36C26320R0064.pdf

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. DUNS: DUNS+4:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 73

36C26320R0064 06/15/2020

MATTHEW DALE 651-293-3054

7/15/2020 1200pm CST

36C263 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

X 100

X

621511

$35.0 mil

X

N/A

X

Department of Veterans Affairs Black Hills VA Medical Center 113 Comanche Rd

Fort Meade, SD 57741

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

Y

Department of Veterans Affairs Financial Services Center PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

Pathology Services for the Black Hills VA Health Care System.

See Attachment 2: Schedule, for CLIN information.

See Performance Work Statement at B.4 for additional details.

See CONTINUATION Page

X

X -ONE-

CHARA L. COLLINS

36C26320R0064

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 CONTRACTOR ADMINISTRATION DATA

B.3 SPECIAL CONTRACT REQUIREMENTS

B.4 PERFORMANCE WORK STATEMENT

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT

2018)

C.2 52.216-18 ORDERING (OCT 1995)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.5 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.6 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.7 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2008)

C.8 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (OCT 2019)

C.9 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.10 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.11 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.12 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008) 40

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

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

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (OCT 2019)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.8 VAAR 852.273-70 Late offers

E.9 852.252-70 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.10 852.273-73 EVALUATION HEALTH-CARE RESOURCES

E.11 852.273-74 AWARD WITHOUT EXCHANGES

E.12 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (DEC 2019)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a) CONTRACTOR:

b) GOVERNMENT: Contracting Officer 36C263

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

c) Contractor and Government points of contact can be changed by written notification to the other party. Notification will be placed in the Contract file and will not require a modification to the Contract.

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor should be mailed to the following address:

3. INVOICES: Invoices shall be submitted in arrears: MONTHLY (in arrears)

4. Billing/Accounting/Invoices

a) Payments shall be made monthly in arrears upon receipt of a properly prepared invoice. IAW FAR 52.212‐4 (g), FAR 52.232‐33, and VAAR 852.232‐72.

b) In order to comply with the Improper Payment Elimination and Recovery Act of 2010 (IPERA), the VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (VAFSC). VAFSC has partnered with Tungsten Corporation e‐ Invoicing network for submissions of all electronic invoices to VA. Tungsten Network electronic invoicing is free to all VA vendors. In order to submit electronic invoices, all VA vendors must register with Tungsten Network by submitting an email to VA.Registration@tungsten‐network.com or calling 1‐877‐752‐0900 option 2 for Enrollment.

c) Contractor shall submit an electronic invoice by the tenth (10th) of the following month services were performed to the Veterans Affairs Financial Services Center (VAFSC) e‐Invoice through the website at https://portal.tungsten‐ network.com/Login.aspx. For questions regarding the submission of VA electronic invoices, OB10 customer service may be contacted at 1‐877‐489‐6135.

d) All invoices shall reference the vendor name and address, customer name, contract number, appropriate obligation/funding order number, description of services provided, quantity, unit price, and total invoice amount. Invoices shall also include any payment discount terms.

e) For questions regarding invoice receipt or payment, please call VAFSC directly at 1‐877‐353‐9791 or email vafsccshd@va.gov.

f) Payment Adjustments:

i) Invoices will be prorated for partial days/hours worked. The contractor shall be paid only for actual work performed onsite. Contract providers shall be responsible for reporting time worked accurately. The Contract shall be paid for actual hours performed. The contract shall be adjusted at the end of the period of performance in accordance with actual performance.

g) Payments in full/no billing VA beneficiaries:

i) The Contractor shall accept payment for services rendered under this contract as payment in full. VA beneficiaries shall not under any circumstances be charged nor their insurance companies charged for services rendered by the Contractor, even if VA does not pay for those services. This provision shall survive the termination or ending of the contract.

h) To the extent that the Veteran desires services which are not a VA benefit or covered under the terms of this contract, the

Contractor must notify the Veteran that there will be a charge for such service and that the VA will not be responsible for payment.

i) The Contractor shall not bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against, any person or entity other than VA for services provided pursuant to this contract. It shall be considered fraudulent for the Contractor to bill other third‐party insurance sources (including Medicare) for services rendered to Veteran enrollees under this contract.

B.2 CONTRACTOR ADMINISTRATION DATA

CONTRACTOR (Offerors are required to designate a person for prompt administration):

Name of Company:

Name:

Title:

Address:

E‐mail Address:

Phone No:

Toll Free No:

Fax No:

Tax ID No:

CAGE Code:

DUNS Number:

B.3 SPECIAL CONTRACT REQUIREMENTS

Under the authority of Public Law 104‐262, 38 U.S.C. 8153 and VA Directive 1663 and VAAR 873, the contractor agrees to provide

Health Care Resources in accordance with the terms and conditions stated herein, to furnish to and at the Department of Veterans

Affairs Medical Center, Black Hills, South Dakota, the services and prices specified in the Section entitled Schedule of Supplies/Services of this contract.

1. SERVICES:

a) The services specified in the Sections entitled Schedule of Services and Special Contract Requirements may be changed by written modification to this contract.

b) Other necessary personnel for the operation of the services contracted for at the VA will be provided by the VA at levels mutually agreed upon which are compatible with the safety of the patient and personnel and with quality medical care programming.

c) The services to be performed by the contractor will be performed in accordance with VA policies and procedures and the regulations of the medical staff by laws of the VA facility.

2. TERM OF CONTRACT:

This contract is effective from 10/1/2020 – 9/30/2021 plus three (3) possible option years that may be exercised by the VA. The contract is subject to the availability of funds.

3. TYPE OF CONTRACT:

This is a Fixed Price contract using FTE (Hourly) and CPT codes. This is a competed contract.

3. RECORD KEEPING:

The VA Medical Center, shall establish and maintain a record keeping system that will record the hours worked by the contractor employee(s). Contractor's employee(s) shall report to Administrative Officer, or designee upon arrival at the facility.

4. CONTRACT PERFORMANCE MONITORING:

Monitoring of contractor’s time shall be demonstrated through sign‐in/ sign‐out sheets. The contractor shall be required to sign an attendance log upon reporting to work and departing from work. James “Tyler” Morris (COR) shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

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

AMENDMENT NO DATE

B.4 PERFORMANCE WORK STATEMENT

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 Black Hills Health Care System.

1.2. Place of Performance

1.2.1. On-site: Contractor shall furnish on-site services at the VA BHHCS, 500 North 5th Street, Hot Springs, SD 57747 and VA BHHCS, 113 Comanche Rd., Fort Meade, SD 57741

1.2.1.1. Frozen section lab space is located at the Fort Meade VAMC campus, Building 113, Room 135A.

1.2.2. Off-site: Pathology services, professional consultation, necropsy services 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: Title 38 USC 8153 Health Care Resources and VA Directive 1663 Health Care Resources.

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=1364

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 1192: Seasonal Influenza Prevention Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5472

1.4.5. VHA Directive 1220: Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures In Any Clinical Setting https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8365

1.4.6. VHA Handbook 1106 Pathology and Laboratory Medicine Service https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7477

1.4.7. VHA Handbook 1106.01 Pathology and Laboratory Medicine Service (P&LMS) Procedures https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169

1.4.8. VHA Directive 1088: Communicating Test Results to Providers and Patients https://www.va.gov/VHAPUBLICAtIONs/ViewPublication.asp?pub_ID=3148

1.4.9. VA Directive 1663: Health Care Resources Contracting - Buying https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

1.4.10. VHA Handbook 1907.01: Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

1.4.11. 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. 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. CAP: College of American Pathology

1.5.5. CDC: Centers for Disease Control and Prevention

1.5.6. CEU: Certified Education Unit

1.5.7. CME: Continuing Medical Education

1.5.8. 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.

1.5.9. 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.

1.5.10. COS: Chief of Staff

1.5.11. CPARS: Contractor Performance Assessment Reporting System

1.5.12. CPRS: Computerized Patient Recordkeeping System- electronic health record system used by the VA.

1.5.13. 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.

1.5.14. DEA: Drug Enforcement Agency

1.5.15. FSMB: Federation of State Medical Boards

1.5.16. HHS: Department of Health and Human Services

1.5.17. HIPAA: Health Insurance Portability and Accountability Act

1.5.18. ISO: Information Security Officer

1.5.19. P&LMS: Pathology and Laboratory Medicine ServicePOP: Period of Performance

1.5.20. PPD: Purified Protein Derivative

1.5.21. PWS: Performance Work Statement

1.5.22. 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 must be facility-specific and provider-specific.

1.5.23. QASP: Quality Assurance Surveillance Plan

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

1.5.25. 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.

1.5.26. Veterans Integrated Services Network (VISN) : The regional oversight for the VA medical centers in Michigan and Indiana.

1.5.27. 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.

1.5.28. VETPro: A federal web-based credentialing program for healthcare Providers

1.5.29. 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 VA Black Hills Health Care System.

1.5.30. VA BHHCS: Veterans Affairs Black Hills Health Care System

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. License - Contract pathologists 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.

All licenses held by the personnel working on this Contract shall be full and unrestricted licenses.

Contract pathologists 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 pathologists shall be board certified in anatomic pathology and clinical pathology by the American Board of Pathology. All continuing education courses required for maintaining board certification must be current.

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 by the American Board of Pathology. All continuing education courses required for maintaining certification must always be kept up to date. 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 by the American Board of Pathology. At least one member in the group must have completed 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 technical work, special stains or specialized testing must be accredited by the College of American Pathologists. Documentation of accreditation will be provided upon request by the COR.

2.1.3. Credentialing and Privileging –Credentialing and privileging shall be in accordance with the provisions of VHA Handbook 1100.19 referenced above. The Contractor is responsible to ensure proposed pathologist(s) possess the requisite credentials enabling the granting of privileges. No on site anatomic pathology services shall be provided by any Contract pathologists prior to obtaining approval by the VA Black Hills Health Care System Professional Standards Board, Medical Executive Board and Medical Center Director. VA BHHCS shall provide a ninety (90) day notice to Contractor to provide adequate time for the credentialing process needed for onsite work by currently noncredentialled Contractor staff.

2.1.3.1. If a Contract pathologist 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 - Contract pathologists 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 Contract pathologists and Contract pathologists 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.

Contract pathologists registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. Contractor shall report CME hours of VA BHHCS privileged pathologists to the credentialing office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for Contract pathologists.

2.1.6. Training (ACLS, BLS and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the Contract pathologists as required by the VA.

Training (The following training is mandatory per VHACO for Contracted Physicians)

Frequency (once a year, etc.)

Annual Hours

VA Privacy & Information Security Awareness

Once a year 1 hour

VA Privacy and HIPPA Once a year 1 hour Hand- Hygiene Once a year 1 hour

2.1.7. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for pathologists working on site 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 pathologists. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results. The TST or IGRA testing shall be repeated annually.

2.1.7.2. MEASLES, MUMPS, RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor physicians.

2.1.7.3. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO

BLOODBORNE PATHOGENS: Contractor shall provide generic self-study training for all Contract pathologists, provide their own Hepatitis B vaccination series at no cost to the VA if they elect to receive it, maintain an exposure determination and control plan, maintain required records, and ensure that proper follow-up evaluation is provided following an exposure incident. 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.

2.1.7.4. VARICELLA: Contractors shall provide proof of immunity for all Contractor pathologists.

2.1.7.5. ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor pathologists.

2.1.7.6. 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 when performing work on site.

2.1.7.7. 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 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 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. DEA: N/A.

2.1.10. Conflict of Interest: The Contractor and all Contract pathologists 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 (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.1.11. Citizenship related Requirements:

2.1.11.1. 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 Department of Veterans Affairs patient referrals;

2.1.11.2. 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.

2.1.11.3. 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.

2.1.11.4. 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.

2.1.11.5. 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.

2.1.11.6. 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. 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 Contract pathologists is 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.

2.1.11.7. 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 Direction: 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. Clinical/Professional performance monitoring and review of all clinical personnel covered by this 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 Contract pathologists 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 Contract pathologists 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 Contract pathologists 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 Contract pathologist (s). When a Contractor or Contract pathologists 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 Contract pathologist (s)) action or non- action shall be the responsibility of the Contractor and/or insurance carrier.

2.9. Key Personnel:

2.9.1. On-Site: The VA Full Time Equivalency (FTE) for the services required is estimated at 0.1 FTE general pathologists’ on-site hours and estimated 0.1 FTE pathology assistants’ hours.

Contractor’s group must contain enough general pathologists to ensure as needed one (1) to three

(3) hour coverage for VA Black Hills Health Care System frozen section requirements and provide a pathology report within 20 minutes of receipt of the surgical sample. FTE is defined by VA as a minimum of 80 hours every two weeks and does not include holidays

2.9.2. The minimum number of Board-Certified Pathologists required to be on site daily is zero (0) pathologist as defined in paragraph Hours of Operation in this section. However, one (1) Board- Certified Pathologist is required on site during surgeries requiring frozen sections, unannounced lab accreditation inspections, and monthly review of laboratory quality assurance data.

2.9.3. Off-Site: Contractor’s group must contain enough pathologists and pathology subspecialists to provide routine pathology reports within 48 hours of receipt of the specimen. At least one cytopathologist, one dermatopathologist and one hematopathologist shall be available to provide professional consultation services off-site during regular business hours. At least one clinical pathologist shall be available to provide professional consultation services off-site outside of normal business hours.

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 days 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 three (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 Contract pathologist (s), s/he may request, without cause, immediate replacement of said Contract pathologist (s). The CO and COR shall deal with issues raised concerning Contract pathologists 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 Contract pathologists leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

3. HOURS OF OPERATION

3.1. VA Business Hours: 24 hours / 7 days a week Emergency Department and Hospital

Pathology and Laboratory Medicine Service

Regular Business Hours: 8:00 a.m. to 4:30 p.m.

3.1.1. Contractor’s physician(s) shall complete on-site quality assurance reviews at the Fort Meade VAMC and Hot Springs VAMC in a timely manner in accordance with College of American Pathologists and VA 1106.01 standards. Contractor shall notify the COR at least monthly about any obstacles to meeting this performance measure.

3.1.2. Contractor’s pathologist shall complete on site work during regular Laboratory hours, at Fort

Meade VAMC and Hot Springs VAMC which will be established, and may be revised, as deemed appropriate for laboratory operations by the Chief of Staff. Currently, normal clinic hours are 8:00 a.m. to 4:30 p.m.

3.1.2.1. On-call contractor’s pathologist(s) must always be available for phone consultations with VA residents and physicians.

3.1.3. Off-hours Coverage: Contractor must make one (1) clinical pathologist available on-call for emergent consultation during all hours when VA BHHCS laboratories are closed for regular business, including evenings, nights, weekends and holidays.

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 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 pathologist according to the agreed upon date and time. Contractor cancellation is not acceptable.

3.3.1. Unless a state of emergency has been declared or services are otherwise cancelled by the VA BHHCS, the Contractor shall be responsible for providing services.

4. CONTRACTOR RESPONSIBILITIES

4.1.1. Clinical Personnel Required: The Contractor shall provide Contract pathologists and pathology assistant(s) who are competent, qualified per this performance work statement and adequately trained to perform assigned duties. Contract pathologist(s) and pathology assistant(s) shall be responsible for checking in with Laboratory management. Deviations from scheduled times will be logged and used by the COR to confirm schedule compliance.

4.2. Standards of Care: The Contract 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 current recognized national standards as established by:

4.2.1. The College of American Pathology https://www.cap.org/protocols-and-guidelines/cap-guidelines

4.2.2. VA Standards: VHA Directive 2006-041 “Veterans’ Health Care Service Standards” (expired but still in effect pending revision) https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443

4.2.3. VHA Handbook 1106 Pathology and Laboratory Medicine Service https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7477

4.2.4. VHA Handbook 1106.01 Pathology and Laboratory Medicine Service (P&LMS) Procedures https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169

4.2.5. VHA Directive 1088: Communicating Test Results to Providers and Patients https://www.va.gov/VHAPUBLICAtIONs/ViewPublication.asp?pub_ID=3148

4.2.6. The professional standards of The Joint Commission (TJC) http://www.jointcommission.org/standards_information/standards.aspx

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

4.2.8. The requirements contained in this PWS.

4.3. MEDICAL RECORDS

4.3.1. Authorities: Contract pathologists providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (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. Based on this exception, a BAA is not required for this contract.

Treatment and administrative patient records generated by this Contract or provided to the Contractors by the VA are covered by the VA system of records entitled Patient Medical Records- VA (24VA19). 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 are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at its expense.

Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the Contract expiration date.

4.3.3. Disclosure: Contract pathologists may have access to patient medical records: however, Contractor shall obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook 1907.1, Health Information management and Health Records and VHA Handbook 1605.1, 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 Handbook 1907.01 Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 and all guidelines provided by the VAMC.

4.3.5. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. In the case of the VA authorizing the Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the Contractor shall be responsible for locating and forwarding records not kept at their facility. The VA’s Release of Information Office shall provide the Contractor with assistance in completing forms. Additionally, the Contractor shall use VA Form 10- 5345, Request for and Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall include the patient’s consent form. Completed Release of Information requests will be forwarded to the VA Privacy Officer at the following address: 113 Comanche Rd, Ft. Meade, SD 57741.

4.4. Indirect Patient Care: 95% of the time involved in indirect patient care which affects patient care, diagnosis and treatment. Contractor shall provide a group of pathologists to provide a wide variety of areas of expertise.

4.4.1. Scope of Care: Contractor pathologist(s) shall be responsible for providing pathological findings (reports) and consultations related to diagnosis and prognosis for a wide variety of disease processes. Contractor is expected to receive, process, and analyze a wide variety of gross specimens, including, but not limited to, surgical sections, biopsies, stones, whole blood, urine, and body fluids. On-site work will be performed by pathologists certified in anatomic pathology, clinical pathology, and certified Pathology Assistant(s). Contracted group of pathologists must include pathologists with specialized fellowship training in dermatopathology, cytopathology, hematopathology to provide off-site professional services and specialized consultation.

4.4.2. Frozen Section Lab: The CLIA license and accreditation of a frozen section lab at the Fort Made VAMC is the sole responsibility of the Contractor. Prior to activating a frozen section lab space, VA BHHCS will notify the Contractor at least ninety (90) days before any frozen section procedures are needed. The Contractor must provide a pathologist credentialed to perform frozen sections at the Fort Meade VAMC. Maintenance, oversight, equipment, stains, supplies and all requirements for the frozen section lab is the Contractor’s responsibility. VA provided equipment may be used for the purposes of this contract.

4.4.3. CLIN 0001: Clinical Pathology Professional Services, Flat hourly rate billed monthly in arrears.

4.4.3.1. Pathologist review of Laboratory quality assurance documentation at the Fort Meade VAMC and Hot Springs VAMC.

4.4.4. CLIN 0002: VA BHHCS Unannounced Accreditation Inspection, Flat hourly rate billed monthly in arrears.

4.4.4.1. Clinical Pathologist on site during accreditation inspections at both the Fort Meade VAMC and Hot Springs VAMC.

4.4.5. CLIN 0003: Necropsy Services, Flat rate per requested autopsy billed monthly in arrears.

4.4.5.1. Anatomic Pathology report comprising all elements of standard autopsy procedures. Includes transport, morgue rental, diener services, clerical support, and associated incidentals (e.g. corps processing, housekeeping).

4.4.6. CLIN 0004: Professional Consultation, Flat hourly rate billed monthly in arrears.

4.4.6.1. Pathologist consultation (specialized pathology consultation, clinical lab consultation, general pathology, frozen sections) with VA BHHCS medical Providers and clinical laboratory staff during regular business hours and outside normal business hours.

4.4.7. CLIN 0005 Pathology Services, Billed per current procedural terminology (CPT) code monthly in arrears.

4.4.7.1. Wide variety of pathology techniques, stains, tests, targets, probes, etc. to support high quality pathological reports. Current procedural terminology (CPT) codes shall be used as the primary billing method over flat hourly or flat cost rates. Billed charges shall not exceed allowable Medicare rates for the year the code is billed.

4.4.7.2. Referral tests for specialized techniques, stains, tests, targets, probes, etc. are needed to support high quality pathological reports.

The cost of referred test will be paid by VA BHHCS. The Contractor is required to get prior authorization for a single referred test exceeding $550.00.

4.4.7.3. All pathology reports shall contain…