JA19-00005_LSJ_Redacted.pdf

ATTACHMENT 1

JUSTIFICATION AND APPROVAL (J&A) TEMPLATE

for

FAR Subpart 6.3 Other Than Full and Open Competition

(June 21, 2018)

Justification and Approval for Other than Full and Open Competition

CAE 19-00796 J&A Tracking No. 19-0005

1. Identification of Agency and Contracting Activity:

The Agency is the Defense Health Agency J10/Healthcare Operation/Clinical Support Division Center for Laboratory Medicine Services.

The Contracting Activity is the Defense Health Agency (DHA) J-4 Contracting Office -Falls Church

(CO-FC).

7700 Arlington Boulevard Falls Church, VA 22042

2. Nature and/or Description of Action Being Approved: Approval is requested for a new contract to support the Defense Health Agency J10/Healthcare Operation/Clinical Support Division Center for Laboratory Medicine Services. The Government intends to negotiate a Firm Fixed Price contract with a 12-month base period and four 12-month option periods to the College of American Pathologists. This organization is the incumbent contractor under contract HT0011-14-C-0009 that expires on December 31, 2018. The new award will use FY 2019 Operations & Maintenance Funds.

3. Description of Supplies/Services: Laboratories performing testing on specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease, or the impairment of, or the assessment of the health of, human beings must meet the requirements set forth in Department of Defense (DoD) Clinical Laboratory Improvement Program (CLIP). The CLIP is the DoD's program in place to meet the regulatory requirements of the Federal regulations pertaining to civilian laboratories which are governed by the Clinical Laboratory Improvement Amendments of 1988 (42 Code of Federal Regulation (CFR) 493). Regulations pertaining to civilian laboratories are overseen by the Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS). Military laboratories must also meet these regulatory standards.

This procurement shall provide for a laboratory accrediting program (LAP), to include on-site inspections to be performed at intervals of every two years by a CMS-approved accreditation organization authorized to evaluate, validate, and enforce compliancechecklists.

This procurement shall provide an annual proficiency testing (PT) program that must include samples of organisms or specimens that are representative of analytes or specimens tested.

This procurement shall provide DoD laboratories with a competency assessment program (CoAP). The CoAP will allow for DoD laboratories to monitor, assign, update and report training and competency assessments of individual laboratorians. The CoAP also must meet the training and assessment requirements of the accrediting agency.

The Performance Work Statement requires that the LAP, PT, and CoAP be part of a comprehensive and fully integrated program to minimize administrative requirements and to ensure coordinated actions between the accreditation agency and the PT program provider.1 Comprehensive for accreditation means that a single entity must be able to and be approved to inspect and accredit all clinical and anatomic pathology disciplines. Comprehensive for PT means that a single entity must provide surveys containing PT challenges for all analytes and tests for all specialties and subspecialties in the clinical laboratory and anatomic pathology services. Comprehensive for CoAP means that it is able to meet the individual laboratory's needs as well as the accrediting agency's standards. Fully integrated, meaning that a single entity provides the three required services.

The estimated contract value is which includes the possibility of a six month extension under the authority of "FAR 52.217-8 Option to Extend Services."

The period of performance and estimated costs will be as follows:

Date Range Estimated Cost Base Period 1 Jan 2019 to 31 Dec 2019 Option Period One 1 Jan 2020 to 31 Dec 2020 Option Period Two 1 Jan 2021 to 31 Dec 2021 Option Period Three 1 Jan 2022 to 31 Dec 2022 Option Period Four 1 Jan 2023 to 31 Dec 2023

(FAR Clause 52.217-8 Extension) 6-Month

TOTAL

4. Statutory and Regulatory Authority Permitting Other Than Full and Open Competition (see FAR 6.302), or the Specification of the Statutory and Regulatory Provision Providing Exception to 8(a) Program Competitive Requirements (see FAR 19.805-1): 10 U.S.C. 2304(c)(1) 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

5. Rationale Justifying Use of the Statutory Authority Cited:

The market research conducted, see Section 8 of this document, revealed that the College of American Pathologists is the only source capable of providing a comprehensive and fully integrated program including the required LAP, PT, and CoAP services. Specifically, College of American Pathologists is the only source that has the capability to provide a LAP for of all clinical and anatomic pathology disciplines in this requirement and also provide all of the required PT and CoAP services.

Any regulatory PT program is normally field tested prior to implementation, making the grading system, which is also a major factor of CoAP, scientifically defensible. The ultimate aim of both CoAP and PT is to positively affect laboratory procedures and improve screening processes. Due to these facts, most accreditation organizations providing PT also provide CoAP, and thus the market research assessment of PT capabilities of the organizations, inherently includes its CoAPcapabilities.

1 GAO has upheld the consolidation of the LAP, PT and CoAP services as not unduly restricting competition.

See GAO Comptroller General Decisions, B-294881 and B-294881.2.

As discussed in Section 3 of this document, the requirement for a comprehensive and fully integrated program is in the best interests of the DoD and does not unduly restrict competition.

Furthermore, as illustrated by the regulations and policies below, not only is accreditation by College of American Pathologists stipulated in the CLIP across the DoD Service Departments, College of American Pathologists is the only accreditation body that is either recommended or mandated, with other accrediting bodies only mentioned in some instances.

U.S. Army Regulation 40–3 Medical Services - Medical, Dental, and Veterinary Care 14–4. Accreditation policies

a. All eligible U.S. Army hospital clinical laboratories (Department of Pathology or Laboratory Service) located in fixed MTFs in the United States, Europe, or Korea will be accredited by the Commission on Inspection and Accreditation of the College of American Pathologists. On-site accreditation inspections are required at least biennially.

b. All fixed MTFs, ambulatory care clinics, and troop medical clinics, including their assigned laboratories, will be accredited by and follow the laboratory guidelines of the JCAHO. The required biennial JCAHO survey of laboratories by a qualified medical technologist inspector will be waived if all laboratories (non-waived testing) assigned to the MTF have been inspected and accredited by College of American Pathologists.

c. Decentralized laboratories (point-of-care testing, separate health clinics or troop medical clinics, or Military Entrance Processing Stations, and so forth) will be inspected biennially and accredited by either College of American Pathologists, JCAHO, or the Commission on Office Laboratory Accreditation (COLA).

U.S. Navy Manual of the Medical Department (MANMED), NAVMED P-117 Chapter 14, Article 14-17(1), Accreditation Policies

(1) All U.S. Navy hospital-based medical laboratories located in fixed MTFs, including their assigned clinic laboratories, must be accredited by the Commission on Inspection and Accreditation of the College of American Pathologists. Onsite accreditation inspections are required at least biennially.

(2) All fixed MTF/clinic decentralized laboratories not accredited by the College of American Pathologists will be accredited by and follow the laboratory guidelines of JC.

The required biennial JC survey of laboratories by a qualified medical technologist inspector will be waived if all laboratories assigned to the MTF/clinic have been inspected and accredited by the College of American Pathologists.

(3) Laboratories not located at hospitals or branch medical/health clinics (e.g., Environmental Preventive Medicine Units, Naval Medical Research Units, Navy Research Labs, etc.)

will be inspected biennially and accredited by the College of American Pathologists, JC, or the Commission on Office Laboratory Accreditation.

U.S. Air Force

AFI 44-102, Medical Care Management Chapter 6, Clinical and Anatomic Pathology Services

6.1. General Guidance.

6.1.1. Each MTF follows DoD standards of laboratory practice defined in the DoD Clinical Laboratory Improvement Program (DoD CLIP) for registration, certification, proficiency testing, patient test management, quality control, personnel, quality improvement and inspection. Each MTF ensures that laboratories are inspected and accredited by the College of American Pathologists, the Joint Commission or other accreditation programs approved by the Office of the Secretary of Defense, Health Affairs. Transfusion Services and Blood Donor Centers will be accredited by the AABB and registered with the Food and Drug Administration (FDA). (T-0, DoDI 6440.2, Clinical Laboratory Improvement Program (CLIP)).

U.S. Department of Defense Manual Number 6440.02 Clinical Laboratory Improvement Program (CLIP) Chapter 5 – Accreditation by a Private, Nonprofit Accreditation Organization

(1) All eligible medical laboratories located in a fixed MTF within the DoD MHS will be accredited by the Commission on Inspection and Accreditation of the College of American Pathologists.

(2) All fixed MTFs, ambulatory care clinics, and troop medical clinics, decentralized laboratories or point-of-care testing sites performing moderate or high complexity testing will be accredited by College of American Pathologists.

(3) All fixed MTFs, ambulatory care clinics, and troop medical clinics, including their assigned laboratories performing waived or PPM testing may be accredited by and follow the guidelines of The Joint Commission (TJC) or be accredited by College of American Pathologists.

(4) Laboratories performing high or moderate complexity testing but not associated with an MTF will be inspected biennially and accredited by the College of American Pathologists, TJC, or the Commission on Office Laboratory Accreditation.

Therefore, College of American Pathologists is the only source capable of meeting DHA's requirement for a comprehensive and fully integrated program including the required LAP, PT, and CoAP services.

6. Efforts to Obtain Competition: A Notice of Intent as required by FAR 5.201 and 5.203 was posted on November 1, 2018 in the Federal Business Opportunities website under Reference Number

HT001119R0009.

7. Determination that Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer hereby determines that this action represents the best value to the Government, as it both meets the regulatory requirement as explained above and the provider covers all the necessary and varied requirements of this acquisition. The anticipated cost to the Government for this contract will determined to be fair and reasonable using the applicable price analysis techniques specified in FAR 15.404-1(b)(2).

8. Market Research: Market research was conducted in March 2018 by the CLMS office to determine the capabilities of LAP and PT services providers and compare to the requirements of the DoD. The CLMS office accessed each of the CMS approved organization's websites to check its respective products and services and to gather market intelligence for comparison purposes. In order to be deemed accredited, and due to the regulatory environment, the DoD must select from the CMS list of authorized accrediting and PT agencies as listed on Web pagehttp://www.cms.hhs.gov/clia/.

There are seven accreditation organizations under the CLIA;

There are ten organizations providing CLIA approved PT programs;

Information from each of the above accrediting organizations and PT program providers was obtained from an extensive search of the internet. This extensive market research revealed that College of American Pathologists is the only organization with capabilities to fulfill all of the requirements of this acquisition, in other words to provide comprehensive LAP and PT programs which include the following:

i. LAP of all clinical and anatomic pathology disciplines [specialties and subspecialties including at a minimum bacteriology, mycobacteriology, mycology, parasitology, virology, chemistry, special chemistry, endocrinology, immunology, urinalysis, toxicology, hematology, coagulation, immunohematology, histocompatibility, cytogenetics, radio bioassay, laboratory response network (testing for biological warfare agents), cytology, histology, forensic, legal, molecular and genetics disciplines];

ii. Fully integrated PT services able to cover all regulated analytes and tests for all specialties and subspecialties in the clinical laboratory and anatomic pathology services, as required within 42 CFR Part 493, Subpart I; and

iii. A versatile CoAP to meet competency and training standards.

The only organization that can provide comprehensive PT services is College of American Pathologists. Comprehensive for PT means that a single entity must provide surveys containing PT challenges for all analytes and tests for all specialties and subspecialties in the clinical laboratory and anatomic pathology services regulated by CMS as stated in 42 CFR Part 493, Subpart I.

9. Other Facts: No other facts.

10. Interested Sources: A Notice of Intent was posted in the Federal Business Opportunities website on November 1, 2018, and no other parties have expressed interest.

11. Actions to overcome barriers: Although the available sources are dictated by Federal Regulation through the DHHS CMS office, which determines which organizations are authorized to accredit and provide PT services to laboratories in the United States, the requiring activity will continue to conduct market research for these type of services. If additional sources are found in the future that are capable of providing all the services required by the DoD, these will be included in any subsequent competitive acquisitions.

COORDINATION:

12. Technical/Functional Representative:

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

13. Requirements Certification:

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

14. Fair and Reasonable Cost Determination:

All prices quoted in response to the solicitation will be put through a price analysis to arrive at a determination of fair and reasonable cost to the Government. This analysis will include techniques as prescribed by FAR 15.403, such as comparison to the IGCE, historical data, as well as available data from other providers. No certified cost or pricing data will be required. Lab accreditation and assessment services are commercial services used by both Government Civilian agencies as well as private industry entities to obtain the necessary accreditation of their medical laboratory facilities.

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

15. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

16. Contracting Officer:

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

17. Competition Advocate:

Based on the foregoing justification, I hereby approve the procurement of laboratory accreditation services, proficiency testing services, and competency assessment program support services on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c)(1), subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.

18. Head of Contracting Activity (HCA) (or designee):

Based on the foregoing justification, I hereby approve the procurement of laboratory accreditation services, proficiency testing services, and competency assessment program support services on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c)(1), subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.