, it is only published bimonthly.

Although it is also a peer-reviewed forum for original research, review, experience, and opinion articles that link science with contemporary pharmacy practice to improve patient care, the JAPhA does not offer the three different editions of safety alert newsletters, that the Government requires.

Website based in accordance with guidelines established by the U.S. Food and Drug Administration (FDA) and an expert committee established by the U.S. Department of Health and Human Services.

This is an online web-based resource only;

and therefore, they do not issue publications that can be reproduced and distributed and circulated electronically via email.

The site offers various resources for patients, but it does not provide the newsletters, safety alerts, or in depth research on device errors or adverse medication reactions.

Neither of these had the reach and comprehensive approach available through ISMP.

Currently, ISMP is the only source that satisfies the mandatory criteria for this requirement for publications with educational articles on medication errors that are specifically addressed to the following three (3) intended target audiences:

(1.) Medical personnel within acute care hospital systems, (2.) Community and ambulatory healthcare professionals, physicians, nurses, pharmacists, pharmacy staff, and other healthcare team members, and (3.) Consumer (patient and family) oriented.

Also, ISMP is the only source that satisfies the following additional unique requirements:

(1.)The subscription services must be a pharmaceutical newsletter published at least on a monthly basis.

(2.)The publication must be based on national standards and guidelines.

(3.)The newsletter must be in a format that may be reproduced and distributed and circulated electronically via email in whole or in part within MHS healthcare facilities.

9. Other Facts:

a. Technical data packages and purchase descriptions suitable for full and open competition are not available because there is no reasonable expectation, based on market research, that two or more responsible offerors, competing independently, would submit priced offers in response to the solicitation’s expressed requirement for this type of subscription services within the field of patient safety services in order to meet the agency’s needs.

b. Historical data. Efforts to retrieve the following items from computer records, contract files, competition advocate office files or other sources are expected. The service is required on an ongoing basis in order to provide the Department of Defense (DoD) with subscriptions to the required pharmaceutical publications and advisories that address the importance of patient safety and medication errors. This has been a long standing requirement of the DoD Patient Safety Program going back to FY04. No other source identified has the capability to provide this type of subscription services within the field of patient safety services in order to meet the agency’s needs.

There were justifications prepared to support the procurement made before this one. The circumstances justifying the buy are briefly explained as only one source available to meet the government’s requirement. There have not been any significant changes.

c. Unusual and compelling urgency. Not Applicable.

10. Interested Sources: There are no interested sources in response to the Sources Sought Notice posted at the Federal Business Opportunities (FBO) Government-wide Point of Entry (GPE) website.

11. Methods to overcome barriers: To maximize competition, the DoD Patient Safety Program will continue to perform market surveillance of the capabilities of the small businesses to determine if they have expanded their services and will meet the agency's needs.

Additionally, the DoD Patient Safety Program will continue to search the web, advertisements and publications for other sources that could provide the services it needs.

Coordination:

12. Technical and Functional Representative:

I certify that the supporting data under my cognizance which are included in the justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Patricia M. Collins Date: Tuesday, March 14, 2017

COLLINS.PAT Digitally signed by

COLLINS.PATRICIA.

Title: Senior Policy Analyst, J3-CSD Signature: RICIA.MARIA.

1008709641 Date: 2017.03.14

13:00:51 -04'00'

MARIA.1008709641

COLLINS.PATRICI Digitally signed by

COLLINS.PATRICIA.MARIA.100

A.MARIA.1008709 8709641

Date: 2017.03.14 13:01:03

641 -04'00' ou=PKI, ou=DHA,

13. Requirements Certification:

I certify that the supporting data under my cognizance which are included in the justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Patricia M. Collins Date: Tuesday, March 14, 2017

Title: Senior Policy Analyst, J3-CSD Signature:

14. Fair and Reasonable Cost Determination: The Contracting Officer hereby determines that the anticipated cost to the Government to be fair and reasonable based on price analysis of previous and current cost and the independent Government estimate. The basis for this determination is that the services have not changed, all required services have been provided with consistent superior past performance ratings, the firm has 35 plus years of vast experience in this area providing healthcare practitioners with medication safety information, the current and previous newsletters published satisfy the government’s requirement, and the current discount offered by the firm is a price that, had this requirement been competed would not be more advantageous. In fact, the current discount will be taken into account because the estimated price of $212,845.10 for the base period and four option periods represents a discount of approximately fifty percent (50%).

Certified cost or price data will not be required because these are commercial services as per the exception in FAR Part 15.403-1(b)(3).

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

Typed Name: Marian Jones-Millwood Date: Tuesday, March 14, 2017

JONES

Digitally signed by JONES MILLWOOD.MARIAN.D.1229166880

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=DHA, cn=JONES MILLWOOD.MARIAN.D.1229166880 Date: 2017.03.14 12:50:26 -04'00'

Title: Contracting Officer Signature: 29166880

15. Legal Review:

I have reviewed this J&A and it is deemed to be legally sufficient.

Typed Name: Randy L. Stone Date: Tuesday, March 14, 2017

Digitally signed by

STONE.RANDY.WIL STONE.RANDY.WILLIAM.126695

Title: Associate General Counsel Signature: LIAM.1266950990

16. Acting Chief, Acquisition Procurement Policy Division (A&PPD):

Date: 2017.03.14 14:25:40 -04'00'

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Winona L. Sewell Hall Date:

SEWELLHALL.WI

Digitally signed by

SEWELLHALL.WINONA.L.1038893811

Title: Acting Chief, A&PPD Signature: NONA.L.1038893 DN: c=US, o=U.S. Government, ou=DoD, cn=SEWELLHALL.WINONA.L.1038893811

811 Date: 2017.03.14 15:16:40 -04'00'

MILLWOOD.MARIAN.D.12

JONES

MILLWOOD.MARIAN.D.12291

66880

Digitally signed by JONES MILLWOOD.MARIAN.D.1229166880 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=DHA, cn=JONES MILLWOOD.MARIAN.D.1229166880 Date: 2017.03.14 17:15:42 -04'00'

Approval:

17. Contracting Officer: Based on the foregoing justification, I hereby approve the procurement services for distribution of medication safety newsletters and advisories for the DoD Patient Safety Program, based on other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(d)(1)(B); and in accordance with FAR 6.302-1(a)(2)(iii)(B), subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Marian Jones-Millwood Date:

Title: Contracting Officer Signature: