S02_36C26122Q0508_1 8.19.22.pdf

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Q523--San Francisco - Neuromonitoring
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PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

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

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

SEE ADDENDUM

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

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

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

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

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

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

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

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

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

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

662-23-1-412-0002

36C26122Q0508 08-19-2022

April Gonzales | april.gonzales@va.gov 775-788-5510 08-30-2022

15:00 PDT

Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Sierra Nevada Health Care System 975 Kirman Avenue Reno NV 89502-2597

X 100

X

621399

$8 Million

N/A

Reference Performance Work Statement

VA Sierra Pacific Network (VISN 21) VA Sierra Nevada Health Care System 975 Kirman Avenue Reno NV 89502-2597

Department of Veteran Affairs FMS-VA-2(101) Financial Services Center

PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

The SFVAMC requires a contractor to provide an Intra-operative Monitoring Specialist (IOM), all equipment and supplies to perform Intraoperative Neurophysiologic monitor-ing and Evoked Potential services in the operating room at 4150 Clement Street, San Francisco, CA 94121 as needed.

-Please refer to the Addendum to the Instructions to Offerors for details on how to respond. Page 65.

-Please refer to the Evaluation Health Care Resources for information on how quotes will be evaluated. Page 71.

IDIQ Period of Performance: 10/01/2022 - 09/30/2027 Ordering Period One: 10/01/2022 - 09/30/2023 Ordering Period Two: 10/01/2023 - 09/30/2024 Ordering Period Three: 10/01/2024 - 09/30/2025 Ordering Period Four: 10/01/2025 - 09/30/2026 Ordering Period Five: 10/01/2026 - 09/30/2027

Point of Contact is April Gonzales, april.gonzales@va.gov Email questions regarding this RFQ to POC by 08/24/2022.

See CONTINUATION Page

662-3630160-412-820200-1031 010020251

Joleo Dianala

36C26122Q0508

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

PERFORMANCE WORK STATEMENT

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2021)

C.2 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (NOV 2021)

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.8 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.9 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.10 852.219-10DEV VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-

OWNED SMALL BUSINESS SET-ASIDE (JUL 2019) (NOV 2020) (DEVIATION)

C.11 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.12 VAAR 852.219-77 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (SEP 2021)

(DEVIATION)

C.13 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 51

C.14 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.15 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2022)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 PRICE LIST

D.2 QASP

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2021)

Submission Instructions:

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

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)

VAAR 852.273-73 EVALUATION – HEALTH-CARE RESOURCES (JAN 2003)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL 2020)

(DEVIATION)

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 36C261

VA Sierra Pacific Network (VISN 21) VA Sierra Nevada Health Care System 975 Kirman Avenue Reno NV 89502-2597

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly/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.

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

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

The guaranteed minimum award amount for this contract is $2,500.00. The maximum aggregate value of orders that can be placed under this contract is $2,000,000.00. The Government does not guarantee that it will place any orders under this contract more than the guaranteed minimum award amount.

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 LT __________________ __________________

Neuromonitoring: Use attachment Price Sheet

Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 621399 - Offices of All Other Miscellaneous Health Practitioners PRODUCT/SERVICE CODE: Q523 - Medical - Surgery

MANUFACTURER PART NUMBER (MPN): NA

Contract Period: Ordering Period 1 POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 621399 - Offices of All Other Miscellaneous Health Practitioners

Contract Period: Ordering Period 2 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 621399 - Offices of All Other Miscellaneous Health Practitioners

Contract Period: Ordering Period 3 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 621399 - Offices of All Other Miscellaneous Health Practitioners

Neuromonitoring: Use attachment Price Sheet Contract Period: Ordering Period 4 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 621399 - Offices of All Other Miscellaneous Health Practitioners

GRAND TOTAL __________________

PERFORMANCE WORK STATEMENT

1. GENERAL:

1.1. Services Provided: The Contractor shall provide an Intraoperative Monitoring Specialist (IOM) under Surgical Service to perform Intraoperative Neurophysiologic Monitoring and Evoked Potential services in the Operating Room at 4150 Clement Street, San Francisco, California 94121 (SFVAMC) on an as needed basis. The Contractor (IOM) shall provide a range of services in accordance with the terms and conditions contained herein.

CPT

Code Description

95940 Intraoperative Neuromonitoring 92585 Auditory evoked potentials (Auditor evoke potential) 95860 EMG, one extremity (muscle test 1 limb) 95861 EMG, two extremities (muscle test 2 limbs) 95863 EMG, three extremities (muscle test 3 limbs) 95864 EMG four extremities (muscle test 4 limbs) 95867 EMG, Cranial nerve supplied muscles, unilateral (muscle test cran nerv unilat) 95868 EMG, Cranial nerve supplied muscles, bilateral (muscle test cran nerv bilat) 95870 EMG, one extremity (limited study) (muscle test nonparaspinal) 95930 Visual evoked potentials 95933 Orbicularis oculi blink reflex (blink reflex test) 95938 Somatosensory evoke potentials, upper and lower (somatosensory testing)

95939 Transcranial elicited motor evoked potentials, upper and lower (Cmotor evloked upr&lwr limbs)

95955 Electroencephalography (EEG during surgery) 95961 Functional cortical/subcortical mapping (electrode stimulation brain-1st hour) 95925 Somatosensory evoked potentials, upper only 95926 Somatosensory evoked potentials, lower only 95928 Motor evoked potentials, upper only 95929 Motor evoked potentials, lower only 95829 Electrocorticography-Includes Grid Electrodes

95961 Functional cortical/subcortical mapping (electrode stimulation brain each additional hour)

95865 EMG, larynx 95870 EMG, anal/urinary sphincter 51792 Bulbocavernosus

1.2. Place of Performance - Primary: San Francisco VA, 4150 Clement Street, CA 94121;

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

1.4. Policy/Handbooks:

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

1.4.2. 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

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

1.4.4. VHA Handbook 1100.18 Reporting And Responding To State Licensing Boards – http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

1.4.5. VHA Handbook 1100.19 Credentialing and Privileging -

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

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

http://www.va.gov/VHAPUBLICATIONS/ViewPublication.asp?pub_ID=3025

1.4.7. 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. CDC: Centers for Disease Control and Prevention

1.5.2. CDR: Contract Discrepancy Report

1.5.3. CEU: Certified Education Unit

1.5.4. CMS: Centers for Medicare and Medicaid Services

1.5.5. 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.

1.5.6. 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.

1.5.7. COS: Chief of Staff

https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910 http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.5.8. CPARS: Contractor Performance Assessment Reporting System

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

1.5.10. 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.

1.5.11. DEA: Drug Enforcement Agency

1.5.12. ED: Emergency Department

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

1.5.14. HHS: Department of Health and Human Services

1.5.15. HIPAA: Health Insurance Portability and Accountability Act

1.5.16. HR: Human Resources

1.5.17. ISO: Information Security Officer

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

1.5.19. 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).

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

1.5.21. NPPES: National Plan and Provider Enumeration System

1.5.22. POP: Period of Performance

1.5.23. PWS: Performance Work Statement

1.5.24. 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.

1.5.25. QASP: Quality Assurance Surveillance Plan

1.5.26. 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.

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

1.5.28. 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.

1.5.29. VetPro: A federal web-based credentialing program for healthcare providers.

1.5.30. 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 San Francisco VA Medical Center, 4150 Clement Street, SF, CA 94121

1.5.31. VANCHCS: Veterans Affairs Northern California Health Care System.

2. QUALIFICATIONS:

2.1. Staff

2.1.1. - The IOM contractor must possess one or more attributes from each of the following areas:

2.1.1.1. Education:

• Doctorate degree (Ph.D.) in a relevant life science or biological field (including but not limited to fields such as physiology, biology, zoology, anatomy, neuroscience)

• Master’s degree in Audiology from a college accredited by the Council on Academic

Accreditation in Audiology and Speech Language Pathology (CCA-ASHA)

• Doctorate degree in Audiology (Au. D.) from a college accredited by the Council on Academic Accreditation in Audiology and Speech Language Pathology (CCA-ASHA)

• Doctorate degree in Medicine (M.D.) from an accredited college approved by the Liaison Committee on Medical Education and Hospitals of the American Medical Association

• Doctorate degree in Osteopathy (D.O.) from a college accredited by the American Osteopathic Association

2.1.1.2. Certification (Specialty/Subspecialty):

• Certified in Neurophysiological Intraoperative Monitoring (CNIM)

• Diplomate of the American Board of Neurophysiologic Monitoring (DABNM).

• Subspecialty in Clinical Neurophysiology, American Board of Psychiatry and

Neurology (ABPN)

• Special Competency in Intraoperative Neuromonitoring, American Board of Clinical

Neurophysiology (ABCN)

• Diplomate in Neurophysiology, EMG and evoked potentials, American Board of

Electrodiagnostic Medicine (ABEM)

• Certificate of Clinical Competence in Audiology, American Speech-Language-

Hearing Association (CCC-A ASHA)

2.1.1.3. Licensure

• If M.D. or D.O., must have current, valid, unrestricted License to practice Medicine, State of California

• If Au.D., must have current, valid, unrestricted license to practice Audiology, State of California

2.1.2. IOM contractors 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.

2.1.3. 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 IOM Technicians possesses the requisite credentials enabling the granting of privileges. No services shall be provided by any contract IOM Technicians prior to obtaining approval by the San Francisco VA Medical Center Chief, Neurosurgery.

2.1.3.1. If a contract IOM Technician 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 IOM Technicians 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 IOM Technicians and 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. Training: Complete annual mandatory VA Privacy and Information Security Awareness training online via the Talent Management System (TMS).

2.1.5.1. Remedial Training: When notified, contract employees must complete remedial training and education to address any detected compliance exceptions.

2.1.5.2. Proof of Training: Contract employees are responsible for submitting proof of awareness and remedial training completed to the Contracting Officer’s Technical Representative (COR) for this contract. The COR will retain proof of training in accordance with applicable Records Control Schedule.

2.1.5.3. Information Security and Privacy Training.

2.1.5.4. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

2.1.5.5. Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E of VA Handbook 6500.6 relating to access to VA information and information systems;

2.1.5.6. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

2.1.5.7. Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

2.1.5.8. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

2.1.5.9. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, are grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

2.1.6. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for IOM Technicians 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.

2.1.6.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative reaction to PPD testing for all contract IOM Technicians. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually.

2.1.6.2. RUBELLA TESTING: Contractor shall provide proof of immunization for all contract IOM Technicians 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. 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 quote.

2.1.8. Conflict of Interest: The Contractor and all contract IOM Technicians are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of quote and during the entirety of contract performance. At the time of quote, 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 solicitation document.

2.1.9. Citizenship related Requirements:

2.1.9.1. 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.

2.1.9.2. 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.

2.1.9.3. 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.

2.1.9.4. 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.

2.1.9.5. The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFQ using the subject attachment in the solicitation document.

2.1.10. 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.

2.1.10.1. 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 contract IOM Technicians 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.

2.1.10.2. By submitting their quote, 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 was signed.

2.1.10.3. Contracted IOM Technicians shall provide a copy of current DEA certificate to the COR/CO if requested.

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 direction of all clinical personnel covered by this contract 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 Personnel Healthcare Services: The parties agree that the Contractor and all contract IOM Technicians shall not be considered VA employees for any purpose.

http://oig.hhs.gov/exclusions/index.asp

2.4. Inherent Government Functions: Contractor and Contract IOM Technicians 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.

2.5. No Employee status: The Contractor shall be responsible for protecting Contract IOM Technicians 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:

2.5.1. Workers’ compensation

2.5.2. Professional liability insurance

2.5.3. Health examinations

2.5.4. Income tax withholding, and

2.5.5. Social security payments.

2.6. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract IOM Technicians. When a Contractor or contract IOM Technicians 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 IOM Technicians action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.7. Personnel:

2.7.1. Contract personnel shall be available Monday through Friday, excluding national holidays, to provide scheduled procedures. Hours of daily operations are normally 7 am to 7:30 pm however additional hours may be required to complete a case.

2.7.2. The number of IOM Technicians required to be on site on a daily basis is variable depending on the cases performed.

2.8. Emergency Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of 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.

2.8.1. 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 personnel.

2.8.2. For temporary substitutions where the person shall not be reporting to work for three (3) consecutive work days or more, the Contractor shall provide a qualified replacement for the person. The substitute shall have comparable qualifications to the person. Any period exceeding two weeks will require the procedure as stated above.

2.8.3. 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 IOM Technicians s/he may request, without cause, immediate replacement of said contract IOM Technicians.

2.8.4. The CO and COR shall deal with issues raised concerning Contract IOM Technicians conduct. The final arbiter on questions of acceptability is the

CO.

2.9. 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 IOM Technicians leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

3. VA Hours of Operation/SCHEDULING:

3.1. VA Business Hours: Hours of daily operations in the VA OR are normally 7 am to 7:30 pm, excluding national holidays.

3.1.1. Work Schedule: Contract personnel shall be available as needed Monday through Friday, excluding national holidays, to provide scheduled procedures. Hours of daily operations are normally 7 am to 7:30 pm however additional hours may be required to complete a case.

3.1.2. Patients must be seen by a contract IOM technician on-site at San Francisco VA, 4150 Clement Street, CA 94121 at the beginning of a scheduled case (7:45AM every day except Wed which is 9:15AM). Contractor shall notify the COR at least monthly about any obstacles to meeting this performance measure.

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

New Year’s Day

President’s Day

Martin Luther King’s Birthday

Memorial Day

Juneteenth National Independence 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.

3.2.1. 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 contract IOM Technicians who are competent, qualified per this performance work statement and adequately trained to perform assigned duties.

4.1.1. Contract IOM Technicians 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 contract IOM Technicians’ care shall cover the range of services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized TJC, VA and national standards as established by:

4.2.1. 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

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

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

4.2.4. The requirements contained in this PWS

4.2.5. Patient Safety- Patient safety incidents occurring while contractor is on service will be reported to SFVA Chief Surgery within 24 hours, along with a completed complication form as indicated.

4.3. Medical Records

4.3.1. Authorities: Contract IOM Technicians 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 https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443 http://www.jointcommission.org/standards_information/standards.aspx http://www.hpoe.org/resources?show=100&type=8 http://www.rms.oit.va.gov/SOR_Records/24VA19.asp 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: Contract IOM Technicians 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 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1469 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1469 http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1423 http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1423 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 http://www4.va.gov/vaforms/va/pdf/VA3288.pdf http://www4.va.gov/vaforms/va/pdf/VA3288.pdf http://www4.va.gov/vaforms/va/pdf/VA3288.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf following address: Shannon Caston, 103 Bodin Circle, Travis AFB, CA 94535, (707) 437-1823, Shannon.Caston@va.gov

4.4. Direct Patient Care:

4.4.1. Knowledge required by the IOM:

a. Knowledge of scientific rationale in coordination of the patient care.

b. Promotes quality patient care by coordinating and evaluating the care of selected patients in collaboration with multidisciplinary and interdepartmental personnel.

c. Knowledge of Universal Precautions.

d. Knowledge of safety and environment of care procedures.

4.4.2. Knowledge and expertise in the following areas of service:

a. Auditory Brainstem Response (ABR)

b. Visual Evoked Response (VER)

c. Somatosensory Evoked Potential (SEP or SSEP)

d. Electroencephalography (EEG)

e. Electromyography (EMG)

f. Nerve Conduction Studies

g. Knowledge of the Axon bio-med computer, Eclypse Model (or similar type of machine), that will be used to provide services.

h. IOM must maintain up-to-date knowledge of developments in the field

Intraoperative Neurophysiologic Monitoring and Evoked Potentials.

4.4.3. Complies with the following VA Operating Room regulations:

a. Surgical Conscience

b. Complies and sets up equipment and supplies utilizing recommended practices and aseptic technique.

c. Maintains integrity of all sterile areas.

d. Arrives in a timely manner when scheduled for a case (OR Start Time: 7:45AM every day except Wed which is 9:15AM) so as not to delay the surgical process.

e. Documents completed procedures and places in the patient’s chart prior to leaving the hospital.

f. The IOM specialist independently sets up and provides Intraoperative

Neurophysiologic Monitoring and Evoked Potentials services for patients.

g. Effective member of patient care team, e.g., participates in patient care activities, telephone usage, communicates effectively with surgical staff.

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

IMPROVEMENT(QI)

4.5.1. Quality Management/Quality Assurance Surveillance: Contractor IOM Technicians shall be subject to Quality Management measures, such as patient satisfaction surveys, timely completion of medical records, and Peer Reviews. Methods of Surveillance: Focused Provider Practice Evaluation (FPPE) and Ongoing Provider Practice Evaluation (OPPE). Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP).

mailto:Shannon.Caston@va.gov

The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

4.5.1.1. The contractor’s IOM Technicians are expected to actively participate in the facility’s performance improvement activities as part of the contracted service time. Performance Improvement Activities may include the following:

5. GOVERNMENT RESPONSIBILITIES

5.1. VA Support Personnel, Services or Equipment

5.2. Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to:

Contracting Officer – TBD after contract award

5.2.1 Contracting Officer Responsibilities:

5.2.1.1. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

5.2.1.2. The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

5.2.1.3. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan;

increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

5.2.2. COR Responsibilities:

The COR for this contract is: TBD after contract award

5.2.2.1. The 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.

5.2.2.2. The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled.

Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to: enter data that may be collected.

5.2.2.3. The COR will maintain a record-keeping system of services by keeping and maintaining monthly a Running Balance Excel spreadsheet of services rendered and invoices paid. The COR will review this data monthly when invoices are received and certify all invoices for payment by comparing the hours documented on the VA record-keeping system and those on the invoices. Any evidence of the Contractor's non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

5.2.2.4. The COR will review and certify monthly invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference.

5.2.2.5. All contract administration functions will be retained by the VA.

6. SPECIAL CONTRACT REQUIREMENTS

6.1. Reports/Deliverables: The Contractor shall be responsible for complying with all reporting requirements established by the Contract. Contractor shall be responsible for assuring the accuracy and completeness of all reports and other documents as well as the timely submission of each. Contractor shall comply with contract requirements regarding the appropriate reporting formats, instructions, submission timetables, and technical assistance as required.

6.1.1. The following are brief descriptions of required documents that must be submitted by Contractor: upon award; weekly; monthly; quarterly’; annually, etc. identified throughout the PWS and is provided here as a guide for Contractor convenience. If an item is within the PWS and not listed here, the Contractor remains responsible for the delivery of the item.

What Submit as noted Submit To

Quality Control Plan: Description and reporting reflecting the contractor’s plan for meeting of contract requirements and performance standards

Upon quote and as frequently as indicated in the performance standards.

Contracting Officer

Copies of any and all licenses, board certifications, NPI, to include primary source verification of all licensed and certified staff

Upon quote and upon renewal of licenses or change of personnel.

Contracting Officer

Certification that staff list have been compared to OIG list

Upon quote and upon new hires.

Contracting Officer

Proof of Identification and Medical Liability Insurance

Upon quote and upon renewals.

Contracting Officer

Certificates of Completion for Cyber Security and Patient Privacy Training Courses

Before receiving an account on VA Network and annual training and new hires.

COR

ACLS/BLS Certification Upon award COR

Contingency plan Upon quote and as updated

COR

ORG Chart Upon quote and upon new hires.

Contracting Officer

Remote Management Plan:

Description reflecting the contractor’s plan for meeting of contract requirements if management/staff is located more than 30 miles away from the San Francisco VA Medical Center.

Upon quote Contracting Officer

Coverage Plan: Description reflecting the contractor’s plan for meeting of coverage requirements if monitoring staff is located more than 30 miles away from the San Francisco VA Medical Center.

Upon quote

Emergency or After Hours Coverage Plan:…

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