36C25524Q0640.docx

36C25524Q0640

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.

UEI:

EFT:

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 ATTACHED

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. SIGNATURE 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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

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

36C25524Q0640 Buchanan, Lisa A/lisa.buchanan1@va.gov 913-946-1990 10-11-2024

10:00 AM

CDT

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 X X 621511 $41.5 Million N/A X Department of Veterans Affairs Kansas City VAMC 4801 East Linwood Blvd.

Kansas City MO 64128 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

36C255 Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin TX 877-353-9791 512-460-5429 See CONTINUATION Page

ALPHA 1 ANTI-TRYPSON TESTING- KANSAS CITY VAMC

The purpose of this solicitation is to establish a firm fixed price for Alpha1 Anti-Trypson Testing Kansas City VA Medical Center. The Period of Performance is November 1, 2024-October 31, 2025.

See Section B.3 Performance Work Statement for full details.

This solicitation is 100% Set-aside for Small Business.

All questions are due no later than Friday, October 4, 2024 at 8:00AM CST.

Responses are due no later than Friday, October 11, 2024 10:00AM CST and should be emailed to lisa.buchanan1@va.gov.

See CONTINUATION Page x x Buchanan, Lisa A Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C255

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

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Financial Services Center http://www.fsc.va.gov/einvoice.asp ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 ADDITIONAL CONTRACT ADMINISTRATION DATA

All contract administration functions will be retained by the Department of Veterans Affairs. The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

Acronyms and Definitions CDR: Contract Discrepancy Report. Report issued by the Government to the contractor to document a supply or service found to be unacceptable during contract performance.

CLIN: Contract Line Item Number. Unit of work (or service) to be performed (or delivered) by the contractor as a pay item.

CO: Contracting Officer. A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

POC: An individual, authorized by the contracting officer to perform specific technical or administrative functions related to the contract.

QA: Quality Assurance. Actions taken by the government to assure contracted services meet PWS requirements.

QASP: Quality Assurance Surveillance Plan. A written document specifying the method used for surveillance of contractor performance.

PWS: Performance Work Statement.

Personnel

1. Non-Personal Services

a. This is a non-personal services contract. Personnel rendering services under this contract are not subject either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees. The Government shall not exercise any supervision or control over the contract service providers performing services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

2. Contractor Compliance with the Immigration and Nationality Act of 1952

a. The Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals.

Hours of Operations Business hours for the VAMC follow:

a. Administrative hours: Monday through Friday, 8:00 a.m. - 4:30 p.m.

· National Holidays: The 10 holidays observed by the Federal Government are:

· New Year’s Day;

· Martin Luther King’s Birthday;

· Presidents Day;

· Memorial Day;

· Independence Day;

· Labor Day;

· Columbus Day;

· Veterans Day;

· Thanksgiving;

· Christmas; and

· any other day specifically declared by the President of the United States to be a national holiday.

b. Off-Duty hours: Monday through Sunday 4:30 pm – 8:00 am.

Quality Control

1. CONTRACT PERFORMANCE MONITORING. The COR may perform surveillance of services by any of the methods listed below:

a. Observing actual performance;

b. Inspecting the services to determine whether or not the performance meets the performance standards; and

c. Review of any other appropriate records.

2. When unacceptable performance occurs, the COR shall inform the Contractor and the Contracting Officer. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file. When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor program manager. The Contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor has to present this corrective action plan to the COR. The Government shall review the Contractor corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer.

3. Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer representative(s); The Government shall periodically evaluate the Contractor performance by appointing a Contracting Officers Representative (COR) to monitor performance to ensure services are received. The Government representative(s) shall evaluate the Contractor performance through inspections of observations, inspection of services or any other form of documentation and all complaints from VA personnel. The Government may inspect as each task is completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures or because of repeated customer complaints. Likewise, the Government may decrease the number of quality assurance inspections if performance dictates. The Government Contracting Officer shall make final determination of the validity of customer complaint(s).

4. If any of the services do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may –

a. Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government.

Contract Security 36C25524Q0640 “The C&A requirements do not apply and a Security Accreditation Package is not required”.

Page 1 of Page 1 of

B.3 PERFORMANCE WORK STATEMENT

BACKGROUND

Alpha-1 antitrypsin (AAT) is a protein that has both anti-inflammatory and anti-proteolytic functions and serves to limit protease-induced injury to lung matrix proteins. A deficiency of AAT predisposes patients to chronic obstructive pulmonary disease (COPD) as well as other disorders including bronchiectasis and liver disease. Early identification of patients with alpha-1 antitrypsin deficiency (AATD) allows for interventions that can slow the effects of this disease, and improves morbidity, loss of lung function and mortality. The AAT buccal swab test is minimally invasive, allowing for collection in clinic as soon as at-risk patients are identified, therefore increasing detection of the disease.

SCOPE OF PROCUREMENT:

1. The Government will award to a single contractor for Alpha-1-antitrypsin Buccal Swab Testing Services.

2. Alpha-1-antitrypsin Buccal Swab Testing Services include but are not limited to specimen storage; transportation of clinical laboratory specimens; performance of analytical testing; reporting of analytical test results; and consultative services.

3. VISN 15 intends to establish the base year of the agreement starting 11/1/2024, with contract completion on 10/31/2029. This will be a firm fixed price contract with a base plus four option years.

4. Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide comprehensive genomic profile services to the Kansas City VA Medical Center and it’s respective CBOCs.

5. Contractor agrees to the following terms of the agreement exclusively with the VISN facilities listed by Attachment A and awarded in the final agreement. However, as requirements change, facilities within VISN 15 may be added or deleted by supplemental agreement of the Government and the Contractor.

GENERAL QUALIFICATIONS

Alpha-1-anti-trypsin Testing

1. The contractor shall provide testing using multiplex Polymerase Chain Reaction (PCR) methodology that identify less frequent rare alpha1 antitrypsin (AAT) deficient alleles.

2. The PCR allele-probes specific must provide detection of allelic variants to include Z, S, F, I mutations and rare alleles associated with AAT deficiency. The test must have the ability to identify 14 allelic variants of the SERPINA gene and identify the most frequently associated AAT deficiency.

a) The contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide Alpha-1-anti-trypsin Buccal Swab Testing Services to Kansas City VA Medical Center, Kansas City MO.

3. Alpha-1-anti-trypsin Buccal Swab Testing Services include but are not limited to specimen storage; transportation of clinical laboratory specimens; performance of analytical testing; reporting of analytical test results; and consultative services.

4. Orders will be initiated when ordered by a physician. Each test will be patient specific; the need is Veteran specific.

5. The Contractor shall provide electronic access to data elements necessary to populate the data tables associated with result reporting within the Veterans Affairs Hospital Information System (HIS) or current Government Laboratory Information System (LIS). This information, at a minimum, shall include the following data elements:

a) Ordering Code (Contractor's Identification Code)

b) LOINC - Logical Observation Identifier Names and Codes

c) Test methodology

d) Test Description, including reference ranges (when appropriate, age and sex adjusted) and units of measurement

e) Specimen collection and handling requirements

f) Test result interpretation or interpretive remarks, if appropriate

6. All testing shall be performed on the Contractor’s premises, or within the Contractor's network of laboratories. Under no circumstances shall the Contractor allow any patient information or lab testing samples to be sent outside the confines of the internationally recognized borders of the United States of America.

Licensing, Accreditation and Certifications

1. Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The Contractor shall have all licenses, permits, accreditation and certificates required by law. The reference laboratory shall be licensed/accredited by the College of American Pathologists (CAP). In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988.

2. The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of all sanctions current or pending throughout the United States of America prior to BPA award. Changes to the requirements shall be addressed by bilateral modification.

3. Contractor Personnel assigned by the Contractor to perform the services covered by this BPA shall be eligible to provide the services of this BPA 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 this BPA shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this BPA shall be licensed by the governing or cognizant licensing board.

4. Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA).

5. The Contractor shall notify the Contracting Officer in writing of all malpractice investigation or licensure or certification suspension that concerns the Contractor or Contractor personnel, or any discovery of any disciplinary action taken against laboratory(ies) performing under the BPA within 24 hours of notification of an investigation or suspension.

6. Contractor Personnel: The Contractor shall maintain current accreditation and notify the Contracting Officer of all lapses in state license, Clinical Laboratory Improvement Amendments (CLIA) certification, or clinical pathology certification. The Contractor shall provide a copy of the renewed licenses/certificates to the Contracting Officer before expiration.

7. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst.

CONTRACTOR’S RESPONSIBILITIES:

Specimen Preparation and Storage or specimens

1. Contractor shall supply each Government facility with its commercial laboratory reference test manual to ensure that the collection and storage of specimens are in accordance with Contractor’s requirements. The testing methodology and reference ranges for a test must be defined in the Contractor’s laboratory reference test manual.

2. The Contractor shall ensure that all tests performed meet the currently acceptable standard deviation and that have daily controls conducted to determine testing accuracy. Upon request by the Contracting Officer (CO) or assigned Contracting Officer’s Representative (COR) for the applicable facility and the Contractor shall make available quality assurance information on specific testing procedures for review.

3. Supplies: The Contractor shall provide all materials and necessary supplies to collect and preserve specimens that are destined to the commercial reference laboratory for testing. These materials and supplies include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory. Testing materials and supplies include:

a) Requisition forms

b) Special instructions

c) Specimen transport containers and shipping forms, to include refrigerated packaging (if applicable).

d) Special media or tubes for samples

4. Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen.

5. The Contractor shall contact the assigned COR for the applicable facility within a minimum of five (5) calendar days after award to coordinate the furnishing and delivery of specimen collection and transportation supplies. The Contractor shall provide a mechanism for specimen pickup. The Contractor shall provide to the ordering facility the supplies and equipment within two (2) workdays after receipt of order. The assigned COR or assigned representative for each facility will request replenishment of supplies from the Contractor on an as needed basis.

Transportation Services for Samples:

1. Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor’s laboratory. These supplies shall include, but may not be limited to:

a) Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor’s laboratory.

b) Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates.

c) Test request forms preprinted with the appropriate Shipping Section details and account information.

d) Test request forms for specialized testing (i.e., cytogenetics, tissue, etc.).

e) The specimen will be returned to ordering facility, free of charge.

Specimen Testing

1. The Contractor shall provide the full range of clinical diagnostic testing capabilities to execute all required Alpa-1-anti-trypsin testing services as annotated in Attachment A. Contractor shall make available the following test information:

a) Requisition form requirements

b) Test order code

c) Specimen collection and preservation requirements

d) Test method employed (indicate if testing performed in duplicate) and interpretations

e) Test reference intervals adjusted for age, sex or race, when required

f) Test specific sensitivity, specificity and interferences, when required

g) Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between pick-up of specimen by the Contractor and receipt of results by a Government facility.

h) Schedule of test performance (specific days of week indicated)

i) Location of test performance by test name (i.e., name of primary laboratory, name of separate branch/division of primary lab).

2. Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change.

3. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.

4. The Contractor shall ensure the accurate and timely performance of laboratory testing services on the biomedical materials.

Reporting of Results

1. A report of laboratory testing results must be issued either as a printed final copy or through the host-to-host electronic transmission of the test results. The Contractor shall deliver the reports without an additional charge by expedited overnight courier shipping, mailing within 24 hours, or by telephone facsimile to a protected machine identified to the Contractor by the VA. Delivery by electronic mail i.e., MS Outlook, etc. is prohibited.

2. Each test report shall, at minimum, include the following information:

a) Patient's full name

b) Patient’s identification number, e.g., social security number (SSN)

c) Physician’s name (if supplied)

d) Government laboratory accession number (if supplied)

e) Submitting facility name

f) Submitting facility account number

g) Patient's location (clinic/ward) (if supplied)

h) Test(s) ordered

i) Date/time of specimen collection (when available)

j) Date/time test completed

k) Test result

l) Reference laboratory accession number

m) Name and address of testing laboratory

n) Any other information the laboratory has that may indicate a questionable validity of test results.

o) Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing.

3. Test results determined by the contractor to be critical, shall be communicated by telephone to a designated Government contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by an electronic transmission.

Customer Service

1. Contractor shall provide customer service that is accessible by toll-free telephone service 24 hours per day; 7 days per week to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this BPA.

2. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the BPA performance period:

a) Telephone Inquiries – Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the Government’s minimum time expectation for meeting this service.

Specimen Collection

1. Routine inquiries, questions and clarifications regarding collection requirements shall be addressed at the time of the initial call.

2. Esoteric inquiries, questions and clarifications regarding collection requirements that require further research shall be addressed within

3. ½ hour of the initial call.

Testing

1. Inquiries regarding the status of pending orders shall be addressed at the time of the initial call.

2. Esoteric inquiries when information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial call.

3. Technical Expertise

4. Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two business hours of initial call.

5. Result interpretation inquiries shall be addressed within four business hours of initial call.

6. Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four business hours of the initial call.

Account follow-up

1. Information general in nature yet specific to the account, e.g., test pricing, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial call.

2. The Contractor shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc.

3. The Government will place orders for specimen collection and transportation supplies and materials by telephone or through written or electronic methods.

Consultative Services

1. Contractor shall prove consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation.

SPECIAL CONTRACTOR REQUIREMENTS

Services

1. Contractor is required to maintain medical liability insurance for the duration of this BPA. Medical Liability insurance must cover the provider(s) for services in all states where services are rendered by the provider. Contractor must indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during BPA performance.

2. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the BPA.

3. Contractor shall not, under any circumstances, furnish reports directly to patients

Qualifications/Requirements of Laboratory & Contractor Personnel

1. Laboratory

a) Offeror must have at least three years of experience in providing laboratory testing services and must have at least one-year experience in transporting biomedical materials.

b) Offerors, including subcontractor(s), must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency(s) with deemed status from the Centers for Medicare & Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The reference laboratory (ies) must maintain valid certifications during the entire performance period of this contract.

c) Copies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America must be supplied in response to this solicitation. In addition, as these documents are reissued or re-awarded, the awarded Contractor must supply a copy to the Contracting Officer’s Representative assigned to each Government facility. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary Contractor.

d) Contractor must notify immediately the Contracting Officer’s Representative (COR) at each of the Government facilities in writing, upon its loss of any required certification, accreditation or licensure.

e) Contractor shall 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.

2. Designation of Contract Representatives

a) The Regional Laboratory Manager – VISN 15 Pathology & Laboratory Medicine Services (PLMS), Kansas City, MO, will be designated as the Lead Contracting Officer Representative (COR) to represent the Contracting Officer in furnishing guidance and advice regarding the work being performed under this contract. The appointed COR will provide technical guidance, verify services were actually performed, and also verify that documentation for services performed is received prior to certifying payment.

3. Contract Performance Monitoring

a) Monitoring of contractor’s performance shall be demonstrated through clinical and administrative record reviews. COR will be responsible for verifying contract compliance. Contracting Officer's Representative(s) (COR) will designate appropriate VA personnel to monitor services through one or a combination of the following mechanisms:

i. Departments being served will monitor Contractor performance to ensure that services called for in the contract have been received by VA in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer.

ii. Documentation of services performed will be reviewed prior to certifying payment. The COR will perform periodic spot checks and document with the using service to ensure records monitoring. VA will pay only for services actually provided, and in strict accordance with the Price Schedule. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided.

4. Quality Assurance Monitoring

a) Contractor shall maintain a Quality Assurance Program related to Reference Laboratory services covered under this contract. The Government shall verify that services being performed by the Contractor are acceptable and in accordance with established standards and requirements of this contract.

b) Contractor shall also participate in a joint quality assurance surveillance program (QASP) with the Government facilities. This program must minimally address the quality aspects representative to the testing process, i.e., pre-analytical, analytical, and post-analytical variables and include a description of monitoring and evaluation activities. There must be a mutually agreed upon procedure for responding to issues, problems and/or concerns identified by the Government with details as to whom and in what timeframe the matters will be reconciled. The issues that may need to be addressed may be general in nature or specific to an incident or event. The contractor will meet or communicate with the facility/VISN 15 staff for process review and improvement of contract performance on an as needed basis.

c) Copies of licensure/certifications are also required to be submitted upon request

d) Quality factors that VA may consider when monitoring quality of care may include, but are not limited to: patient medical records, security/privacy, adverse event reporting, turn-around times, timeliness to customer service requests, missed/delayed routes, etc.

The Authorization requirements do not apply, and that a Security Accreditation Package is not required

5. Quality Assurance/Quality Control

a) The Contractor facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the government at any time during the term of the contract.

b) The Contractor shall comply with all applicable OSHA, Federal laws, State laws, the Joint Commission, and regulations as required for performing the type of services required.

c) The Contractor shall comply with the following Quality Assurance guidelines relating to shipping and test performance:

i. Number of modified test results, not due to incorrect requisition information from the referring lab: <0.02% per year

d) In all cases, surveillance shall not be so intrusive as to impact the Contractor’s successful accomplishment of the mission.

e) When unacceptable performance occurs, the assigned COR for the applicable facility shall inform the Contractor and contracting officer. This notification shall normally be in writing unless circumstances necessitate verbal communication.

In any case, the assigned COR for the applicable facility shall document the discussion and provide a copy of the document to the Contractor and Contracting Officer. When the assigned COR for the applicable facility determines formal written communication is required, the assigned COR for the applicable facility shall prepare a Contract Discrepancy Report (CDR) and present it to the Contractor's program manager and the Contracting Officer. The Contractor shall acknowledge receipt of the CDR in writing. The CDR shall specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR shall also state how long after receipt the Contractor must present this corrective action plan to the assigned COR for the applicable facility. The assigned COR for the applicable facility and Contracting Officer shall review the Contractor's corrective action plan to determine acceptability. All CDRs may become a part of the supporting documentation for any action deemed necessary by the Contracting Officer.

f) Quality assurance monitoring documentation shall become an official Government record of the Contractor’s performance.

6. Transportation

a) Specimen Shipment

i. Sample Preparation: Each ordering activity shall prepare and package laboratory specimens in accordance with the requirements defined in the Contractor's laboratory user’s manual. The Contractor shall provide at no charge an adequate supply of requisition forms, specimen collection materials, cooling packs, and special instructions. These requirements shall be defined in the laboratory user manual. The Contractor shall supply any special preservatives required for specimen preservation. Each ordering activity is responsible for packaging the specimens.

b) Shipping Biological and Infectious Substances:

i. Regulatory Requirements. The regulations governing the packaging and shipment of biological, infectious, and hazardous substances are primarily found in 49 CFR parts 100-185 and 397. The parts of 49 CFR specifically dealing with biological and infectious specimens are 107, 171, 172, and

173. While the majority of shipments packaged and processed by the clinical laboratories are classified as diagnostic specimens, all specimens, as well as any select agents and toxins that are identified, must be packed and shipped in accordance with the applicable guidance provided in 49 CFR. Contractor or Subcontractors that package, transport, or ship biological, infectious, and hazardous substances shall comply with all laws, regulations, and policies of Federal, State, and Local governments, the Centers for Disease Control (CDC), Department of Transportation (DOT), International Air Transport Association (IATA), and the Department of Veterans Affairs.

7. Release of Medical Information:

a) The Contractor shall release medical information obtained during the course of this contract to authorized VISN staff.

SERVICE DELIVERY SUMMARY

Performance Requirement

The Contractor shall provide reference laboratory’s current license/accreditation by the College of American Pathologists

(CAP).

GENERAL QUALIFICATIONS

Licensing, Accreditation and Certifications Pg 2 100% - No deviations accepted

Licensing, Accreditation and Certifications 100% - No deviations accepted

Pathology certified pathologist or appropriately certified bio-analyst.

The Contractor shall contact the assigned COR for the applicable facility within a minimum of five

(5) calendar days after BPA award to coordinate the furnishing and delivery of specimen collection and transportation supplies.

CONTRACTOR’S RESPONSIBILITIES:

Specimen Preparation and Storage or specimens Pg 4 97% of time

Specimen Preparation and Storage or specimens Pg 4 97% of time

Changes to test information modifications shall be made to the Government no later than two weeks prior to implementation date of test change.

CONTRACTOR’S RESPONSIBILITIES:

Specimen testing Pg 5 100%

The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint Commission, and regulations as required for performing the type of services required.

SPECIAL CONTRACTOR REQUIREMENTS

Qualifications/Requirements of Laboratory & Contractor Personnel Pg 9 100%. No deviations accepted.

B.4 PRICE/COST SCHEDULE

ITEM INFORMATION

Buccal AlphaD Screening Test:

includes test kit and mailer Contract Period: Base POP Begin: 11-01-2024 POP End: 10-31-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Buccal AlphaD Screening Test:

Contract Period: Option 1 POP Begin: 11-01-2025 POP End: 10-31-2026

Buccal AlphaD Screening Test:

Contract Period: Option 2 POP Begin: 11-01-2026 POP End: 10-31-2027

Buccal AlphaD Screening Test:

Contract Period: Option 3 POP Begin: 11-01-2027 POP End: 10-31-2028

Buccal AlphaD Screening Test:

Contract Period: Option 4 POP Begin: 11-01-2028 POP End: 10-31-2029

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(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 Federal Acquisition Regulation (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 to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this…