36C26121Q0530_2.docx

36C26121Q0530

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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

36C26121Q0530 April White, April.white3@va.gov 775-788-5510 09-27-2021 15:00

PDT

36C261 Department of Veterans Affairs Network Contracting Office (VISN 21) Network Contracting Office 21 (NCO 21) 975 Kirman Ave Reno

NV

89502-2597 X 622110 $41.5 Million N/A X **See Statement of Work**

CA

95652 Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) Network Contracting Office 21 (NCO 21) 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 X See CONTINUATION Page The VA Northern California Health Care System (VANCHCS) has an indefinite delivery, indefinite quantity requirement for laser leasing, services, and technical support.

Performance will be from Nov 1, 2021 - Oct 31, 2026 See CONTINUATION Page X Joleo B. Dianala Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR: TBD

b. GOVERNMENT: Contracting Officer 36C261 Department of Veterans Affairs Network Contracting Office (VISN 21) Network Contracting Office 21 (NCO 21) 975 Kirman Ave Reno NV 89502-2597

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 Veteran Affairs FMS-VA-2(101) 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:

36C26121Q0530 See attached document: SCHEDULE.

Page 1 of Page 1 of

PERFORMANCE WORK STATEMENT

FOR ONSITE LASER TECHNICIAN SERVICES

1. GENERAL

1.1. Services Provided: The Contractor shall provide contract laser technician personnel services, which is defined as the timely and proper handling, operation, testing, set-up, cleaning, and pre-cleaining of operating room laser equipment and accessories before and after surgeries, on site in accordance with the specifications contained herein to beneficiaries of the Department of Veterans Affairs (VA) and the VA Northern California Health Care System (VANCHCS).

1.2. Place of Performance: Contractor shall furnish services at the Sacramento VA Medical Center, Surgical Service, 10535 Hospital Way Mather Way, Mather, CA 95655 and the Martinez VA Outpatient Clinic, Surgical Service, 150 Muir Road, Martinez, CA 94553.

1.3. 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.

1.3.1. ACLS: Advanced Cardiac Life Support

1.3.2. Beneficiary: An individual who is entitled to receive healthcare service provided under this contract, pursuant to VA eligibility requirements as determined by VA.

1.3.3. BLS: Basic Life Support

1.3.4. CDC: Centers for Disease Control and Prevention

1.3.5. CDR: Contract Discrepancy Report

1.3.6. CMS: Centers for Medicare and Medicaid Services

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

1.3.8. 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.

1.3.9. CPARS: Contractor Performance Assessment Reporting System

1.3.10. ESWL: Extracorporeal shock wave lithotripsy (ESWL) uses shock waves to break a kidney stone into small pieces that can more easily travel through the urinary tract camera.gif and pass from the body.

1.3.11. HHS: Department of Health and Human Services

1.3.12. HIPAA: Health Insurance Portability and Accountability Act

1.3.13. ISO: Information Security Officer

1.3.14. 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.

1.3.15. 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).

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

1.3.17. NPPES: National Plan and Provider Enumeration System

1.3.18. OR: Operating Room

1.3.19. PA: Technician Assistant

1.3.20. POP: Period of Performance

1.3.21. PPD: Purified Protein Derivative

1.3.22. PWS: Performance Work Statement

1.3.23. QASP: Quality Assurance Surveillance Plan

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

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

1.3.26. 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 Veterans Affairs Medical Center.

2. QUALIFICATIONS

2.1. Staff/Facility

2.1.1. License: Contract laser technician(s) assigned by the Contractor to perform the services covered by this contract shall have manufacturer or comparable certification in lasers for operating room use, or similar certification. Contract technician(s) must meet the minimum of two years as a certified laser technician AND must be independently proficient in set-up, use, and tear down of laser equipment. The technician will follow the protocols that will ensure the greatest margin of patient safety as outlined by ANSI or the equipment manufacturer.

2.1.2. Technical Proficiency: Contract laser technician(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, operating room nurse manager or desigee 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 experience, including any gaps in educational history for all Contractor technician(s). Contractor technician(s) shall be responsible for abiding by the VA Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.1.3. Training (BLS, ACLS, 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 technician(s) as required by the VA.

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

2.1.4.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative reaction to PPD testing for all Contractor technician(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.

2.1.4.2. RUBELLA TESTING: Contractor shall provide proof of immunization for all Contractor technician(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.

2.1.4.3. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide generic self-study training for all Contractor technician(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.

2.1.5. Conflict of Interest: The Contractor and all Contractor technician(s) are responsible for identifying and communicating to the CO and COR any 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 that 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.

2.1.6. Citizenship related Requirements: While performing services for the VA, the Contractor shall not knowingly employ, contract, or subcontract with an illegal alien foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. The Contractor must return a signed certification at the time of proposal 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 the VA. 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 and is applicable to the entire period of performance (POP). The certification shall be made as part of the offerors response to the request for proposal (RFP) using the subject attachment in Section D of the solicitation document.

2.1.7. 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.

2.1.7.1. HHS OIG Exclusion List: 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 technician(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. CMPs may also be imposed against the Contractor that employs or enters into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

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

2.2. Clinical/Professional Direction: The qualifications of Contractor personnel are subject to review by the Chief of Surgical Service or his/her designee and the VA Medical Center Chief of Staff (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 Personal Healthcare Services: The parties agree that the Contractor and all Contractor technician(s) shall not be considered VA employees for any purpose.

2.4. Inherent Government Functions: Contractor and Contractor technician(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.

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

2.5.1. 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 Contractor technician(s). When a Contractor or Contractor technician(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 contract technician(s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.7. Key Personnel: Contract personnel will be requested as needed, per surgery case basis only.

2.7.1. Under subject Solicitation, and any resultant Award executed, it should be noted that any in-house personnel, subcontractors, outside associates, or consultants shall be limited to individuals or firms that are specifically identified in the Contractor’s accepted offer/proposal. The Contractor shall obtain the Contracting Officer’s written approval before making any substitution for these designated in-house personnel, subcontractors, outside associates, or consultants. If the Contractor proposes a substitution, it shall submit the same type of information that had veen submitted in the accepted offer/proposal to the Contracting Officer for evaluation and approval. The level of qualifications and experience submitted in the accepted offer/proposal, or the level rquired by and mandated in the Solicitation, whichever is greater is the minimum standard for any substitution.

2.8. Emergency Substitutions: If the key person is not available to report to work, the contractor shall provide a qualified substitution to key personel. The substitute shall have comparable qualification to the key person.

2.8.1. 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 technician(s), s/he may request, without cause, immediate replacement of said Contractor technician(s).

2.8.2. The CO and COR shall deal with issues raised concerning Contractor technician(s) conduct. The final arbiter on questions of acceptability is the CO.

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

3. HOURS OF OPERATION

3.1. VA Business Hours: Normal weekday work hours are typically Monday through Friday, 7:00 am to 7:30 pm in the operating room.

3.2. Work Schedule: Intermittent and on-call. (See paragraph 3.3 and 3.4)

3.3. Variable Work Hours: Contractor personnel work hours will vary depending upon the need of laser services and the availability of staff personnel. Overnight and weekend requests will be on an on-call basis with little notification, and cannot be anticipated. Duration of services required during regular business hours will be dependent upon the type of surgery. For any surgical case requiring services, contract personnel are expected to be in the VA medical facility no less than one hour prior and one hour following the scheduled case; and longer as requested by the lead operating physician for the case. Cases which require laser services can often accumulate a duration of several hours and frequently will exceed past normal business hours. Laser services WILL NOT halt for any reason during a case unless directed specifically by the attending physician.

3.4. On-Call Coverage: Contractor personnel may provide emergency on-call coverage, on the uncommon tour of duty shifts, including weekends and holidays.

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

· New Year’s Day

· Presidents Day

· Martin Luther King’s Birthday

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving

· Christmas

· Any day designated by the President of the United States to be a Federal Day off for Federal Employees, OR, the designation by the Congress of the United States to be a National Holiday.

3.6. Cancellations: Cancellation, or more usually reduction of the hours, for a Contractor laser technician scheduled cases may occasionally occur with cancellation or changes in the operating room schedule of patient procedures.

3.6.1. Unless a state of emergency has been declared or the operating room schedule is otherwise cancelled by the VAMC, the Contractor shall be responsible for providing services.

4. CONTRACTOR RESPONSIBILITIES

4.1. Clinical Personnel Required: The Contractor shall provide Contractor laser technician(s) who are competent, qualified as defined in this performance work statement, and adequately trained to perform assigned duties.

4.1.1. Contractor technician(s) is responsible for reporting in to the OR Nurse manager or representative. Responsible for submitting a case sheet at the completion of services provided. The contractors case sheet must be signed by the operating room nurse manager or designee, and will be used by the COR to confirm case/days and services provided against the Contractor’s invoices. The assigned COR for this contract shall be:

Carol Ross, Adminsitrative Officer, Surgical Service Office: (916) 843-7264 Email: carol.ross2@va.gov

4.1.2. The contractor shall check in the the VA police upon arrival to the VA facility. The contractor shall follow the VA NCHCS visitor rquirements for check in and validdtaion process for visitor and vendor services.

4.1.3. Contractor technician(s) will provide all necessary equipment, fibers and accessories for each laser case.

4.1.4. Contractor’s technician(s) will have full responsibility for maintaining adequate supplies necessary for laser system utilization.

4.2. Standards of Care: The Contractor technician(s)’ care shall cover the range of laser technician 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:

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

4.2.4. The requirements contained in this PWS.

4.3. Medical Records:

4.3.1. Authorities: Contractor technician(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 business associate agreement (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 technician(s) may have access to patient medical records; however, Contractor technician(s) 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 the 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 Privacy Officer at the following address:

4.4. Direct Patient Care: Contractor technician(s) will spend 95% of their work time involved in direct patient care.

4.4.1. Services: Contractor shall assign qualified laser technicians to deliver equipment and assist VANCHCS surgeons in the effective application of lasers and other advanced technological devices during surgical procedures. Services shall be provided on a case-by-case basis. Contractor shall submit with the offerors quote the Technician Qualification Sheets that lists training and equipment certificates on file with the contractor for each technician who will perform duties under this contract. It is preferred that the contractor provide their mission statement and policy & procedures for technician pre-employment requirements, competency and credentialing, incident reporting, quality assurance, biomed and preventative maintenance, operating room protocol, laser safety, exposure control, smoke plume management, and handling in terms of proper set-up, testing, and safe use of systems and equipment. Contractor is responsible for obtaining all necessary licenses and approvals to be in compliance with all federal, state, and local laws and regulations applicable to the equipment and delivery of lasers. Laser equipment includes, but is not limited to, ESWL, CO2, KTP, Vbeam, Holmium, and Argon Beam Coagulator. The contractor will submit a laser services log to OR (Operating Room) staff that details specific laser services information such as the date of the case, scheduled start time, surgeon, equipment used, equipment operator, laser safety checklist, and pre-procedure checklist.

4.4.1.1. Cases: The Contractor technician(s) will perform laser services, as requested, for all types of cases. The contract personnel will work under the direction of the attending surgeon of the case for which laser services are required.

4.4.1.2. Call Coverage: Contractor technician(s) and VANCHCS Surgical Service mutually agree that Contractor technician(s) will be required to participate in some after-hours surgery and night and weekend in-hospital coverage duties.

4.4.1.3. Holidays: Holiday work and pay does not normally apply. Contractor technician(s) will not normally be scheduled for holiday work. Holiday work will be scheduled with the Contractor only with mutual agreement to the assignment and will be paid per case. Holidays are defined by the Office of Personnel Management as: New Year’s Day, Martin Luther King’s Birthday, Presidents Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving, Christmas, AND any other day specifically declared by the President of the United States to be a national holiday.

4.4.2. Scope of Care: Contractor technician(s) as appropriate and within scope of practice/ privileging shall be responsible for providing Laser Technician Services, including, but not limited to:

4.4.2.1. Clinic and Surgical Care: Contractor technician(s) shall provide clinical laser technician services. Contractor technician(s) shall be present on time for any scheduled clinics/surgeries as documented by physical presence in the clinic or operating room at the scheduled start time.

4.4.2.2. Operative Services: Contractor technician(s) shall provide all material to safely operate the laser equipment, to include but not limited to KTP, Omniguide, CO2, and Holmium Lasers, and consumable medical supplies such as but not limited to laser signs, wavelength specific safety eyewear, single use disposable fibers and a fully trained, licensed/insured operator with verification of preventive maintenance conducted.

4.4.2.3. Equipment: The Vendor will ensure the proper set-up and safe operation of equipment during the scheduled surgical procedure (contractor remains with the equipment during the case at all times). At the conclusion of the case, the contract laser technician will safely remove the laser device from the Operating Room and coordinate with Operating Room Staff for any decontamination requirements. All single use disposable items will be disposed of in accordance with VHA policies.

4.4.2.4. Responsibility: The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical or professional aspects of services rendered (e.g., professional judgments, diagnosis for specific medical treatment).

4.4.3. Administrative: For Contractor technician(s), up to 5% of their time may entail involvement in administrative work other than direct patient care.

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

4.4.3.2. Patient Safety Compliance and Reporting: Contractor technician(s) shall follow all established patient safety and infection control standards of care. Contractor technician(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.

4.4.3.3. Patient safety incidents must be reported immediately to the COR and OR nurse manager of the respective unit. The appropriate documentation the ePER (Electronic Patient Event Reporting) system as required under VANCHCS Policy 00Q-20 will be accomplished by appropriate VA personnel. At the time of submission of the ePER, Contractor technician(s) shall forward a copy to COR and shall follow-up with VA as required or requested.

4.5. Performance Standards, Quality Assurance (QA) and Quality Improvement (QI)

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

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

4.5.3. Performance Standards: The following performance standards are based on required laser services to be performed by an ongoing part-time flexibly available pool of Contractor technicians who will be individually scheduled on an as-needed basis in the operating room. Unfavorable Contractor technician performance will be noted for Contractor performance evaluations. For lack of conformity to these performance standards the methods and process of monetary deduction are explained in the billing section 6.6 of this PWS. Monetary incentives are not provided. The following Performance Measures and their associated Requirements, Standards, Acceptable Quality Level, Surveillance Methods, Incentives, and Disincentives are listed and fully explained in the Sample Performance Measures table included in the Quality Assurance Surveillance Plan (QASP) for this contract.

4.5.3.1. Qualifications of Key Personnel. All Contractor technician(s) shall be certified in accordance with manufacturer expectations.

4.5.3.2. Scope of Practice/Privileging. Contractor technician(s) perform within their individual scopes of practice/privileging.

4.5.3.3. Patient Access. The Contractor shall provide Contractor technician(s) in accordance with the operating hours and VA clinical schedule outlined in this PWS.

4.5.3.4. Patient Safety. Patient safety incidents shall be reported using the Electronic Patient Incident Report (ePIR). All incidents reported immediately (within 24 hours).

4.5.3.5. Maintains Certification. Updated certification shall be provided as they are renewed.

4.5.3.6. Mandatory Training. Contractor technician shall complete all required training on time per VANCHCS policy.

4.5.3.7. Privacy, Confidentiality, and HIPAA. All (100%) of Contractor technicians are compliant with Privacy, Confidentiality, and HIPAA regulations.

4.5.4. Registration with Contractor Performance Assessment Reporting System.

4.5.4.1. CPARS: As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed $150,000, and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, New Hampshire. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

4.5.4.2. CPARS Registration: Each Contractor whose contract award is estimated to exceed $150,000 is required to register with CPARS database at the following web address: www.cpars.csd.disa.mil. Help in registering can be obtained by contacting Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690. Registration should occur no later than thirty days after contract award and must be kept current should there be any change to the Contractor’s registered representative.

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

4.5.4.4. CPARS Failure: Failure to have a current registration with the CPARS database, or to re-assign the report to the CO within those thirty days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond.

4.5.5. Clinical Services Review: All clinical services provided under this contract will be subject to Quality Assurance and Utilization Review procedures of VANCHCS. Quality assurance of clinical procedures provided by Contractor technician(s) are monitored through personal observations of the operating physician and Chief of Surgical Service or his designee.

4.5.6. Quality Assurance Standards: The contractor personnel shall perform services under this contract in accordance with the ethical, professional, and technical standards of the healthcare industry, and must meet, or exceed, the current quality assurance standards recognized by The Joint Commission and mandated by VHA quality assurance policies and/or performance measures.

4.5.7. Quarterly Review: The results of contractor’s services are subjected to quarterly review and identified against quality assurance outcome indicators of primary and secondary major morbidity, minor morbidity, and additional complications. Quality Assurance Outcome Indicators are detailed further in the Quality Assurance Surveillance Plan for this contract.

4.5.8. New Procedures: In order to adequately protect VA patients, the contractor personnel shall not introduce substantially new procedures or services without prior recommendation to and approval from the VANCHCS Chief of Surgical Service and Chief of Staff or Director.

4.5.9. Conflicting Situations: The contractor personnel will not participate in, nor be a party to, any activities that are in conflict with Federal and/or State guidelines. In the event the contractor employee encounters said conflicting situations, the contractor employee will notify the COR or the Contracting Officer to resolve such issues. The Contracting Officer will document and be responsible for resolution of any such situations. Neither the VA nor the contractor employee will be responsible for any delays or failures to perform due to causes beyond each party's control.

5. GOVERNMENT RESPONSIBILITIES

5.1. VA Support Personnel, Services, or Equipment: All equipment is supplied for the preferred certification for specific laser equipment. Equipment is not supplied for an equivalent certification, nor will extra expense be charged to the government for the contractor furnishing alternate equipment. Contractor personnel will have use of all required patient care equipment, supplies, and forms for performing services required by this contract. Contractor employee shall maintain their work area in a safe and orderly manner and use all protective clothing when required. Protective clothing shall be provided by the VANCHCS and will remain the property of the VANCHCS.

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 Carol Ross, COR.

5.2.1. CO Responsibilities:

· Name: Contract Changes: 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.

5.2.1.1. Contract Complaints: The Contracting Officer shall resolve complaints concerning Contractor technician 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.

5.2.1.2. Contract Complaint Remedies: 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 technician personnel to be provided by the VA, replacement of the Contractor personnel, and/or renegotiation of the contract terms or termination of the contract.

5.2.2. COR Responsibilities:

5.2.2.1. Contract Compliance: 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. Contract Monitoring: 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 patient satisfaction surveys, timely completion of medical records, and Peer Reviews. Methods of Surveillance include 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).

5.2.2.3. Contractor Payment: to Contractors is based on per case procedure not an hourly rate. The COR monitors contract compliance by personal observation and the feedback and information provided of VA staff employees of Contractor technician presence and weekly reporting of hours.

5.2.2.4. Contract Records: The COR will maintain a record-keeping system of services by retaining a sequential file of all timesheets verified and sent electronically to Contractor Management. The COR will review this data monthly when invoices are received and certify all invoices for payment by comparing the hours documented on the timesheets retained in 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.

5.2.2.5. Contract Invoices: The COR will review and certify monthly invoices for payment. Invoices shall match the item description and price with contract item description and price. Case sheets with VA OR nurse manager or designee signatures shall be attached to all invoices.

5.2.2.6. Contract Administration: 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.