Springfield Missouri Ambulatory Surgical Center PWS.docx

Performance Work Statement (PWS) Springfield Missouri Ambulatory Surgical Center

SCHEDULE OF SERVICES

Place of Performance: Services shall be provided off-site, at an Ambulatory Surgical Center in Springfield, Missouri.

Pricing Instructions: For pricing and evaluation purposes, the current Centers for Medicare and Medicaid Services (CMS) ASC Fee Schedule rates should be used in completing each Line-Item Number (LIN) for the base year and option years.

Pricing for this contract is based on actual services provided. Adjustments in pricing during the term of the contract shall be limited to published changes in CMS ASC Fee Schedule rates.

The basis used for calculating your price at the time of award shall remain the same throughout the life of the contract and may be validated by post award audits.

Instructions for requesting Economic Price Adjustments: The burden of notifying the Contracting Officer of any changes in Medicare rates lies with the Contractor. The Contractor’s notification to the Contracting Officer should include a list detailing the new Medicare rates and published documentation that substantiates these rates are currently effective or will be effective at a future date. Within seven (7) calendar days of being properly notified of the change(s) in Medicare rates by the Contractor, the Contracting Officer will attempt to verify the change(s) with the Centers for Medicare and Medicaid Services (CMS). If the change(s) cannot be verified, the Contracting Officer will notify the Contractor of this determination and will work with the Contractor to identify the issue(s) preventing verification. If the change(s) can be verified, the Contracting Officer will implement the corresponding adjustments within fourteen (14) calendar days of verification unless the effective date has not yet arrived. In the latter case, the Contracting Officer will implement the change(s) on the effective date unless the effective date falls within the fourteen (14) calendar days that Contracting Officer is afforded to implement the change(s) after verification. The Contracting Officer reserves the right to retain any of the remaining fourteen (14) calendar days between verification and implementation regardless of the effective date of the change(s).

The Offeror shall complete the enclosed price schedule breakdown found in Section D Attachment. No LIN or codes should be left blank. If for some reason a code on the CPT Code Attachment found in section D has expired or is for any other reason unusable, offerors shall annotate the Price per Code block with “N/A” or otherwise notate the replacement code.

The Contractor is not entitled to retroactive payment rate adjustments prior to implementation of the change(s) in Medicare rates by the Contracting Officer. “Piecemeal” changes to Medicare rates, such as only seeking per-procedure rate adjustments for select codes or a select group of codes, will not be permitted under any circumstance. The Contractor shall accept all Medicare rate changes for the period in which they are effective. VA reserves the right to adjust the Per-Procedure rates under this contract at any time should Medicare rates change regardless of whether the Contractor notified the Contracting Officer of the change(s). The Contractor will be given a notice of such actions at least seven (7) calendar days prior to the effective date of the change(s). Should there be any disagreement with the Contracting Officer’s proposed changes; the Contractor must submit a response outlining those areas in which the Contractor disagrees. This response must be provided to the Contracting Officer within seven (7) calendar days of notification of the anticipated change. The Contracting Officer reserves the right to make the final determination with regard to any change. Should the Contracting Officer implement any change(s) in Medicare rates under this contract, the Contractor shall accept all corresponding adjustments in which they are effective.

The Offeror shall base pricing on the application of Medicare reimbursement rules. All spreadsheets must be submitted in Microsoft Excel and without protected/locked portions or other methods which prevent or do not facilitate expeditious pricing validation. PDF files and similarly constructed files are not acceptable.

Indicate source for CMS rate proposed: For ASC Fee Schedule rates you must visit https://www.cms.gov/MAC-info and find the appropriate Medicare Administrative Contractor for your state and navigate to the ASC Fee Schedule.

The following information is the basis for Medicare base rates and any subsequent rate changes.

Medicare Payment System Utilized for Payment: Ambulatory Surgical Center (ASC) Payment System Schedule Updated Price Adjustment in Medicare Rates: Rates for the Ambulatory Surgical Center (ASC) Payment Schedule are updated on a calendar year basis and become effective on January first of any given year.

Orders: Orders shall be placed against this Fixed Price Economic Price Adjustment – Indefinite Delivery, Indefinite Quantity (FP-EPA – IDIQ) contract at the time of contract award, and as needed during the term of the contract. Task Orders shall specify the estimated quantities of services for the period of performance and shall comply with FAR 52.216-18 and 52.216-19. Individual task orders will be funded annually by the Contracting Officer and issued to the contractor.

Ordering Procedures: VA staff will identify appropriate patients for off-site ambulatory surgical services. These patients will be entered into the Electronic Medical Records (EMR) using standard VA scheduling processes. VA will notify the contractor of the planned operating room schedule two (2) business days or more prior to the planned operative date. Substitutions for late cancellations (within 2 days of the planned operative date) will be requested as substitution by the VA in a timely fashion and should be accepted/denied by the contractor timely.

The guaranteed minimum for the initial fiscal year in which this contract is awarded is $500,000.00. The maximum total value of the contract, inclusive of the base year and all options exercised, shall not exceed $5,550.000.00. The Government does not guarantee that it will place any orders under this contract more than the guaranteed minimum award amount.

Period of Performance: BASE YEAR: October 1, 2025, to September 30, 2026.

(See Section D Attachment _CPT Codes_ for breakdown of costs)

OPTION YEAR 1: October 1, 2026, to September 30, 2027.

(See Section D Attachment _CPT Codes_ for breakdown of costs)

REPEAT FOR OPTION YEARS 2-4

Total for base performance period and all option years: $5,500,000.00

Performance Work Statement for Ambulatory Surgical Center Services

1. GENERAL:

1.1 Services Provided: The Contractor shall provide Ambulatory Surgical Center services for cataract surgery offsite in accordance with the specifications contained herein to beneficiaries of the Department of Veterans Affairs (VA) and the Veteran’s Healthcare System of the Ozarks, Fayetteville, Ar.

1.2 Place of Performance: Contractor’s location

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

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

1.4.1 VA Directive 1663: Health Care Resources (HCR) Contracting – Buying Title 38 U.S.C. 8153: https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

1.4.2 VHA Directive 1003.04: VHA Patient Advocacy: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5970

1.4.3 VHA Directive 1088(1): Communicating Test Results to Providers and Patients: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3148

1.4.4 VHA Directive 1100.18: Reporting And Responding To State Licensing Boards:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9174

1.4.9 VHA Directive 1400.01: Supervision of Physician, Dental, Optometry, Chiropractic, and Podiatry Residents:

Ahttps://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8579

1.4.10 VHA Directive 1605.01: Privacy and Release of Information: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3233

1.4.11 VHA Directive 1907.01: VHA Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235

1.4.12 VHA Handbook 1100.17: National Practitioner Data Bank (NPDB) Reports: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

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

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

1.5.1 AAAHC: Accreditation Association for Ambulatory Health Care

1.5.2 ABA: American Board of Anesthesiology http://www.theaba.org/

1.5.3 ACGME: Accreditation Council for Graduate Medical Education

1.5.4 ACLS: Advanced Cardiac Life Support

1.5.5 AOA: American Osteopathic Association

1.5.6 AORN: Association of Operating Room Nurses

1.5.7 ASC: Ambulatory Surgical Center

1.5.8 BAA: Business Associate Agreement

1.5.9 BLS: Basic Life Support

1.5.10 CARF: Commission on Accreditation of Rehabilitation Facilities

1.5.11 CCNE: Commission on Collegiate Nursing Education: www.aacn.nche.edu/accreditation

1.5.12 CDC: Centers for Disease Control and Prevention

1.5.13 CDR: Contract Discrepancy Report

1.5.14 CEU: Certified Education Unit

1.5.15 Clinical Privileging: Clinical Privileging is the process by which a practitioner, licensed for independent practice; e.g., without supervision, direction, required sponsor, preceptor, mandatory collaboration, etc.; is permitted by law and the facility to practice independently, to provide specific medical or other patient care services within the scope of the individual’s license, based upon the individual’s clinical competence as determined by peer references, professional experience, health status, education, training and licensure. Clinical privileges must be facility-specific and provider-specific.

1.5.16 CME: Continuing Medical Education

1.5.17 CMS: Centers for Medicare and Medicaid Services

1.5.18 CO: Contracting Officer – The person executing this contract on behalf of the Government with the authority to enter and administer contracts and make related determinations and findings.

1.5.19 COR: Contracting Officer’s Representative – A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

1.5.20 COS: Chief of Staff

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

1.5.22 CPARS: Contractor Performance Assessment Reporting System

1.5.23 CPT: Current Procedural Terminology

1.5.24 Credentialing: Credentialing is the process of obtaining, verifying, and assessing the qualifications of a health care provider to provide care or services in or for the VA health care system. Credentials are documented evidence of licensure, education, training, experience or other qualifications.

1.5.25 CRNA: Certified Registered Nurse Anesthetist

1.5.26 DEA: Drug Enforcement Agency

1.5.27 ED: Emergency Department

1.5.28 EHR: Electronic Health Records. Electronic health record system used by the VA.

1.5.29 EMR: Electronic Medical Record

1.5.30 FSMB: Federation of State Medical Boards

1.5.31 FTE: Full Time Equivalent: VA’s definition for full time- working the equivalent of 80 hours every two weeks, 2080 hours per year.

1.5.32 HCFA: Health Care Financing Administration

1.5.33 HHS: Department of Health and Human Services

1.5.34 HICPAC: Healthcare Infection Control Practices Advisory Committee - a federal advisory committee made up of 14 external infection control experts who provide advice and guidance to the CDC and the Secretary of HHS regarding the practice of health care infection control, strategies for surveillance and prevention and control of health care associated infections in United States health care facilities.

1.5.35 HIPAA: Health Insurance Portability and Accountability Act

1.5.36 HR: Human Resources

1.5.37 Implants: Implants are defined as any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.

1.5.38 ISO: Information Security Officer

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

1.5.40 MOD: Medical Officer of the Day

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

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

1.5.43 NP: Nurse Practitioner

1.5.44 NPPES: National Plan and Provider Enumeration System

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

1.5.46 PA: Physician Assistant

1.5.47 POP: Period of Performance

1.5.48 PPD: Purified Protein Derivative

1.5.49 PWS: Performance Work Statement

1.5.50 QA/QI: Quality Assurance/Quality Improvement

1.5.51 QASP: Quality Assurance Surveillance Plan

1.5.52 QAPI: Quality Assessment and Performance Improvement

1.5.53 QM/PI: Quality Management/Performance Improvement

1.5.54 TJC: The Joint Commission

1.5.55 VA: Veterans Affairs

1.5.56 VetPro: is VHA’s mandatory credentialing software platform to document the credentialing of VHA health care providers. This system facilitates completion of a uniform, accurate, and complete credentials file.

1.5.57 VHA: Veterans Health Administration

1.5.58 VISN: Veterans Integrated Services Network

1.5.59 VISTA: Veterans Integrated Systems Technology Architecture

2. QUALIFICATIONS:

2.1 Staff/Facility:

2.1.1 The contractor shall provide qualified staff under the Medicare Program and shall meet the requirements of the TJC or Accreditation Association for Ambulatory Health Care (AAAHC) or equivalent accreditation.

2.1.2 The Contractor shall have written policies and procedures regarding staff credentials and privileging.

2.2 Technical Proficiency: Contractor’s staff shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all Contractor’s staff and Contractor’s staff shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.3 Standard Personnel Testing (PPD, etc): Contractor shall provide statement that all required infectious disease testing for personnel is current and that the contractor is compliant with all applicable laws to include OSHA regulations concerning occupational exposure to blood borne pathogens. The Contractor shall also notify the VA of any significant communicable disease exposures and the VA will also notify the contractor of the same, 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 https://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for disease control. If personnel are absent from work secondary to infectious disease, then contractor shall provide follow up documentation of clearance prior to return to the workplace.

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

2.5 Citizenship related Requirements:

2.5.1 The Contractor certifies that the Contractor shall comply with all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals;

2.5.2 While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

2.5.3 If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

2.5.4 This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

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

2.6 Annual Office of Inspector General (OIG) Statement: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

2.6.1 Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed Contractor’s support staff are not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

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

2.7 Non-Personal Healthcare Services: The parties agree that the Contractor and all Contractor’s support staff shall not be considered VA employees for any purpose.

2.8 Indemnification: The Contractor shall be liable for, and shall indemnify and hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the Contractor, its agents, or employees.

2.9 Prohibition Against Self-Referral: Contractor’s support staff are prohibited from referring VA patients to contractor’s or their own practice(s).

2.10 Inherent Government Functions: Contractor and Contractor’s support staff 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.

2.11 No Employee status: The Contractor shall be responsible for protecting Contractor’s staff 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:

2.11.1 Workers’ compensation

2.11.2 Professional liability insurance

2.11.3 Health examinations

2.11.4 Income tax withholding, and

2.11.5 Social security payments.

2.12 Tort Liability: The Federal Tort Claims Act does not cover Contractor or Contractor’s support staff. When a Contractor or Contractor’s support staff has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or Contractor’s support staff) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

3. HOURS OF OPERATION/SCHEDULING:

3.1 BUSINESS HOURS: Monday – Friday, 0700 – 1600.

3.2 FEDERAL HOLIDAYS: The following holidays are observed by the Department of Veterans Affairs:

· New Year’s Day

· President’s Day

· Martin Luther King’s Birthday

· Memorial Day

· Juneteenth

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving

· Christmas

· Any day specifically declared to be a national holiday.

3.3 Surgical Suite or Operating Room Access/Timeliness of Scheduling:

3.3.1 Contractor will provide 2 operating rooms

3.3.2 Contractor will provide 3 preop areas and 3 postop recovery areas

3.3.3 Contractor will provide 2 operating rooms, 1 day per week.

3.3.4 Contractor will provide the VA with a contact number to schedule patients for surgery. VA will call the number provided and schedule the patients’ surgery.

3.3.5 Patients will be discharged from the ambulatory surgery center after their surgery based on a standardized approved protocol.

3.3.6 Contractor will provide instructions for day of surgery, arrival time, location, etc.

3.3.7 VA will provide procedure specific education, postoperative instructions, preop and postop medication management.

3.3.8 Contractor will contact patient with preop instructions for day of surgery, perform preop screening as needed, provide preop testing guidelines and provide (on a weekly basis) a schedule of future cases that have been booked for the next 30 days.

3.4 Cancellations and Substitutions: Patients may contact the VA or the facility to cancel their surgery. Both facilities will contact each other regarding the cancellation and the VA will attempt to schedule another patient if possible.

4. CONTRACTOR RESPONSIBILITIES:

4.1 Services will be utilized for those same day surgery cases referred by the GOVERNMENT surgical staff to be performed by VA Surgeons in Operating Room Suites at Contractor’s site. The contractor shall provide access to Operating Room Suites including pre procedural and post procedural areas and use of Ancillary Staff including Registered Nurses, Scrub Technicians, Certified Registered Nurse Anesthetists and Anesthesiologists. Contractor will comply with minimal required staffing standards as defined by AORN and ASPAN.

4.2 The Contractor shall be responsible for supervising the daily services provided under this contract by the Contractor’s support staff.

4.3 Contractor shall be responsible for all existing on-site equipment (equipment not owned by the VA), supplies, disposables, implants or one-time use items. Operating room equipment is defined as surgical lights and booms, tables, surgical mattresses, cushions, equipment around the room, cabinetry, stretchers and stretcher accessories, surgical cauterization machines, anesthesia machines, patient monitoring systems, extension cords, video equipment monitors, c-arm radiology machines, portable x-ray machine, etc. Disposables and supplies are defined as single use items needed by the surgeon that is not already listed and reimbursed in the CPT code approved by Medicare; examples include, syringes, needles, cotton swabs and pads, medications, dyes used during surgery.

4.4 If the GOVERNMENT requires any equipment not supplied by the contractor, GOVERNMENT shall be responsible for bringing/providing the equipment. This does not include disposable items; the contractor shall supply all disposable items.

4.5 The Contractor shall provide necessary and dedicated and shared areas to accommodate VA workstations for VA to perform administrative and clinical documentation tasks in support of procedures conducted at the contractor’s site. These areas will be identified by mutual agreement between the contractor and the VA.

4.6 Standards of Practice: Contractor shall meet or exceed VA and AAAHC (or equivalent) standards.

4.7 Medical Records- Medical Records are the property of the Contractor, but copies will be provided to the VA for each VA patient.

4.7.1 Authorities: Contractor 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 (Health Insurance Portability and Accountability Act) for medical records created as a result of services Contractor provides under this contract.

4.7.2 HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA 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.

4.7.3 Disclosure: Contractor’s personnel may have access to patient medical records: however, Contractor shall obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook 1907.1, Health Information management and Health Records and VHA Handbook 1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor and its subcontractors.

4.7.4 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 facility.

4.7.5 Release of Information: The VA shall maintain control of releasing any VA patient medical information. Contractor will refer veterans to Gene Taylor Outpatient VA Clinic Release of Information section to request copies of records.

4.7.5.1 Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

4.7.5.2 In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

4.7.5.3 In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4.7.5.4 The Government and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of GOVERNMENT or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to GOVERNMENT. The agency must report promptly to NARA in accordance with 36 CFR 1230.

4.7.5.5 The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to GOVERNMENT control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

4.7.5.6 The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and GOVERNMENT guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

4.7.5.7 The Contractor shall not create or maintain any records containing any non-public GOVERNMENT information that are not specifically tied to or authorized by the contract.

4.7.5.8 The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

4.7.5.9 The GOVERNMENT owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which GOVERNMENT shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

4.8 Per the qualification section of this PWS, the Contractor shall provide all necessary personnel other than the surgeon.

4.9 It is the expectation that the performance of contracted services will meet basic principles of risk reduction, safety, staff competence, and performance improvement. The VA retains the right of oversight of quality and safety of services provided through the contractual agreement. Methods of oversight will include but not be limited to periodic chart reviews and possible site visit.

4.10 The contract staff will ensure that all contracted services provided by licensed independent practitioners and/or allied health physician extenders will be within the scope of their privileges.

4.11 The contract staff will provide documents such as policies and procedures to demonstrate compliance with the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC) or TJC standards related to credentialing and privileging, competency assessment and initial and ongoing training for staff provision of care, treatment and/or services performed.

4.12 The contract staff will provide documents such as policies and procedures to demonstrate prevention and management of safety risks; and, upon request, reports of incidents involving care, treatment and/or services of VA patients.

4.13 Contingency Plan: Because continuity of care is an essential part of the facility’s medical services, The Contractor shall have a contingency plan in place to be utilized if the Contractor’s operating room staff is unable to continue performance in accordance with the terms and conditions of the resulting contract.

4.14 The Contractor shall provide at a minimum the following staff for each. Operating Room (OR): a circulating Registered Nurse (RN), and a scrub technician or Registered Nurse (RN), Fluoroscopy technician, Anesthesiologist or CRNA or as indicated by the specific procedure to ensure appropriate staffing levels for each procedure performed. The Contractor shall maintain a policy or protocol defining training and competencies consistent with the Association of Operating Room Nurses (AORN) and the Association of Surgical Technicians (AST).

4.15 The Contractor shall provide a duplication of all major instrument sets, including emergency instrument set available for use. The contractor shall provide disposable instruments for cataract surgery.

4.16 The Contractor shall provide the equipment necessary to fully equip each OR for the scheduled operations for the following types of surgeries: General Surgery, Gynecology, Plastic, Podiatry, Ophthalmology, Orthopedic, Otolaryngology, Interventional Pain Management surgery, Anesthesiology, and any other services as surgeons/residents are available. Minimally this equipment shall include suction, electro- cautery unit, anesthesia machine, and capability for basic physiological monitoring including EKG, end-tidal carbon dioxide (CO2), and pulse oximetry. There shall always be at least one functioning anesthesia machine in excess of the number of ORs scheduled for procedures. There shall be a code cart and defibrillator, flash sterilizer, and intra-operative radiologic C- arm and a C-arm for interventional spine procedures available.

4.17 The Contractor shall provide a designated Post Anesthesia Care Unit (PACU) or equivalent of appropriate capacity to provide all peri-operative care and treatment for Phase I and Phase II post-operative patient recovery.

4.17.1 The Contractor shall provide the Phase I PACU with the minimum staffing of two licensed providers with a 1 to 1 provider to patient ratio as required, consistent with the American Society of Peri-Anesthesia Nursing (ASPAN) guidelines.

4.17.2 The Contractor shall provide the Phase II PACU with the minimum staffing of a registered nurse with demonstrated competencies available, consistent with ASPAN guidelines.

4.17.3 The Contractor shall provide the Discharge Guidelines for post-operative patients discharge from Phase 1 PACU and Phase II PACU services based upon a defined protocol.

4.18 Two (2) computer workstations connected to internet in both Preoperative Holding Area and in PACU for the purposes of obtaining access to VA electronic medical records.

4.19 The Contractor and GOVERNMENT shall jointly establish protocols to transfer patients within 60 minutes of determination to transfer patient to GOVERNMENT, and in cases where transfer cannot be accomplished to GOVERNMENT, the patient shall be transferred to the Contractor’s site for up to 48 hours for observation.

4.20 Contractor is responsible to ensure that all intraoperative clinical documentation, including operative reports, intraoperative nursing notes, implant information and preoperative anesthesia assessment and anesthesia records, and surgical pathology records are maintained when appropriate and faxed to VA within 15 working days of the procedure (or within 5 days of finalization of path reports (for pathology only)). Fax number for VA Release of Information (ROI) is 479-587-5899. Please fax to the attention of “FOR SCANNING” the subspecialty Surgical Coordinator who will verify/review the documentation and forward to HIMS for inclusion in the patient record.

4.21 Contractor shall follow the Accreditation Association for Ambulatory Health Care and ACR standards and to maintain documentation of appropriate peer review statistics as needed for quality management and credentialing.

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

4.23 PROCEDURES:

4.23.1 Contractor shall comply with any regulatory guidance applicable to the type of procedure being performed.

4.24 PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY IMPROVEMENT (QI)

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

4.24.2 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. 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. The CO and COR shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

4.25 Performance Standards:

4.25.1 Measure: Clinical Support Staff meeting standards of care Performance Requirement: All Contractor’s support staff shall perform in accordance with clinical standards and perform within their scope of practice and privileges.

Standard: 100% of care provided within clinical standards of care and within their scope of practice and privileges.

Acceptable Quality Level: 100% of the time.

Surveillance Method: Ongoing Provider Practice Evaluation (OPPE)

Frequency: Biannually

4.25.2 Measure: Availability of equipment and supplies to complete operating room procedures.

Performance Requirement: Contractor’s equipment and supplies shall be available in accordance with PWS.

Standard: All (100%) Contractor’s equipment and supplies shall be available 100% of the time.

Acceptable Quality Level: 100% Contractor’s equipment and supplies shall be available 100% of the time.

Surveillance Method: Random Sampling of records

Frequency: Biannually

4.25.3 Measure: Maintains efficiency metrics: On time starts, turnover times, cancellation rates, and delays.

Performance Requirement: The contractor shall provide operating room suites timely to VA.

Standard: All (100%) of schedule will be met.

Acceptable Quality Level: 90% of time.

Surveillance Method: Periodic Inspection or Random Sampling

Frequency: Biannually

4.25.4 Measure: Anesthesia staff maintains licensing, registration, and certification

Performance Requirement: Updated Licensing, registration and certification shall be provided as they are renewed. Licensing and registration information kept current.

Standard: All (100%) licensing, registration(s) and certification(s) for Contractor’s support staff shall be provided as they are renewed. Licensing and registration information kept current.

Acceptable Quality Level: 100% licensing, registration(s) and certification(s) for Contractor’s support staff shall be provided as they are renewed. Licensing and registration information kept current. No acceptable deviation.

Surveillance Method: Periodic Inspection or Random Sampling

Frequency: Biannually

4.25.5 Measure: Operating Room and perioperative nursing standards consistent with AORN, ASPN and VA standards.

Performance Requirement: The contractor shall adhere to nursing standards consistent with AORN, ASPN and VA Standards.

Standard: All (100%) nursing staff shall be compliant with AORN, ASPAN and VA standards.

Acceptable Quality Level: 95% of time

Surveillance Method: Periodic Inspection or Random Sampling

Frequency: Biannually

4.25.6 Measure: Patient Safety

Performance Requirement: Patient safety incidents shall be reported using VA Patient Safety Reporting System. All incidents reported immediately (within 24 hours.)

Standard: All (100%) of patient safety incidents are reported using VA Patient Safety Reporting System within 24 hours of incident.

Acceptable Quality Level: 95% of patient safety incidents are reported using VA Patient Safety Reporting System within 24 hours of incident.

Surveillance Method: Periodic Inspection or Random Sampling

Frequency: Biannually

4.25.7 Measure: Patient Access - Availability of assigned OR time for VA staff to utilize.

Performance Requirement: The Contractor shall provide Contractor’s staff in accordance with the operating hours and VA clinical schedule outlined in this PWS

Standard: All (100%) Contractor’s support staff are on time and available to perform services.

Acceptable Quality Level: 95% of the time.

Surveillance Method: Periodic Inspection of Time and Attendance System

Frequency: Biannually

4.25.8 Measure: ASC/hospital maintains accreditation by the JCAHO.

Performance Requirement: The contractor facility shall maintain appropriate level of accreditation.

Standard: All (100%) accreditation certification(s) for Contractor’s facility shall be provided as they are renewed. Accreditation information kept current.

Acceptable Quality Level: 100% accreditation for Contractor’s facility shall be provided as they are renewed. Accreditation information kept current. No acceptable deviation.

Surveillance Method: Periodic Inspection or Random Sampling

Frequency: Annually

4.25.9 Measure: Privacy, Confidentiality and HIPAA

Performance Requirement: Contractor is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA and complies with all standards Zero breaches of privacy or confidentiality

Standard: All (100%) Contractor’s support staff comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA

Acceptable Quality Level: 100% compliance

Surveillance Method: Periodic Inspection; Contractor shall provide evidence of annual training required by the facility, reports violations per VA Handbook 6500.6.

Frequency: Annually

4.25.10 Maintains licensing, registration, and certification

Performance Requirement: Updated Licensing, registration and certification shall be provided as they are renewed. Licensing and registration information kept current.

Standard: All (100%) Contractor’s support staff comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA

Standard: All (100%) licensing, registration(s) and certification(s) for Contractor’s support staff shall be provided as they are renewed. Licensing and registration information kept current.

Acceptable Quality Level: 100% compliance

Surveillance Method: Periodic Inspection or Random Sampling

Frequency: Annually

4.26 Registration with Contractor Performance Assessment Reporting System

4.26.1 As…