RFP 36C10G25R0041_Laboratory Accreditation Services.pdf

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. 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 PRODUCTS AND COMMERCIAL SERVICES

36C10G25R0041 07-02-2025

07-25-2025

3:00 PM ET

36C10G U.S. Department of Veterans Affairs Strategic Acquisition Center 10300 Spotsylvania Ave

Fredericksburg VA 22408

X

Y

813920

$23.5 Million

N/A

X

36C10G

U.S. Department of Veterans Affairs

OPAL

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

36C10G

U.S. Department of Veterans Affairs Strategic Acquisition Center 10300 Spotsylvania Ave

Fredericksburg VA 22408

TBD

GQHJXSKK19R5

U.S. Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin TX 78714-8917

The purpose of this solicitation is to provide Accreditation Services for the Veterans Health Administration Laboratory facilities.

X X

X 1

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 ACKNOWLEDGMENT OF AMENDMENTS:

B.3 PERFORMANCE WORK STATEMENT

B.4 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.202-1 DEFINITIONS (JUNE 2020)

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR

2000)

C.8 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)

C.9 COMPLIANCE WITH EXECUTIVE ORDER 13899. (DEVIATION) (APR 2025) ... 60

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.11 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.12 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.13 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.14 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025) DEVIATION (FEB 2025)

C.15 MANDATORY WRITTEN DISCLOSURES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.204-24 REPRESENTATION REGARDING CERTAIN

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR

EQUIPMENT (NOV 2021)

E.2 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.3 52.209-2 PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC

CORPORATIONS-REPRESENTATION (NOV 2015)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY

MATTERS (OCT 2018)

E.5 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.6 QUOTE SUBMISSION INSTRUCTIONS

E.7 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.8 BASIS FOR AWARD

E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

E.10 52.216-1 TYPE OF CONTRACT (APR 1984)

E.11 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.12 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (SEP 2018)

E.13 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEB 1998)

THIS SECTION INTENTIONALLY LEFT BLANK / SEE NEXT PAGE

CONTINUATION PAGE 36C10G25R0041 Page 4 of 119

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:

Contractor Name: TBD

b. GOVERNMENT:

Contracting Officer 36C10G Primary: Rodney Burgos Cabassa, Rodney.burgoscabassa@va.gov Alternate: TBD Alternate: TBD

Contact Specialist 36C10G Primary: Nicole Lowther, Nicole.Lowther@va.gov Alternate: TBD Alternate: TBD

U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

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, or

[ ] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. [ ] Monthly

b. [ ] Quarterly

c. [ ] Semi-Annually

d. [X] Upon completion of work; quantities identified per CLIN; and/or monthly.

mailto:Rodney.burgoscabassa@va.gov mailto:Nicole.Lowther@va.gov

CONTINUATION PAGE 36C10G25R0041 Page 5 of 119

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:

U.S. Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin TX 78714-8917

5. FSC MANDATORY ELECTRONIC INVOICE SUBMISSION: Contractors are required to submit payment requests in electronic form in accordance with the submission instructions.

TUNGSTEN ELECTRONIC INVOICE SUBMISSION

FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

Contracting POC: Nicole Lowther, Nicole.lowther@va.gov COR (Contracting Officers Representative): TBD Contract Number: 36C10G25D00XX Purchase Order Number: N/A

a. Vendor Electronic Invoice Submission Methods: Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below.

1. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website:

http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

2. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org)

b. Vendor e-invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below.

1. Tungsten e-Invoice Setup Information: 1-877-489-6135

2. Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.x12.org/ mailto:VA.Registration@Tungsten-Network.com

CONTINUATION PAGE 36C10G25R0041 Page 6 of 119

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

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

See https://www.fsc.va.gov/einvoice.asp for more information.

6. MINIMUM GUARANTEE: The minimum amount that the Government agrees to order under the contract is $500,000.00. The Government's obligation for the contract minimum applies only to the base period of the awarded contract.

7. MAXIMUM CEILING AMOUNT: The maximum ceiling amount is $15,000,000.00 for this contract.

B.2 ACKNOWLEDGMENT OF AMENDMENTS:

The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

THIS SECTION INTENTIONALLY LEFT BLANK

AMENDMENT NO DATE

mailto:vafsccshd@va.gov https://www.fsc.va.gov/einvoice.asp

CONTINUATION PAGE 36C10G25R0041 Page 7 of 119

B.3 PERFORMANCE WORK STATEMENT

A. GENERAL INFORMATION

A.1. Title of Project:

Pathology and Laboratory Medicine (PLM) Laboratory Accreditation Service

A.2. General History:

The Pathology and Laboratory Medicine (PLM) National Enforcement Office (NEO) is granted authority as the Clinical Laboratories Improvement Amendment (CLIA) provider for Veterans Health Administration (VHA) to oversee and approve laboratory activities of every VHA laboratory, enterprise-wide under 38 C.F.R. § 17.3500. As part of this authority, the Department of Veterans Affairs (VA), VHA has a requirement for non-personal services to provide laboratory accreditation services to monitor quality and compliance with federal regulations. These services must be performed by a contractor identified by the Centers for Medicare and Medicaid Services (CMS) as a “deemed” accrediting agency under the CLIA per VHA Directive 1106.

VHA Laboratory accreditation services have been provided by a contractor for VHA clinical laboratories and community-based outpatient centers (CBOCs) for over 40 years. Due to the specialized nature of these services, VA staff are not equipped with the expertise to perform these audits. The laboratory accreditation services include continuous monitoring, on-site audit and pre/post audit activity for all VHA laboratories that perform laboratory testing classified as moderate or high complexity by the U.S. Food and Drug Administration (FDA). The contractor shall align and follow the Centers for Medicare and Medicaid Services (CMS) audit process for the required elements of the PWS.

The audit activity must occur as outlined in federal statutes and regulations:

1. 42 USC 263a - Certification of laboratories (also known as Clinical

Laboratory Improvement Amendments of 1988 (CLIA))

2. 42 CFR Part 493 Subpart E - Accreditation by a Private, Nonprofit

Accreditation Organization or Exemption Under an Approved State Laboratory Program

3. 38 CFR 17.3500 - VA application of 42 CFR part 493 standards for clinical laboratory operations

4. VHA Directive 1106 - Pathology and Laboratory Medicine Service

5. VHA Directive1100.16 - Health Care Accreditation of VHA Facilities and

Programs

A.3. Overall Desired Outcomes/Objectives:

The objectives of this requirement are to have biennial on-site audits and continuous monitoring services for laboratory accreditation for VHA clinical laboratories and community-based outpatient clinics (CBOCs) that perform moderate and/or high complexity testing.

CONTINUATION PAGE 36C10G25R0041 Page 8 of 119

Accreditation services ensure that laboratory facilities meet the necessary standards for providing high-quality, accurate, and reliable diagnostic testing, and medical services for veterans. Accreditation helps verify that the lab’s processes, equipment, and personnel adhere to regulatory and professional guidelines, ensuring laboratories maintain compliance with safety, quality assurance, and operational protocols that align with the standards set by the Department of Veteran Affairs. Laboratory accreditation confers recognition that a laboratory meets certain standards of quality, safety, and compliance with healthcare quality standards.

The purpose of this service is to assure quality laboratory service through:

1. auditing of laboratory services through direct observations and record reviews against requirements outlines in section C.6 below.

2. assessing clinical laboratories to determine if each CLIA location is in compliance with applicable 42 C.F.R. Part 493 and VHA Directive 1106 requirements.

3. evaluating corrective action responses to non-conformance and/or deficiencies identified during audit for compliance with requirements.

4. providing information on best practices and the standards of care as appropriate.

5. continuously monitor compliance throughout audit cycle.

6. investigating quality complaints or issues related to audit elements.

7. making a final determination of accreditation of laboratory services for each CLIA location audited.

B. SCOPE OF WORK

The contractor shall perform all services as defined in the PWS. The contractor shall provide all qualified personnel, equipment, supplies, facilities, transportation, travel, tools, materials, supervision, and other items and non-personal services necessary to successfully perform the services as defined in this PWS except for those items specified as Government furnished property and services. Contractor shall ensure requirements in PWS are accomplished in accordance with (IAW) the applicable deliverables list in Section D: Contract Documents, Exhibits, or Attachments. No Government employee shall be used for, or perform any portion of, the audit.

The Government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual contractor employees. It shall be the sole responsibility of the contractor to manage its employees and to guard against any actions in the PWS that are of the nature of personal services or give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor’s responsibility to notify the Contracting Officer (CO) immediately.

CONTINUATION PAGE 36C10G25R0041 Page 9 of 119

This requirement outlines the laboratory accreditation services for VHA laboratories with CLIA defined Food and Drug Administration (FDA) complexity levels of high or moderate, where patient testing is performed. This requirement includes laboratories across the VHA enterprise encompassing all CLIA specialties and subspecialties. There are approximately 257 VHA patient testing CLIA certificate defined sites that require accreditation under this requirement. Based on FDA categorization, there are 230 sites of high complexity and 27 of moderate complexity. Additional locations may be added based on VHA need throughout the life of the contract, but not to exceed 275 locations. VHA laboratory testing sites are currently located in the contiguous 48 states as well as Alaska, Hawaii, Philippines, and Puerto Rico.

See Technical Exhibit A (Attachment 1) for current VHA laboratory CLIA Number, Laboratory Name, Location, Accreditation End Date, Complexity Level, Facility type, Parent Facility Affiliation, Pathologist Auditor Indicator, NEO Region for each VHA laboratory that is a VHA patient testing CLIA certificate designed site that necessitates accreditation under this requirement.

NOTE: There are several activities that will not be required to be accredited under this acquisition. CMS may require contractors to have some activities in place for commercial laboratory audits as part of their “deemed” accrediting authority. VHA has internal or alternate vendors providing some services as allowed under 38 CFR§

17.3500. It is understood that the contractor will only issue accreditation to activities that are audited, in accordance with this PWS. In order to prevent duplication of work, the following activities are prohibited by the contractor at VHA locations and are not a requirement of this acquisition.

1. Blood bank/Transfusion service accreditation or audit of Immunohematology specialty/subspecialties, except Therapeutic Phlebotomy review as outlined in C.6.2

2. Audits of VHA laboratory locations that hold a CLIA certificate for only FDA classified Waived or Provider Performed Microscopy (PPM) testing.

3. Proficiency Testing (PT) activities must not be assessed during an on-site audit.

Including PT record review of:

• evaluation sheets

• attestation sheet signatures

• coded results

• unacceptable PT notices/results

• failures

• result review sign offs

• corrective action documentation

B.1. Quality Assurance

B.1.1. Quality Assurance:

The contractor shall have an established Quality Assurance Program which details procedures to verify services being performed to those Government standards according to the Acceptable Performance

CONTINUATION PAGE 36C10G25R0041 Page 10 of 119

Objectives (APO) and Acceptable Quality Levels (AQLs).

B.1.2 Quality Assurance Plan (QAP):

The QAP shall demonstrate effective measures of the accuracy, quality, and reliability of adherence to the requirements of this contract throughout the contract’s duration. The QAP shall provide a detailed description of the management and operational strategy which sequences the events that this organization shall employ to ensure prompt and efficient delivery of the products and services required.

The QAP is developed by the contractor and submitted to the Government in compliance with their contract deliverables. The Contractor, and not the Government, is responsible for management and quality control actions necessary to meet the quality standards set forth by the contract performance. The QAP shall be used to guide and to comprehensively document the implementation of the required management and quality control actions to achieve the specified results/outcomes.

B.1.3 Government Observations / Evaluations:

The COR will conduct evaluations of deliverables supplied as part of

Activity 4 (Reports) below, as well as VHA laboratory feedback and audits of contractor work. Deliverable observations are inclusive of the contractor’s compliance to following the PWS deliverables, and administrative functions.

The COR reserves the right to conduct observations / evaluations of the audit process, both for any virtual or onsite audit. Audit observations are inclusive of the contractor’s auditors’ compliance in following the CMS audit process, PWS deliverables, professional accountability, adherence to required infection control protocols, and accuracy of auditors’ assessment and interpretation of 42 CFR. part 493 regulations.

B.2. Contract Information

B.2.1. Period of Performance:

The period of performance shall be a 12 month base period and four, 12 month option periods. As prescribed in Federal Acquisition Regulation (FAR) 17.208 option periods for services, when the inclusion of an option is appropriate per FAR 52.217-9, “Option to Extend the Term of the Contract” and 52.217-8 “Option to Extend Services” the Government may require continued performance of any services within the limits and at the rates specified in the contract.

The Government may require continued performance of any services within the limits and at the rates specified in the contract in accordance with FAR 52.217-8. There is the possibility that the option can be exercised at any time and can be exercised in increments of one to six

CONTINUATION PAGE 36C10G25R0041 Page 11 of 119 months, but for no more than a total of six months during the life of the contract. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be at the same rates as those in effect under the contract at the time the option is exercised.

Base Year September 15, 2025 – September 14, 2026 Option Year 1 September 15, 2026 – September 14, 2027 Option Year 2 September 15, 2027 – September 14, 2028 Option Year 3 September 15, 2028 – September 14, 2029 Option Year 4 September 15, 2029 – September 14, 2030

B.2.2. Type of Contract:

The Government will award a single Indefinite Delivery/Indefinite Quantity (ID/IQ) Fixed Price (FP) contract.

Firm Fixed Price (FFP) Task Orders (TOs) will be placed during the period of performance for required services per Federal Acquisition Regulation (FAR) 16.504 Indefinite-Quantity Contract.

B.2.3. Place of Performance:

The work to be performed under the resulting contract will be performed at VHA facilities requiring audit under this contract, through virtual meetings, and at the contractor’s facility.

B.2.4. Recognized Holidays:

The contractor shall not perform services on the following Federal holidays.

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veterans Day Memorial Day Thanksgiving Day Independence Day Christmas Day Juneteenth

B.2.5. Hours of Operation:

The Contractor is responsible for conducting business on-site between the hours of 08:00 – 4:30 (local time for the facility being audited), Monday thru Friday, except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility unavailability such as, blackout dates for individual location on-site audits outlined in C.6.2 shall also be observed when planning on-site activity.

B.2.6. Business Day:

For purposes of communication with and submission of deliverables to the Government, an administrative business day is 7:30am Eastern Time to 5:00pm Eastern Time. These are the days between and including Monday to Friday and do not include public holidays and

CONTINUATION PAGE 36C10G25R0041 Page 12 of 119 weekends, or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closing.

B.2.7. Government Furnished Equipment, Items, and Services This contract shall not provide any Government Furnished Equipment, Items, or Services.

B.3. Contract Terms & Conditions These supplemental terms and conditions have the full force and effect of any other terms and conditions contained in the solicitation and the resulting contract.

B.3.1. Contracting Officer Representative (COR):

The COR will be identified by separate letter. The COR monitors technical aspects of the contract and assists in contract administration, per the contractor provided Performance / Quality Assurance Plan for quality monitoring.

A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially regarding changes in cost or price, or in estimates or changes in delivery dates. The COR is not authorized to change the terms and conditions of the resulting contract.

B.3.2. Contractor Travel:

No Additional travel expenditures are authorized on this contract as travel is embedded in one or several Contract Line Item Number(s) (CLIN) and is therefore not separately priced. All travel expenditures should be in accordance with the Federal Travel Regulation (FTR).

B.3.3. Identification of Contractor Employees:

Contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They shall also ensure that documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. Contractor employees or personnel working on behalf of the contractor shall wear name badges identifying them as representatives of the contractor when at Government facilities.

B.3.4. Commercial Contractor Accreditation Terms:

The Government will not be bound by contractor commercial audit or accreditation terms. Terms of agreement for accreditation services, audit and/or continuous monitoring are outlined in this PWS. VHA employees shall not be required to perform any work on behalf of the contractor, such as reciprocal audits.

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B.3.5. Security Requirements:

The certification and accreditation/authorization (C&A) requirements do not apply, and a Security Accreditation Package is not required. The contractor representatives will not be left alone with VA sensitive information. No VA sensitive information will leave the site of contract performance. Corrective action response information submitted to contractor for audit finding resolution will be de-identified of protected health information.

NOTE: This requirement does not require a contractor to have an account or ongoing access to the VHA computer system. A contractor is not allowed to connect their computer equipment to the VHA system.

B.3.6. Physical Security:

The Contractor shall be responsible for safeguarding government equipment, information, and property provided for contractor use. Any Government equipment provided to the contractor shall be handled and safeguarded per the Federal Acquisition Regulation (FAR) 45.104(a), Responsibility and Liability for Government Property and FAR 24.103 Procedures (Protection of Individual Privacy). Contractor will be escorted at all times during their site visit by a VA employee or designated Federally contracted employees with access badge, such as security.

B.3.7. Data Rights:

The Government has unlimited rights to all documents and material produced under this contract per FAR 27.409(b)(1). All documents and materials, produced exclusively for the VA under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer.

B.3.8. Confidentiality of Data:

The contractor may, during performance, observe or handle information subject to the Privacy Act or other Federal regulations.

Duplication or disclosure of data and other information to which the contractor will or may have access because of this contract is prohibited by law. It is understood that throughout the performance of the contract, the contractor may have incidental access to confidential data that is either the sole property of VA or is the sole property of other than the contracting parties. The contractor hereby agrees to maintain the confidentiality of all such data to which access may be gained throughout contract performance, whether title thereto vests in VA or otherwise. The contractor hereby agrees not to disclose said data, any interpretation thereof, or data derivative thereto unauthorized parties in contravention of the provisions, without the written approval

CONTINUATION PAGE 36C10G25R0041 Page 14 of 119 of the CO, or the party in which the title is wholly vested.

B.3.9. Type of Orders Task Orders shall be issued only by the Strategic Acquisition Center (SAC) Contracting Officer(s) as requirements for additional number of services are required within any current period of performance. No oral orders are authorized, and no other field units can place orders.

Not all Contract Line Items Number(s) (CLIN) are required to be ordered on any given Task Order. CLINs will be identified on every order and the quantity being ordered. For the minimum and maximum order limitations, reference Section C: Contract

Clauses:

52.216-18 ORDERING

52.216-19 ORDER LIMITATIONS

B.3.10. Definitions:

The following definitions are used throughout the PWS and are to be construed as the statement of the meaning of a word, word group, a sign, or symbol; a statement expressing the essential nature of something; a product of defining; the action or the power of describing, explaining, or making definite.

For additional contractual definitions, see the Federal Acquisition Regulation (FAR) Subpart 2.101 – Definitions, The Department of Veteran’s Affairs Acquisition Regulations (VAAR) 802 - Definitions of Words and Terms. These regulations parts define words and terms that are frequently used, provide cross-references to other definitions in the regulations of the same word or term, and provide for the incorporation of these definitions in solicitations and contracts by reference.

Blackout days: Days determined by the laboratory or PLM NEO office as part of the on-site audit planning that the contractor agrees not to perform on-site activity.

Community-Based Outpatient Clinics (CBOCs): Extensions of VHA healthcare facilities offering a range of medical services and providing an accessible and convenient environment for veterans to receive primary care services closer to their homes.

Complete: Full; entire; Including every item or element of the thing spoken of, without omissions or deficiencies; as, a “complete” copy, record, schedule, or transcript.

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Comprehensive: means complete; including all or nearly all elements or aspects of something.

Day: unless otherwise specified, synonymous with business day, a weekday that is not a holiday

Deeming Authority: granted authority by the Centers for Medicare & Medicaid Service (CMS) to organizations to audit laboratory testing locations against 42 CFR 493 requirements, authority granted based on specialty/subspecialty.

Deliverable: used to describe the quantifiable goods or services that must be provided upon the completion of a project. Deliverables can be tangible or intangible in nature. A deliverable is a product or service created or performed in the completion of a project. When you consider a project, there are elements of input (what goes into the project such as time, resources, information, etc.) and elements of output - the deliverables. Key deliverables are the main outputs set and produced in the completion of a project.

Plan: a delineation; a design, a draft, a draft or form or representation;

the representation of anything drawn on a plane, as a map or chart; a scheme; a sketch; also a method of action, procedure, or arrangement.

Specialty: FDA classification of tests as determined as part of the CLIA categorization. This is often related to the area of a laboratory where a test is performed.

Subspeciality: FDA classification under a Specialty CLIA categorization.

Subcontractor: a company or person that enters into a contract with a prime contractor to perform a specific task as part of an overall project.

The Government does not have privity of contract with the subcontractor. Subcontractors are under the responsibility of the primary contractor and must meet the same requirements outlined in the PWS. This term also applies to contractor engaged volunteers working on behalf of the prime contractor.

Test Activity Menu: comprehensive listing of all tests and activities (scope of service) performed under a single CLIA certificate, down to the analyte level. Menu includes the identification of the analyte specialty/sub-specialty defined by CLIA, the method/instrument used for testing, and the corresponding proficiency testing kit being used to fulfill the proficiency testing requirement.

Update: to change (something) by including the most recent information; to make (something) more modern; to give (someone) the most recent information about something.

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B.3.11 Acronyms:

The following acronyms are used throughout the PWS and are to be construed as the statement of the meaning of a word(s) abbreviated but holding the same meaning. This list is not all inclusive, but represents the main acronyms used throughout.

BAA Business Associate Agreement(s) CAR Corrective Action Request CFR Code of Federal Regulations CLIN Contract Line Items Number(s) CO Contracting Officer COR Contracting Officer’s Representative CMS Centers for Medicare and Medicaid Services CPARS Contractor Performance Assessment Reporting System FDA Food and Drug Administration FISMA Federal Information Security Management Act FFP Firm Fixed Price GFE Government Furnished Equipment / Services IAW In Accordance With IDIQ Indefinite Delivery/Indefinite Quantity ISO Information Security Officer MOU Memorandum of Understanding NEO National Enforcement Office PDF Portable Document Format PII Personally Identifiable Information PLM Pathology and Laboratory Medicine PO Purchase Order PWS Performance Work Statement QAP Quality Assurance Plan QM Quality Measures SAC Strategic Acquisition Center USC United States Code VA Department of Veterans Affairs VHA Veterans Health Administration

C. SPECIFIC MANDATORY ACTIVITIES, TASKS, and ASSOCIATED

DELIVERABLES

C.1. General Requirements

All activities, tasks, and associated deliverables specified in this section shall be awarded at the start of a performance period. The Contract Line Item Number(s) (CLIN) shall identify the task number and quantity required. All aspects of any task shall be performed as required in the contract. CLINs will be designated with either activity, task, and/or associated deliverables. The activities are the overarching requirements which correlate to tasks and deliverables.

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If for any reason the delivery date for a deliverable cannot be met, the contractor shall submit a written explanation to the COR within three business days before the deliverable date. This notice to the COR shall include the original deliverable due date, cite the reasons for the delay, describe the impact on the overall program, and include a firm commitment of when the work shall be completed. This is intended to be required as part of any deliverable requirement. The COR will then review the facts and discuss with the CO. The COR shall respond to the contractor acknowledging receipt and communicating any additional concerns within two business days in accordance with applicable regulations.

C.2. Activity 1: Program Management

Program management is critical to effective program execution in the areas of risk management, quality assurance, and changing mission priorities. Good planning builds effective partnerships, establishes open communications, sets clear expectations, defines roles and responsibilities, and sets the framework for mission success. Contract management is a multi-disciplined process which encompasses technical, business, and procurement perspectives.

VA requires Program Management to ensure contract performance, defined objectives, and tracking of required deliverables for each activity are performed at the (highest level, required level). One of the ways to ensure standards are met is an established Quality Assurance Program essential to detailing the procedures to verify services being performed to those Government standards according to the Acceptable Performance Objectives (APO) and Acceptable Quality Levels (AQLs).

Desired Outcome / Objective To focus on aligning program objectives and program performance, identify interdependencies and triage any issues that occur, simplify resource allocation, accurately, prevent risks and jump on opportunities. Also, to improve communication, improve productivity and performance, achieve the program objectives within the given constraints, mitigate risks in advance, manage stakeholder expectations, and maximize results for all stakeholders. In turn, the Government can achieve its objectives while simultaneously reducing cost, technical and schedule risks, ultimately providing a framework to assist the VA and the Contractor’s project managers in improving contract oversight and strengthening performance accountability.

C.2.1. Task 1: Quality Assurance Plan (QAP)

The contractor shall provide a Quality Assurance Plan (QAP). The Quality Assurance Plan shall demonstrate effective measures of the accuracy, quality, and reliability of adherence to the requirements of this contract throughout the contract’s duration. At a minimum, the QAP shall be based on the Performance Requirements Summary (PRS), outcomes, and identify how the Performance Objectives will be achieved. It shall address all the personnel, specific tasks in the PWS, and remedial actions. The QAP is developed by the contractor and

CONTINUATION PAGE 36C10G25R0041 Page 18 of 119 submitted to the Government in compliance with their contract deliverables. The Contractor, and not the Government, is responsible for management and quality control actions necessary to meet the quality standards set forth by the contract performance.

The QAP shall be used to guide and to comprehensively document the implementation of the required management and quality control actions to achieve the specified results/outcomes. The final version shall be submitted per the PRS to the CO and COR and be submitted per the solicitation. After acceptance of the QAP the contractor shall receive the Contracting Officer’s acceptance in writing of any proposed change to his quality control program.

C.2.2. Task 2: Business Associate Agreement

The contractor shall sign and agree to the Business Associate Agreement (BAA) to establish requirements in accordance with the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health Act (HITECH) Act, and the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (“HIPAA Rules”), 45 C.F.R. Parts 160 and 164, for the Use and Disclosure of Protected Health Information (PHI) under the terms and conditions set forth (see sample Attachment 2).

A business associate agreement (BAA) between VHA and the contractor must be in place within 30 days and before on-site audit activity occurs, to cover any incidental viewing of VHA protected information that may occur in the process of performing this requirement. A contractor may request physical review of VHA information and VHA information systems only while at audit location sites covered under this contract and to the extent necessary to perform the services specified in the requirement. A contractor may review electronic records from the VHA computer system only by observing an authorized VHA employee user who is reviewing the electronic record as part of the requirement process.

C.2.3. Task 3: Contract Authority

The contractor shall possess and maintain deeming authority issued by CMS to perform laboratory accreditation audits for the specialties/subspecialties of testing performed by VHA laboratories under Clinical Laboratories Improvement Amendment (CLIA). CMS may deem a laboratory to meet all applicable CLIA program requirements through accreditation by a private nonprofit accreditation program.

C.2.4. Task 4: Account Manager Contractor shall assign a contract account manager who shall have full authority to act for the contractor (i.e., resolve disputes, sign documents, etc.) on all matters relating to this acquisition. The name and contact information for the contract account manager shall be designated in writing to the Contracting Officer and COR within 15

CONTINUATION PAGE 36C10G25R0041 Page 19 of 119 business days of award. In the event of personnel changes, the new account manager must be notified to the Contracting Officer and COR within 5 business days. Contract account manager must be able to respond within 48 hours and shall assist COR with troubleshooting and resolving concerns to the daily performance of this contract.

Deliverable #1: Quality Assurance Plan Deliverable #2: Business Associate Agreement Deliverable #3: Confirmation of Approved Deeming Authority for

Laboratory Accreditation under CLIA Deliverable #4: Account Manager

C.3 Activity 2: Meetings

Meetings shall be conducted throughout the performance period to allow for contract management, updates, and dialogue on aspects, issues, and concerns related to the performance of the contractor with the COR. These meetings shall be coordinated and scheduled monthly to quarterly depending on necessity. All meetings are expected to be virtual.

Desired Outcome / Objective:

Meetings may pertain and include these aspects, but not limited to: introduce Government and contractor team members including roles and responsibilities, update contact information of all parties, complete a full review of the PWS along with associated timeframes and deadlines, discuss responsibilities, authorities, discuss plans for clear lines of communication between the Government and the contractor, identify any potential successes, conflicts or issues in performance, and provide clear understanding of quality assurance measures of all requirements of the contractor.

Meetings may also serve to facilitate dialogue and discussion of matters pertinent to disputes, process improvement, resolution management, and review of any matters related to specific task completion, deliverable submission, interpretation variances of requirement, and Contractor Performance Assessment Reporting System (CPARS). By having these meetings throughout the process, the goal is to establish a mutual understanding of how to achieve the highest program standards.

C.3.1. Task 5: Kick-Off Meeting

The Kick-off meeting between the Program Office, Contracting, and the contractor shall be scheduled within 10 business days after Notice to Proceed is issued to the contractor. This shall be part of the base contract year requirement. Contracting shall coordinate the date, time, location (in person or virtual) of the meeting. The contractor shall attend meeting with the appropriate staff, prepare an agenda, presentation materials, and attendee list (with email addresses), which shall be provided to Contracting in PDF format and approved for distribution to all attendees at least five business days prior to the meeting. The contractor shall provide a final QAP (as described in

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B.1.2) to Contracting in PDF format. This meeting shall occur at the beginning of the base period only.

C.3.2. Task 6: Progress Meeting

The Contractor shall attend progress meeting with the appropriate staff, on an as needed basis. The COR and contractor will collaborate on the agenda topics. The main purpose of the Progress Meetings is to facilitate discussion on status updates, schedule deviations or barriers, any areas of concern or of interest, introduction of new personnel and positions as well as staff losses, and feedback evaluations. This meeting will be scheduled as needed, but no more frequently than one

(1) hour monthly. The COR shall establish a virtual invitation, disseminated by email, for the progress meeting calls.

C.3.3. Task 7: Annual Meeting The contractor shall provide webinar presentation information related to the VHA laboratory accreditation services or associated topic of PLM Central Office choosing at the PLM annual conference or educational event, if extended an invitation by the government. This requirement will not be exercised more than once per period of performance, not to exceed one (1) hour.

Deliverable #5: Kick-Off Meeting, Agenda Collaboration, Meeting Participation (includes QAP)

C.4. Activity 3: Lab Accreditation Support Services

Support Services refers to the various assistance and resources provided to laboratories to ensure they meet the necessary standards and requirements for accreditation by the Department of Veteran Affairs. These services are aimed at helping laboratories maintain compliance with regulations, improve quality, and enhance operations.

Desired Outcome / Objective:

The tasks in this section support the on-site audit activity and ensures the administrative functions and organization of the activities meet the VA and regulatory expectations for Laboratory Accreditation Services. This ensures VA laboratories streamline their processes, achieve accreditation, and maintain a high standard of care and service for veterans.

C.4.1. Task 8: Customer Service and Technical Support

The contractor shall provide a method for VHA general laboratory staff to receive live technical support and/or customer service from the contractor for activities including audit standard interpretation, web site portal issues, clarification of on-site activity during normal business hours, in accordance with each laboratory time zone.

Communications sent directly to laboratories covered under this contract must not contradict activity outlined in terms of this contract shall be, in accordance with the requirements of this PWS.

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C.4.2. Task 9: Electronic Portal

The contractor shall provide a method for laboratories covered under this contract to create an electronic account with the contractor, such as a contractor-hosted web server. This account shall be used by all laboratories to electronically track, reproduce and submit audit related materials. Access for staff shall be allowed outside of normal business hours.

The portal must provide a method for laboratories to submit accreditation process required information to the contractor, such as laboratory demographics, specialty/subspeciality activity and blackout dates. Both pre-audit and as organizational changes may be communicated through the portal.

Additionally, VHA NEO access to electronic accounts shall be grouped for oversight activities in VHA regions as designated in Technical Exhibit A (Attachment 1) or communicated by the COR. NEO access shall include audit reports, communications with the laboratories, individual lab test menu and other accreditation data.

C.4.3. Task 10: Training Materials/Education

The contractor shall provide ongoing training materials or educational offerings on that outline how VA staff participate in the accreditation process. This may include webinars, live trainings, in-person sessions, printed materials/papers, formal continuing education opportunities, and website tools.

Communication about these educational webinars and tools must be made available to the laboratories covered under this contract and PLM NEO office.

Deliverable #6: Electronic Portal Access Deliverable #7: Training Materials/Education

C.5. Activity 4: Reports Reports are the backbone of effective communication. Reports enhance ability to convey information and influence decisions, in the evaluation process. Reports can describe evaluation of performance, progress, or outcomes. Reports act as a decision-making tool that can assist in making decisions based on facts and evidence. VA requires multiple reports about Laboratory Accreditation activities under this PWS.

The contractor shall collaborate and provide the COR with reports in agreed standardized format (such as XML, CSV or Excel) within 30 days of award.

Format shall remain standardized throughout the life of the contract. Data elements must be approved by the COR.

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The objective is to provide efficient communication of all service activities, trends, findings associated with the surveys and related aspects for the VA to make well informed decision of potential strategic changes throughout the enterprise.

C.5.1. Task 11: Ad-hoc data reports

The contractor shall provide an ad-hoc data report associated to activity under this contract, upon the COR request. Not to exceed 2 reports per period of performance. The report shall not be locked and provide the ability to track, trend, search, sort, and filter data for opportunities for improvement. Report shall be provided to the COR within 20 calendar days of request.

C.5.2. Task 12: Monthly Reports – Audit Activity

The contractor shall provide a monthly report of on-site audit activity, both past and upcoming planned audits.

The data shall not be locked and shall provide the ability to track, trend, search, sort, and filter data for opportunities for improvement.

Aggregated rolling summary shall be provided to the COR within 10 calendar days following the end of each month.

Note: PLM NEO will not share this information outside the NEO.

Required information includes:

o CLIA ID Number o Identifying Unique Accreditation Number o Laboratory Name o Scheduled Audit Date o Actual Audit Date o Audit Type o Audit Status o Accreditation End Date o Post-Audit Activity Complete Date

C.5.3. Task 13: Quarterly Reports – Lab Findings

The contractor shall provide quarterly reports on Laboratory Findings.

Aggregated rolling summary shall be provided to the COR within 15 calendar days following the end of quarter.

Required information includes:

o Requirement (ID)/Standard o Checklist/Standard Edition o Checklist/Standard Section

CONTINUATION PAGE 36C10G25R0041 Page 23 of 119 o Subject Header/Chapter o Section Unit o Audit Date o Phase/Safer Placement o Requirement Text / Standard Text o Findings Text o Site Identifying Number o CLIA Number

C.5.4. Task 14: Quarterly Reports – Labs with no Findings

The contractor shall provide a quarterly report of Labs with no findings.

Aggregated rolling summary shall be provided to the COR within 15 calendar days following the end of quarter.

Required information includes:

o CLIA ID o Site Identifying Number o Laboratory Name o City o State o Audit Date

C.5.5. Task 15: Quarterly Customer Satisfaction Audit Results

The contractor shall provide quarterly customer satisfaction audit results…