B.2 Applicability-of-CDC-Class-J-A-for-2019-Novel-Coronavirus--COVID-19--to-Current-Requirement-mxr2.pdf

Applicability of CDC Class J&A for 2019 Novel Coronavirus (COVID-19) to Current Requirement

ERR/PR#: 20 25 4178 00HCBCD9-202

Applicability of CDC Class J&A for 2019 Novel Coronavirus (COVID-19) to Current Requirement The Centers for Disease Control and Prevention (CDC) has established a Class J&A for COVID-19 contract actions. Actions taken under the authority of this class J&A shall include (1) documentation of market research performed and prospective sources of supply and services, (2) evidence of the urgent and compelling nature of the particular action, reviewed and approved at a level above the Contracting Officer, (3) documentation of the contractor's qualifications and ability to perform the work as part of the Contracting Officer's responsibility determination,

(4) Documentation of the extent of competition undertaken, and (5) documentation of the price/cost analysis conducted and that the proposed price is fair and reasonable. The Class J&A shall be included with this document in the file folder.

When this document is printed, the blue italic instructions are automatically deleted on the printed version.

Please enter ERR number and, if applicable, PR number. If not associated with an ERR, please enter PR number

ERR/PR #: 20 25 4178 00HCBCD9-2021-54076

Name of Proposed Contractor(s): Mako Medical Laboratories LLC

A. Contractor's Unique Qualifications:

One of eight contracts awarded to seven contractors for the same services on a sole source basis after market research proposals were received by the program office. Mako has the capability for SARS-CoV-2 next generation sequencing covering a very large and broad national testing footprint.

They currently receive about 50K COVID-19 samples/day from 42 states and DC which provides them access to positive samples for surveillance. They have an existing CAP/CLIA accredited reference laboratory where all pre-analytical, analytical and post analytical genomic sequencing step will be performed. Mako will require no ramp up time to start seqeuncing up to 6000 specimens per week and can ramp up to 200,000 specimens a week if needed. They currently report SARS-CoV-2 RT-PCR results electronically to all state health departments and have the ability to transmit additional data related to the sequence in HIPAA compliant formats. They are uploading variant data to GISAID now and is already establishing pipelines to NCBI/SRA and GenBank.

B. Identification of Services or Supplies:

Short description of the services or supplies required to meet the agency's needs. (e.g., "Q Stations PPE" / "Web Development")

Collecting, performing genetic sequencing, and reporting of sequence data to the CDC and other state, local, or tribal entities as required.

C. Documentation of Market Research Performed & Prospective Sources of Supplies & Services (Class J&A Section 8):

Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If action is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-on. See FAR 10.002(b)(2).

The Office of Advanced Molecular Detection (OAMD) used estimated market share of COVID-10 testing capacity provided by the Joint Coordination Cell/HHS/Lab testing and Diagnostic Work Group and CDC/Laboratory task force to conduct market research of commercial and academic laboratories within the US. Potential sources need to have access to a large number of SARS-CoV-2 positive samples and have the capacity to perform large scale genomic sequencing. OAMD sent out SARS-CoV-2 Next Generation Sequencing Capabilities Information Request letters to 14 laboratories making up 52% of the market share to identify interested sources. Interested sources are being evaluated on:

Number of complete sequences delivered per week Geographic area coverage Ramp up timeline Ability to perform genomic sequencing under CLIA certification at start of contract Ability to do bioinformatics (genome assembly, variant calling)

ERR/PR#: 20 25 4178 00HCBCD9-202

Ability to submit data to public repositories (NCBI/SRA, NCBI/GenBank, and GISAID)

D. Basis and Rationale for Unusual & Compelling Nature (Class J&A Section 5.a):

Explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

Contract does not exceed one year. Mako has the capability for SARS-CoV-2 next generation sequencing covering a very large and broad national testing footprint.

They currently receive about 50K COVID-19 samples/day from 42 states and DC which provides them access to positive samples for surveillance. They have an existing CAP/CLIA accredited reference laboratory where all pre-analytical, analytical and post analytical genomic sequencing step will be performed. Mako will require no ramp up time to start seqeuncing up to 6000 specimens per week and can ramp up to 200,000 specimens a week if needed. They currently report SARS-CoV-2 RT-PCR results electronically to all state health departments and have the ability to transmit additional data related to the sequence in HIPAA compliant formats. They are uploading variant data to GISAID now and is already establishing pipelines to NCBI/SRA and GenBank.

Reviewed and Approved by:

Official Name & Title Signature

Program Representative Melissa Olsen-Rasmussen, OAMD Program CORIII

Contracting Officer Gordon D. Barritt, Contracting Officer

Approver at a Level Above the Contracting Officer Kristopher Lemaster, Team Lead

The File Includes the Following Documentation:

1. Contractor's Qualifications and Ability to Perform the Work As Part Of The Contracting Officer's Responsibility

Determination per FAR 9.103(b) (Class J&A Section 5.a). See Document(s) Identified Below:

Contracting Officer to Identify Specific Documents

Mako Medical is uniquely qualified to provide CDC with the needed sequencing and data requirements. Mako has the capability for SARS-CoV-2 next generation sequencing covering a very large and broad national testing footprint.

They currently receive about 50K COVID-19 samples/day from 42 states and DC which provides them access to positive samples for surveillance. They have an existing CAP/CLIA accredited reference laboratory where all pre-analytical, analytical and post analytical genomic sequencing step will be performed. Mako will require no ramp up time to start seqeuncing up to 6000 specimens per week and can ramp up to 200,000 specimens a week if needed. They currently report SARS-CoV-2 RT-PCR results electronically to all state health departments and have the ability to transmit additional data related to the sequence in HIPAA compliant formats. They are uploading variant data to GISAID now and is already establishing pipelines to NCBI/SRA and GenBank.

2. Extent of competition undertaken (Class J&A Section 6). See Document(s) Identified Below:

Contracting Officer to Identify Specific Documents

Mako will rapidly sequence 5000 SARS-CoV-2 samples each week from across the nation and submit the sequencing and some metadata data to CDC or to public depositories such as NCBI, Genbank, and GISAID. The base period of performance will be for at least 26 weeks with 2 option periods of 13 weeks each that may be exercised at any time if the COVID-19 requires additional samples.

3. Price/cost analysis conducted and that the proposed price is fair and reasonable (Class J&A Section 7). See Document(s) Identified Below:

Contracting Officer to Identify Specific Documents

The Office of Advanced Molecular Detection (OAMD) used estimated market share of COVID-10 testing capacity provided by the Joint Coordination Cell/HHS/Lab testing and Diagnostic Work Group and CDC/Laboratory task force to conduct market research of commercial and academic laboratories within the US. Potential sources need to have access to a large number of SARS-CoV-2 positive samples and have the capacity to perform large scale genomic sequencing.

OAMD sent out SARS-CoV-2 Next Generation Sequencing Capabilities Information Request letters to 14 laboratories

ERR/PR#: 20 25 4178 00HCBCD9-202

making up 52% of the market share to identify interested sources. Final sources were based on:

Number of complete sequences delivered per week Geographic area coverage Ramp up timeline Ability to perform genomic sequencing under CLIA certification at start of contract Ability to do bioinformatics (genome assembly, variant calling) Ability to submit data to public repositories (NCBI/SRA, NCBI/GenBank, and GISAID) Current status on reporting SARS-CoV-2 results electronically to state health departments Ability to transmit sample related data information electronically to state health departments Cost per specimen of doing the sequencing

Contracting Officer's Confirmation of Required Documentation:

Official Name Initials

Contracting Officer Gordon D. Barritt gdb

Page of \\cdc.gov\private\L331\kpy2\Contracting Documents\SSJs & JOFOCs\COVID-19 Class J&A\CDC Letterhead.tiff Applicability of CDC Class J&A for 2019 Novel Coronavirus (COVID-19) to Current Requirement The Centers for Disease Control and Prevention (CDC) has established a Class J&A for COVID-19 contract actions. Actions taken under the authority of this class J&A shall include (1) documentation of market research performed and prospective sources of supply and services, (2) evidence of the urgent and compelling nature of the particular action, reviewed and approved at a level above the Contracting Officer, (3) documentation of the contractor's qualifications and ability to perform the work as part of the Contracting Officer's responsibility determination, (4) Documentation of the extent of competition undertaken, and (5) documentation of the price/cost analysis conducted and that the proposed price is fair and reasonable. The Class J&A shall be included with this document in the file folder.

When this document is printed, the blue italic instructions are automatically deleted on the printed version.

Please enter ERR number and, if applicable, PR number. If not associated with an ERR, please enter PR number A. Contractor's Unique Qualifications:

B. Identification of Services or Supplies:

Short description of the services or supplies required to meet the agency's needs. (e.g., "Q Stations PPE" / "Web Development") C. Documentation of Market Research Performed & Prospective Sources of Supplies & Services (Class J&A Section 8):

Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If action is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-on. See FAR 10.002(b)(2).

D. Basis and Rationale for Unusual & Compelling Nature (Class J&A Section 5.a):

Explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

Reviewed and Approved by:

Official Name & Title Signature Program Representative Contracting Officer Approver at a Level Above the Contracting Officer The File Includes the Following Documentation:

Contractor's Qualifications and Ability to Perform the Work As Part Of The Contracting Officer's Responsibility Determination per FAR 9.103(b) (Class J&A Section 5.a). See Document(s) Identified Below:

Contracting Officer to Identify Specific Documents Extent of competition undertaken (Class J&A Section 6). See Document(s) Identified Below:

Contracting Officer to Identify Specific Documents Price/cost analysis conducted and that the proposed price is fair and reasonable (Class J&A Section 7). See Document(s) Identified Below:

Contracting Officer to Identify Specific Documents Contracting Officer's Confirmation of Required Documentation:

Official Name Initials Contracting Officer 11.0.0.20130303.1.892433.887364 Justification & Approval - Other Than Full and Open Competition Health and Human Services Justification & Approval - Other Than Full and Open Competition Kristopher Lemaster, Team Lead gdb

They currently receive about 50K COVID-19 samples/day from 42 states and DC which provides them access to positive samples for surveillance. They have an existing CAP/CLIA accredited reference laboratory where all pre-analytical, analytical and post analytical genomic sequencing step will be performed. Mako will require no ramp up time to start seqeuncing up to 6000 specimens per week and can ramp up to 200,000 specimens a week if needed. They currently report SARS-CoV-2 RT-PCR results electronically to all state health departments and have the ability to transmit additional data related to the sequence in HIPAA compliant formats. They are uploading variant data to GISAID now and is already establishing pipelines to NCBI/SRA and GenBank.

Number of complete sequences delivered per week Geographic area coverage Ramp up timeline Ability to perform genomic sequencing under CLIA certification at start of contract Ability to do bioinformatics (genome assembly, variant calling) Ability to submit data to public repositories (NCBI/SRA, NCBI/GenBank, and GISAID) Explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply. : Contract does not exceed one year. Mako has the capability for SARS-CoV-2 next generation sequencing covering a very large and broad national testing footprint.

They currently receive about 50K COVID-19 samples/day from 42 states and DC which provides them access to positive samples for surveillance. They have an existing CAP/CLIA accredited reference laboratory where all pre-analytical, analytical and post analytical genomic sequencing step will be performed. Mako will require no ramp up time to start seqeuncing up to 6000 specimens per week and can ramp up to 200,000 specimens a week if needed. They currently report SARS-CoV-2 RT-PCR results electronically to all state health departments and have the ability to transmit additional data related to the sequence in HIPAA compliant formats. They are uploading variant data to GISAID now and is already establishing pipelines to NCBI/SRA and GenBank.

They currently receive about 50K COVID-19 samples/day from 42 states and DC which provides them access to positive samples for surveillance. They have an existing CAP/CLIA accredited reference laboratory where all pre-analytical, analytical and post analytical genomic sequencing step will be performed. Mako will require no ramp up time to start seqeuncing up to 6000 specimens per week and can ramp up to 200,000 specimens a week if needed. They currently report SARS-CoV-2 RT-PCR results electronically to all state health departments and have the ability to transmit additional data related to the sequence in HIPAA compliant formats. They are uploading variant data to GISAID now and is already establishing pipelines to NCBI/SRA and GenBank.

Number of complete sequences delivered per week Geographic area coverage Ramp up timeline Ability to perform genomic sequencing under CLIA certification at start of contract Ability to do bioinformatics (genome assembly, variant calling) Ability to submit data to public repositories (NCBI/SRA, NCBI/GenBank, and GISAID) Current status on reporting SARS-CoV-2 results electronically to state health departments Ability to transmit sample related data information electronically to state health departments Cost per specimen of doing the sequencing