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Q301--Germline Genetic Testing Federal contract opportunity
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36C25921Q0618
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Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 19

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36C25921Q0618

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9.

ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE

WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15

CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTA

CHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNAT

URE OF OFFEROR/CONTRACTOR

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C259-21-AP-1

660-21-4- 36C25921Q0618 08-1 -2021 Ian Boettcher 303-712-5722 09-1 -2021 12:30pm

MDT

36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111 X 621511 $35 Million N/A X 36C660 Department of Veterans Affairs Salt Lake City VA Medical Center Genomic Services 500 Foothill Drive Salt Lake City UT 84148 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

Submitted Electronically Department of Veterans Affairs Financial Service Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page Germline Genetic Testing Services Period of Performance: September 30, 2021 through September 29, 2024 See CONTINUATION Page X X Ronnie Jones

VA-VHA-2020-E9AB8090

Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS1
SECTION B - CONTINUATION OF SF 1449 BLOCKS3
B.1CONTRACT ADMINISTRATION DATA3
B.2STATEMENT OF WORK – Germline Genetic Testing Services5
B.2SCHEDULE OF SERVICES/COSTS11
SECTION C - CONTRACT CLAUSES25
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)25
C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)30
C.3 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)31
C.4 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)31
C.5 MANDATORY WRITTEN DISCLOSURES31
C.6 IT CONTRACT SECURITY31
C.7 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)41
C.8 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)42
C.9 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)43
C.10 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)44
C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JUL 2021)44
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS52
BUSINESS ASSOCIATE AGREEMENT BETWEEN THE DEPARTMENT OF VETERANS AFFAIRS VETERANS HEALTH ADMINISTRATION, Salt Lake City VAMC, AND ___________________52
SECTION E - SOLICITATION PROVISIONS58
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUL 2021)58
E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)63
E.3 52.209-5 CERTIFICATION REGARDING RESPONSIBILITY MATTERS (AUG 2020)66
E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)67
E.5 52.216-1 TYPE OF CONTRACT (APR 1984)69
E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)69
E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018)69
E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)70
E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)70
E.10 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008)71
E.11 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)71
E.12 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (FEB 2021)73

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

B.1.1. Contract Administration: All contract administration matters will be handled by the following individuals:

B.1.1.1. CONTRACTOR: Name_____________________________
Title_____________________________
Company_____________________________
Address_____________________________
Telephone #_____________________________
E-mail address_____________________________

B.1.1.2. GOVERNMENT: Ian Boettcher, Contract Specialist Department of Veterans Affairs Rocky Mountain Network NCO 19 Contracting 6162 South Willow Drive, Suite 300 Greenwood Village, CO 80111 Telephone: 303-712-5722

FAX: 303-712-5800

E-mail: Ian.Boettcher@va.gov

B.1.2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer - System for Award Management (SAM), or
[N/A] 52.232-36, Payment by Third Party

B.1.3. GOVERNMENT INVOICE ADDRESS: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]

c. Other [X] MONTHLY IN ARREARS B.1.4. GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be submitted electronically to the VA Financial Services Center for payment processing, free of charge. For any questions about the e-invoicing program, please contact the FSC at the phone number or email address listed below:

1. TUNGSTEN e-Invoice Setup Information: (877) 752-0900

1. TUNGSTEN e-Invoice email: USClientServices@ob10.com

1. FSC e-Invoice Contact Information: (877) 353-9791

1. FSC e-invoice email: vafsccshd@va.gov

1. The following two codes will be required when creating a vendor profile in TUNGSTEN:

· TUNGSTEN Buyer Number AAA544240062

· Promo Code: VAPC7Y18

B.1.5. DUNS NUMBER: Please provide the Dun and Bradstreet Number assigned to your firm in the space provided: _____________________________

B.1.6. TAX IDENTIFICATION NUMBER: Please provide the tax identification number to be utilized for this contract: _____________________________ B.1.7. PERIOD OF PERFORMANCE: Services required herein shall be for the following time period: September 30, 2021 through September 29, 2024 Ordering Period 1 - 9/30/21 – 9/29/22 Ordering Period 2 - 9/30/22 – 9/29/23 Ordering Period 3 - 9/30/23 – 9/29/24 36C25921Q0618

Page 1 of Page 1 of B.2 STATEMENT OF WORK – Germline Genetic Testing Services

On behalf of the Department of Veterans Affairs (VA), the Genomic Medicine Program intends to secure specialized, comprehensive reference laboratory germline genetic testing. All services provided shall be in accordance with the costs, terms, and conditions of this contract. The contract will be administered through the Salt Lake City VA Health Care System.

DESCRIPTION OF SERVICES/INTRODUCTION: The contractor(s) shall provide all personnel, equipment, supplies, facilities, tools, materials, supervision, and other items and services necessary to services as defined in the Statement of Work (SOW) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract and maintain compliance with policies and procedures with the Health Insurance Portability and Accountability Act (HIPAA),the Clinical Laboratory Improvement Act (CLIA), and accreditation with the American College of Medical Genetics and Genomics (ACMG) or the College of American Pathologists (CAP).

OBJECTIVES: The objective of this request is to ensure access to germline genetic testing for patients eligible to receive care throughout the VA enterprise.

SCOPE: The contractor’s laboratory shall have the ability to perform analysis, interpretation, and reporting for one or more germline genetic tests, as described herein. These services require a CAP- or ACMG-accredited, CLIA-certified laboratory with the ability to perform complex genetic testing. Services require the ability to provide customized gene panels (e.g., add and remove genes from already curated panels) as part of typical test ordering. Evaluation of variants of uncertain significance (VUS) through a variety of methods (e.g., RNA sequencing, family resolution studies) will be made available by the contractor’s laboratory with no additional billing. Appropriateness of VUS evaluation will be determined by the ordering provider in collaboration with the contractor laboratory.

TESTING REQUIRED: The Genomic Medicine Program seeks to contract with germline genetic testing laboratories that can receive, process, and report results for at least one or more of the test types and methodologies for the diagnostic areas as described. Since the genetic testing field is dynamic, when a new type of test or test methodology is released that is relevant to the required clinical areas, the VA will have access to that offering without amending the contract.

Germline genetic testing expertise is mandatory in following clinical areas: cancer, cardiovascular diseases, gastrointestinal disorders, neurological disorders, endocrinology and metabolic conditions, ophthalmologic disorders, renal disorders, allergy and immunologic disorders, autoimmune and rheumatologic disorders, connective tissue and skeletal disorders, birth defects, and preconception carrier screening. Preferred areas of expertise include chromosomal disorders, non-invasive prenatal testing, pharmacogenetics, mitochondrial disorders, paired tumor/germline testing, and polygenic risk scores.

Mandatory and preferred methodologies:

· Mandatory methodologies: DNA-based testing such as multi-gene panels, single gene assays, and single allele assays using next generation (massively parallel) sequencing Sanger sequencing, or other methodologies.

· Preferred methodologies (but not limited to): DNA repeat analysis, DNA methylation analysis, RNA sequencing including quantification of gene and transcript levels, visualization, differential gene expression, alternative splicing, functional analysis, gene fusion detection, eOTL mapping, mitochondrial DNA testing, exome sequencing, genome sequencing, and chromosomal analyses and tests, such as karyotype, fluorescent in situ hybridization (FISH), and chromosomal microarrays.

The contractor shall provide the following services:

(a) Provide the following for transport of the specimens to include:

1. Laboratory test request forms (vendor may need to customize forms to include information required by the VA). At minimum:

a. Ordering provider data

b. Patient data

i. full name

ii. date of birth

iii. social security number or a second identifier

iv. sex (biological)

v. gender

vi. test(s) to be performed

vii. specimen collection date/time

viii. specimen type

2. Special instructions for handling of specimen

3. Description of specimen types that can be accepted for each test

4. Specimen collection supplies for specialized testing

5. Mailing account number to cover the costs of shipping within the US

(b) Analyze samples

(c) Provide an invoice for tests completed within a month of service. Invoicing must identify patient information, tests ordered, ordering provider and VA location.

(d) Provide access to a local account representative (e.g., a genetic counselor or other genetic or laboratory professional) for consultation regarding test results and interpretation by telephone and email, as needed, during regular business hours.

(g) A variant evaluation/interpretation program, which at a minimum conforms to ACMG Standards and guidelines for the interpretation of sequence variants

(h) A variant resolution program that includes family studies (i.e., provides for testing of family members whose results may help inform variant reclassification) or functional studies (e.g., RNAseq) with no additional billing to VA or the patient.

(i) A proficiency testing program. The VA reserves the right to request the results of any proficiency testing to which the contractor subscribes.

The Contractor Laboratory shall have the following processes and procedures in place:

(a) Ensure testing is completed at the prime Contractor’s facilities, to include wholly owned subsidiaries, but not subcontractor or joint venture operated sites. Ensure that samples are not further transported to any other facility for testing, nor interpreted by any other personnel than prime contractor employed, medical directors, laboratory or medical geneticists, or molecular pathologist. These professionals must be employees of the Contractor’s facility or wholly owned subsidiary and be available at the site to remedy quality concerns, and testing challenges.

(b) Accept and store the National Provider Identifier (NPI) for ordering providers. All are licensed healthcare providers in the VA, including genetic counselors, nurse practitioners, and physicians.

(c) Accept orders without requiring additional signed consent from patients beyond a provider’s attestation on the test requisition form.

(d) Provide a list of tests currently available with a price list.

(e) Provide a secure online ordering portal. Portal ordering must include tests searchable by name and/or gene. Full list of genes for each panel must be listed online. Portal should allow for creation of customizable gene panels. Portal should automatically alert providers and relevant VA staff when test results are available.

(f) Perform analytical testing for VA patients for the tests requested. The Contractor shall bill only for the tests specified in the request sent by VA laboratory service.

(g) Provide a reference test manual and report of analytical test results, upon award, describing the full scope of its laboratory operations.

(h) Provide VA with laboratory supplies (collection tubes, postage-paid transport packaging, etc.) not customarily utilized by VA laboratories. These supplies are to be used by VA laboratories only in connection with specimens being sent for testing to the contractor.

(i) Carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations.

(j) Provide test report electronically or by fax in an encrypted fashion compliant with VHA requirements.

(k) Ability to send raw molecular data files (e.g., BAM, BAI and VCF files) is preferred. Contractor must have ability to securely transfer electronically by method acceptable to VA. All formats must use standard formats (and recent version) or a format acceptable to VA. Contractor to provide technical files describing the format of each file, including BED files. Contact information to be provided upon contract award.

(l) Ability to interface with the VA laboratory information system to facilitate test ordering and reporting is preferred.

(m) Provide a point of contact including names and telephone number(s) to make inquiries on weekdays. of Laboratory Directors, technicians, and other laboratory personnel available for consultation.

(n) Maintain the minimum acceptable service, reporting systems, and quality control as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency.

(o) Ensure germline genetic test results are not released to anyone other than the ordering healthcare provider or staff associated with the order. The only exception to release of results is for select VA staff in charge of oversight; details provided at award. All records shall be treated as confidential, to comply with all state and federal laws regarding the confidentiality of patient’s records. This provision shall survive termination of the resulting contract award.

(p) Certify and ensure that all laboratory employees, officers, or agents comply with standards set forth in the Health Insurance Portability and Accountability Act (HIPAA).

(q) Prepare at least quarterly reports that provide information to the VA regarding genetic test orders and results at the test level. Reporting requirements include but are not limited to: patient first and last name, medical record number, ordering provider name and NPI, date of specimen collection, date of test result report, test name, procedure, and cost. These reports shall be available within 30 days after the end of each quarter. These reports should be submitted in Microsoft Excel or similar format.

(r) Prepare an annual report that summarizes germline genetic test utilization and costs overall and by ordering provider and VA facility.

Test Sample Preparation The VA laboratories will be responsible to provide laboratory specimens prepared in accordance with the contractor’s Laboratory User’s Manual. All specimens will be properly identified and labeled for testing to include at least two identifiers (e.g., patient name, medical record number, date of birth). The contractor shall provide an adequate supply of requisition forms, special instructions, and a current list of tests with specimen requirements. These requirements shall be defined in the laboratory user’s manual.

Transport of Specimens The contractor laboratory client Services shall provide a mailing account number to send specimens directly to the contractor’s laboratory.

The contractor laboratory shall have the ability to send saliva kits and/or buccal swab kits directly to a patient’s home and provide packaging/mailing supplies for the patient to send a specimen directly back to the contractor laboratory. The contractor laboratory shall not use patient address for any other purpose beyond mailing specimen collection supplies.

Reporting of Test Results A report is defined as a printed final copy of a genetic test result interpreted by individuals with training in genetics and signed out by a ABMGG board-certified geneticist or molecular genetic pathologist. Consult reports shall be sent by contractor electronically or by fax to the ordering provider and VA laboratory. Each report shall, at a minimum, indicate the following information:

(a) Patient’s full name

(b) Patient’s date of birth

(c) Patient’s unique medical record number

(d) Ordering provider’s name

(e) Ordering provider’s NPI

(f) Purchase order account number

(e) Test(s) ordered

(f)Date/time of specimen collection (when available)
(g)Date/time specimen received in Reference Lab
(h)Date test signed and reported
(i)Type of specimen/source
(j)Test result(s)
(k)Flag abnormal results

(l) Comments on interpretation for variants of uncertain significance, likely pathogenic, and pathogenic results, which may include but are not limited to: Clinical summary, comments on familial testing, variant effect on protein, ClinVar entries, in silico models, experimental studies, reference to population databases.

(m) Methodology used and limitations of listed methodology

(n) Name of testing laboratory (contractor and/or wholly owned subsidiary), address, CLIA number

(o) Testing laboratory specimen number

(p) Information that may indicate a questionable validity of test result

(q) Unsatisfactory specimen shall be reported with reason as to its unsuitability for testing

Licensing and accreditation – Contractor Laboratory shall:

(a) Have all licenses, permits, accreditation certificates required by Federal law and State law.

(b) Maintain Department of Health and Human Services Clinical Laboratory Improvement Act of 1988 (CLIA) certification and accreditation by the College of American Pathologists (CAP) or the American College of Medical Genetics and Genomics (ACMG). Copies of all professional certifications, licensures and renewal certifications shall be provided and updated as needed to the Contracting Officer to include the contractor laboratory’s Laboratory Director(s) and/or Medical Director(s).

· Medical Director(s) shall have suitable Molecular Genetics qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA, ACMG and CAP standards.

(c) Have personnel assigned to perform the services covered by the contract who are eligible to provide these services and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on the contract shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board.

(d) Comply with the regulatory requirements of Health and Human Services Health Care Financing Administration, Centers for Medicare and Medicaid (CMS).

(e) Maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

(f) Notify the Contracting Officer immediately, in writing, upon its loss (or any of its subsidiaries) of any required certification, accreditation, or licensure.

Upon award, provide an electronic Laboratory Manual containing:

(a) Department hours of operation

(b) Accreditation

(c) Technical Staff

(d) Service Departments (Method of contacting, phone numbers, hours of availability)

(e) Quality Control and Quality Assurance Information

(f) Billing Procedures & fee schedules for services provided

(g) Procedures and criteria for phoning reports and other important information

Contract Performance Monitoring: Quality Control: The contractor shall operate a successful quality assurance program as required by CAP/CLIA. Services are to be performed in accordance with the SOW. The quality control program shall include procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s quality control program is the means by which the contractor laboratory assures that work complies with the requirement of the contract.

The contractor’s facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the Genomic Medicine Program during the life of the contract.

Quality Assurance: The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint commission and regulations required for performing the type of services described herein and provide that quality assurance plan. The government shall evaluate the contractor’s performance under the contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

Hours of Operation: The contractor is responsible for providing services 8:00am – 5:00pm Monday – Friday, local time, except for Federal Holidays. The Contractor shall at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within the SOW. When hiring personnel, the Contractor shall hire in a manner congruent with the established stability and continuity of the workforce.

Physical Security: The contractor shall be responsible for safeguarding all government equipment, information, and property provided to the contractor laboratory.

Contractor Furnished Items and Responsibilities: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work as outlined in this contract.

Periodic reporting. Provide at least four quarterly (Oct- December, January- March, April-June, July- September) utilization/cost reports and an annual report (for contract performance period) to the Genomic Medicine Program Director and Administrative Officer. The reports shall be in Microsoft excel format and include at minimum the following for each test ordered: patient name, patient medical record number, ordering provider, ordering provider NPI, date of specimen collection, date of results report, test name, test procedure and relevant CPT codes. In addition, a summary report should include volume of testing for each test type, cost per test, total cost, and median days (with range) for test turnaround from accessioning to reporting date. These reports shall be available within 30 days after the end of each quarter.

B.2 SCHEDULE OF SERVICES/COSTS

Mandatory Tests – September 30, 2021 through September 29, 2024

CLINS
Generic Test Name
Genes Included (minimum)
ESTIMATED ANNUAL QTY
Unit
Unit Cost
Estimated Annual Total Cost
0001
Single Gene
varies depending on familial mutation
280
Each
$
$
0002
Breast Cancer Panel
ATM, BARD1, BRCA1, BRCA2, BRIP1, CDH1, CHEK2, NBN, NF1, PALB2, PTEN, RAD50, STK11, TP53
90
Each
$
$
0003
Breast/Gyn Cancer Panel
ATM, BARD1, BRCA1, BRCA2, BRIP1, CDH1, CHEK2, DICER1, EPCAM, MLH1, MSH2, MSH6, NBN, NF1, PALB2, PMS2, PTEN, RAD50, RAD51C, RAD51D, SMARCA4, STK11, TP53
160
Each
$
$
0004
Colorectal Cancer Panel
APC, AXIN2, BMPR1A, CDH1, CHEK2, EPCAM, GREM1, MLH1, MSH2, MSH3, MSH6, MUTYH, NTHL1, PMS2, POLD1, POLE, PTEN, SMAD4, STK11, TP53, ATM, BLM, BUB1B, CEP57, ENG, FLCN, GALNT12, MLH3, RNF43, RPS20
150
Each
$
$
0005
Common Hereditary Cancers
APC, ATM, AXIN2, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDK4, CDKN2A, CHEK2, CTNNA1, DICER1, EPCAM, GREM1, HOXB13, KIT, MEN1, MLH1, MSH2, MSH3, MSH6, MUTYH, NBN, NF1, NTHL1, PALB2, PDGFRA, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, SDHA, SDHB, SDHC, SDHD, SMAD4, SMARCA4, STK11, TP53, TSC1, TSC2, VHL
250
Each
$
$
0006
Multicancer Panel
AIP ALK APC ATM AXIN2 BAP1 BARD1 BLM BMPR1A BRCA1 BRCA2 BRIP1 CASR CDC73 CDH1 CDK4 CDKN1B CDKN1C CDKN2A CEBPA CHEK2 CTNNA1 DICER1 DIS3L2 EGFR EPCAM FH FLCN GATA2 GPC3 GREM1 HOXB13 HRAS KIT MAX MEN1 MET MITF MLH1 MSH2 MSH3 MSH6 MUTYH NBN NF1 NF2 NTHL1 PALB2 PDGFRA PHOX2B PMS2 POLD1 POLE POT1 PRKAR1A PTCH1 PTEN RAD50 RAD51C RAD51D RB1 RECQL4 RET RUNX1 SDHA SDHAF2 SDHB SDHC SDHD SMAD4 SMARCA4 SMARCB1 SMARCE1 STK11 SUFU TERC TERT TMEM127 TP53 TSC1 TSC2 VHL WRN WT1
615
Each
$
$
0007
Prostate Cancer Panel
ATM, BARD1, BRCA1, BRCA2, BRIP1, CHEK2, FANCL, EPCAM, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53
2500
Each
$
$
0008
Renal/Urinary Tract Cancer Panel
BAP1, CDC73, CDKN1C, DICER1, DIS3L2, EPCAM, FH, FLCN, GPC3, MET, MLH1, MSH2, MSH6, PMS2, PTEN, REST, SDHB, SDHC, SMARCA4, SMARCB1, TP53, TSC1, TSC2, VHL, WT1
35
Each
$
$
0009
Pancreatic Cancer Panel
APC, ATM, BMPR1A, BRCA1, BRCA2, CDKN2A, EPCAM, MEN1, MLH1, MSH2, MSH6, NF1, PALB2, PMS2, SMAD4, STK11, TP53, TSC1, TSC2, VHL
300
Each
$
$
0010
Pancreatitis Panel
CASR, CFTR, CPA1, CTRC, PRSS1, SPINK1
10
Each
$
$
0011
Paraganglioma / Pheochromocyt-oma Panel
MAX, NF1, RET, SDHA, SDHAF2, SDHB, SDHC, SDHD, TMEM127, VHL
10
Each
$
$
0012
Melanoma Panel
BAP1, BRCA2, CDK4, CDKN2A, MITF, POT1, PTEN, RB1, TP53
18
Each
$
$
0013
Gastric Cancer Panel
APC, BMPR1A, CDH1, CTNNA1, EPCAM, KIT, MLH1, MSH2, MSH6, NF1, PDGFRA, PMS2, SDHA, SDHB, SDHC, SDHD, SMAD4, STK11, TP53
27
Each
$
$
0014
Hyperparathyr-oidism Panel
AP2S1, CASR, CDC73, CDKN1B, GNA11, MEN1, RET
10
Each
$
$
0015
Lynch Syndrome Panel
EPCAM, MLH1, MSH2, MSH6, PMS2
45
Each
$
$
0016
Schwannomato-sis Panel
LZTR1, NF2, SMARCB1
4
Each
$
$
0017
Neurofibromato-sis Type 1
NF1
10
Each
$
$
0018
Neurofibromato-sis Type 2
NF2
4
Each
$
$
0019
Polyposis Panel
APC, MSH3, MUTYH, NTHL1, POLD1, POLE
20
Each
$
$
0020
Familial Hypercholester-olemia Panel
APOB, LDLR, LDLRAP1, PCSK9
45
Each
$
$
0021
Cardiomyopathy Panel
ABCC9, ACTC1, ACTN2, AGL, BAG3, CACNA1C, CAV3, CRYAB, CSRP3, DES, DMD, DOLK, DSC2, DSG2, DSP, EMD, EYA4, FHL1, FKRP, FKTN, FLNC, GAA, GLA, HCN4, JUP, LAMP2, LMNA, MYBPC3, MYH7, MYL2, MYL3, PKP2, PLN, PRKAG2, RAF1, RBM20, RYR2, SCN5A, SGCD, SLC22A5, TAZ, TCAP, TMEM43, TNNC1, TNNI3, TNNT2, TPM1, TTN, TTR, VCL
50
Each
$
$
0022
Hypertrophic Cardiomyopathy Panel
ACTC1, ACTN2, AGL, BAG3, CACNA1C, CAV3, CSRP3, DES, FHL1, FLNC, GAA, GLA, LAMP2, MYBPC3, MYH7, MYL2, MYL3, PLN, PRKAG2, TCAP, TNNC1, TNNI3, TNNT2, TPM1, TTR, VCL
27
Each
$
$
0023
Dilated Cardiomyopathy Panel
ABCC9, ACTC1, ACTN2, BAG3, CAV3, CRYAB, CSRP3, DES, DMD, DOLK, DSC2, DSG2, DSP, EMD, EYA4, FKRP, FKTN, FLNC, JUP, LAMP2, LMNA, MYBPC3, MYH7, PKP2, PLN, RAF1, RBM20, RYR2, SCN5A, SGCD, SLC22A5, TAZ, TCAP, TMEM43, TNNC1, TNNI3, TNNT2, TPM1, TTN, TTR, VCL
20
Each
$
$
0024
Hereditary Hemorrhagic Telangiectasia
ACVRL1, ENG, GDF2, RASA1, SMAD4
6
Each
$
$
0025
Familial Transthyretin Amyloidosis
TTR
35
Each
$
$
0026
Arrhythmia Panel
ABCC9, ACTN2, ANK2, CACNA1C, CACNB2, CALM1, CALM2, CALM3, CASQ2, CAV3, DES, DSC2, DSG2, DSP, EMD, FLNC, GPD1L, HCN4 ,JUP, KCNA5, KCNE1, KCNE2, KCNH2, KCNJ2, KCNQ1, LMNA, MYL4, NKX2-5, PKP2, PLN, PRKAG2, RBM20, RYR2, SCN5A, TMEM43, TNNI3, TNNT2, TRDN, TTN
20
Each
$
$
0027
Long QT Panel
ANK2, CACNA1C, CALM1, CALM2, CALM3, CAV3, KCNE1, KCNE2, KCNH2, KCNJ2, KCNQ1, SCN5A, TRDN
20
Each
$
$
0028
Polycystic Kidney Disease Panel
DNAJB11, GANAB, HNF1B, PKD1, PKD2
20
Each
$
$
0029
Muscular Dystrophy Panel
ANO5, B3GALNT2, B4GAT1, CAPN3, CAV3, CHKB, COL12A1, COL6A1, COL6A2, COL6A3, DAG1, DES, DMD, DNAJB6, DPM1, DPM2, DPM3, DYSF, EMD, FHL1, FKRP, FKTN, GAA, GMPPB, ISPD, ITGA7, LAMA2, LARGE1, LMNA, MYOT, PLEC, PNPLA2, POMGNT1, POMGNT2, POMK, POMT1, POMT2, RXYLT1, SGCA, SGCB, SGCD, SGCG, TCAP, TNPO3, TOR1AIP1, TRAPPC11, TRIM32, TTN
10
Each
$
$
0030
Limb Girdle Muscular Dystrophy Panel
ANO5, CAPN3, CAV3, DAG1, DES, DMD, DNAJB6, DYSF, FKRP, FKTN, GAA, GMPPB, ISPD, LMNA, MYOT, PLEC, PNPLA2, POMGNT1, POMK, POMT1, POMT2, SGCA, SGCB, SGCD, SGCG, TCAP, TNPO3, TOR1AIP1, TRAPPC11, TRIM32, TTN
10
Each
$
$
0031
Hereditary Neuropathy Panel
AARS, AIFM1, ATL1, ATL3, ATP7A, BICD2, BSCL2, CHCHD10, DCTN1, DNAJB2, DNM2, DNMT1, DST, DYNC1H1, EGR2, ELP1, FBXO38, FGD4, FIG4, GAN, GARS, GDAP1, GJB1, GNB4, HARS, HINT1, HSPB1, HSPB8, IGHMBP2, INF2, KIF1A, LITAF, LMNA, LRSAM1, MED25, MFN2, MORC2, MPZ, MTMR2, NDRG1, NEFL, NGF, NTRK1, PDK3, PLEKHG5, PMP22, PRPS1, PRX, RAB7A, REEP1, RETREG1, SBF2, SCN11A, SCN9A, SH3TC2, SIGMAR1, SLC25A46, SLC52A2, SLC52A3, SLC5A7, SPG11, SPTLC1, SPTLC2, TFG, TRIM2, TRPV4, TTR, UBA1, VAPB, VRK1, WNK1, YARS
27
Each
$
$
0032
Charcot-Marie Tooth Panel
AARS, AIFM1, BSCL2, DNAJB2, DNM2, DYNC1H1, EGR2, FGD4, FIG4, GARS, GDAP1, GJB1, GNB4, HARS, HINT1, HSPB1, HSPB8, IGHMBP2, INF2, LITAF, LMNA, LRSAM1, MED25, MFN2, MORC2, MPZ, MTMR2, NDRG1, NEFL, PDK3, PLEKHG5, PMP22, PRPS1, PRX, RAB7A, SBF2, SH3TC2, SLC25A46, SPG11, TFG, TRIM2, TRPV4, YARS
18
Each
$
$
0033
ALS Panel
ALS2, CHCHD10, DCTN1, FUS, KIF5A, OPTN, PFN1, SETX, SOD1, SPG11, TARDBP, TBK1, TFG, UBQLN2, VAPB, VCP, CHMP2B, MATR3, SIGMAR1, SQSTM1
20
Each
$
$
0034
Frontotemporal Dementia Panel
CHCHD10, DCTN1, FUS, GRN, MAPT, TARDBP, TBK1, UBQLN2, VCP, CHMP2B, HNRNPA2B1, PSEN1, SQSTM1
18
Each
$
$
0035
CADASIL
NOTCH3, HTRA1
9
Each
$
$
0036
Inherited Alzheimer disease
APP, PSEN1, PSEN2
9
Each
$
$
0037
Hereditary Spastic Paraplegia Panel
ABCD1, ALDH18A1, ALS2, AP4B1, AP4E1, AP4M1, AP4S1, AP5Z1, ATL1, B4GALNT1, BSCL2, C12orf65, CYP2U1, CYP7B1, DDHD1, DDHD2, ERLIN2, FA2H, GBA2, GJC2, HEXA, HSPD1, KDM5C, KIF1A, KIF1C, KIF5A, L1CAM, NIPA1, NT5C2, PLP1, PNPLA6, REEP1, REEP2, RTN2, SACS, SLC16A2, SPART, SPAST, SPG11, SPG21, SPG7, TECPR2, VAMP1, WASHC5, ZFYVE26
18
Each
$
$
0038
Pulmonary Hypertension
ACVRL1, BMPR2, CAV1, ENG, SMAD9
2
Each
$
$
0039
Malignant Hyperthermia
CACNA1S, RYR1, STAC3
9
Each
$
$
0040
Macular Dystrophies Panel
ABCA4, BEST1, C1QTNF5, CDH3, CERKL, CFH, CNGB3, CRB1, CTNNA1, EFEMP1, ELOVL4, FSCN2, GUCA1B, HMNCN1, IMPG1, IMPG2, MFSD8, PRDM13, PROM1, PRPH2, RBP3, RDH12, RLBP1, RPIl1, RPGR, RPGRIP1, RS1, TIMP3
9
Each
$
$
0041
Retinitis Pigmentosa Panel
up to 80 genes
18
Each
$
$
0042
Familial Hypocalciuric Hypercalcemia
AP2S1, CASR, GNA11
27
Each
$
$
0043
Maturity Onset Diabetes of the Young
ABCC8, APPL1, BLK, GCK, HNF1A, HNF1B, HNF4A, INS, KCNJ11, KLF11, NUEROD1, PAX4, PDX1
9
Each
$
$
0044
Acute hepatic porphyria
ALAD, CPOX, HMBS, PPOX
4
Each
$
$
0045
Myopathy panel
9
Each
$
$
0046
Primary Immunodefici-encies
9
Each
$
$
0047
Connective tissue panel/aortopa-thies
ABCC6, ACTA2, ADAMTS2, AEBP1, ALDH18A1, ATP6V0A2, ATP6V1E1, B3GALT6, B3GAT3, B4GALT7, BGN, C1R, C1S, CBS, CHST14, COL11A1, COL11A2, COL12A1, COL1A1, COL1A2, COL2A1, COL3A1, COL4A1, COL5A1, COL5A2, COL9A1, COL9A2, CRTAP, DSE, EFEMP2, ELN, FBLN5, FBN1, FBN2, FKBP14, FLNA, LOX, LTBP4, MAT2A, MED12, MFAP5, MYH11, MYLK, NOTCH1, P3H1, PLOD1, PRDM5, PRKG1, PYCR1, RIN2, SGMS2, SKI, SLC2A10, SLC39A13, SMAD3, SMAD4, TGFB2, TGFB3, TGFBR1, TGFBR2, TNXB, ZNF469
209
Each
$
$
0048
Decreased Bone Density Panel/Osteo-genesis imperfecta
ALPL, ANO5, B4GALT7, BMP1, CLCN5, COL1A1, COL1A2, CRTAP, DMP1, ENPP1, FGF23, FKBP10, GNAS, GORAB, IFITM5, LMNA, LRP5, MAFB, MMP2, NOTCH2, P3H1, PHEX, PLOD2, PPIB, SERPINF1, SERPINH1, SLC34A3, SP7, SPARC, TMEM38B, TNFRSF11A, WNT1
9
Each
$
$
0049
Comprehensive Metabolic Panel
ABCC8, ABCD1, ABCD4, ACAA1, ACAD9, ACADL, ACADM, ACADS, ACADVL, ACAT1, ACOX1, ACSF3, ACY1, ADAMTSL2, ADAR, ADSL, AGA, AGK, AGL, AGPAT2, AKT2, ALAD, ALAS2, ALDH5A1, ALDH7A1, ALDOA, ALG1, ALG11, ALG12, ALG13, ALG2, ALG3, ALG6, ALG8, ALG9, AMACR, AMT, ANO10, ANTXR2, APTX, ARG1, ARSA, ARSB, ASAH1, ASL, ASPA, ASS1, ATP13A2, ATP6V0A2, AUH, B3GLCT, B4GALT1, BCKDHA, BCKDHB, BSCL2, BTD, C12orf65, CA2, CACNA1S, CAV1, CAV3, CAVIN1, CBS, CD320, CKMT1A, CKMT1B, CKMT2, CLCN1, CLDN16, CLDN19, CLN3, CLN5, CLN6, CLN8, CNNM1, CNNM2, CNNM4, COG1, COG4, COG5, COG6, COG7, COG8, COL11A2, COL2A1, COQ2, COQ6, COQ8A, COQ9, CPOX, CPS1, CPT1A, CPT1B, CPT2, CTNS, CTSA, CTSC, CTSD, CTSK, DBT, DDOST, DGUOK, DHCR7, DHDDS, DLD, DOLK, DPAGT1, DPM1, DPM2, DPM3, DPYD, DYM, ECHS1, EGF, ENO3, EPM2A, ETFA, ETFB, ETFDH, FAH, FBP1, FBXL4, FECH, FH, FLNA, FLNB, FOLR1, FUCA1, FXYD2, G6PC, GAA, GALC, GALNS, GAMT, GATM, GBA, GBE1, GCDH, GCH1, GCK, GIF, GLA, GLB1, GLDC, GLUD1, GMPPA, GNE, GNPAT, GNPTAB, GNPTG, GNS, GPC3, GPHN, GUSB, GYG1, GYS1, GYS2, HADH, HADHA, HADHB, HAMP, HCFC1, HEXA, HEXB, HFE, HGSNAT, HJV, HLCS, HMBS, HMGCL, HMGCS2, HNF1A, HNF1B, HNF4A, HPD, HRAS, HSD17B10, HSD17B4, HYAL1, IDS, IDUA, IFIH1, INSR, ISCU, IVD, KCNA1, KCNJ11, KCNJ2, L2HGDH, LAMA2, LAMP2, LDB3, LDHA, LIPA, LMBRD1, LMNA, LPIN1, MAGT1, MAN1B1, MANBA, MCCC1, MCCC2, MCEE, MCOLN1, MFN2, MFSD8, MGAT2, MMAA, MMAB, MMACHC, MMADHC, MMGT1, MOCS1, MOCS2, MOGS, MPDU1, MPI, MPV17, MTHFR, MTR, MTRR, MUT, MYOT, NAGLU, NAGS, NDUFS1, NEU1, NHLRC1, NIPA2, NPC1, NPC2, OAT, OPA1, OPA3, OTC, OXCT1, PAH, PC, PCBD1, PCCA, PCCB, PCK1, PCK2, PDHA1, PDHB, PDHX, PDSS1, PDSS2, PDX1, PEX1, PEX10, PEX11B, PEX12, PEX13, PEX16, PEX2, PEX26, PEX3, PEX5, PEX6, PEX7, PFKM, PGAM2, PGK1, PGM1, PHKA1, PHKA2, PHKB, PHKG1, PHKG2, PHYH, PLIN1, PLPBP, PMM2, POLG, POLG2, PPARG, PPOX, PPT1, PRKAG2, PRKAG3, PRODH, PSAP, PTS, PYGL, PYGM, QDPR, RAI1, RBCK1, RFT1, RNASEH2A, RNASEH2B, RNASEH2C, RPN2, RRM2B, RYR1, SAMHD1, SCN4A, SEC23B, SGSH, SLC12A3, SLC16A1, SLC17A5, SLC22A5, SLC25A13, SLC25A15, SLC25A20, SLC25A3, SLC25A4, SLC2A2, SLC30A10, SLC35A1, SLC35A2, SLC35C1, SLC37A4, SLC39A4, SLC3A1, SLC40A1, SLC41A2, SLC41A3, SLC46A1, SLC6A19, SLC6A8, SLC7A7, SLC7A9, SMPD1, SPG7, SRD5A3, SSR4, STT3A, STT3B, SUCLA2, SUCLG1, SUMF1, SUOX, TAZ, TBC1D4, TCF4, TCN2, TFR2, TIMM8A, TK2, TMEM126A, TMEM165, TMEM70, TPP1, TREX1, TRPM6, TRPM7, TUSC3, TWNK, TYMP, UCP2, UROD, UROS, WFS1, ZMPSTE24
15
Each
$
$
0050
Rhabdomyolysis Panel
ACAD9, ACADL, ACADM, ACADVL, AGL, AMPD1, CPT1B, CPT2, ETFA, ETFB, GAA, GYS1, HADHA, HADHB, LPIN1, OPA1, OPA3, PFKM, PGAM2, PGM1, PHKA1, POLG, POLG2, PYGM, RRM2B, RYR1, SUCLA2, TK2, TWNK, TYMP
9
Each
$
$
0051
Comprehensive Cardiac Panel
A2ML1, ABCC9, ACADVL, ACTA2, ACTB, ACTC1, ACTG1, ACTN2, ACVR2B, ACVRL1, ADA2, AGL, AKAP9, ALMS1, ANK2, ANKRD1, APOA5, APOB, B4GALT7, BAG3, BBS10, BCOR, BMPR2, BRAF, C1R, C1S, CACNA1C, CACNA2D1, CACNB2, CALM1, CALM2, CALM3, CALR3, CASQ2, CAV1, CAV3, CAVIN4, CBL, CBS, CCDC103, CCDC39, CCDC40, CHD7, CHRM2, COL3A1, COL5A1, COL5A2, COX15, CPT1A, CPT2, CRELD1, CRYAB, CSRP3, CTF1, CTNNA3, DEPDC5, DES, DMD, DNAAF1, DNAAF2, DNAAF3, DNAAF4, DNAAF5, DNAH11, DNAH5, DNAI1, DNAI2, DNAJC11, DNAJC19, DNAL1, DOLK, DSC2, DSG2, DSP, DTNA, EFEMP2, ELAC2, ELN, EMD, ENG, EYA4, FBN1, FBN2, FGD1, FHL1, FHL2, FKRP, FKTN, FLNA, FLNC, FOXH1, FXN, GAA, GATA4, GATA6, GATAD1, GDF1, GJA1, GJA5, GLA, GPC3, GPD1L, GYG1, HAMP, HAND1, HCN4, HFE, HJV, HRAS, ILK, INVS, JAG1, JPH2, JUP, KAT6B, KCNA5, KCND3, KCNE1, KCNE2, KCNE3, KCNE5, KCNH2, KCNJ2, KCNJ5, KCNJ8, KCNK3, KCNQ1, KCNQ2, KCNQ3, KCNT1, KRAS, LAMA4, LAMP2, LDB3, LDLR, LDLRAP1, LEFTY2, LMNA, LZTR1, MAP2K1, MAP2K2, MED12, MED13L, MFAP5, MIB1, MKS1, MMP21, MRPL3, MTO1, MYBPC3, MYH11, MYH6, MYH7, MYL2, MYL3, MYLK, MYLK2, MYOM1, MYOZ2, MYPN, NDUFAF1, NDUFB11, NEBL, NEK8, NEXN, NF1, NKX2-5, NKX2-6, NME8, NODAL, NOTCH1, NPHP3, NPPA, NR2F2, NRAS, NSD1, OFD1, PCDH19, PCSK9, PDLIM3, PKD1L1, PKP2, PLN, PLOD1, PRDM16, PRKAG2, PRKG1, PRRT2, PSEN2, PTPN11, RAF1, RANGRF, RASA1, RBM20, RIT1, RRAS, RYR2, SCN10A, SCN1A, SCN1B, SCN2B, SCN3B, SCN4B, SCN5A, SCN8A, SCN9A, SDHA, SGCD, SHOC2, SKI, SLC22A5, SLC25A20, SLC2A1, SLC2A10, SLC40A1, SLMAP, SMAD3, SMAD4, SMAD6, SMAD9, SNTA1, SOS1, SOS2, SPRED1, SYNE1, TAZ, TBX1, TBX20, TBX5, TCAP, TFR2, TGFB2, TGFB3, TGFBR1, TGFBR2, TMEM43, TMEM70, TMPO, TNNC1, TNNI3, TNNT2, TPM1, TRDN, TRPM4, TTC8, TTN, TTR, TXNRD2, VCL, YWHAE, ZFPM2, ZIC3
27
Each
$
$
Total Estimated Cost per Year for Mandatory Tests
$
Total Estimated Cost for all three years for Mandatory Tests
$

36C25921Q0618

Preferred Tests - September 30, 2021 through September 29, 2024

CLINS
Generic Test Name
Genes Included (minimum)
ESTIMATED ANNUAL QTY
Unit
Unit Cost
Estimated Annual Total Cost
0052
Custom Panel
varies depending on personal/family history
500
Each
$
$
0053
Ataxia Repeat Expansion Panel
ATN1, ATXN1, ATXN10, ATXN2, ATXN3, ATXN7, ATXN8OS, BEAN1, CACNA1A, FMR1, FXN, NOP56, PPP2R2B, TBP
35
Each
$
$
0054
C9orf72 Gene
C9ORF72
18
Each
$
$
0055
Spinal Bulbar Muscular Atrophy
AR gene
9
Each
$
$
0056
Myotonic Dystrophy Type 1
DMPK
18
Each
$
$
0057
Myotonic Dystrophy Type 2
CNBP
9
Each
$
$
0058
Huntington Disease
HTT
35
Each
$
$
0059
Focal_Segmental Glomerulosclerosis
3
Each
$
$
0060
Carrier Screen
CFTR, SMN1, FMR1
35
Each
$
$
0061
Expanded_Carrier Screen
ABCC8, ABCD1, ACADM, ASPA, ASS1, BCKDHA, BCKDHB, BLM, CFTR, CLN3, CLRN1, DHCR7, DLD, DMD, ELP1, FAH, FANCC, FKTN, FMR1, G6PC, GAA, GALC, GALT, GBA, GJB2, HBA1, HBA2, HBB, HEXA, IDUA, IL2RG, MCOLN1, NEB, OTC, PAH, PCDH15, PEX1, PEX6, PEX7, PKHD1, PMM2, SLC26A4, SMN1, SMPD1, TMEM216, USH2A
35
Each
$
$
0062
Mitochondrial Panel
AAAS, AARS, AARS2, AASS, ABAT, ABCB11, ABCB4, ABCB6, ABCB7, ABCB8, ABCC8, ABCC9, ABCD1, ABCD3, ABCD4, ABHD5, ACACA, ACAD8, ACAD9, ACADL, ACADM, ACADS, ACADSB, ACADVL, ACAT1, ACAT2, ACHE, ACLY, ACO2, ACSF3, ACSL4, ACSL5, ACSM3, ADSL, AFG3L2, AGK, AGL, AGPS, AGXT, AGXT2, AIFM1, AK2, AK3, AKAP10, AKR7A2, AKT1, AKT2, ALAS2, ALDH18A1, ALDH2, ALDH3A2, ALDH4A1, ALDH5A1, ALDH6A1, ALDH7A1, ALDOA, ALDOB, ALG1, ALG11, ALG13, ALG2, ALG3, ALG6, ALG9, AMACR, AMT, ANK2, ANKRD26, APOPT1, APTX, ARG1, ARMS2, ARX, AS3MT, ASL, ASS1, ATAD3A, ATAD3B, ATIC, ATP10D, ATP5F1A, ATP5F1B, ATP5F1E, ATP7B, ATP8B1, ATPAF2, ATXN7, AUH, B4GALT1, BAX, BCAT1, BCAT2, BCKDHA, BCKDHB, BCL2, BCS1L, BOLA3, C12orf65, C19orf12, CA5A, CACNA1A, CACNA1S, CACNA2D1, CARS2, CASP8, CCT7, CDC42BPB, CDKL5, CFTR, CHAT, CHCHD10, CHDH, CHKB, CHRNA4, CHRNB2, CISD2, CKM, CKMT1B, CLCN1, CLCN2, CLCN5, CLCN7, CLCNKB, CLN3, CLN5, CLN6, CLN8, CLPB, CLPP, CLYBL, CNR1, COA5, COA6, COASY, COG4, COG5, COG6, COG7, COG8, COMT, COQ2, COQ4, COQ5, COQ6, COQ7, COQ8A, COQ8B, COQ9, COX10, COX14, COX15, COX20, COX4I1, COX4I2, COX6A1, COX6B1, COX7A1, COX7A2, COX7B, COX8A, CPOX, CPS1, CPT1A, CPT1B, CPT2, CTSD, CYB5A, CYB5R3, CYBA, CYBB, CYC1, CYCS, CYP11A1, CYP11B1, CYP11B2, CYP24A1, CYP27A1, CYP27B1, D2HGDH, DARS, DARS2, DBT, DDAH1, DDC, DDHD1, DDHD2, DDOST, DECR1, DGUOK, DHODH, DHTKD1, DIABLO, DISC1, DLAT, DLD, DMAC2, DMGDH, DNA2, DNAJC19, DNAJC5, DNM1L, DNM2, DOLK, DPAGT1, DPM1, DPM3, DTNBP1, EARS2, ECHS1, ECI1, ECSIT, ELAC2, ELN, ENO1, ENO3, ETFA, ETFB, ETFDH, ETHE1, FAAH, FAH, FARS2, FASN, FASTKD2, FBP1, FBXL4, FDPS, FDX2, FECH, FH, FLAD1, FOLR1, FOXC1, FOXG1, FOXRED1, FTH1, FXN, G6PC, G6PD, GAA, GAD1, GAD2, GALC, GAMT, GARS, GATD3A, GATM, GBE1, GCDH, GCK, GCSH, GDAP1, GFER, GFM1, GFM2, GK, GLDC, GLO1, GLRA1, GLRX5, GLS, GLUD1, GLYCTK, GMPPA, GNAS, GNPAT, GPAM, GPD1, GPD2, GPI, GPX1, GPX4, GSS, GTPBP3, GYG1, GYG2, GYS1, GYS2, H6PD, HADH, HADHA, HADHB, HARS, HARS2, HCCS, HCFC1, HIBCH, HIGD2A, HK1, HK2, HLCS, HMGCL, HMGCS2, HOGA1, HSD17B10, HSD17B4, HSD3B1, HSD3B2, HSPA9, HSPB7, HSPD1, HSPE1, HTRA2, IARS2, IBA57, IDE, IDH1, IDH2, IDH3B, IMMP2L, IMMT, INPP5E, INSR, ISCA2, ISCU, IVD, KARS, KCNA1, KCNE1, KCNE2, KCNH2, KCNJ11, KCNJ2, KCNQ1, KCNQ2, KCNQ3, KIF1B, KRT5, KYNU, L2HGDH, LAMP2, LARS, LARS2, LDHA, LDHB, LETM1, LIAS, LIPT1, LMBRD1, LRPPRC, LRRK2, LYRM4, LYRM7, MAOA, MAOB, MARS, MARS2, MAVS, MCCC1, MCCC2, MCEE, MDH1, MECP2, MECR, MED23, MEN1, MFF, MFN2, MFSD8, MGAT2, MGLL, MGME1, MGST3, MICU1, MLYCD, MMAA, MMAB, MMACHC, MMADHC, MOCOS, MOCS1, MOCS2, MOGS, MPC1, MPDU1, MPI, MPV17, MRPL12, MRPL15, MRPL19, MRPL3, MRPL43, MRPL44, MRPL48, MRPL57, MRPS12, MRPS16, MRPS17, MRPS18A, MRPS22, MRPS7, MRRF, MTCH2, MTFMT, MTHFD1, MTHFD1L, MTO1, MTPAP, MTR, MTRR, MUT, MUTYH, NADK2, NAGS, NARS2, NDUFA1, NDUFA10, NDUFA11, NDUFA12, NDUFA13, NDUFA2, NDUFA4, NDUFA6, NDUFA7, NDUFA8, NDUFA9, NDUFAF1, NDUFAF2, NDUFAF3, NDUFAF4, NDUFAF5, NDUFAF6, NDUFAF7, NDUFB1, NDUFB11, NDUFB3, NDUFB6, NDUFB8, NDUFB9, NDUFC2, NDUFS1, NDUFS2, NDUFS3, NDUFS4, NDUFS5, NDUFS6, NDUFS7, NDUFS8, NDUFV1, NDUFV2, NDUFV3, NFS1, NFU1, NGLY1, NIPSNAP1, NIPSNAP3A, NLRX1, NME1, NNT, NOS3, NPL, NR2F1, NRXN1, NUBPL, OAT, OGG1, OPA1, OPA3, OTC, OXCT1, PACRG, PAH, PAK5, PANK2, PARL, PARP1, PARS2, PC, PCCA, PCCB, PCK1, PCK2, PDHA1, PDHB, PDHX, PDP1, PDSS1, PDSS2, PDX1, PET100, PEX1, PEX10, PEX11B, PEX12, PEX13, PEX14, PEX16, PEX19, PEX2, PEX26, PEX3, PEX5, PEX6, PEX7, PFKM, PGAM2, PGK1, PGM1, PHB, PHKA1, PHKA2, PHKB, PHKG2, PHYH, PKLR, PMM2, PNKD, PNMT, PNPT1, POLG, POLG2, POLRMT, PPARGC1A, PPOX, PPT1, PREPL, PRKAG2, PRKN, PRODH, PRPS1, PTGES2,REEP1, RFT1, RMND1, RMRP, RNASEL, RPL35A, RPS14, RRM2B, RSPH9, RYR1, RYR2, SACS, SARDH, SARS2, SCN1A, SCN1B, SCN2A, SCN4A, SCN5A, SCO1, SCO2, SCP2, SDHA, SDHAF1, SDHAF2, SDHB, SDHC, SDHD, SECISBP2, SERAC1, SFXN4, SHMT1, SHMT2, SIRT1, SIRT3, SIRT5, SLC16A1, SLC19A2, SLC19A3, SLC22A4, SLC22A5, SLC25A1, SLC25A12, SLC25A13, SLC25A15, SLC25A16, SLC25A19, SLC25A20, SLC25A21, SLC25A22, SLC25A3, SLC25A32, SLC25A35, SLC25A38, SLC25A39, SLC25A4, SLC25A42, SLC25A5, SLC25A6, SLC27A4, SLC2A1, SLC2A2, SLC35A1, SLC35A2, SLC35C1, SLC37A4, SLC3A1, SLC5A8, SLC6A8, SLC7A7, SOD2, SPART, SPAST, SPG7, SPR, SPTLC1, SPTLC2, SRD5A3, SSR4, STAR, STT3A, STT3B, STXBP1, SUCLA2, SUCLG1, SUGCT, SUOX, SURF1, TACO1, TAP1, TARS2, TAT, TAZ, TCIRG1, TDP1, TFAM, TFB1M, TIMM13, TIMM44, TIMM50, TIMM8A, TIMM9, TK2, TKT, TMEM126A, TMEM165, TMEM70, TOMM40, TOP1MT, TP53, TPH2, TPI1, TPK1, TPP1, TRIT1, TRMU, TRNT1, TSFM, TSPO, TST, TTC19, TUFM, TWNK, TXN2, TXNRD2, TYMP, UBE3A, UCP1, UCP2, UCP3, UNG, UQCC2, UQCC3, UQCRB, UQCRC2, UQCRQ, UROS, USP24, VARS2, WARS2, WDR4, WFS1, WWOX, XPNPEP3, YARS2, MT-ATP6, MT-ATP8, MT-CO1, MT-CO2, MT-CO3, MT-CYB, MT-ND1, MT-ND2, MT-ND3, MT-ND4, MT-ND4L, MT-ND5, MT-ND6, MT-RNR1, MT-RNR2, MT-TA, MT-TC, MT-TD, MT-TE, MT-TF, MT-TG, MT-TH, MT-TI, MT-TK, MT-TL1, MT-TL2, MT-TM, MT-TN, MT-TP, MT-TQ, MT-TR, MT-TS1, MT-TS2, MT-TT, MT-TV, MT-TW, MT-TY
18
Each
$
$
0063
Exome Sequencing
All 22,000 Genes
25
Each
$
$
0064
Genome Sequencing
5
Each
$
$
0065
Polygenic risk scores
breast cancer, prostate cancer, colon cancer, cardiovascular
300
Each
$
$
0066
Pharmacogenetic
HLA-A, HLA-B, HLA-DQA1, HLA-DRB1, NAT2, CYP2D6, TPMT, NUDT15, UGT1A1, DPYD, CYP2C9, CYP2C19, BCHE, CYP3A5, CYP4F2, VKORC1, SLO1B1
50
Each
$
$
0067
Pharmacogenetic
HLA-A, HLA-B, CYP2B6, CYP2D6, CYP2C9, CYP2C19, CYP3A5, CYP4F2, UGT1A1, TPMT, NUDT15, DPYD, CACNA1S, RYR1, CFTR, IFNL3, IFNL4, G6PD, SLCO1B1, VKORC1, POLG, MT-RNR1, GBA,
50
Each
$
$
0068
Paired tumor/germline
Following abnormal Lynch syndrome screening or VUS in multiple cancer types
100
Each
$
$
Total Estimated Cost per Year for Preferred Tests
$
Total Estimated Cost for all three years for Preferred Tests
$

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement…

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