36C24425Q0606.docx

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Q301--646-25-2-124-0020 | Cytotechnologist Services | NCO 4 Services 1
Solicitation number
36C24425Q0606
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This document is a Request for Quote (RFQ) for Cytotechnologist Services issued by the Department of Veterans Affairs (VA) Pittsburgh Healthcare System. The solicitation is a 5-year, Firm-Fixed-Price Indefinite-Delivery/Indefinite-Quantity (ID-IQ) contract set aside exclusively for Service-Disabled Veteran-Owned Small Business (SDVOSB) concerns, with a NAICS code of 561320 and a small business size standard of $34 Million. The contract will provide onsite cytotechnology services at the VA Pittsburgh Healthcare System, with a performance period from August 1, 2025, through July 31, 2030.

The government will evaluate offers based on three factors: Technical Capability, Past Performance, and Price, using a comparative evaluation process. Offerors must submit a quality control plan, cytotechnologist curricula vitae, documentation of licenses and certifications, proof of medical liability insurance, and past performance references. The successful contractor will be responsible for providing graduate-level cytotechnologists who meet specific qualifications, including ASCP certification, ongoing training requirements, and compliance with VA medical standards and protocols. Quotes must be submitted electronically to the contract specialist by July 21, 2025, at 4:30 PM EDT, with all questions to be submitted no later than July 14, 2025.

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SOLICITATION-DESCRIPTION

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

36C24425Q0606 Jami Cade | Jami.Cade@va.gov

(570) 550-5570 07-21-2025 16:30

EDT

36C244 Department of Veterans Affairs Network Contracting Office 4 Wilkes-Barre VA Medical Center 1111 East End Boulevard Wilkes-Barre PA 18711 Jami Cade | Jami.Cade@va.gov

(570) 550-5570 X X 561320 $34 Million N/A X Department of Veterans Affairs VA Pittsburgh Healthcare System University Drive C 1010 Delafield Road Pittsburgh PA 15240 36C244 Department of Veterans Affairs Network Contracting Office 4 Wilkes-Barre VA Medical Center 1111 East End Boulevard Wilkes-Barre PA 18711

Austin Payment Center Department of Veterans Affairs PO Box 149971 Austin TX 78714-9971

(877) 353-9791

(512) 460-5429 See CONTINUATION Page Subject: Cytotechnologist Services for the VA Pittsburgh Healthcare System (VAPHS) This is a Request For Quote (RFQ). A 5-year, Firm-Fixed Price ID-IQ contract will result from this solicitation.

Offeror are advised to refer to FAR 52.212-1 and FAR 52.212-2 in Section "E" for submittal instructions and the Government's evaluation method.

All quotes must be submitted to Jami.Cade@va.gov, NLT the date and time identified in "Block 8", above.

All questions must be submitted to the Contract Specialist no later than 16:30 on Monday, 07/14/2025. Questions submitted after this date and time will not be answered.

See CONTINUATION Page X X Lev V. Stowe Contracting Officer Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES1
SECTION B - CONTINUATION OF SF 1449 BLOCKS3
B.1 CONTRACT ADMINISTRATION DATA3
B.2 PRICE/COST SCHEDULE24
ITEM INFORMATION24
SECTION C - CONTRACT CLAUSES28
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)28
C.2 IT CONTRACT SECURITY33
C.3 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (NOV 2021)42
C.4 52.216-18 ORDERING (AUG 2020)44
C.5 52.216-19 ORDER LIMITATIONS (OCT 1995)44
C.6 52.216-22 INDEFINITE QUANTITY (OCT 1995)45
C.7 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)45
C.8 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN 1997)46
C.9 SUPPLEMENTAL INSURANCE REQUIREMENTS46
C.10 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)47
C.11 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)47
C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025)48
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS56
SECTION E - SOLICITATION PROVISIONS57
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)57
E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)61
E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)63
E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)64
E.5 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018)65
E.6 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)66
E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)66
E.8 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)66
E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION FEB 2025)68

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: TBD

b. GOVERNMENT: Contracting Officer 36C244 Department of Veterans Affairs Network Contracting Office 4 Wilkes-Barre VA Medical Center 1111 East End Boulevard Wilkes-Barre PA 18711

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. Quarterly[]
b. Semi-Annually[]
c. Other[]

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.

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

AMENDMENT NO
DATE

36C24425Q0606

Page 1 of

PERFORMANCE WORK STATEMENT

The Contractor shall furnish all key personnel to provide services necessary to perform onsite Cytotechnologist Services to eligible beneficiaries of the Department of Veterans Affairs (VA) Medical Center, VA Pittsburgh Healthcare System. The Contractor’s cytotechnologist (s)’ care shall cover the range of Pathology and Laboratory services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by the American Society of Clinical Pathology (ASCP): https://www.ascp.org Place of Performance: Services shall be provided onsite, VA Pittsburgh Healthcare System, University Drive, Pittsburgh, PA 15240

1. GENERAL:

1.1. Services Provided: The Contractor shall provide a graduate of an accredited program, Diploma associate degree or greater Cytotechnologist Services onsite in accordance with the specifications contained herein to beneficiaries of the VA and the VA Pittsburgh Healthcare System.

1.2. Place of Performance: Contractor shall furnish services at the VA Pittsburgh Healthcare System, University Drive, Pittsburgh, PA 15240.

1.3. Authority: Title 38 USC 513 General Contracting Authority. VA Acquisition Regulation (VAAR) part 873)

1.4. Policy/Directives/Handbooks. The contractor shall be subject to the following policies, including any subsequent updates during the period of performance. The policies listed below can be accessed electronically at the following: VA Publications VHA Publications

1.4.1. VA Directive 1663: Health Care Resources (HCR) Contracting – Buying Title 38 U.S.C. 8153

1.4.2. VHA Directive 1003.04: VHA Patient Advocacy

1.4.3. VHA Directive 1065: Productivity and Staffing Guidance for Specialty Provider Group Practice

1.4.4. VHA Directive 1088(1): Communicating Test Results to Providers and Patients

1.4.5. VHA Directive 1100.18: Reporting and Responding to State Licensing Boards

1.4.6. VHA Directive 1100.20: Credentialing of Health Care Providers

1.4.7. VHA Directive 1100.21: Privileging

1.4.8. VHA Directive 1192.01: Seasonal Influenza Vaccination Program for VHA Health Care Personnel

1.4.9. VHA Directive 1220(1): Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures in Any Clinical Setting

1.4.10. VHA Directive 1400.01: Supervision of Physician, Dental, Optometry, Chiropractic, and Podiatry Residents:

1.4.11. VHA Directive 1605.01: Privacy and Release of Information

1.4.12. VHA Directive 1907.01: VHA Health Information Management and Health Records

1.4.13. VHA Handbook 1100.17: National Practitioner Data Bank (NPDB) Reports

1.4.14. VHA Handbook 1400.04: Supervision of Associated Health Trainees:

1.4.15. Privacy Act of 1974 (5 U.S.C. 552a) as amended: http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.5. Acronyms/Definitions: Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

1.5.1. ASCP: American Society of Clinical Pathology https://www.ascp.org

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. ACLS: Advanced Cardiac Life Support

1.5.4. AJIC: American Journal for Infection Control

1.5.5. AQL: Acceptable Quality Level

1.5.6. BAA: Business Associate Agreement

1.5.7. BBA: Balanced Budget Act

1.5.8. BLS: Basic Life Support

1.5.9. CDC: Centers for Disease Control and Prevention

1.5.10. CDR: Contract Deficiency Report

1.5.11. CEU: Certified Education Unit

1.5.12. Clinical Privileging: Clinical Privileging is the process by which a practitioner, licensed for independent practice; e.g., without supervision, direction, required sponsor, preceptor, mandatory collaboration, etc.; is permitted by law and the facility to practice independently, to provide specific medical or other patient care services within the scope of the individual’s license, based upon the individual’s clinical competence as determined by peer references, professional experience, health status, education, training and licensure. Clinical privileges must be facility-specific and provider-specific, and within available resources.

1.5.13. CME: Continuing Medical Education

1.5.14. CMP: Civil Monetary Penalty

1.5.15. CMS: Centers for Medicare and Medicaid Services

1.5.16. CO: Contracting Officer: The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.

1.5.17. COI: Conflict of Interest

1.5.18. COR: Contracting Officer’s Representative: A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

1.5.19. COS: Chief of Staff

1.5.20. CPARS: Contractor Performance Assessment Reporting System

1.5.21. Credentialing: Credentialing is the process of obtaining, verifying, and assessing the qualifications of a health care provider to provide care or services in or for the VA health care system. Credentials are documented evidence of licensure, education, training, experience or other qualifications.

1.5.22. DEA: Drug Enforcement Agency

1.5.23. EHR: Electronic Health Record - electronic health record system used by the VA

1.5.24. EPA: Environmental Protection Agency

1.5.25. FAPIIS: Federal Awardee Performance and Integrity Information System

1.5.26. FAR: Federal Acquisition Regulation

1.5.27. FOIA: Freedom of Information Act

1.5.28. FPPE: Focused Provider Practice Evaluation

1.5.29. FSMB: Federation of State Medical Boards

1.5.30. FTE: Full Time Equivalent: VA’s definition for full time-working the equivalent of 80 hours every two weeks, 2080 hours per year. In calculating FTE, any hours not worked on national holidays shall not be included.

1.5.31. HHS: Department of Health and Human Services

1.5.32. HICPAC: Hospital Infection Practices Advisory Committee

1.5.33. HIPAA: Health Insurance Portability and Accountability Act

1.5.34. IGRA: Interferon-gamma Release Assays

1.5.35. ISO: Information Security Officer

1.5.36. Key Personnel: The individuals specified in this contract who are essential to work performance.

1.5.37. MRI: Magnetic Resonance Imaging

1.5.38. MST: Military Sexual Trauma

1.5.39. NPI: National Provider Identifier. NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The VHA must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers).

1.5.40. NPPES: National Plan and Provider Enumeration System

1.5.41. NSO: National Surgery Office

1.5.42. OGC: Office of General Counsel

1.5.43. OIG: Office of Inspector General

1.5.44. OPPE: Ongoing Provider Practice Evaluation

1.5.45. OR: Operating Room

1.5.46. POP: Period of Performance

1.5.47. PPD: Purified Protein Derivative

1.5.48. PPIRS: Past Performance Information Retrieval System

1.5.49. PWS: Performance Work Statement

1.5.50. QA/QI: Quality Assurance/Quality Improvement

1.5.51. QM/PI: Quality Management/Performance Improvement

1.5.52. QASP: Quality Assurance Surveillance Plan

1.5.53. RFP: Request for Proposal

1.5.54. SCS: Specialty Care Services

1.5.55. SSAC: Sole Source Affiliate Contract

1.5.56. TJC: the Joint Commission

1.5.57. TST: Tuberculosis Skin Test

1.5.58. USC: United States Code

1.5.59. VA: Department of Veterans Affairs

1.5.60. VA-FSC: VA Financial Services Center

1.5.61. VAAR: VA Acquisition Regulation

1.5.62. VETPro: is VHA’s mandatory credentialing software platform to document the credentialing of VHA health care Providers. This system facilitates completion of a uniform, accurate and complete credentials file.

1.5.63. VHA: Veterans Health Administration

1.5.64. VistA: Veterans Integrated Systems Technology Architecture

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. License: The Contractor’s Cytotechnologist(s) assigned by the Contractor to perform the services covered by this contract shall have a current license to practice medicine in any State, Territory, or Commonwealth of the United States or the District of Columbia) when services are performed onsite on VA property.

All licenses held by the key personnel working on this contract shall be full and unrestricted licenses. Contractor’s cytotechnologist(s) who have current, full and unrestricted licenses in one or more states, but who have, or ever had, a license restricted, suspended, revoked, voluntarily revoked, voluntarily surrendered pending action or denied upon application will not be considered for the purposes of this contract.

2.1.2. Board Certification: All Contractor’s cytotechnologist(s) shall be graduate of an accredited program, Diploma associate degree or greater cytotechnologist Services hold an active ASCP certification and be currently certified in BLS, ACLS or equivalency. All continuing education courses required for maintaining certification must be kept up to date at all times. Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance.

2.1.3. Technical Proficiency: Contractor’s cytotechnologist(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all Contractor’s cytotechnologist(s) and Contractor’s cytotechnologist(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior. Candidate must have proof that they have passed PAP proficiency in the previous 12-month period.

2.1.4. Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements: Contractor shall provide the COR copies of current CMEs as required or requested by the facility. Contractor’s cytotechnologist(s) registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. Contractor shall report CME hours to the credentials office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for Contractor’s cytotechnologist(s).

2.1.5. Training (ACLS, BLS, EHR and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contractor’s cytotechnologist(s) as required by the VA. Other training may become required. VA will communicate any changes to the training requirement to the contractor.

Training
Frequency (Once a Year)
Annual Hours
ACLS/BLS
Every (2) years
1.00
Active Threat Training
Once a year
1.00
Blood Administration: Complications
Once a year
1.00
EHR
Once a year
1.00
Government Ethics
Once a year
1.00
Hospice and Palliative Care for VA Clinicians
Once a year
1.00
Military Sexual Trauma (MST) for Medical Providers
Once a year
1.00
Moderate Sedation In-Service Training
Once a year
1.00
PACT Act 2022 Toxic Exposure Screening (TES)
Once a year
1.00
Patient Abuse
Once a year
1.00
Patient Rights
Once a year
1.00
Patient Safety
Once a year
1.00
Prevention/Management of Disruptive Behavior/Violence Prevention Level I
Once a year
1.00
Prevention of Workplace Harassment/No Fear Act
Once a year
1.00
Suicide Prevention: Suicide Risk Management Training for Clinicians
Once a year
1.00
SUX Infection Control and Blood Borne Pathogens
Once a year
1.00
VA Core Values Training (ICARE Recommitment)
Once a year
1.00
VA Privacy and Information Security Awareness and Rules of Behavior
Once a year
1.00
VHA MRI Safety Training Level 1 Training (all who enter MRI suites)
Once a year
1.00
VHA Privacy and HIPAA Focused Training
Once a year
1.00
VistA Imaging
Once a year
1.00

2.1.6. STANDARD INFECTION CONTROL MEASURES (PPD, IMMUNIZATIONS, ETC.): Contractor shall provide proof of the following for cytotechnologist within five (5) calendar days after contract award and prior to the first duty shift to the COR and CO. Tests shall be current within the past year.

2.1.6.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s cytotechnologist(s) upon hire in accordance with CDC guidance. (This is applicable to all health care workers). A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results.

2.1.6.2. MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor cytotechnologist {This is applicable to all health care workers}.

2.1.6.3. VARICELLA: Contractors shall provide proof of immunity for all Contractor cytotechnologist {This is applicable to all health care workers}.

2.1.6.4. ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor cytotechnologist {This is applicable to all health care workers}.

2.1.6.5. INFLUENZA: Contractors shall provide proof that all Contractor cytotechnologists have received the annual Influenza vaccine unless it is contraindicated. If the Contractor cytotechnologist has a medical contraindication to the vaccine they shall be required to wear a mask during the Influenza season. {This is applicable to all health care workers}.

2.1.6.6. COVID-19: The Contractor will be required to adhere to the COVID rules and restrictions set forth by the facility.

2.1.6.7. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor’s cytotechnologist(s) {This is applicable to all health care workers}; provide their own Hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

2.1.6.8. The facility shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel (as published in American Journal for Infection Control - AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for disease control. Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

2.1.7. NPI: NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The VHA must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the CMS NPPES be provided to the CO with the proposal.

2.1.8. DEA: Contractor shall provide copy of current DEA certificate.

2.1.9. Conflict of Interest (COI): The Contractor and all Contractor’s cytotechnologist(s) are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.1.10. Citizenship related Requirements:

2.1.10.1. The Contractor certifies that 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 VA patient referrals.

2.1.10.2. While performing services for the VA, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable FAR.

2.1.10.3. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the VA may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services VA patient referrals; or other place where the Contractor provides services to veterans who have been referred by the VA; and shall form the basis for termination of this contract for breach.

2.1.10.4. This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

2.1.10.5. The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFQ.

2.1.11. Annual OIG Statement: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the HHS OIG has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

2.1.11.1. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed Contractor’s cytotechnologist(s) are not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

2.1.11.2. By submitting their proposal, the Contractor certifies that the HHS OIG List of Excluded Individuals/Entities has been reviewed and that the Contractors are and/or firm is not listed as of the date the offer/bid was signed.

2.2. Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by facility COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Directive 1100.20 and VHA Directive 1100.21. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the facility COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

2.3. Non Personal Healthcare Services: The parties agree that the Contractor and all Contractor’s cytotechnologist(s) shall not be considered VA employees for any purpose.

2.4. Indemnification: The Contractor shall be liable for, and shall indemnify and hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the Contractor, its agents, or employees.

2.5. Prohibition against Self-Referral: Contractor’s cytotechnologist are prohibited from referring VA patients to contractor’s or their own practice(s).

2.6. Inherent Government Functions: Contractor and Contractor’s cytotechnologist(s) shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees (outside a clinical context), selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

2.7. No Employee status: The Contractor shall be responsible for protecting Contractor’s cytotechnologist(s) furnishing services. To carry out this responsibility, the Contractor shall provide or certify that the following is provided for all their staff providing services under the resultant contract:

2.7.1. Workers’ compensation

2.7.2. Professional liability insurance

2.7.3. Health examinations

2.7.4. Income tax withholding, and

2.7.5. Social security payments.

2.8. Tort Liability: The Federal Tort Claims Act does not cover Contractor or Contractor’s cytotechnologist(s). When a Contractor or Contractor’s cytotechnologist(s) has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or Contractor’s cytotechnologist(s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.9. Key Personnel:

2.9.1. The VA Full Time Equivalent (FTE) for the services required is 1.00 FTE is defined by VA as minimum of 80 hours every two weeks (after Contractor vacation, holidays, and continuing medical education days are subtracted).

2.9.2. The minimum number of graduates of accredited program, Diploma associate degree or greater Cytotechnologist Services required to be onsite daily is __1.00_ as defined in paragraph Hours of Operation in this section.

2.9.3. The Contractor shall be responsible for providing coverage to the VA during periods of vacancies of the Contractor’s personnel due to sick leave, personal leave, vacations and additional coverage as required. In the event a scheduled cytotechnologist is unable to complete an assigned shift, the Contractor shall provide replacement cytotechnologist coverage within 2 hours and notify the COR immediately of the schedule change.

2.9.4. Personnel Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. The Contractor shall notify the CO, in writing, within _15__ calendar day(s) after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least _15__ calendar days prior to making any permanent substitutions.

2.9.4.1. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the Contractor within _15__ calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

2.9.4.2. For temporary substitutions where the key person shall not be reporting to work for _3__ consecutive workdays or more, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

2.9.4.3. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA COS or designee show documented clinical problems or continual unprofessional behavior/actions with any Contractor’s cytotechnologist(s), s/he may request, without cause, immediate replacement of said Contractor’s cytotechnologist(s). The CO and COR shall deal with issues raised concerning Contractor’s cytotechnologist(s) conduct. The final arbiter on questions of acceptability is the CO.

2.9.4.4. Contingency Plan: Because continuity of care is an essential part of Facility’s medical services, The Contractor shall have a contingency plan in place to be utilized if the Contractor’s cytotechnologist(s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

3. VA HOURS OF OPERATION/SCHEDULING:

a. VA Business Hours: _Monday through Friday 8:00 am – 4:30 pm

b. The following terms have the following meanings:

(1) Work hours: Personnel shall typically perform services 40 hours a day, seven days a week, including Federal Holidays with actual work schedules to be mutually agreed upon by Contractor and VA based on patient care needs. A 30 minute, unpaid, lunch break is included in each shift. The shift has two 15-minute paid breaks.

(2) Alternate Shifts are acceptable provided they are approved by the COR prior to
implantation.

3.1. Federal Holidays: The following holidays are observed by the VA:

· New Year’s Day

· President’s Day

· Martin Luther King’s Birthday

· Memorial Day

· Juneteenth

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving

· Christmas

· Any day specifically declared to be a national holiday.

3.2. Cancellations: Unless a state of emergency has been declared or laboratory are otherwise cancelled by the VAMC, the Contractor shall be responsible for providing services.

4. CONTRACTOR RESPONSIBILITIES:

4.1. Clinical Personnel Required: The Contractor shall provide Contractor’s cytotechnologist(s) who are competent, qualified per this performance work statement and adequately trained to perform assigned duties.

4.1.1. Copies of paper timecards are unacceptable. The VA has an electronic timecard system that can be made available to the vendor. If the vendor wishes to utilize an alternate electronic timecard, then the vendor must implement within 60 days of task order award and electronic time keeping system capability for their contract employees. This system must be accepted by the VA. Vendor is responsible for training VAPHS personnel in the use of this system. In addition to tracking employee time, this system will be utilized by VAPHS personnel to validate contractor invoices. This system must be capable of producing customized reports that include the name of contractor, hours and days worked, overtime, etc. The system must allow for VAPHS personnel to approve contract employee timecards. It is likely that this system will not be able to attach to the VAPHS internal computer network.

4.2. Standards of Care: The Contractor’s cytotechnologist(s)’ care shall cover the range of Pathology services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized the Joint Commission (TJC), VA and national standards as established by:

4.2.1. The American Society of Clinical Pathology: https://www.ascp.org

4.2.2. The professional standards of TJC: http://www.jointcommission.org/standards_information/standards.aspx

4.2.3. The standards of the American Hospital Association (AHA): http://www.hpoe.org/resources?show=100&type=8

4.2.4. The requirements contained in this PWS

4.3. Medical Records:

4.3.1. Authorities: Contractor’s cytotechnologist(s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the 5 U.S.C.552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

4.3.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment of VA patients. Based on this exception, a BAA is not required for this contract. Health records generated by this contract or provided to the Contractors by the VA are covered by the VA Privacy Act system of records entitled ‘Patient Medical Records-VA’ (24VA10A7). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services provided to VA patients are captured in the VA electronic health record system as required by VA policy as discussed in 4.4.4.

4.3.3. Disclosure: Contractor’s cytotechnologist(s) may have access to patient medical records for the purpose of providing medical care and services to VA patients and performing services under the contract; however, Contractor shall obtain permission from the VA before disclosing any patient information outside VA. VA authorizes the Contractor to discuss patient health information for coordination of care within community health care providers in compliance with VA regulations, HIPAA and VHA Directive 1605.1, Privacy and Release of Information. The VA will provide the Contractor with a copy of VHA Directive 1907.01, Health Information Management and Health Records and VHA Directive1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

4.3.4. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Directive 1907.01 Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 and all guidelines provided by the facility.

4.3.5. Release of Information: The VA shall maintain control of releasing any copies of patient health information or health records and will follow policies and standards as defined, but not limited to Privacy Act requirements. The Contractor will not release or disclose copies of records and will refer all such requests to the Release of Information Department at the VA facility where assigned.

4.3.6. Management for Medical Records: National Archives and Records Administration record disposition requirements are found in RCS 10-1 Chapter 6, 6000 series.

4.4. Direct Patient Care: Estimated __0_% of the time involved in direct patient care.

4.4.1. Scope of Care: Contractor’s cytotechnologist(s) shall be responsible for providing CYTOLOGY care, including, but not limited to

4.4.1.1. Communication of Test Results: Mechanisms must be in-place to provide notification of test results for patients receiving care in accordance with VHA Directive 1088, Communicating Test Results to Providers and Patients.

4.4.2. ADMINISTRATIVE: Estimated _0__% of time not involved in direct patient care

4.4.2.1. Quality Improvement Meetings: The Contractor’s cytotechnologist(s) shall participate in continuous quality improvement activities and meetings with committee participation as required by the facility Chief of Service, COS, or designee.

4.4.2.2. Staff Meetings: The Contractor’s cytotechnologist(s) shall attend staff meetings as required by the facility Chief of Service, COS, or designee. Contractor to communicate with COR on this requirement and report any conflicts that may interfere with compliance with this requirement.

4.4.2.3. QA/QI documentation: The Contractor’s cytotechnologist(s) shall complete the appropriate QM/PI documentation pertaining to all procedures, complications and outcome of examinations.

4.4.2.4. Patient Safety Compliance and Reporting: Contractor’s cytotechnologist(s) shall follow all established patient safety and infection control standards of care. Contractor’s cytotechnologist(s) shall make every effort to prevent medication errors, falls, and patient injury caused by acts of commission or omission in the delivery of care. All events related to patient injury, medication errors, and other breeches of patient safety shall be documented in the medical record of those impacted and disclosed to the patient or surrogate. As soon as practicable (but within 24 hours) Contractors shall notify COR of incident and submit an entry in the VA Patient Safety Reporting System, following up with COR as required or requested.

4.5. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY IMPROVEMENT(QI):

4.5.1. Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys, timely completion of medical records, and Peer Reviews. Methods of Surveillance: Focused Provider Practice Evaluation (FPPE) and Ongoing Provider Practice Evaluation (OPPE). Contractor performance will be monitored by the government using the standards as outlined in this PWS and methods of surveillance detailed in the QASP. The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

4.5.2. Patient Complaints: The CO will resolve complaints concerning Contractor relations with the Government employees or patients. The CO is final authority on validating complaints. If the Contractor is involved and named in a validated patient complaint, the Government reserves the right to refuse acceptance of the services of such personnel. This does not preclude refusal in the event of incidents involving physical or verbal abuse.

4.5.3. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The CO and COR shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

4.5.4. Performance Standards:

4.5.4.1. Measure: Qualifications of Key Personnel

Performance Requirement: All Contractor’s cytotechnologist(s) shall be graduate of accredited program, Diploma associate degree or greater cytotechnologist services . ASCP certification. All continuing education in accordance with ASCP Standards for Pathology Successful PAP proficiency testing in the previous 12 month period.

Standard: All (100%) Contractor’s cytotechnologist(s) are graduate of accredited program, Diploma associate degree or greater cytotechnologist services

AQL: _100__%

Surveillance Method: Random Sampling of qualification documents Frequency: Upon request, When the Contractor is proposing to add key personnel to the contract.

4.5.4.2. Measure: Patient Access

Performance Requirement: The Contractor shall provide Contractor’s cytotechnologist(s) in accordance with the operating hours and VA clinical schedule outlined in this PWS Standard: All (100%) Contractor’s cytotechnologist(s) are on time and available to perform services AQL: Contractor’s cytotechnologist(s) is on-time and available to perform services _95__% of the time Surveillance Method: Periodic Inspection of Time and Attendance Sheets Frequency: Upon request

4.5.4.3. Measure: Patient Safety

Performance Requirement: Patient safety incidents shall be reported using VA Patient Safety Reporting System. All incidents reported immediately (within 24 hours.)

Standard: All (100%) of patient safety incidents are reported using VA Patient Safety Reporting System within 24 hours of incident AQL: _100__% of patient safety incidents are reported using VA Patient Safety Reporting System within 24 hours of incident Surveillance Method: Direct Observation Frequency: Upon request

4.5.4.4. Measure: Maintains licensing, registration, and certification Performance Requirement: Updated licensing, registration and certification shall be provided as they are renewed. Licensing and registration information kept current Standard: All (100%) licensing, registration(s) and certification(s) for Contractor’s cytotechnologist(s) shall be provided as they are renewed. Licensing and registration information kept current AQL: _100__% licensing, registration(s) and certification(s) for Contractor’s cytotechnologist(s) shall be provided as they are renewed. Licensing and registration information kept current. No acceptable deviation.

Surveillance Method: Periodic Inspection or Random Sampling Frequency: Upon request

4.5.4.5. Measure: Mandatory Training

Performance Requirement: Contractor shall complete all required training on time per facility policy Standard: All (100%) of required training is complete on time by Contractor’s cytotechnologist(s) AQL: _100__% completions Surveillance Method: Periodic Sampling Frequency: Upon request

4.5.4.6. Measure: Privacy, Confidentiality and HIPAA

Performance Requirement: Contractor is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA and complies with all standards Zero breaches of privacy or confidentiality Standard: All (100%) Contractor’s cytotechnologist(s) comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA AQL: _100__% compliance Surveillance Method: Periodic Inspection; Contractor shall provide evidence of annual training required by the facility, reports violations per VA Handbook 6500.6 Frequency: Yearly

4.5.5. Registration with Contractor Performance Assessment Reporting System

4.5.5.1. As prescribed in FAR Part 42.15, the VA evaluates Contractor past performance on all contracts that exceed the Simplified Acquisition Threshold and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Sea Logistics Center in Portsmouth, New Hampshire. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the Federal Awardee Performance and Integrity Information System (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

4.5.5.2. Each Contractor whose contract award is estimated to exceed the Simplified Acquisition Threshold requires a CPARS evaluation. A government Focal Point will register your contract within thirty days after contract award and, at that time, you will receive an email message with a User ID (to be used when reviewing evaluations). Additional information regarding the evaluation process can be found at www.cpars.gov or if you have any questions, you may contact the Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690.

4.5.5.3. For contracts with a period of one year or less, the CO will perform a single evaluation when the contract is complete. For contracts exceeding one year, the CO will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will have sixty (60) days to submit any comments and re-assign the report to the CO.

4.5.5.4. Failure for the Contractor’s representative to respond to the evaluation within those sixty (60) days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond; the Contractor’s representative will be “locked out” of the evaluation and may no longer send comments.

5. GOVERNMENT RESPONSIBILITIES:

5.1. VA Support Personnel, Services or…

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