ATTACHMENT PERFORMANCE WORK STATEMENT.pdf

PERFORMANCE WORK STATEMENT

Pathology Physician and Laboratory Services

1. GENERAL:

1.1. Services Provided: The Contractor shall provide Board Certified Pathology services on-site, AND associated pathology reference testing and consultative services (off-site) in accordance with the specifications contained herein to beneficiaries of the Department of Veterans Affairs (VA) and the VA Central Iowa Health Care System. The Contractor agrees to furnish comprehensive pathology services, including all pathologist, required to provide daily on-site pathology professional services to perform microscopic and diagnostic examination of surgical samples.

The contractor will also provide a Pathology Assistant (or pathologist) to perform on-site gross examination of pathology samples. In addition to on-site services, the contractor will provide off-site professional consultation as needed. Off-site professional services will include pathologists with subspecialty fellowship training in Dermatopathology, Cytopathology and Hematopathology.

Off-site services will include all cytology services (excluding GYN and urine cytology), both pathologist examination and diagnosis, and technical staff. Off-site services will also include all technical surgical pathology testing and stains outside the scope of Veterans Affairs Central Iowa Health Care System (hereinafter referred to as VACIHCS). Contractor shall provide General Pathologist Board Certified in both clinical and anatomic pathology to perform on-site work and shall provide a certified Pathology Assistant or Pathologist to perform on-site gross examination. The contractor shall have at least one pathologist in the group with each of the following sub-specialties: Dermatopathology, Hematopathology, Cytopathology to provide off-site consultation. The contractor shall provide testing listed in CLIN 2 that is beyond the scope of their laboratory by sending it to a College of American Pathologist accredited facility.

1.2. Place of Performance –

1.2.1. On-site: Contractor shall furnish on-site services at the VA Central Iowa Health Care System, Pathology & Laboratory Medicine Service, 3600 30th Street, Des Moines, IA 50310

1.2.2. Off-site: Services and Technical Component, will be performed at the contracted pathology group’s place of business or at a subcontracted laboratory that is accredited by the College of American Pathologists.

1.3. Authority: 38 USC 8153, Health Care Resources (HCR) sharing Authority

1.4. Policy/Handbooks the contractor shall be subject to the following policies, including any subsequent updates during the period of performance:

1.4.1. VHA Handbook 1100.17: National Practitioner Data Bank Reports:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

1.4.2. VHA Handbook 1100.18: Reporting And Responding To State Licensing Boards:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9174

1.4.3. VHA Handbook 1100.19: Credentialing and Privileging:

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

1.4.4. VHA Directive 1003.04: VHA Patient Advocacy:

https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=5970

1.4.5. VHA Directive 1088: Communicating Test Results to Providers and Patients:

https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=3148

1.4.6. VHA Directive 1192.01: Seasonal Influenza Prevention Program:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8948

1.4.7. VA Directive 1663: Health Care Resources Contracting – Buying:

https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

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

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.va.gov%2Fvhapublications%2FViewPublication.asp%3Fpub_ID%3D2135&data=04%7C01%7C%7Cbd34382e5a73410e47ac08d880d1e67e%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637400986286870079%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=0PGc7b188zbfr8%2BtS3Y5bFiIO9kQ5%2Fmldd5V6O9ZX0I%3D&reserved=0 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9174 https://gcc01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.va.gov%2Fvhapublications%2FViewPublication.asp%3Fpub_ID%3D2910&data=04%7C01%7C%7Cbd34382e5a73410e47ac08d880d1e67e%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637400986286880040%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=V15n6NlzrDGn6OWYuR0jD03AmvTxzXZfxRoB%2Bd4cIWY%3D&reserved=0 https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=5970 https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fvaww.va.gov%2Fvhapublications%2FViewPublication.asp%3Fpub_ID%3D3148&data=04%7C01%7C%7Cbd34382e5a73410e47ac08d880d1e67e%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637400986286889992%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=BHR2cflWKBvQopyHKAfiK8zAwejTF7Ln6K%2Fqi6jtJPY%3D&reserved=0 https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.va.gov%2Fvhapublications%2FViewPublication.asp%3Fpub_ID%3D8948&data=04%7C01%7C%7Cbd34382e5a73410e47ac08d880d1e67e%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637400986286889992%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=z6i6xgCtRL209dZ4lVso7malIRXzs7lHCofZ2LgHbqA%3D&reserved=0 https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.va.gov%2Fvapubs%2FviewPublication.asp%3FPub_ID%3D969%26FType%3D2&data=04%7C01%7C%7Cbd34382e5a73410e47ac08d880d1e67e%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637400986286909911%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=5xR7Kyt0JvY%2B70Yo8vvcad8jLhW0cbbhsIVH5akJG4c%3D&reserved=0 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235

1.4.9. VHA Directive 1100.20 Credentialing of Health Care Providers:

https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=9444

1.4.10. Privacy Act of 1974 (5 U.S.C. 552a) as amended:

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.4.11. Joint Commission - http://www.jointcommission.org/standards/

1.4.12. HHS OIG Website – http://oig.hhs.gov/exclusions/index.asp

1.4.13. American Journal for Infection Control - AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

1.4.14. VHA Handbook 1106.1: Pathology and Laboratory Medicine Service (January 2018) http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1779

1.4.15. Blood Borne Pathogens Standards, 28 CFR Part 1910.1030 https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table

1.5. Definitions/Acronyms: 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. ABP: American Board of Pathology

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. ASCP: American Society of Clinical Pathologists

1.5.4. ACLS: Advanced Cardiac Life Support

1.5.5. AOD: Admitting Officer of the Day

1.5.6. BLS: Basic Life Support

1.5.7. CAP: College of American Pathology

1.5.8. CDC: Centers for Disease Control and Prevention

1.5.9. CDR: Contract Discrepancy Report

1.5.10. CEU: Certified Education Unit

1.5.11. CME: Continuing Medical Education

1.5.12. CMS: Centers for Medicare and Medicaid Services

1.5.13. Contracting Officer (CO): 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.

1.5.14. Contracting Officer’s Representative (COR): 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.

1.5.15. COS: Chief of Staff

1.5.16. COVID-19: Coronavirus Disease 2019

1.5.17. CPARS: Contractor Performance Assessment Reporting System https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fvaww.va.gov%2Fvhapublications%2FViewPublication.asp%3Fpub_ID%3D9444&data=04%7C01%7C%7C5a2fc81d5c9e4c31696308d9ca3b3c47%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637763178024295633%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=g4iIWP0fMWV1ITn9%2F0vT4lpul7nFJAe%2FDMHlz4MTfT8%3D&reserved=0 https://gcc01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.justice.gov%2Foip%2Ffoia_updates%2FVol_XVII_4%2Fpage2.htm&data=04%7C01%7C%7Cbd34382e5a73410e47ac08d880d1e67e%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637400986286909911%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=gjDWRZK4OpsLW6Ik9kEJEfEYONe5AV5j%2B0%2FfQvQoGtM%3D&reserved=0 http://www.jointcommission.org/standards/ http://oig.hhs.gov/exclusions/index.asp http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1779 https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table

1.5.18. Credentialing: Credentialing is the systematic process of screening and evaluating qualification and other credentials, including licensure, required education, relevant training and experience and current competence and health status.

1.5.19. DEA: Drug Enforcement Agency

1.5.20. ED: Emergency Department

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

1.5.22. FSMB: Federation of State Medical Boards

1.5.23. Full Time Equivalent (FTE): 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.

1.5.24. HHS: Department of Health and Human Services

1.5.25. HIPAA: Health Insurance Portability and Accountability Act

1.5.26. HR: Human Resources

1.5.27. ISO: Information Security Officer

1.5.28. Medical Emergency - a sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity that the absence of immediate medical attention could reasonably result in: Permanently placing a patient's health in jeopardy, causing other serious medical consequences, causing impairments to body functions, or causing serious or permanent dysfunction of any body-organ or part.

1.5.29. MOD: Medical Officer of the Day

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

1.5.31. Non-Contract Provider: any person, organization, agency, or entity that is not directly or indirectly employed by the Contractor or any of its subcontractors

1.5.32. NP: Nurse Practitioner

1.5.33. NPPES: National Plan and Provider Enumeration System

1.5.34. PA: Pathologist Assistant

1.5.35. PALS: Pediatric Advanced Life Support

1.5.36. POP: Period of Performance

1.5.37. PPD: Purified Protein Derivative

1.5.38. PWS: Performance Work Statement

1.5.39. Privileging (Clinical Privileging): 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 shall be facility-specific and provider-specific.

1.5.40. QA/QI: Quality Assurance/Quality Improvement

1.5.41. QM/PI: Quality Management/Performance Improvement

1.5.42. QASP: Quality Assurance Surveillance Plan

1.5.43. Veterans’ Health Administration (VHA): The central office for administration of the VA medical centers through throughout the United States. The VHA is located in Washington, D.C.

1.5.44. Veterans Integrated Services Network (VISN): The regional oversight for the VA medical centers.

1.5.45. VISTA (Veterans Integrated Systems Technology Architecture): A PC based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient’s medical record and with the hospital information system.

1.5.46. VetPro: a federal web-based credentialing program for healthcare providers.

1.5.47. Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA medical Center, for purposes of this contract, this term shall mean the VA Central Iowa Health Care System Medical Center.

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. License: The Contractor’s pathologist (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.

2.1.1.1. All licenses held by the personnel working on this contract shall be full and unrestricted licenses. Contractor’s pathologist(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:

2.1.2.1. On-site Pathologists: All contract pathologist(s) shall be board certified in both Anatomic and Clinical Pathology. All continuing education courses required for maintaining certification shall 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.

2.1.2.2. On-site Pathology Assistants: All contract pathology assistant(s) shall be board certified. All continuing education courses required for maintaining certification shall 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.

2.1.2.3. Off-site Pathologists providing professional consultation and services shall be board certified in Anatomic and Clinical Pathology. At least one member in the group shall have completed a fellowship training in each of the following subspecialties (Dermatopathology, Hematopathology, Cytopathology). Documentation of subspecialty certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance.

2.1.2.4. Off-site laboratory providing any technical work, special stains or specialized testing shall be accredited by the College of American Pathologists. Documentation of accreditation will be provided upon request of the COR.

2.1.3. Credentialing and Privileging –Credentialing and privileging is to be done in accordance with the provisions of VHA Handbook 1100.19 and VHA Directive 1100.20 referenced above. The Contractor is responsible to ensure that proposed pathologist(s) possesses the requisite credentials enabling the granting of privileges. No services shall be provided by any contractor’s pathologist(s) prior to obtaining approval by the VACIHCS Professional Standards Board, Medical Executive Board and Medical Center Director. Only pathologist(s) providing on-site services shall be credentialed at VACIHCS.

2.1.3.1. If a contractor’s pathologist(s) is not credentialed and privileged or has credentials/ privileges suspended or revoked, the Contractor shall furnish an acceptable substitute without any additional cost to the government.

2.1.4. Technical Proficiency - Contractor’s pathologist(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 pathologist(s) and contractor’s pathologist(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.1.5. Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements:

Contractor shall provide the COR copies of current CMEs as required or requested by the VAMC. Contractor’s pathologist(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 pathologist(s).

2.1.6. Training (VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training shall be completed by the contractor’s pathologist(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 Annual Hours

VA Privacy and Information Security Awareness and Rules of Behavior

Once per year 1

VHA Privacy and HIPAA Focused Training

Once per year 1

2.1.7. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for pathologists within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

2.1.7.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s pathologist(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.

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

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

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

2.1.7.5. INFLUENZA: Contractors shall provide proof that all Contractor pathologists have received the annual Influenza vaccine unless it is contraindicated. If the Contractor pathologist 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}.

2.1.7.6. COVID-19: Contractors shall comply with VHA Supplemental Contract Requirements for Combatting COVID-19 {This is applicable to all health care workers}. – See Section D attachment.

2.1.7.7. 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 pathologist (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.

2.1.7.8. The VAMC 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.

2.1.8. National Provider Identifier (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration shall 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 Centers for Medicare and Medicaid Services (CMS) National Plan and Provider Enumeration System (NPPES) be provided to the Contracting Officer with the proposal.

2.1.9. Conflict of Interest: The Contractor and all contractor’s pathologist(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 shall 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 (Jan 2008) 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 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals;

2.1.10.2. While performing services for the Department of Veterans Affairs, 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 Federal Acquisition Regulations.

2.1.10.3. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs 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 Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; 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 RFP using the subject attachment in Section D of the solicitation document.

2.1.11. Annual Office of Inspector General (OIG) Statement: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Department of Health and Human Services (HHS) Office of Inspector General (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 pathologist(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 VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1100.19 and VHA Directive 1100.20.

Clinical/Professional performance monitoring and review of all clinical personnel covered by this http://oig.hhs.gov/exclusions/index.asp contract for quality purposes will be provided by the VAMC 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 pathologist(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 pathologists are prohibited from referring VA patients to contractor’s or their own practice(s)

2.6. Inherent Government Functions: Contractor and Contractor’s pathologist(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 pathologist(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 pathologist(s). When a Contractor or contractor’s pathologist(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 pathologist(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 Equivalency (FTE): FTE is defined by VA as a minimum of 80 hours every two weeks and does not include holidays.

2.9.1.1. On-Site: The VA Full Time Equivalency (FTEE) for the services required is estimated at 4.5 FTEE general pathologist(s)/pathology assistant. Contractor’s group shall contain sufficient general pathologists to ensure daily 1-3 hour on-site coverage, daily 1-hour on-site grossing coverage, and daily 1-hour off-site coverage for VACIHCS.

The contractor group shall have the following specialty pathologists (Dermatopathology, Cytopathology and Hematopathology) to ensure timely results and meet timelines outlined in QASP.

2.9.1.2. Off-Site: At least one Cytopathologist, one Dermatopathologist, and one Hematopathologist shall be available to provide consultation/services off-site.

2.9.2. The minimum number of Board-Certified pathologists required to be on-site on a daily basis is one (1), as defined in paragraph Hours of Operation in this section. The minimum number of Board-Certified pathology assistants for grossing required to be on-site on a daily basis is one (1), 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 pathologist is unable to complete an assigned shift, the contractor shall provide replacement pathologist coverage within 2 hours and notify the Contracting Office Representative (COR) at the VA Central Iowa HCS 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 pathologist (s), s/he may request, without cause, immediate replacement of said Contractor’s pathologist (s). The CO and COR shall deal with issues raised concerning Contractor’s pathologist (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 VAMC’s medical services, The Contractor shall have a contingency plan in place to be utilized if the Contractor’s pathologist (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:

3.1. VA Business Hours: Pathology and Laboratory Medicine Service is a 24/7 operation.

3.1.1. CLIN 1 Pathology Professional Services: Pathologist required at the Pathology Office VACIHCS between 8 a.m. and 11 a.m., Monday through Friday, to complete on-site Surgical and Anatomic Pathology daily workload. Estimated hours for daily workload are 2.3 hours per day. Pathologist is expected to return to the VA for scheduled and emergency Frozen Section examinations, urgent hematology slides, and for scheduled meetings.

These are scheduled between 8 a.m. and 4:30 p.m. Monday-Friday. On rare occasions, an off-shift (4:30 p.m. to 8 a.m. weekdays and anytime on weekends) emergency frozen section or hematology case might occur (approximately once per year), and the pathologist is expected to report to VACIHCS during off-shift. Average total call back (scheduled and unscheduled) is 5 times per month or 60 per year. Contractor shall provide an emergency call number(s) for anytime the Pathologist is not on-site. This will be utilized 24/7 excluding any hours the pathologist is on-site. Examples include transfusion-related questions from VACIHCS laboratory staff or calls from VACIHCS ordering physicians regarding consultation on surgical cases.

Pathology Assistant (or Pathologist) is required at Pathology & Laboratory Medicine Service at approximately 12:30 p.m. Monday through Friday to complete grossing of daily specimens. Estimated hours are 1 hour per day.

Routine daily courier service to transport samples or slides to off-site location will occur between 8 a.m. and 4 p.m. at the discretion of the contractor (as long as turn-around expectations defined in the PWS are met). Urgent transport (as determined by VACIHCS staff physicians) is expected within 2 hours of notification.

Off-Site Professional Services shall be provided between 8 a.m. and 4:30 p.m.

3.1.2. CLIN 2 Per Procedure Technical Component and Pathology Referral: Technical services that are outside the scope of VACIHCS technical personnel, such as surgical pathology special stains, immunohistochemistry stains, and cytology, will be provided off-site between 8 a.m. and 4:30 p.m. Monday through Friday and will be billed by CPT code. Referral of complex or specialized testing and services outside the scope of the contractor will be referred to a pathology reference center and billed by CPT code.

3.2. Federal Holidays: The following holidays are observed by the Department of Veterans Affairs:

• 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.

3.3. Cancellations: Contractor is required to provide an on-site generalist pathologist Monday-Friday excluding Federal Holidays. Contractor cancellation is not acceptable. Unless a state of emergency has been declared or services are otherwise cancelled by the VACIHCS, the Contractor shall be responsible for providing services.

4. CONTRACTOR RESPONSIBILITIES

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

4.1.1. Contractor’s pathologist (s) and pathology assistant(s) shall be responsible for checking in with the Path & Lab Program Support Assistant or Histopathology staff member at scheduled times. Deviations from scheduled times will be logged and used by the COR to confirm schedule compliance.

4.2. Standards of Care: The contractor’s pathologist (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 TJC, VA and national standards as established by:

4.2.1. The College of American Pathology http://www.cap.org/apps/cap.portal

4.2.2. The professional standards of the Joint Commission (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 and;

4.2.4. The requirements contained in this PWS

4.3. Medical Records

4.3.1. Authorities: Contractor’s pathologist (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 pathologist(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 with community health care providers in compliance with VA regulations, HIPAA and VHA Directive 1605.01, Privacy and Release of Information. The VA will provide the Contractor with a copy of VHA Handbook 1907.01, Health Information Management and Health Records and VHA Directive 1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of http://www.cap.org/apps/cap.portal http://www.jointcommission.org/standards_information/standards.aspx http://www.hpoe.org/resources?show=100&type=8

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 Handbook 1907.01 Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 and all guidelines provided by the VAMC.

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. 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 were 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.

4.5. Indirect Patient Care: estimated 99.75% of the time involved in indirect patient care that directly affects patient care, diagnosis, and treatment.

4.5.1. Per the qualification section of this PWS, the Contractor shall provide a group of Pathologists to provide a wide variety of areas of expertise. On-site work will be performed by General Pathologist(s) certified in anatomic and clinical pathology and certified Pathology Assistant(s). Contracted group of pathologists shall include pathologists with specialized fellowship training in dermatopathology, cytopathology, hematopathology to provide off-site professional services and specialized consultation.

4.5.1.1. Board Certified Pathologist(s) (on-site)

4.5.1.1.1. Microscopic examination of all surgical specimens; entry of diagnostic results of all cases (including cytology, peripheral smear results, and reference lab testing that may have been performed off-site) into VACIHCS computer system. VACIHCS Program Support Assistant will type the dictated results into VACIHCS computer system with Pathologist reviewing and electronically signing the patient report.

Daily Cases: The number of pathology cases varies per day. In 2022, VACIHCS averaged 15-20 cases per day or 25-35 blocks per day. Many surgical cases have more than one tissue sample submitted.

Annual total number of (tissue) blocks was approximately 7,500, which includes the following specimen types: Dermatology, Gastrointestinal, ENT/Respiratory, GU/Prostate, Liver, Gross description only, Ortho/Decal, and Other.

Other duties include Frozen Sections, Peripheral Smears, Bone Marrows, Renal Biopsies, and 10% Random Review of cases by a second pathologist.

4.5.1.2. Board Certified Pathology Assistant (on-site)

4.5.1.2.1. Provides dictated gross description of all pathology samples submitted for examination. Case load for 2022 is outlined above.

4.5.1.3. Board Certified Pathologist(s) (off-site)

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235

4.5.1.3.1. Consultation with a second pathologist within the contracted group on any case, including second review of all new malignancies and 10% random (quality) reviews by a second pathologist.

All Professional interpretations completed by the contracted group associated with off-site procedures. Examples include flow cytometry interpretation, cytogenetic interpretation, FISH/MDS interpretation, and bone marrow interpretation and cytology interpretation/diagnosis for urgent cytology cases (non-GYN, non-urine).

Peripheral smears by a pathologist.

Provide availability by phone during business hours.

Provide on-call pathologist for off-hour consultation/call back. Off-hour call is infrequently utilized, approximately 3-4 calls for consultation per year between 5 p.m. and 8 a.m. and approximately 1 call that requires on-site presence.

4.5.1.4. Courier Service

4.5.1.4.1. Contractor shall provide daily courier (Monday through Friday) to transport samples to reference lab or contractor’s place of business. Routine daily transport will occur between 8 a.m. and 4 p.m. at the discretion of the contractor (as long as turn-around expectations defined in the PWS are met).

Urgent transport (as determined by the VACIHCS staff physicians) is expected within 2 hours of notification.

4.5.1.5. CLIN 2 Per Procedure Technical Component & Pathology Referral

4.5.1.5.1. Contractor will provide pathology technical components that are outside the scope of VACIHCS as listed in the schedule of services. Pathology professional referral to a pathology reference center such as the Mayo Clinic or the University of Iowa Pathology Department are billed per CPT code, referral within the Contracted Pathology group is included in Pathology services above.

4.5.2. Scope of Care: Contractor’s pathologist(s) (as appropriate and within scope of practice/privileging) shall be responsible for providing Pathology care, including, but not limited to:

4.5.2.1. Contract Pathologists are primarily and professionally engaged in the examination, interpretation and diagnosis of body fluids, tissue, frozen sections and other anatomic and surgical pathology samples submitted to the laboratory. This includes entering results in the Surgical Pathology section of the computerized medical record, communicating critical results to the ordering provider and discussion of cases with the ordering provider as needed. Provision of Services will include on-site generalist pathologist(s) and pathology assistant(s) and off-site consultation with specialized pathologists (dermatopathology, cytopathology, hematopathology) and well as technical cytology prep work and special surgical pathology stains and procedures per CPT code.

4.5.2.2. Communication of Test Results: Mechanisms shall be in-place to provide notification of test results for patients receiving care in accordance with VHA Directive 1088, Communicating Test Results

4.5.3. ADMINISTRATIVE: estimated 0.25% of time not involved in indirect patient care

4.5.3.1. Quality Improvement Meetings: The contractor’s pathologist(s) shall participate in continuous quality improvement activities and meetings with committee participation as required by the VAMC Chief of Service, Chief of Staff, or designee.

This includes a monthly Tumor Board presentation by the Pathologist. Quality Assurance activities include a 10% random retrospective review of cases signed off by each contract pathologist by a second pathologist within in the group to check for quality and consistency in diagnosis.

Meeting Frequency Annual Hours

Tumor Board First Thursday of every month at 12:00 p.m.

4.5.3.2. QA/QI documentation: The contract pathologist group shall provide a quarterly quality management report for their business as a whole and participate in quality measures and performance improvement measures as required by Pathology and Laboratory Medicine Service.

4.5.3.3. Technical Supervisor: The contracted pathology group shall designate one pathologist (approved by VACIHCS P&LMS Laboratory Director) as the Technical Supervisor for Anatomic Pathology, if requested. This pathologist shall review all Anatomic Pathology procedures for technical content and will fulfill all Technical Supervisor functions for Anatomic Pathology as required by the College of American Pathology.

4.5.3.4. Patient Safety Compliance and Reporting: Contractor’s pathologist(s) shall follow all established patient safety and infection control standards of care. Contract pathologist

(s) shall report any significant changes (corrections) to the Surgical Pathology patient record that would impact patient treatment and care. 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.

4.6. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY

IMPROVEMENT(QI)

4.6.1. Quality Management/Quality Assurance Surveillance: Contractor’s pathologist(s) 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 Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

Contract pathologist (s) and pathology assistant (s) shall check in with the Laboratory Secretary or Histopathology technician at scheduled times. Deviations from scheduled times will be logged and used by the COR to confirm schedule compliance. The COR is responsible for monitoring the professional components of the contract. All adverse actions shall be reported to the Contracting Officer immediately. The Contracting Officer and COR shall examine methodologies and quality control procedures during the contract term. All activities shall comply with Joint Commission standards and the policies and procedures of the VACIHCS.

4.6.2.