36C26318R0084-002.docx

36C26318R0084

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

TBD

36C26318R0084 11-15-2017 Joel Felberg 651-293-3022 12-15-2017 9:00am CST Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Attn: Joel Felberg - Contracting Officer 316 Robert Street N. Suite 506 St. Paul

MN

55101 X 621511 $32.5 Million X N/A X Department of Veterans Affairs Minneapolis VA Medical Center One Veterans Drive, Building 70 Minneapolis

MN

55417 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Attn: Joel Felberg - Contracting Officer 316 Robert Street N. Suite 506 St. Paul

MN

55101

Y Department of Veterans Affairs Financial Services Center PO Box 149971 Austin

TX

78714-9971

0.5 FTEE clinical pathologist/transfusion medicine physician

in accordance with the attached schedule of services and performance work statement.

$0.00 X X Joel Felberg

VA-VHA-SAOC-2016-99396ED5

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C618 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Attn: Joel Felberg - Contracting Officer 316 Robert Street N. Suite 506 St. Paul MN 55101

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center PO Box 149971

Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PERFORMANCE WORK STATEMENT

1. GENERAL:

1.1. Services Provided: The Contractor shall provide a 0.5 FTEE licensed physician who is a board certified/eligible Clinical Pathologist as well as a board certified/eligible in Transfusion Medicine, to perform duties for the Minneapolis VA Health Care System (MVAHCS). The contractor physician will report directly to the Director, Pathology and Laboratory Medicine Service (PALMS), at the MVAHCS. Duties include, but may not be limited to, the following, and must be provided 24/7 either on-site or on-call by phone or pager:

1.2. Contracted physician(s) will comply with appropriate MVAHCS policies, procedures, and regulations. Examples include medical staff bylaws, rules and regulations, narcotic control and use, personnel policies, labor/management relations, infection control, medical records, and required training regarding privacy, security, ethics, and the use of the MVAHCS EMR/computers.

1.3. Place of Performance - Contractor shall furnish services at the Minneapolis VA Health Care System, 1 Veterans Drive, Minneapolis, MN 55077

1.4. Authority: Services to be provided in this agreement are under the authority of Section 301 of Public Law 104-262, Veterans Health Care Eligibility Reform Act of 1996 (VHCERA) and Title 38 USC 8153, Health Care Resources (HCR) sharing Authority.

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

· VA Directive 1663: Health Care Resources Contracting - Buying http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347

· 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

· VHA Handbook 1100.17: National Practitioner Data Bank Reports - http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

· VHA Handbook 1100.18 Reporting and Responding to State Licensing Boards - http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

· VHA Handbook 1100.19 Credentialing and Privileging - http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

· VHA Handbook 1907.01 Health Information Management and Health Records: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791

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

1.6. 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.

· ACGME: Accreditation Council for Graduate Medical Education

· ACLS: Advanced Cardiac Life Support

· AOD: Admitting Officer of the Day

· BLS: Basic Life Support

· CDC: Centers for Disease Control and Prevention

· CDR: Contract Discrepancy Report

· CEU: Certified Education Unit

· CME: Continuing Medical Education

· CMS: Centers for Medicare and Medicaid Services

· 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.

· 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.

· COS: Chief of Staff

· CPARS: Contractor Performance Assessment Reporting System

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

· 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.

· DEA: Drug Enforcement Agency

· ED: Emergency Department

· FSMB: Federation of State Medical Boards

· HHS: Department of Health and Human Services

· HIPAA: Health Insurance Portability and Accountability Act

· HR: Human Resources

· ISO: Information Security Officer

· 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.

· MOD: Medical Officer of the Day

· 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).

· NLNAC: National League for Nursing Accrediting Commission. www.nlnac.org

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

· NP: Nurse Practitioner

· NPPES: National Plan and Provider Enumeration System

· PA: Physician Assistant

· PALS: Pediatric Advanced Life Support

· POP: Period of Performance

· PPD: Purified Protein Derivative

· PWS: Performance Work Statement

· 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.

· QA/QI: Quality Assurance/Quality Improvement

· QM/PI: Quality Management/Performance Improvement

· QASP: Quality Assurance Surveillance Plan

· 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.

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

· 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.

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

· 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 Veterans Administration Medical Center.

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. License – The Physician(s) assigned by the Contractor to perform the services covered by this contract shall be appropriately licensed to perform the services as set forth in the agreement. The Contractor’s physician (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. Contractor personnel must meet the professional qualification criteria of VA, as reasonably determined by the VA, prior to commencement of work under this contract. The qualifications of such personnel shall also be subject to review by VA Chief of Staff and approval by VA Facility Director.

All licenses held by the personnel working on this contract shall be full and unrestricted licenses. Contractor’s physician (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 - Contractor must have a MD degree from a recognized medical school. He/She shall have completed an approved Clinical Pathology residency training program. Contractor’s physician (s) shall be Board Certified /Board Eligible in Clinical Pathology. Must be Board Certified in Blood Banking/Transfusion Medicine or be board-eligible by completing a minimum of a one year fellowship in an approved program in Blood Banking/Transfusion Medicine. Be currently certified in Basic Life Support (BLS) Advanced Cardiac Life Support (ACLS) or equivalency. All continuing education courses required for maintaining certification must be kept up to date at all times. Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance.

2.1.3. Credentialing and Privileging –Credentialing and privileging is to be done in accordance with the provisions of VHA Handbook 1100.19 referenced above. The Contractor is responsible to ensure that proposed physician(s) possesses the requisite credentials enabling the granting of privileges. No services shall be provided by any Contractor’s physician (s)prior to obtaining approval by the MVAHCS Professional Standards Board, Medical Executive Board and Medical Center Director.

2.1.3.1. If a Contractor’s physician (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.

2.1.3.2. All contracted physicians must undergo identity verification, security background check, fingerprinting, and medical clearance.

2.1.4. Technical Proficiency - Contractor’s physician (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 physician (s)and Contractor’s physician (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 MVAHCS. Contractor’s physician (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 physician (s).

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

2.1.7. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for physicians 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 reaction to PPD testing for all Contractor’s physician (s). A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually.

2.1.7.2. RUBELLA TESTING: Contractor shall provide proof of immunization for all Contractor’s physician (s) for measles, mumps, rubella or a rubella titer of 1.8 or greater. If the titer is less than 1.8, a rubella immunization shall be administered with follow-up documentation to the COR.

2.1.7.3. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide generic self-study training for all Contractor’s physician(s); 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.

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

2.1.10.2. 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 physician (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. 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 Contractor’s physician (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 physicians are prohibited from referring VA patients to contractor’s or their own practice(s)

2.6. Inherent Government Functions: Contractor and Contractor’s physician (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 physician (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:

· Workers’ compensation

· Professional liability insurance

· Health examinations

· Income tax withholding, and

· Social security payments.

2.8. Tort Liability: The Federal Tort Claims Act does not cover Contractor or Contractor’s physician (s). When a Contractor or Contractor’s physician (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 physician (s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.9. Key Personnel:

2.9.1. The Contractor shall provide a 0.5 FTEE licensed physician who is a board certified/eligible Clinical Pathologist as well as a board certified/eligible in Transfusion Medicine at the onset of the contract. Note: Physicians must be credentialed and privileged by MVAHCS prior to commencing work under this contract. Contractor will be responsible to ensure that the contractor personnel providing work on this contract are fully trained and fully competent to perform the required services for the duration of the contract period. Contractor’s personnel provided under this contract must meet the qualifications, training, and all requirements as stated above in Section 2.1.

2.9.1.1. A full-time equivalent employee (1.0 FTEE) is defined as a contractor employee working eight (8) hours per day, five (5) days per week or 40 hours per week. Contractor’s employees must be present at the Minneapolis VA Medical Center and must be actually performing the required services for the period specified in the contract or the contract cost will be decreased accordingly during each billing cycle.

2.9.1.2. The number of board certified Blood Bank Physicians for the services required to be on-site on a daily basis is 0.5 FTEE. The work schedule is defined below in Section 3 – Hours of Operation.

2.9.1.3. Contractor shall submit a listing of proposed key personnel performing delivery of services in the following format:

· Provider Name: Title/Rank:

· Curriculum Vitae and qualification documents of each key personnel shall be submitted with the proposal.

2.9.2. 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 physician is unable to complete an assigned shift; the contractor shall provide replacement physician coverage within 2 hours and notify the Contracting Office Representative (COR) at the MVAHCS immediately of the schedule change.

2.9.3. 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 fifteen (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 fifteen (15) calendar days prior to making any permanent substitutions.

2.9.3.1. 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.

2.9.3.2. For temporary substitutions where the key person shall not be reporting to work for three (3) consecutive work days 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.

2.9.3.3. 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 physician (s), s/he may request, without cause, immediate replacement of said Contractor’s physician (s). The CO and COR shall deal with issues raised concerning Contractor’s physician (s) conduct. The final arbiter on questions of acceptability is the CO.

2.9.3.4. The CO or COR shall deal with issues raised concerning Contract physician(s) conduct. The final arbiter on questions of acceptability is the CO.

2.9.3.5. Removing/Replacing/Adding Staff: Contractor personnel performing in accordance with the contract are considered essential to the work being performed under this contract. Before removing, replacing, adding or diverting any of the personnel, the contractor shall (1) notify the COR and the Contracting Officer reasonably in advance; (2) submit justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on this contract; and (3) provide required documentation to the VA Chief of Staff for credentialing and privileging. With consent of both Contracting parties, the list of specific personnel may be amended by the VA Contracting Officer to add or delete personnel.

2.9.3.6. 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 physician (s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

2.9.4. Insurance: Contractor shall maintain commercial general liability and professional liability insurance of at least one million dollars ($1,000,000.00) applicable to its blood banking activities. Contractor’s employed physician(s) shall be covered by Contractor’s professional liability/medical malpractice insurance within the terms and conditions of the actual policy. Contractor shall also maintain worker’s compensation insurance for its employees in accordance with all statutory requirements. Contractor will provide a certificate of insurance evidencing its commercial general liability, professional liability, and worker’s compensation insurance prior to on-site work. Such certificate shall provide for not less than thirty days written notice to the Government of cancellation.

2.9.5. Limitation of Liability: the Contractor and/or his employee will not be held responsible for any loss or damage arising out of the following, as applicable:

2.9.5.1. The services provided unless directly attributable to the Contractor/or his employee’s negligence or willful misconduct.

2.9.5.2. Patient care provided by the MVAHCS, an unknow condition of any VA patient, or the underlying condition of any VA patient.

2.9.6. Nondiscrimination in Services Provided to VA Beneficiaries: The contractor agrees to provide all services specified in this contract for any person determined eligible by the Chief Medical Director or designee, regardless of race, color, religion, gender, or national origin of the person for whom such services are ordered. The contractor further warrants that he/she will not resort to subcontracting as means of circumventing this provision.

3. HOURS OF OPERATION

3.1. VA Business Hours: The Minneapolis VA Medical Center is open 24 hours per day 7 days a week 365 days per year. Administrative offices, clinics, and the O.R. general hours of operation are Monday through Friday, 7:00 am to 5:30 pm. The services covered by this contract shall be furnished by the contractor as defined in the work schedule below. The contractor shall also be required to furnish emergency on-call services on Federal Holidays and during off-duty hours.

3.1.1. The Contractor physician shall provide on-site services to the MVAHCS 4 hours each day, five days each week, or provide an equivalent of 20 hours of on-site services per week. Note: The MVAHCS recognizes that there may be times when related duties may take the contract physician off-site when working in his/her capacity as the MVAHCS Blood Bank Physician. (All related duties that take the contractor physician off site must be approved by the MVAHCS Director of Pathology and Laboratory Medicine to be credited to the contract physician’s tour of duty).

3.1.2. The Contractor may provide a partnership through shared physician services to cover the 0.5 FTEE position. The CV(s) of the proposed physician(s) must be submitted to the MVAHCS Chief of Staff’s office for credentialing and privileging and security background checks must be initiated by the VA prior to a physician commencing work at the MVAHCS.

3.1.3. Personnel scheduled to perform services under this contract shall be subject to review and acceptance or rejection by the Director of Pathology and Laboratory Medicine Service (PALMS) and the MVAHCS Chief of Staff. The contracting officer must be notified of any change in personnel.

3.1.4. Off-hours Coverage:

3.1.4.1. Contractor physician(s) will be available by phone or pager for on-call coverage and consolations 24 hours per day, 7 days per week including all weekends and holidays.

3.1.4.2. On-call contractor’s physician(s) must be available at all times for phone consultations with VA residents and physicians.

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 by the President of the United States to be a national holiday.

3.3. Cancellations:

3.3.1. Unless a state of emergency has been declared, the Contractor shall be responsible for providing services.

4. CONTRACTOR RESPONSIBILITIES

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

4.1.1. Contractor’s physician(s) shall be responsible for signing in and out when in attendance. Time sheets will be used by the COR to confirm hours/day and services provided against the contractor’s invoices.

4.2. Standards of Care: The Contractor’s physician(s)’ care shall cover the range of Blood Bank and Transfusion Service Medical Director services as would be provided in a state-of-the-art health care facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by:

· AABB: http://www.AABB.org

· 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

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

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

· All services performed and provided at the MVAHCS shall comply with appropriate and applicable policies, procedures and regulations of the MVAHCS to ensure compliance with all applicable Joint Commission guidelines. The contractor shall continuously meet or exceed all of The Joint Commission (TJC) applicable standards including the National Patient Safety Goals, Provision of Care, Human Resources, Waived Testing and all other applicable standards from the Hospital and Ambulatory Care manuals.

· The requirements contained in this PWS

4.3. MEDICAL RECORDS

4.3.1. Authorities: Contractor’s physician (s) 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 his 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: Contractor’s physician(s) 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: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 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 Section 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: Sandra Sampair, Sandra.Sampair@va.gov

4.4. Indirect Patient Care: 70% of the time involved in indirect patient care.

4.4.1. Scope of Care: Contractor’s physician (s) (as appropriate and within scope of practice/privileging) shall be responsible for providing oversight, direction and acting as a consultant to physicians on staff at the MVAHCS, including, but not limited to:

4.4.1.1. Contractor’s physician (s)shall provide expert consultation on transfusion utilization practices and procedures within the medical center. Contractor’s physician(s) shall be available 24/7.

4.4.1.2. Provide medical coverage on transfusion practices for clinical procedures performed at the MVAHCS including investigation of cases that deviate from approved transfusion guidelines.

4.4.1.3. Participate on the MVAHCS Transfusion Utilization Committee including review of transfusion practices, review of physician ordering practices, and monitoring of the safety and adequacy of the blood supply.

4.4.1.4. Conduct investigation of infectious complication and other adverse outcomes which may be due to blood or blood product transfusion.

4.4.1.5. Serve as an advisor for the distribution, handling, use and administration of blood and blood products.

4.4.1.6. Act as consultant to therapeutic apheresis services by writing orders, seeing patients, recommending frequency of care and writing progress notes.

4.4.1.7. Contract physician(s) will be required to enter their own progress notes in the electronic medical record.

4.4.1.8. Medications: Contractor’s physician(s) shall follow all established medication policies and procedures. No sample medications shall be provided to patients.

4.5. ADMINISTRATIVE: 30% of time not involved in indirect patient care.

4.5.1. Transfusion Utilization Committee Meetings: The Contractor’s physician(s) shall participate in the Transfusion Utilization Committee meetings. and meetings with committee participation as required by the VAMC Chief of Service, Chief of Staff, or designee.

4.5.2. Laboratory Quality Management Meetings: The Contractor’s physician(s) shall participate in the Laboratory Quality Management meetings. continuous quality improvement activities and meetings with committee participation as required by the VAMC Chief of Service, Chief of Staff, or designee.

4.5.3. The Contractor’s physician(s) shall participate in activities and meetings with committee participation as required by the VAMC Chief of Service, Chief of Staff, or designee.

4.5.4. Provide direction of the MVAHCS Transfusion Service Quality Management Program and abstract, compile and report Performance Improvement data as requested by the Pathology and Laboratory Medicine Service Director.

4.5.5. Reviewing and approving new and revised procedures and practices of the MVAHCS Blood Bank within seven (7) days of receipt, and approving any deviations from written procedures or policies

4.5.6. Assure compliance of all procedures and practices with standards required by all pertinent accrediting agencies, to include FDA, AABB, CAP and The Joint Commission (TJC)

4.5.7. Being available on site and being able to represent the MVAHCS Laboratory service at on-site inspections of the Blood Bank by the national regulatory accrediting agencies to include FDA, AABB, CAP and The Joint Commission.

4.5.8. Oversee Process Improvement projects in the Blood Bank laboratory.

4.5.9. Provide professional and technical direction for the Blood Bank to assist physicians and laboratory staff.

4.5.10. Contribute to the Medical Education Program and Staff Continuing Education by annually providing at least 4 hours of lectures or small group sessions with the physicians, clinical and laboratory staff and/or students if requested by the Pathology and Laboratory Medicine Service Director

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

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

4.5.13. Patient Safety Compliance and Reporting: Contractor’s physician (s) shall follow all established patient safety and infection control standards of care. Contractor’s physician (s) shall make every effort to prevent medication errors, falls, and patient injury caused by acts of commission or omission in the delivery of care. All events related to patient injury, medication errors, and other breeches of patient safety shall be reported to the COR VA Safety Policy. As soon as practicable (but within 24 hours) Contractors shall notify COR of incident and submit to the COR the Patient Safety Report, 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 physician (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).