Laser and Technician Services PWS DRAFT.pdf

PERFORMANCE WORK STATEMENT FOR

ONSITE LASER TECHNICIAN SERVICES

SECTION 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-cleaning 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: The Contractor shall furnish services at the following locations:

Sacramento VA Medical Center, Surgical Service, 10535 Hospital Way, Mather, CA 95655

Martinez VA Outpatient Clinic, Surgical Service, 150 Muir Road, Martinez, CA 94553

The Period of Performance (POP) is as follows:

Period Start Date End Date

Base Year November 1, 2026 October 31, 2027

Option Year 1 November 1, 2027 October 31, 2028

Option Year 2 November 1, 2028 October 31, 2029

1.3. Definitions and Acronyms

Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In the event of a conflict in language between this section and other sections of this contract, the language in this section shall govern.

ACLS: Advanced Cardiac Life Support

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

BLS: Basic Life Support

CDC: Centers for Disease Control and Prevention

CDR: Contract Discrepancy Report

CMS: Centers for Medicare and Medicaid Services

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.

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.

CPARS: Contractor Performance Assessment Reporting System

ESWL: Extracorporeal Shock Wave Lithotripsy — uses shock waves to break a kidney stone into small pieces that can more easily travel through the urinary tract and pass from the body.

HHS: Department of Health and Human Services

HIPAA: Health Insurance Portability and Accountability Act

ISO: Information Security Officer

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

National Provider Identifier (NPI): 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).

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

NPPES: National Plan and Provider Enumeration System

OR: Operating Room

PA: Technician Assistant

POP: Period of Performance

PPD: Purified Protein Derivative

PWS: Performance Work Statement

QASP: Quality Assurance Surveillance Plan

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

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

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 Sacramento VA Medical Center.

SECTION 2 — QUALIFICATIONS

2.1 Staff and Facility

2.1.1 License

Contract laser technician(s) assigned by the Contractor to perform 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 a minimum of two

(2) years as a certified laser technician AND must be independently proficient in set-up, use, and tear-down of laser equipment. The technician shall follow protocols that 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. The Contractor shall provide documents upon request of the CO, COR, operating room nurse manager, or designee to verify current and ongoing competency, skills, certification, and/or licensure related to the provision of care, treatment, and/or services performed. The 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 abide by the VA Facility's Medical Staff By-Laws, rules, and regulations that govern medical staff behavior.

2.1.3 Training (BLS, ACLS, CPRS, and VA Mandatory)

The Contractor shall meet all VA educational requirements and mandatory course requirements defined herein. All training must be completed by Contractor technician(s) as required by the VA.

2.1.4 Standard Personnel Testing (PPD, etc.)

The Contractor shall provide proof of the following tests for technicians within five (5) 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.

Tuberculosis Testing: The 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.

Rubella Testing: The Contractor shall provide proof of immunization for all Contractor technician(s) for measles, mumps, and 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.

2.1.5 OSHA Regulation — Occupational Exposure to Bloodborne Pathogens

The 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.

The Contractor shall adhere to current CDC/HICPAC Guidelines for Infection Control in Healthcare Personnel for disease control. The Contractor shall provide follow-up documentation of clearance to return to the workplace prior to their return.

2.1.6 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 its 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 VAAR provision 852.209-70, Organizational Conflicts of Interest, and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.1.7 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 of 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. This certification is applicable to the entire Period of Performance (POP) and shall be made as part of the offeror's response to the Request for Proposal (RFP) using the subject attachment in Section D of the solicitation document.

2.1.8 Annual Office of Inspector General (OIG) Statement

In accordance with HIPAA and the Balanced Budget Act (BBA) of 1997, 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.

HHS OIG Exclusion List: The Contractor shall review the HHS OIG List of Excluded Individuals/Entities at https://oig.hhs.gov/exclusions/ to ensure that proposed Contractor technician(s) are not listed. 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 https://oig.hhs.gov/exclusions/ furnished during a period of exclusion and may be subject to treble damages. 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.

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 Contractor's firm and/or Contractor technicians provided are not listed as of the date the offer/bid was signed.

2.1.9 Clinical and 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 and 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 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.

2.1.10 Non-Personal Healthcare Services

The parties agree that the Contractor and all Contractor technician(s) shall not be considered VA employees for any purpose.

2.1.11 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, approval of position descriptions and performance standards for Federal employees, approval of contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

2.1.12 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 staff performing services under the resultant contract:

Workers' compensation Professional liability insurance Health examinations Income tax withholding Social security payments

2.1.13 Tort Liability

The Federal Tort Claims Act does not cover the 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.

2.2 Key Personnel

Contract personnel will be requested as needed, on a per-surgery case basis only.

Under the subject solicitation and any resultant award, any in-house personnel, subcontractors, outside associates, or consultants shall be limited to individuals or firms specifically identified in the Contractor's accepted offer/proposal. The Contractor shall obtain the Contracting Officer's written approval before making any substitution for designated in-house personnel, subcontractors, outside associates, or consultants.

If the Contractor proposes a substitution, it shall submit the same type of information that was 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 required and mandated in the solicitation, whichever is greater, is the minimum standard for any substitution.

2.2.1 Emergency Substitutions

If the key person is not available to report to work, the Contractor shall provide a qualified substitute. The substitute shall have qualifications comparable to the key person.

2.3 Refusal of Contractor Personnel

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 patients 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 document 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).

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

2.4 Contingency Plan

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

SECTION 3 — HOURS OF OPERATION

3.1 VA Business Hours

Normal weekday work hours are typically Monday through Friday, 7:00 a.m. to 7:30 p.m.

in the operating room.

3.2 Work Schedule

Intermittent and on-call (see Sections 3.3 and 3.4).

3.3 Variable Work Hours

Contractor personnel work hours will vary depending upon the need for laser services and the availability of staff. Overnight and weekend requests will be on an on-call basis with little advance notification. Duration of services required during regular business hours will depend 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 (1) hour prior to and one (1) hour following the scheduled case, and longer as requested by the lead operating physician. Cases requiring laser services can often accumulate a duration of several hours and frequently will exceed 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 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 — January 1

Martin Luther King Jr.'s Birthday — Third Monday in January

Presidents' Day (Washington's Birthday) — Third Monday in February

Memorial Day — Last Monday in May

Juneteenth National Independence Day — June 19

Independence Day — July 4

Labor Day — First Monday in September

Columbus Day — Second Monday in October

Veterans Day — November 11

Thanksgiving Day — Fourth Thursday in November

Christmas Day — December 25

Any other day specifically designated by the President of the United States as a Federal holiday, or designated by Congress as a National Holiday.

3.6 Cancellations

Cancellation, or reduction of hours, for a Contractor laser technician's scheduled cases may occasionally occur due to cancellations or changes in the operating room schedule of patient procedures. 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.

SECTION 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.

4.2 Reporting and Case Sheets

Contractor technician(s) are responsible for reporting to the OR Nurse Manager or representative and for submitting a case sheet upon completion of services provided.

The Contractor's case sheet must be signed by the operating room nurse manager or designee and will be used by the COR to confirm cases/days and services provided against the Contractor's invoices.

COR name, title, phone number, and email address prior to submission.

The assigned COR for this contract shall be:

Carol Branch, COR, Surgical Service Office: (916) 843-7264 Email:

Carol.Branch@va.gov

4.3 Visitor and Vendor Check-In

The Contractor shall follow VA NCHCS visitor requirements for the check-in and validation process for visitor and vendor services.

4.4 Equipment and Supplies

Contractor technician(s) shall provide all necessary equipment, fibers, and accessories for each laser case. Contractor technician(s) shall have full responsibility for maintaining adequate supplies necessary for laser system utilization.

4.5 Standards of Care

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. The standard of care shall be of a quality meeting currently recognized national standards as established by:

VA Standards: VHA Directive 2006-041, Veterans' Health Care Service Standards (or current successor directive).

The Joint Commission (TJC): https://www.jointcommission.org/standards/

American Hospital Association (AHA): https://www.aha.org

The requirements contained in this PWS.

4.6 Medical Records

https://www.jointcommission.org/standards/ https://www.aha.org/

4.6.1 Authorities

Contractor technician(s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with 5 U.S.C. § 552a (Privacy Act), 38 U.S.C. § 5701 (Confidentiality of Claimants Records), 5 U.S.C. § 552 (FOIA), 38 U.S.C. § 5705 (Confidentiality of Medical Quality Assurance Records), 38 U.S.C. § 7332 (Confidentiality of Certain Medical Records), Title 5 U.S.C. § 522a (Records Maintained on Individuals), and 45 C.F.R. Parts 160, 162, and 164

(HIPAA).

4.6.2 HIPAA

This contract and its requirements meet the exception in 45 CFR § 164.502(e) and do not require a Business Associate Agreement (BAA) in order for the Covered Entity to disclose Protected Health Information to a health care provider for treatment.

Treatment and administrative patient records generated by this contract or provided to the Contractor 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. The 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 the Contractor's expense. The Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

4.6.3 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 records at VA's place of business upon request during normal business hours. The VA will provide the Contractor with copies of applicable VHA Handbooks governing health information management, privacy, and release of information.

The penalties and liabilities for the unauthorized disclosure of VA patient information, mandated by the statutes and regulations referenced herein, apply to the Contractor.

4.6.4 Professional Standards for Documenting Care

Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by the current edition of VHA Handbook 1907.01, Health Information Management and Health Records, and all guidelines provided by the VAMC.

4.6.5 Release of Information

The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined by, but not limited to, Privacy Act requirements. In cases where the VA authorizes the Contractor to release patient information, the Contractor shall use VA Form 3288, Request for and Consent to Release of Information from Individual's Records, in compliance with VA regulations and at the Contractor's own expense. The Contractor shall also 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. Completed Release of Information requests will be forwarded to:

Privacy/FOIA Officer, VA NCHCS (001/PO/FOIA/FF), Office Line: 707-437-1823 Fax: 707- 437-1855

4.7 Services

The 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. The Contractor shall submit with the offeror's quote the Technician Qualification Sheets listing training and equipment certificates on file for each technician who will perform duties under this contract.

It is preferred that the Contractor provide their mission statement and policies and procedures for technician pre-employment requirements, competency and credentialing, incident reporting, quality assurance, biomed and preventive 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.

The 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 shall submit a laser services log to OR staff that details specific laser services information such as: date of case, scheduled start time, surgeon, equipment used, equipment operator, laser safety checklist, and pre-procedure checklist.

4.8 Cases

Contractor technician(s) will perform laser services as requested for all types of cases.

Contract personnel will work under the direction of the attending surgeon of the case for which laser services are required.

4.9 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.

4.10 Holidays

Holiday work and pay do 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 as defined in Section 3.5 of this PWS.

4.11 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:

4.11.1 Clinic and Surgical Care

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

4.11.2 Operative Services

Contractor technician(s) shall provide all material to safely operate the laser equipment 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.

4.11.3 Equipment

The Contractor shall ensure the proper set-up and safe operation of equipment during the scheduled surgical procedure. The Contractor remains with the equipment at all times during the case. At the conclusion of the case, the contract laser technician shall 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.

4.11.4 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).

4.11.5 Administrative

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

4.11.6 QA/QI Documentation

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

4.12 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 breaches of patient safety shall be reported to the COR in accordance with VA Safety Policy.

Patient safety incidents must be reported immediately to the COR and OR nurse manager of the respective unit. Appropriate documentation in the Electronic Patient Event Reporting (ePER) 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 the COR and shall follow up with the VA as required or requested.

SECTION 5 — PERFORMANCE STANDARDS, QUALITY ASSURANCE, AND QUALITY

IMPROVEMENT

5.1 Contract Quality Management and 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 outlined in this Performance Work Statement (PWS) and the 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.

5.2 Patient Complaints

The CO will resolve complaints concerning Contractor relations with Government employees or patients. The CO is the final authority on validating complaints. In the event 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.

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. Performance deductions are detailed in Section 6.6 of this PWS. Monetary incentives are not provided.

The following Performance Measures, their associated Requirements, Standards, Acceptable Quality Levels, 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:

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

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

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

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

Maintains Certification: Updated certification shall be provided as certifications are renewed.

Mandatory Training: Contractor technician(s) shall complete all required training on time per VANCHCS policy.

Privacy, Confidentiality, and HIPAA: All (100%) Contractor technicians shall be compliant with Privacy, Confidentiality, and HIPAA regulations.

5.4 Registration with Contractor Performance Assessment Reporting System (CPARS)

5.4.1 CPARS Overview

As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs 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 VA uses the online database CPARS to fulfill the requirement to provide the Contractor an opportunity to comment on past performance evaluations prior to each report closing. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS), which is available to all Federal agencies, and also includes access to the Federal Awardee Performance and Integrity Information System (FAPIIS) for Contractor responsibility determination information.

5.4.2 CPARS Registration

Each Contractor whose contract award is estimated to exceed $150,000 is required to register with the CPARS database at https://www.cpars.gov. Registration should occur no later than thirty (30) days after contract award and must be kept current should there be any change to the Contractor's registered representative.

5.4.3 CPARS Evaluation

For contracts with a period of one (1) year or less, the Contracting Officer will perform a single evaluation when the contract is complete. For contracts exceeding one (1) 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

(30) days to submit any comments and re-assign the report to the CO.

5.4.4 CPARS Failure

Failure to maintain a current registration with the CPARS database, or to re-assign the report to the CO within thirty (30) days, will result in the Government's evaluation being placed on file in the database with a statement that the Contractor failed to respond.

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) is monitored through personal observations of the operating physician and Chief of Surgical Service or designee.

5.6 Quality Assurance Standards

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.

5.7 Quarterly Review

The results of the Contractor's services are subject 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.

5.8 New Procedures

In order to adequately protect VA patients, 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.

5.9 Conflicting Situations

Contractor personnel shall not participate in, nor be a party to, any activities that are in conflict with Federal and/or State guidelines. In the event a Contractor employee encounters such conflicting situations, the Contractor employee shall 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.

SECTION 6 — GOVERNMENT RESPONSIBILITIES

6.1 VA Support Personnel, Services, and 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 employees shall maintain their work area in a safe and orderly manner and use all protective clothing when required. Protective clothing shall be provided by VANCHCS and will remain the property of VANCHCS.

6.2 Contract Administration and Performance Monitoring

After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to the designated COR.

6.3 Contracting Officer (CO) Responsibilities

6.3.1 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, including but not limited to terms affecting price, quantity, or quality of performance.

6.3.2 Contract Complaints

The Contracting Officer shall resolve complaints concerning Contractor technician relations with Government employees or patients. The Contracting Officer is the final authority on validating complaints. In the event the Contractor effects any 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.

6.3.3 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 contracted services, consultation or training for Contractor technician personnel to be provided by the VA, replacement of Contractor personnel, and/or renegotiation of contract terms or termination of the contract.

6.4 Contracting Officer's Representative (COR) Responsibilities

6.4.1 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 monitoring procedures shall be forwarded immediately to the Contracting Officer.

6.4.2 Contract Monitoring

The COR will be responsible for monitoring the Contractor's performance to ensure all specifications and requirements are fulfilled. Quality Improvement data 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 FPPE and OPPE. Contractor performance will be monitored by the Government using the standards as outlined in this PWS and methods of surveillance detailed in the QASP.

6.4.3 Contractor Payment

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

6.4.4 Contract Records

The COR will maintain a record-keeping system of services by retaining a sequential file of all case sheets verified and sent to Contractor management. The COR will review this data monthly when invoices are received and certify all invoices for payment by comparing the documentation retained in the VA record-keeping system against the invoices. Any evidence of the Contractor's non-compliance shall be forwarded immediately to the Contracting Officer.

6.4.5 Contract Invoices

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

6.4.6 Contract Administration

All contract administration functions will be retained by the VA.

SECTION 7 — SPECIAL CONTRACT REQUIREMENTS

7.1 Reports and Deliverables

The Contractor shall be responsible for complying with all reporting requirements established by the contract. The Contractor shall be responsible for assuring the accuracy and completeness of all reports and other documents, as well as timely submission of each. The following table provides a summary of required documents. If an item is addressed in the PWS but not listed here, the Contractor remains responsible for its delivery.

Deliverable Submission Requirement Submit To

Copies of all licenses, board certifications, NPI, and primary source verification of all licensed and certified staff Upon proposal; upon renewal of licenses; upon exercise of option periods; or upon change of key personnel Contracting Officer

Certification that staff list has been compared to OIG Exclusion List Upon proposal and upon new hires Contracting Officer

Proof of Indemnification and Medical Liability Insurance Upon proposal and upon renewals Contracting Officer

Certificates of Completion for Cybersecurity and Patient Privacy Training Before receiving VA network account access; annually; and upon new hires Contracting Officer

BLS/ACLS Certification Upon award and every two (2) years thereafter COR

Contingency Plan Upon proposal and as updated COR

7.2 Billing

7.2.1 Invoice Requirements and Supporting Documentation

Supporting documentation and invoices must be submitted no later than the 20th workday of the month. All invoice statements shall be consolidated and submitted monthly in arrears. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for a proper invoice in accordance with FAR 52.212-4(g), all invoices must include:

Name and address of the Contractor

Invoice date and invoice number

Contract number and purchase/task order number

Date of service

Contractor technician name

Hourly rate

Equipment description and fees

Attached case sheet with detailed information (case ID, case date, start and end time, purchase order number, doctor, patient, equipment and fees, and OR nurse manager or designee signature)

Quantity

Total price

7.2.2 Vendor Electronic Invoice Submission Methods

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:

VA FSC Electronic Invoice System: The VA's Financial Services Center (FSC) uses an electronic invoice presentment and payment system. Contact FSC for current enrollment information and submission methods.

FSC e-Invoice Contact: 1-877-353-9791

FSC e-Invoice Email: vafsccshd@va.gov

EDI Format: A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Committee (ASC) chartered by the American National Standards Institute (ANSI). See https://www.x12.org.

7.3 Payment for Performance and Adjustments

7.3.1 Actual Work

The Contractor shall be paid only for actual work performed on-site. The Contractor shall be paid for actual hours performed based on a per-case rate.

7.3.2 Prorated Invoices

Invoices will be prorated for partial days/hours worked. In the event that a Contractor technician works a portion of an hour, the Government adjusts payments by rounding time up to the next 15-minute increment.

7.3.3 Time Sheets

Contractor technician providers shall be responsible for submitting a summary of work performed. The COR monitors contract compliance by confirmation using the signed billing case sheet. Performance is monitored and reported by the OR nurse manager or designee to the COR quarterly.

7.3.4 Performance Deductions

If the Contractor technician fails to meet the Acceptable Quality Level (AQL) on any performance measure that references a deduction as a disincentive, the following method for calculating and applying the deduction shall be employed:

The COR will prepare a Contract Discrepancy Report (CDR) and will notify the CO in the event the Contractor technician failed to meet the AQL established for any performance measure. The CO will provide the Contractor with the CDR and supporting documentation reflecting the Government's intent to apply a twenty-five percent (25%) reduction of the monthly invoice, in accordance with the contract and as noted under the Performance Measures in Section 5.3 of this PWS. The 25% reduction shall be applied to the next invoice billed. The Contractor has thirty (30) days to respond if the

Contractor wishes to provide evidence that the AQL was met or to assert that Government action or inaction prevented the Contractor technician from reaching performance at the AQL. The Contracting Officer shall make the final determination regarding the deduction after reviewing the Contractor's response.

7.3.5 Payments in Full — No Billing VA Beneficiaries

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

7.3.6 Non-VA Benefits

To the extent that the Veteran desires services which are not a VA benefit or covered under the terms of this contract, the Contractor technician must notify the Veteran that there will be a charge for such service and that the VA will not be responsible for payment.

7.3.7 Billing Restrictions

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

7.4 Contractor Information Security Requirements

The Contractor shall comply with VA Handbook 6500, VA Information Security Program, which establishes the VA comprehensive information security program and practices that protect the confidentiality, integrity, and availability of information created, processed, stored, aggregated, and transmitted by VA's information systems and business processes.

7.5 Records Management

The following standard items relate to records generated in executing the contract:

Citations to pertinent laws, codes, and regulations include: 44 U.S.C. Chapters 21, 29, 31, and 33; Freedom of Information Act (5 U.S.C. § 552); Privacy Act (5 U.S.C. § 552a); 36 CFR Part 1222 and Part 1228.

The Contractor shall treat all deliverables under the contract as the property of the U.S.

Government, for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data as it determines to be in the public interest.

The Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or otherwise protected by the Freedom of Information Act.

The Government Agency owns the rights to all data/records and all electronic information (electronic data, electronic information systems, electronic databases, etc.) produced as part of this contract. The Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

The Contractor agrees to comply with Federal and Agency records management policies, including those associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format (paper, electronic, etc.), mode of transmission (e-mail, fax, etc.), or state of completion (draft, final, etc.).

No disposition of documents will be allowed without the prior written consent of the Contracting Officer. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. § 2701.

The Contractor is required to obtain the Contracting Officer's approval prior to engaging any subcontractor in support of this contract that requires the disclosure of information, documentary material, and/or records generated under or relating to this contract. The Contractor (and any subcontractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.