P01 - 2027 CAP local funded _ Statement of Work.docx

Statement of Work Proficiency Testing Surveys and Linearity Kits

Purpose All VHA Pathology and Laboratory Medicine Service (P&LMS) laboratories and Ancillary Testing Sites that performs patient testing, regardless of complexity, must subscribe to an external proficiency testing program that meets the Clinical Laboratory Improvement Act 1988 (CLIA ’88) and its amendments; to ensure reliability of patient testing and meet accreditation requirements.

Many testing systems within P&LMS also require validation of the Analytical Measurement Range (AMR) for an analyte both initially and at least every six months thereafter. This can be accomplished through purchase of linearity material that is both matrix specific and spans the range of the AMR for each analyte, when required. This is addressed in 42 CFR 493.1255 (b) and the College of American Pathologists (CAP) standard CHM.13600.

This Statement of Work (SOW) is requesting the procurement of proficiency and linearity materials that are not provided through the P&LMS VA Central Office (VACO); but are still required by the guidelines set forth in VA Handbook 1106, 42 CFR 493 Subpart H and K, and many CAP standards. Therefore, procurement of the materials described above is not an option, but a requirement of accreditation for all VA laboratories.

Scope The overall purpose of this requirement is to obtain a vendor to provide CLIA ’88 approved proficiency testing and linearity materials, which are not already provided through P&LMS VACO funding. This will ensure that all laboratories and ancillary testing sites that perform patient testing, within the Veterans Administration North Texas Health Care System (VANTHCS), are in compliance with VHA Handbook 1106, 42 CFR 493 Subpart H & K requirements, and CAP accreditation standards. For this award, the proficiency testing program must be approved for the following CLIA specialties: Anatomic Pathology, Microbiology, Diagnostic and General Immunology, and Routine and Special Chemistry.

Location The proficiency and linearity materials will be utilized for compliance testing in the P&LMS Department of the VANTHCS System, including laboratories in: Dallas VAMC, Sam Rayburn Memorial Medical Center (Bonham, TX), and Fort Worth VA Outpatient Clinic.

Period of Performance The Contract period of performance shall be January 01, 2027, through January 01, 2028.

Type of Contract VANTHCS intends to award a contract to the vendor who can supply the following for the Beckman DxC 700 AU (Bonham), Beckman DxI 9000 Access (Bonham, Fort Worth and Dallas), Beckman Coulter AU 5822 (Dallas), TOSOH A1c G8 (Bonham, Fort Worth, and Dallas) and Abbott Alinity I (Dallas) during the contract period:

A. General Chemistry/Lipid/Enzyme Linearity material for plasma/serum Albumin, Calcium, Chloride, CO2, Creatinine, Glucose, Iron, Magnesium, Osmolality, Phosphorous, Potassium, Total Protein, Sodium, BUN, Uric Acid, Alkaline Phos, ALT (GPT), Amylase, AST (SGOT), CK, CKMB, GGT, LDH, Lipase, Total and Direct Bilirubin, Cholesterol, HDL, and Triglycerides linearity/calibration verification (4 surveys per year).

B. Therapeutic Drug Linearity material for plasma/serum Lithium (2 surveys per year).

C. Urine Chemistry Linearity material for Calcium, Chloride, Creatinine, Glucose, Osmolality, Phosphorus, Potassium, Total Protein, Sodium, Urea Nitrogen, Uric Acid (2 surveys per year).

D. Linearity material to monitor test: Ammonia (4 surveys per year).

E. Linearity material to monitor test: Serum Ethanol (3 surveys per year).

F. Linearity material for molecular diagnostics tests: HBV, HCV, and HIV Viral Loads (1 survey for each Viral Load per year).

G. Linearity material to monitor test: Hemoglobin A1C (3 surveys per year).

Vendor will also provide the following proficiency testing (PT) surveys, calibration/linearity, and competency assessment materials for the following:

A. Instrumentation calibration/linearity verification materials including Gravimetric pipette calibration, Microtiter plate linearity, Refractometer calibration, Spectrophotometer stray light check, Fluorescent intensity check, and pH meter check.

B. Interlaboratory Comparison Non-GYN Cytology PT surveys for nine (9) pathologists and one (1) cytotechnologist. (2 surveys per year).

C. Laboratory Preparedness check for Microbiology section to ensure the laboratory is ready for handling of dangerous organisms (1 survey per year).

D. Eluate competency assessment for Transfusion Medicine section (2 surveys per year).

E. Miscellaneous survey replacement samples are required as needed in the case of instrument malfunction during processing or technical exception.

Tasks

Task 1: Proficiency Testing and Linearity program A. The contractor must be on the CMS list of CLIA-approved proficiency testing providers for Chemistry, Diagnostic Immunology, Immunoglobulins, Microbiology/Bacteriology, Urinalysis, and Cytology.

B. The contractor’s program must be a CLIA approved proficiency testing program that supplies both proficiency testing and linearity materials.

C. The proficiency testing/linearity program must:

1) Provide at a minimum the following specimens or materials within the VANTHCS System:

a) General Chemistry Linearity materials for both plasma/serum that include all listed analytes to be shipped to Dallas VAMC (2), FWOPC (1), and Bonham (1) approximately every six months.

b) Therapeutic Drug Linearity materials for Lithium (2 shipments approximately every six months to Dallas VAMC).

c) Urine Chemistry Linearity materials (2 shipments approximately every six months to Dallas VAMC).

d) Ammonia Linearity materials shipped to Dallas VAMC (2), Bonham (1), and FWOP (1) approximately every six months.

e) Serum Ethanol Linearity materials shipped to Dallas VAMC (2) and Bonham (1) approximately every six months.

f) HBV, HCV and HIV Viral Load Linearity materials shipped to Dallas VAMC (1 of each Viral Load noted) approximately every six months.

g) Hemoglobin A1C Linearity material to monitor A1C test shipped to Dallas VAMC (2) FWOPC (1), and Bonham (1) approximately every six months.

h) Instrumentation Linearity materials shipped to Dallas VAMC approximately every six months.

i) Interlaboratory Comparison Non-GYN Cytology PT surveys for nine (9) pathologists and one (1) cytotechnologist shipped to Dallas VAMC approximately every six months.

j) Laboratory Preparedness Survey materials shipped to Dallas VAMC (1) approximately every six months.

k) Eluate competency assessment materials shipped to Dallas VAMC (2) approximately every six months.

2) Include a mechanism for the contractor to notify the following in the VANTHCS System: VANTHCS Contract Officer Representative (COR), VANTHCS Laboratory Manager, VANTHCS Quality Manager (QM), and each individual laboratory point of contact (POC) of any PT/linearity updates.

3) Include a contractor established event calendar and/or shipping table that identifies the date each PT/linearity is scheduled to be shipped to the laboratory.

4) The contractor is to ensure that PT/linearity materials are shipped at the proper temperature to ensure viability of specimens when they arrive at the testing laboratory.

5) Have a mechanism that allows each individual laboratory to transmit PT/linearity results electronically via a secured website or by facsimile.

6) Include formal evaluation of results for each test. Formal evaluation reports must include:

a) A mechanism for each laboratory to compare its PT performance or results against peer laboratories using the same method (when applicable).

b) A summary of the individual laboratory’s historic performance over the past three PT events.

c) Overall performance that indicates whether current performance is satisfactory, at risk pending future performance, or unsatisfactory.

d) A summary of peer participant results (when applicable).

e) The reason any proficiency testing result was not scored or graded.

f) Provide the VANTHCS Laboratory Manager, VANTHCS Quality Manager (CLS), individual laboratory’s point of contact (POC), the National Compliance Officer, and the laboratory’s accrediting organization:

i. Documentation of PT/linearity formal evaluations.

ii. Written notification when PT results are not received by the contractor, when analyte performance is scored as unacceptable, and when analyte overall performance is assessed as unsatisfactory.

g) Provide a plan for replacement of defective or damaged PT/linearity materials.

h) Provide a glossary of terms when technical terminology is used in a PT survey or calibration/linearity verification kit.

i) Have an electronic method (i.e., website, fax, email) for receipt of VA furnished correspondence. Contract prices should include any costs associated with the electronic data transmission.

Task 2: Deliverables: Mailed, Written Correspondence, Database Files A. All Mailed deliverables, which includes PT/linearity materials shall be shipped Freight On Board (FOB) Destination (paid by contractor) and shipped directly to the performing laboratory.

B. Written correspondence may be shipped FOB Destination (paid by the contractor) or delivered electronically to the COR, QM, laboratory POC, VA National Compliance Officer, and accrediting agency. The electronic format must mirror the contents of a paper format. Written or electronic correspondence must be sent for the following:

1) PT/linearity updates will be provided within 10 working days of a change.

2) PT/linearity manuals, catalogs, and event calendars (with shipping tables) will be made available to all above parties within 10 working days of the award for base and each option year.

3) PT/linearity formal evaluation reports will be made available to all above parties within 30 calendar days of the evaluation.

C. Database files (i.e. XML, Excel, HTML) shall be submitted to the COR, QM, and laboratory POCs electronically.

1) PT/linearity ordering, shipping, pricing information (to include updates/changes), and cut-off dates shall be provided to the COR, QM, and laboratory POC within 10 working days.

2) Summary/Confirmation of all order changes and a running balance report shall be provided monthly (30 calendar days) to the COR, QM, and laboratory POC.

3) The contractor shall provide PT/linearity performance data in both a paper format and XML format through a secured FTP server connection.

D. The contractor shall submit any required documentation to the laboratory’s accrediting organization using a format that is routinely accepted by the accrediting organization.

Authorized Ordering Offices

Task orders, for all individual VANTHCS laboratories, will be awarded and managed by the COR. Changes to orders can be made as needed during the contract. The actual (running) balance will be reconciled between the contractor and the COR monthly.

Government Furnished Items

A. Each VANTHCS Laboratory will provide PT/linearity testing results to the contractor via electronic method(s) determined by the contractor.

B. VANTHCS QM will provide respective laboratory POC(s) and other demographics using forms provided by the contractor.

C. The COR will provide contact information for the National Compliance Officer post award.

D. The COR will provide the initial (annual) PT/linearity material order in the format and period determined by the contractor, using the forms provided by the contractor.

E. The COR will provide any order changes, via electronic transmission, within a week when needed.

Contractor Security Contract Requirements.

A. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

B. Access to VA Information and VA Information Systems

1) A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

2) All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

3) Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

4) Custom software development and outsourced operations must be in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

5) The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

C. VA Information Custodial Language

1) Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

2) VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

3) Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

4) The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

5) The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. NOTE: NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

6) All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

NARA Records Management Language for Contracts (May 2017)

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VA North Texas Health Care System and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VA North Texas Health Care System or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VA North Texas Health Care System. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VA North Texas Health Care System control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA North Texas Health Care System guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA North Texas Health Care System policy.

8. The Contractor shall not create or maintain any records containing any non-public VA North Texas Health Care System information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The VA North Texas Health Care System owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VA North Texas Health Care System shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.