NEW PWS - ONSITE SCRUB TECHNICIAN.pdf

REVISED

PWS for Onsite Surgical Technologist/Technician Services

1. GENERAL:

1.1. Services Provided: The contractor shall provide four full-time (4.0) FTE Surgical Technicians (Scrub Techs) onsite in accordance with the specifications contained herein to beneficiaries of the VA and the Minneapolis VA Health Care System (MVAHCS).

1.2. Place of Performance: Contractor shall furnish services at the MVAHCS, One Veterans Drive, Minneapolis, MN 55417.

1.3. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority and Federal Acquisition Regulation (FAR) 12 in combination with 15.

1.4. Policy/Directives/Handbooks. The contractor shall be subject to the following policies, including any subsequent updates during the period of performance. The policies listed below can be accessed electronically at the following: VA Publications VHA Publications

1.4.1. VA Directive 1663: Health Care Resources (HCR) Contracting – Buying Title 38 U.S.C. 8153

1.4.2. VHA Directive 1003.04: VHA Patient Advocacy

1.4.3. VHA Directive 1065: Productivity and Staffing Guidance for Specialty Provider Group Practice

1.4.4. VHA Directive 1088(1): Communicating Test Results to Providers and Patients

1.4.5. VHA Directive 1100.18: Reporting and Responding to State Licensing Boards

1.4.6. VHA Directive 1100.20: Credentialing of Health Care Providers

1.4.7. VHA Directive 1100.21: Privileging

1.4.8. VHA Directive 1192.01: Seasonal Influenza Vaccination Program for VHA Health Care Personnel

1.4.9. VHA Directive 1220(1): Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures in Any Clinical Setting

1.4.10. VHA Directive 1605.01: Privacy and Release of Information

1.4.11. VHA Directive 1907.01: VHA Health Information Management and Health Records

1.4.12. VHA Handbook 1100.17: National Practitioner Data Bank (NPDB) Reports

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. ABS: American Board of Surgery http://www.absurgery.org/

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. ACLS: Advanced Cardiac Life Support

https://www.va.gov/vapubs/ https://www.va.gov/vhapublications/index.cfm http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm http://www.absurgery.org/

1.5.4. AJIC: American Journal for Infection Control

1.5.5. AQL: Acceptable Quality Level

1.5.6. BAA: Business Associate Agreement

1.5.7. BBA: Balanced Budget Act

1.5.8. BLS: Basic Life Support

1.5.9. CDC: Centers for Disease Control and Prevention

1.5.10. CDR: Contract Deficiency Report

1.5.11. CEU: Certified Education Unit

1.5.12. 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, and within available resources.

1.5.13. CME: Continuing Medical Education

1.5.14. CMP: Civil Monetary Penalty

1.5.15. CMS: Centers for Medicare and Medicaid Services

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

1.5.17. COI: Conflict of Interest

1.5.18. 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.

1.5.19. COS: Chief of Staff

1.5.20. CPARS: Contractor Performance Assessment Reporting System

1.5.21. 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.

1.5.22. DEA: Drug Enforcement Agency

1.5.23. EHR: Electronic Health Record - electronic health record system used by the VA

1.5.24. EPA: Environmental Protection Agency

1.5.25. FAPIIS: Federal Awardee Performance and Integrity Information System

1.5.26. FAR: Federal Acquisition Regulation

1.5.27. FOIA: Freedom of Information Act

1.5.28. FPPE: Focused Provider Practice Evaluation

1.5.29. FSMB: Federation of State Medical Boards

1.5.30. FTE: Full Time Equivalent: VA’s standard definition is for full time working the equivalent of 80 hours every two weeks, 2080 hours per year. However, providers may propose using their standard FTE definition.

1.5.31. HHS: Department of Health and Human Services

1.5.32. HICPAC: Hospital Infection Practices Advisory Committee

1.5.33. HIPAA: Health Insurance Portability and Accountability Act

1.5.34. IGRA: Interferon-gamma Release Assays

1.5.35. ISO: Information Security Officer

1.5.36. Key Personnel: The individuals specified in this contract who are essential to work performance.

1.5.37. MRI: Magnetic Resonance Imaging

1.5.38. MST: Military Sexual Trauma

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

1.5.40. NPPES: National Plan and Provider Enumeration System

1.5.41. NSO: National Surgery Office

1.5.42. OGC: Office of General Counsel

1.5.43. OIG: Office of Inspector General

1.5.44. OPPE: Ongoing Provider Practice Evaluation

1.5.45. OR: Operating Room

1.5.46. POP: Period of Performance

1.5.47. PPD: Purified Protein Derivative

1.5.48. PPIRS: Past Performance Information Retrieval System

1.5.49. PWS: Performance Work Statement

1.5.50. QA/QI: Quality Assurance/Quality Improvement

1.5.51. QM/PI: Quality Management/Performance Improvement

1.5.52. QASP: Quality Assurance Surveillance Plan

1.5.53. RFP: Request for Proposal

1.5.54. SCS: Specialty Care Services

1.5.55. SSAC: Sole Source Affiliate Contract

1.5.56. TJC: the Joint Commission

1.5.57. TST: Tuberculosis Skin Test

1.5.58. USC: United States Code

1.5.59. VA: Department of Veterans Affairs

1.5.60. VA-FSC: VA Financial Services Center

1.5.61. VAAR: VA Acquisition Regulation

1.5.62. 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.

1.5.63. VHA: Veterans Health Administration

1.5.64. VistA: Veterans Integrated Systems Technology Architecture

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. License: N/A.

2.1.2. Board Certification: Certification is preferred but not required. If certified, all contractor’s personnel shall be certified as a Certified Operating Room Technician or Surgical Technologist by the National Board of Surgical Technology and Surgical Assisting (www.nbstsa.org).

2.1.3. Contractor’s personnel shall be currently certified in Basic Life Support (BLS). All continuing education courses required for maintaining certification must be kept up to date at all times. Documentation verifying current certification shall be provided by the contractor to the VA COR on an annual basis for each year of contract performance.

2.1.4. Key Personnel: Must have a minimum of 2 years current experience (within the last 6 months) in a busy operating room with experience scrubbing for complex cases to include:

Cardiothoracic, Colon Rectal, General Surgery, Neurosurgery, Ophthalmology, Orthopedic Surgery, Otolaryngology, Plastic Surgery, Urology, Vascular and including robotics.

2.1.5. Technical Proficiency: Contractor’s Key Personnel 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 Key Personnel and Contractor’s Key Personnel shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.1.6. Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements:

Contractor shall provide the COR copies of current CMEs as required or requested by the facility. Contractor’s Key Personnel registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. Contractor shall report CME hours to the credentials office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for Contractor’s Key Personnel.

2.1.7. Training (ACLS, BLS, EHR and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contractor’s Key Personnel as required by the VA. Other training may become required. VA will communicate any changes to the training requirement to the contractor.

Training Frequency Annual Hours

BLS (#324129) Every 24 months 4 hours

VA Privacy and Information Security Awareness and Rules of Behavior (#10176)

Once a Year 1 hour

Mandatory Training for Transitory, Part-time and Intermittent Clinical Staff (#20152)

Once a Year 1 hour

EHR Once 4 hours

Additional training may be required per VHA or Medical Center directives

Unknown Unknown

2.1.8. STANDARD INFECTION CONTROL MEASURES (PPD, IMMUNIZATIONS, ETC.): Contractor shall provide proof of the following for physicians 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.

2.1.8.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s Key Personnel upon hire in accordance with CDC guidance. (This is applicable to all health care workers). A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results.

2.1.8.2. MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}.

2.1.8.3. VARICELLA: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}.

2.1.8.4. ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor physicians {This is applicable to all health care workers}.

2.1.8.5. INFLUENZA: Contractors shall provide proof that all Contractor physicians have received the annual Influenza vaccine unless it is contraindicated. If the Contractor physician has a medical contraindication to the vaccine they shall be required to wear a mask during the Influenza season. {This is applicable to all health care workers}.

2.1.8.6. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE

PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor’s Key Personnel{This is applicable to all health care workers}; provide their own Hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

2.1.8.7. The facility shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel (as published in American Journal for Infection Control - AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for disease control. Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

2.1.9. NPI: N/A.

2.1.10. Conflict of Interest (COI): The Contractor and all Contractor’s Key Personnel 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.

2.1.11. Citizenship related Requirements:

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

2.1.11.2. While performing services for the VA, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. 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 FAR.

2.1.11.3. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the VA may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf 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 VA patient referrals; or other place where the Contractor provides services to veterans who have been referred by the VA; and shall form the basis for termination of this contract for breach.

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

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

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

2.1.12.1. 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 Key Personnel are not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

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

2.2. Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by facility COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Directive 1100.20 and VHA Directive 1100.21. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the facility COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

2.3. Non Personal Healthcare Services: The parties agree that the Contractor and all Contractor’s Key Personnel shall not be considered VA employees for any purpose.

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

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

2.5. Prohibition against Self-Referral: N/A.

2.6. Inherent Government Functions: Contractor and Contractor’s Key Personnel shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees (outside a clinical context), selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

2.7. No Employee status: The Contractor shall be responsible for protecting Contractor’s Key Personnel 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:

2.7.1. Workers’ compensation

2.7.2. Professional liability insurance

2.7.3. Health examinations

2.7.4. Income tax withholding, and

2.7.5. Social security payments.

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

2.9. Key Personnel:

2.9.1. The VA Full Time Equivalency (FTE) for the services required is 4.0 FTE is defined by VA as a minimum of 80 hours every two weeks and does not include holidays.

2.9.2. The minimum number of Board Certified Surgical Technologist/Technicians required to be onsite daily is four (4) to be onsite as defined in paragraph Hours of Operation in this section.

2.9.3. The contractor shall be responsible for providing back up coverage to the VA during extended periods of vacancies of the contractor’s personnel due to sick leave, personal leave, and vacations.

2.9.4. Personnel Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. The Contractor shall notify the CO, in writing, within 15 calendar day(s) after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 15 calendar days prior to making any permanent substitutions.

2.9.4.1. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the Contractor within fifteen (15) calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

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

2.9.4.3. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility.

Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA COS or designee show documented clinical problems or continual unprofessional behavior/actions with any Contractor’s Key Personnel, s/he may request, without cause, immediate replacement of said Contractor’s Key Personnel. The CO and COR shall deal with issues raised concerning Contractor’s Key Personnel conduct. The final arbiter on questions of acceptability is the CO.

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

3. VA HOURS OF OPERATION/SCHEDULING:

3.1. VA Business Hours: The Minneapolis VAHCS is open 24 hours per day, 7 days a week, 365 days per year. The MVAHCS operating room hours are Monday through Friday 6:30 a.m. – 7:30 p.m. Weekend hours are based on urgent and emergent cases.

OR Schedule:

3.1.1. Contractor’s personnel must be on-site at the Minneapolis VAHCS in a timely manner in accordance with VA Rules and Regulations. Shift posted at a minimum of 3 weeks in advance. Contract key personnel will be scheduled (Monday – Friday) for the following shifts:

• 7:00 am – 3:30 pm

• 9:30 am – 6:00 pm

• 11:00 am – 7:30 pm

Note: The daily tour of duty is eight and a half hours including a 30-minute unpaid lunch break.

3.1.2. Contractor key personnel must be on-site at the MVAHCS for their assigned shift, in their scrubs and ready to work at the start of their assigned shift. The Contractor must notify the COR prior to the start of any tour when assigned key personnel are unavailable for their assigned shift.

3.1.3. Off-hours Coverage: Contractor must make the Contractor’s Key Personnel available on-call during all hours when the Minneapolis VAHCS clinic is closed, including evenings, weekends and holidays.

3.1.3.1. Contract personnel will rotate with VA staff to provide off hours call coverage. Off hours call coverage hours are:

• Weekday: Monday – Thursday, 7:00 pm – 6:30 am

• Weekend: Friday at 7:00 pm – Monday at 6:30 am

• Holidays: varies depending on the holiday

3.1.3.2. Call coverage may result in call back to staff the OR at the medical center.

On-call personnel must be available with 15 minutes by phone and on-site within 60 minutes.

3.2. Federal Holidays: The following holidays are observed by the VA:

• New Year’s Day

• Martin Luther King’s Birthday

• President’s Day

• Memorial Day

• Juneteenth

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving

• Christmas

3.3. Any day specifically declared to be a national holiday.

4. CONTRACTOR RESPONSIBILITIES:

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

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

4.2. Standards of Care: The Contractor’s Key Personnel’ care shall cover the range of General Surgery services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized the Joint Commission (TJC), VA and national standards as established by:

4.2.1. The professional standards of TJC:

http://www.jointcommission.org/standards_information/standards.aspx

4.2.2. The standards of the American Hospital Association (AHA):

http://www.hpoe.org/resources?show=100&type=8

4.2.3. The requirements contained in this PWS

4.3. Medical Records:

4.3.1. Authorities: Contractor’s Key Personnel providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the 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) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

4.3.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment of VA patients. Based on this exception, a BAA is not required for this contract. Health records generated by this contract or provided to the Contractors by the VA are covered by the VA Privacy Act system of records entitled ‘Patient Medical Records-VA’ (24VA10A7). 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 provided to VA patients are captured in the VA electronic health record system as required by VA policy as discussed in 4.4.4.

4.3.3. Disclosure: Contractor’s Key Personnel may have access to patient medical records for the purpose of providing medical care and services to VA patients and performing services under the contract; however, Contractor shall obtain permission from the VA before disclosing any patient information outside VA. VA authorizes the Contractor to discuss patient health information for coordination of care within community health care providers in compliance with VA regulations, HIPAA and VHA Directive 1605.1, Privacy and Release of Information. The VA will provide the Contractor with a copy of VHA Directive 1907.01, Health Information Management and Health Records and VHA Directive1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

4.3.4. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Directive 1907.01 Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 and all guidelines provided by the facility.

4.3.5. Release of Information: The VA shall maintain control of releasing any copies of patient health information or health records and will follow policies and standards http://www.jointcommission.org/standards_information/standards.aspx http://www.hpoe.org/resources?show=100&type=8 http://www.rms.oit.va.gov/SOR_Records/24VA19.asp http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1423 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 as defined, but not limited to Privacy Act requirements. The Contractor will not release or disclose copies of records and will refer all such requests to the Release of Information Department at the VA facility where assigned.

4.3.6. Management for Medical Records: National Archives and Records Administration record disposition requirements are found in RCS 10-1 Chapter 6, 6000 series.

4.4. Direct Patient Care: Estimated 99% of the time involved in direct patient care.

4.4.1. Scope of Care: Contractor’s Key Personnel shall be responsible for providing the following personnel: Surgical Technologist/Technician

4.4.1.1. Surgical Care: Contractor Key Personnel shall provide clinical surgical scrubbing services in the scrubbing roll. Contractor key personnel shall be present on time for any scheduled shifts as documented by physical presence in the operating room at the scheduled start time. Contractor key personnel shall provide on call coverage as assigned including nights, weekends, and holidays. Contractor key personnel shall cover all shifts rotating evenly amongst staff. Surgical care includes, but is not limited to:

4.4.1.1.1. Customer Service:

A. Assist in training and provides guidance to residents, medical, nursing, and surgical technology students in the operating room. Assist staff in surgical techniques and operating room procedures to include scrub person role during surgical procedures.

B. Provides emotional support to patients in a variety of stage of adult development.

C. Delivers care to patients in a respectful, nonjudgmental manner.

D. Maintains patient privacy/confidentiality.

4.4.1.1.2. Oral Communications:

A. Informs surgeons and staff about specialty surgical preferences.

B. Provides patients and staff with consistent information according to established policies and procedures.

C. Supports the healthcare team through the reinforcement of patient education.

4.4.1.1.3. Partnering:

A. Remains current on updates in surgical technology through continuing education courses.

B. Assists surgical team members in quality improvement activities.

C. Assists the team members with care of the patient, i.e., positioning, prepping, and obtaining supplies.

D. Plans and discusses each procedure with surgical professionals and assures that all supplies and equipment are available prior to the surgical procedure.

E. Handles instruments, supplies and equipment during surgical procedures such as open heart, ophthalmology, neurosurgery, etc.

ranging from simple to complex.

F. Observes and responds promptly to each stage of the surgical procedure and anticipates the needs of the surgeon by maintaining a high level of concentration for extended periods of time.

G. Prepares prosthesis and surgical devices during procedures.

4.4.1.1.4. Safety Engineering:

A. Sets up sterile field with all required items for each procedure such as air-powered equipment, fiber optic equipment, laparoscopic equipment, microscopes, lasers, arthroscopy equipment, urological equipment, recording devices, and other operating room supplies and equipment.

B. Utilizes universal precautions and follows infection control policies and procedures when handling specimens, supplies and equipment.

C. Performs sponge, needle, and instrument counts prior to the surgical incision before the closure of all cavities and at the termination of the operation.

D. Accountable for all instruments, needles, sharps and equipment utilized during the surgical procedure.

E. Maintaining the sterile field throughout the surgical procedure.

F. Assures that all instruments, supplies, and equipment are ready for the surgical procedure.

4.4.1.1.5. Medical Information:

A. Maintains delivery or care to patients in a variety of stages of adult development.

B. Recognize and respond to a variety of critical situations, including emergency and life-threatening conditions.

C. Provides patient information to the RN/Anesthesia team for inclusion in the patient’s plan of care.

D. Handles all specimens appropriately.

4.4.1.1.6. Biomedical Equipment Technology and Supply Logistics:

A. Performs non-technical maintenance on equipment to ensure proper operating prior to usage.

B. Maintains surgical work area such as routinely cleaning area and removing outdates or expired items.

C. Identifies potentially hazardous situations and removes hazardous equipment from the work area.

4.4.1.2. Communication of Test Results: Mechanisms must be in-place to provide notification of test results for patients receiving care in accordance with VHA Directive 1088, Communicating Test Results to Providers and Patients.

4.4.1.3. Medications: Contractor’s Key Personnel shall follow all established medication policies and procedures. No sample medications shall be provided to patients.

4.4.1.4. Discharge education: Provide discharge education and follow up instructions that are coordinated with the next care setting for all GENERAL SURGERY clinical or surgical patients.

4.4.2. ADMINISTRATIVE: Estimated 1% of time not involved in direct patient care.

4.4.2.1. Quality Improvement Meetings: The Contractor’s Key Personnel shall participate in continuous quality improvement activities and meetings with committee participation as required by the facility Chief of Service, COS, or designee.

Meeting Frequency Annual Hours

Quality Improvement Monthly 12

4.4.2.2. Staff Meetings: The Contractor’s Key Personnel shall attend staff meetings as required by the facility Chief of Service, COS, or designee. Contractor to communicate with COR on this requirement and report any conflicts that may interfere with compliance with this requirement.

Meeting Frequency Annual Hours

Staff Meetings Biweekly 26

4.4.2.3. QA/QI documentation: The Contractor’s Key Personnel shall complete the appropriate QM/PI documentation pertaining to all procedures, complications and outcome of examinations.

4.4.2.4. Patient Safety Compliance and Reporting: Contractor’s Key Personnel shall follow all established patient safety and infection control standards of care.

Contractor’s Key Personnel 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 documented in the medical record of those impacted and disclosed to the patient or surrogate. As soon as practicable (but within 24 hours) Contractors shall notify COR of incident and submit an entry in the VA Patient Safety Reporting System, following up with COR as required or requested.

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

IMPROVEMENT(QI):

4.5.1. Quality Management/Quality Assurance Surveillance: Contract personnel 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 PWS and methods of surveillance detailed in the QASP. The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

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

4.5.3. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility.

Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The CO and COR shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the

CO.

4.5.4. Performance Standards:

4.5.4.1. Measure: Qualifications of Key Personnel

Performance Requirement: All contractor’s personnel shall be in accordance with Association Surgical Technologist Standards (AST) and Association of periOperative Registered Nurses (AORN) recommendations for surgical practice.

Standard: All (100%) contractor’s personnel.

Acceptable Quality Level: 100% Surveillance Method: Periodic Inspection or Random Sampling of qualification documents Frequency: Annually

4.5.4.2. Measure: Scope of Practice/Privileging

Performance Requirement: Contractor’s personnel perform within their individual scopes of practice/privileging.

Standard: All (100%) contractor’s personnel perform within their scope of practice/privileges 100% of the time.

Acceptable Quality Level: 100% contractor’s personnel perform within their scope of practice/privileges 100% of the time. No deviations accepted.

Surveillance Method: Periodic Inspection or Random Sampling of records.

4.5.4.3. Measure: Time and Attendance

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

Standard: All (100%) contractor’s personnel are on time and available to perform services.

Acceptable Quality Level: Contractor’s provider(s) is on-time and available to perform services 100% of the time.

Surveillance Method: Periodic Inspection or Random Sampling of Time and Attendance Sheets Frequency: Quarterly

4.5.4.4. 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: 100% of patient safety incidents are reported using VA Patient Safety Reporting System within 24 hours of incident.

Surveillance Method: Periodic Inspection or Random Sampling

4.5.4.5. Measure: 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 personnel 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 personnel shall be provided as they are renewed. Licensing and registration information kept current.

4.5.4.6. Measure: Mandatory Training

Performance Requirement: Contractor shall complete all required training on time per VAMC policy Standard: All (100%) of required training is complete on time by contractor’s personnel Acceptable Quality Level: 100% completions, no deviations.

4.5.4.7. Measure: Privacy, Confidentiality and HIPAA

Performance Requirement:

Standard: All (100%) contractor provider(s) comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA Acceptable Quality Level: 100% compliance; no deviations Surveillance Method: Periodic Inspection or Random Sampling; Contractor shall provide evidence of annual training required by VAMC, reports violations per VA Handbook 6500.6.

4.5.4.8. Measure: Evaluation

Performance Requirement: Maintain sterility, participate in time out, attentive to case active starting: any delay due to instruments, no errors in specimens, no errors arising from medical labeling, fluids available for fire intervention Standard: All (100%) contractor provide Surgical Technologist/Technicians and Registered Nurse (with Surgical Technologist/Technician experience) comply

Acceptable Quality Level: 100% compliance; no deviations Surveillance Method: Spot observations, ten (10) each quarter. Not to exceed ten

(10) per individual Surgical Technologist/Technician and Registered Nurse (with Surgical Technologist/Technician experience).

Frequency: Quarterly

4.5.5. Registration with Contractor Performance Assessment Reporting System

4.5.5.1. As prescribed in FAR Part 42.15, the VA evaluates Contractor past performance on all contracts that exceed the Simplified Acquisition Threshold and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Sea Logistics Center in Portsmouth, New Hampshire.

CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the Federal Awardee Performance and Integrity Information System (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

4.5.5.2. Each Contractor whose contract award is estimated to exceed the Simplified Acquisition Threshold requires a CPARS evaluation. A government Focal Point will register your contract within thirty days after contract award and, at that time, you will receive an email message with a User ID (to be used when reviewing evaluations). Additional information regarding the evaluation process can be found at www.cpars.gov or if you have any questions, you may contact the Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690.

4.5.5.3. For contracts with a period of one year or less, the CO will perform a single evaluation when the contract is complete. For contracts exceeding one year, the CO 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 sixty (60) days to submit any comments and re-assign the report to the CO.

4.5.5.4. Failure for the Contractor’s representative to respond to the evaluation within those sixty (60) days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond; the Contractor’s representative will be “locked out” of the evaluation and may no longer send comments.

5. GOVERNMENT RESPONSIBILITIES:

5.1. Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to: (enter contract administration if not already listed in another area- list the title (not name) and contact information for COR, Clinical point of contact, and any other relevant personnel involved).

http://www.cpars.gov/

5.1.1. CO Responsibilities:

CO: Name/Address/Phone/email

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

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

5.1.1.3. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

5.1.2. COR Responsibilities:

The COR for this contract is: William VandenBergh; One Veterans Drive, Minneapolis, MN 55417, 612-467-3395, william.vandenbergh@va.gov

5.1.2.1. The COR shall be the VA official responsible for verifying contract compliance.

After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the CO.

5.1.2.2. The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to enter data that may be collected.

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

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

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

6. SPECIAL CONTRACT REQUIREMENTS:

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

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

What Submit as noted Submit To

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

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

Contracting Officer

Copy of Subcontracting Plan is required for all large businesses. Copy of Contractor Certification Statement if no subcontracting possibilities exist.

Upon proposal and as updated Contracting Officer

Copies of any and all licenses, board certifications to include…