Draft - Peformance Work Statement - Venipuncture.pdf

1. GENERAL:

1.1. Services Provided: The Contractror shall provide venipuncture lab draws, collection of other specimens, specimen processing and storage until those specimens are picked up by a VA contracted courier to transport to an Eastern Oklahoma Health Care System VA Medical Center in accordance with the specifications contained herein to beneficiaries of the Department of Veterans Affairs (VA) and the Vinita Outpatient Clinic.

1.2. Place of Performance: Contractor shall furnish services at theVinita Outpatient Clinic.

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. 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 1400.01: Supervision of Physician, Dental, Optometry, Chiropractic, and Podiatry Residents

1.4.11. VHA Directive 1605.01: Privacy and Release of Information

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

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

1.4.14. VHA Handbook 1400.04: Supervision of Associated Health Trainees:

1.4.15. Privacy Act of 1974 (5 U.S.C. 552a) as amended:

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.4.16. 42 Code of Federal Regulations (CFR) Part 482 Conditions of Participation Hospitals:https://www.ecfr.gov/cgi-bin/text-idx?node=pt42.5.482&rgn=div5

1.4.17. VHA Directive 1106 Pathology and Laboratory Medicine Service

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. ACGME: Accreditation Council for Graduate Medical Education

1.5.2. ACLS: Advanced Cardiac Life Support

1.5.3. BLS: Basic Life Support

1.5.4. CDC: Centers for Disease Control and Prevention

1.5.5. CEU: Certified Education Unit

https://gcc01.safelinks.protection.outlook.com/ https://www.va.gov/vhapublications/index.cfm http://www.hpoe.org/resources https://us.tungsten-network.com/?node=pt42.5.482&rgn=div5

1.5.6. 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.

1.5.7. CME: Continuing Medical Education

1.5.8. CMS: Centers for Medicare and Medicaid Services

1.5.9. 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.

1.5.10. 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.

1.5.11. COS: Chief of Staff

1.5.12. CPARS: Contractor Performance Assessment Reporting System

1.5.13. 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.

1.5.14. DEA: Drug Enforcement Agency

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

1.5.16. FSMB: Federation of State Medical Boards

1.5.17. 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.

1.5.18. HHS: Department of Health and Human Services

1.5.19. HIPAA: Health Insurance Portability and Accountability Act

1.5.20. ISO: Information Security Officer

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

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

1.5.23. POP: Period of Performance

1.5.24. PPD: Purified Protein Derivative

1.5.25. PWS: Performance Work Statement

1.5.26. QA/QI: Quality Assurance/Quality Improvement

1.5.27. QASP: Quality Assurance Surveillance Plan

1.5.28. QM/PI: Quality Management/Performance Improvement

1.5.29. 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.

1.5.30. VHA: Veterans’ Health Administration

1.5.31. VISN: Veterans Integrated Services Network

1.5.32. VISTA: Veterans Information Systems Technology Architecture

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. Certifified and/or trained phlebotomist: The contractor shall provide a Certified Phlebotomist, or a trained phlebotomist with at least six months experience, to support Pathology & Laboratory Medicine Service, outpatient, as needed.

2.1.2. Must provide evidence of professional training and/or certificates, current transcripts and/or certificates of training (if applicable).

2.1.3. Credentialing and Privileging (if applicable): Credentialing and privileging is to be done in accordance with the provisions of VHA Directive 1100.20 and VHA Directive 1100.21 referenced above. The Contractor is responsible to ensure that proposed physician(s) possesses the requisite credentials enabling the granting of privileges. No services shall be provided by any contract physician(s) prior to obtaining approval by the Facility Medical Executive Board and Medical Center Director.

3. DESCRIPTION OF RESPONSIBILITES:

3.1.1. The service is needed at the Department of Veterans Affairs (VA) in support of an estimated total workload of approximately 2400 outpatient draws per year, equivalent to approximately 10 draws per day, 5 days per week. The contractor should provide enough FTE phlebotomists certified/trained in phlebotomy by an accredited program or school.

3.1.2. Individuals will work normal business hours, 5 days a week, Monday – Friday , excluding any federal holiday.

3.1.3. The contracted employee will be responsible for following all Eastern Oklahoma VA Health Care Pathology & Laboratory Medicine Service established policies and procedures to correctly identify the patient, perform the phlebotomy, correctly label specimens, and process for transport to VA Medical Center.

3.1.4. Contract employees are expected to demonstrate an attitude of caring and courtesy. All Veterans, family members, and employees will be treated with dignity and respect.

3.1.5. Contractor is responsible, in the management of private health information of patients, to maintain highest level of patient privacy and confidentiality and shall release medical information obtained during the course of the contract only to hospital staff involved in the care and treatment of that individual patient.

3.1.6. Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPPA) of 1998 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI).

3.1.7. Contract phlebotomist will have very limited computer access to patient records (access will be only the accessioning and “lookup” options) and will be under direction of VA staff. Therefore, security risk is low.

3.1.8. The C&A requirements do not apply. A Security Accreditation Package is not required.

3.1.9. Contractor shall safeguard all government property, including controlled forms provided for contractor use. At the close of each work period, government equipment, facilities, and other valuable materials shall be secured.

3.1.10. Provide Phlebotomy Services for treatment of eligible Veterans. These services shall fulfill the VA’s healthcare delivery requirements in accordance with all terms, conditions, and provisions of the solicitation for the performance period of June 1, 2025 throught May 31, 2025, plue (9) option years that may be exercised based on need and funding.

3.1.11. Training:

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 contract physician(s) as required by the VA.

Training Frequency (once a year, etc) Annual Hours

VA Privacy and Information Security Awareness and Rules of Behavior annually 1 hour

Privacy and HIPPA Training annually 1 hour

3.1.12. STANDARD INFECTION CONTROL MEASURES (PPD, IMMUNIZATIONS, ETC.):

Contractor shall provide statement that all required infection control measures are current and that the contractor is compliant with 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 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. Tests shall be current within the past year.

3.1.12. Conflict of Interest: The Contractor 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.

4. DESCRIPTION OF RESPONSIBILITES:

4.1 Citizenship related Requirements:

4.1.1 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 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf 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;

4.1.2 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.

4.1.3 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.

4.1.3.1 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.

4.1.3.2 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.

4.1.4 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.

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

4.1.4.2 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.

4.2 Clinical/Professional Direction: The qualifications of Contractor personnel are subject to review by VA Medical Facility COS or his/her clinical designee and approval by the Medical Facility Director as provided in VHA Directive 1100.20 and VHA Directive 1100.21. Clinical/Professional direction 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 https://www.ecfr.gov/cgi-bin/text-idx

CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

4.3 Non Personal Healthcare Services: The parties agree that the Contractor shall not be considered VA employees for any purpose.

4.4 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.

4.5 Inherent Government Functions: Contractor 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.

4.6 No Employee status: The Contractor shall be responsible for protecting contractor 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:

4.6.2 Workers’ compensation

4.6.3 Professional liability insurance

4.6.4 Health examinations

4.6.5 Income tax withholding, and

4.6.6 Social security payments.

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

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

4.81.1 Contractor shall submit a listing of proposed key personnel performing technical delivery of services.

4 VA HOURS OF OPERATION/SCHEDULING

4.9 Business Hours: Monday – Friday, 8:00am – 16:30pm, excluding any Federal Holiday.

4.10 Contractor shall be available to the Facility for consultation and interpretation Monday – Friday, 08:00am – 16:30pm, 52 weeks a year for stat, urgent, and routine exams.

4.11 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 other day specifically declared by the President of the United States to be a National Holiday.

4.12 Continuity of services under contact:

4.12.1 Contractor is responsible for providing qualified personnel to perform venipuncture lab draws. The VA must be informed at least 48 hours in advance if there will be a significant change in contractor’s ability to perform to allow for planning of service coverage and workload distribution.

4.12.2 The contractor shall maintain open and professional communication with members of the Facility Pathology & Laboratory Medicine Service staff. The contractor shall provide up-to-date points of contact to facilitate communication on clinical, technical and administrative issues. Clinical staff will be available by phone and pager 24/7..

4.12.3 The Contractor shall provide a single phone number with a list of individuals who could be contacted to immediately resolve any difficulties experienced during the hours of venipuncture services and STAT draws. The COR will assure up-to-date rosters of staff are provided to the Contractor.

5 CONTRACTOR RESPONSIBILITIES

5.9 Management and Supervision:

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

5.9.2 The Facility will provide to the Contractor policies, procedures and processes necessary to allow cooperative functioning between the agency and Facility. Updates and refreshers will be provided to the Contractor upon request and when policy procedures or process changes.

5.9.3 The Contractor shall complete background investigations to insure that employees do not have a record of criminal offenses or substantiated incidents of patient abuse; and, if required to perform their duties, employees are properly licensed and insured to operate motor vehicles.

5.9.4 The professional standards of the Joint Commission (TJC):

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

5.9.5 The standards of the American Hospital Association (AHA):

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

5.9.6 The requirements contained in this PWS

6 SCOPE OF WORK

6.9.1 Pathology and Laboratory Medicine Service requires venipuncture services for routine scheduled Veteran Outpatient draws. Services include but not limited to phlebotomy, specimen processing and preparation for transport to VA Medical Center.

6.9.2 Routine scheduled venipuncture services shall be available during normal business hours, Monday-Friday, excluding the following Federal and Observed Federal holidays: New Year’s Day, Martin Luther King’s Birthday, President’s Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans’ Day, Thanksgiving, and https://fcp.vetpro.org/Admin/Login/Index http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf?show=100&type=8

Christmas, in addition to any other day specifically declared by the President of the United States to be a national holiday.

6.9.3 Direct Patient Care: estimated 100% of the time involved in direct patient care. Contractor shall be responsible for venipuncture and specimen processing for transport.

6.9.4 Unscheduled, Emergent (STAT) venipuncture services shall also be available during normal business hours.

6.9.5 Inclement Weathr and Emergency Provision:

6.9.5.1 The contractor shall contact the COR or designee if conditions exist which may affect their ability to perform contract requirements. The contractor must have an established contingency plan for problems which may be experienced in the transport time frame

(i.e. breakdown, accident, inclement weather).

6.9.5.2 Inclement weath incidents are defined as severe weather conditions resulting in road closures by the city, county, and/or state (i.e. hurricanes, tornadoes, snow and ice) in which could result in clinic closure or significant delays.

6.9.5.3 Direct Patient Care: estimated 100% of the time involved in direct patient care.

Contractor shall be responsible for venipuncture and specimen processing for transport.

6.9.6 SYSTEM REQUIREMENTS:

6.9.6.1 Contractor warrants that any data containing patient-specific identifiers will be handled in such a way as to prevent disclosure to unauthorized parties. This includes transmission of the data (from the point at which the data leaves the VA network to the point at which the images are interpreted) as well as storage of the data by the Contractor. Contractor agrees to comply with all applicable data security laws and guidelines, as well as HIPAA and various JCAHO provisions. The contractor will provide utmost care and attention to patient data. All patients will be assured of their privacy and personal dignity in accordance with applicable laws, rules and regulations.

Refer to Attachment A for specific guidelines regarding protected health information.

All patient information remains the sole property of the US Government and may not be used for any purpose other than those stipulated in this agreement.

6.9.6.2 VA will act as primary custodian of the patient information for all purposes related to VA and Government records retention requirements.

6.9.6.3 Patient information will be retained by the Contractor only for the minimum period of time required to comply with any applicable laws, and should then be purged.

6.9.6.4 Upon request, Contractor will provide VA with access to information pertaining to the way in which the Contractor maintains VA patient data and thesteps taken on an ongoing basis to assure the privacy and security thereof. This includes, but is not limited to, information regarding computer network architecture, configuration of firewall(s), routers, and other pieces of networking equipment, information about installed security software, and audits of patches of known security vulnerabilities. All relevant security-related patches and anti-virus updates must be installed within 30 days of initial release.

6.10 PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY

IMPROVEMENT(QI)

6.10.1 Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys. Methods of Surveillance: 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.

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

6.10.3 Performance Standards

6.10.3.1 Measure: Access

Performance Requirement: Patients mys receive treatment in a timely manner.

Standard: Staff on-site and available during all scheduled clinic hours.

Acceptable Quality Level: 95% meet timeliness standards

Surveillance Method: Direct Observation and random inspection

Frequency: Random

6.10.3.2 Measure: Quality of Service

Performance Requirement: Proper patient identification, specimen container, specimen labeling, and specimen processing,packaging, and transport.

Standard: Each quality indicator must meed standard of 90%

Acceptable Quality Level: 90% meet Standards

Surveillance Method: Review of documentation .

Frequency: Daily

6.10.3.3 Measure: Patient Safety

Performance Requirement: Patient safety incidents must be investigated, confirmed, resolved and reported to the EOVAHCS and the COR.

Standard: All incidents reported immediately (within 24 hours) and are investigated, confirmed and resolved.

Acceptable Quality Level: 100% No deviations accepted.

Surveillance Method: Direct Observation

Frequency: Random inspection.

6.10.3.4 Measure: Customer Satisfaction

Performance Requirement: Immediate reporting of patient care quality complaints to COR.

Standard: All complaints.

Acceptable Quality Level: 100%

Surveillance Method: Review of complaints.

Frequency: Random inspection.

6.10.3.5 Measure: Mandatory Training

Performance Requirement: Contractor shall complete all required training on time per Facility policy

Standard: All (100%) of required training is complete on time by Contractor’s physician(s).

Acceptable Quality Level: 100% completions.

Surveillance Method: Periodic Inspection or Random Sampling

Frequency: Periodically

6.10.3.6 Measure: Privacy, Confidentiality and HIPAA

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

Standard: All (100%) Contractor’s physician(s) 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

6.10.4 Registration with Contractor Performance Assessment Reporting System

6.10.4.1 As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed 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.

6.10.4.2 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.

6.10.4.3 For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will have sixty

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

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

6.10.4.4 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.

7 GOVERNMENT RESPONSIBILITIES

7.1 The connectivity/functionality should be approved and verified by the VISN prior to acceptance. VISN will be responsible for providing connectivity and infrastructure from the VA facilities to the contractor’s site. The teleradiology equipment such as

7.2 Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to Contracting Officer and/or COR.

7.2.1 CO RESPONSIBILITIES:

CO - TBA

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

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

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

replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

7.2.2 COR Responsibilities:

The COR for this contract is: TBA

7.2.2.1 The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

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

7.2.2.3 The COR will maintain a record-keeping system of services by receiving, reviewing, and approving payment for monthly invoices from vendor. The COR will review this data monthly when invoices are received and certify all invoices for payment by comparing the procedures 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.

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

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

8 SPECIAL CONTRACT REQUIREMENTS

8.1 Reports/Deliverables: The Contractor shall be responsible for complying with all reporting requirements established by the Contract. Contractor shall be responsible for assuring the accuracy and completeness of all reports and other documents as well as the timely submission of each.

Contractor shall comply with contract requirements regarding the appropriate reporting formats, instructions, submission timetables, and technical assistance as required.

8.1.1 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: Quality Control Plan:

Description of procedures for specimen collection

Upon proposal and updates as required.

Contracting Officer

Proof of Phlebotomist Certification/Training:

Certificates or transcripts showing completion of an accredited phlebotomy training program or certification from a recognized institution.

Upon proposal and upon renewal or change in key personnel.

Contracting Officer

Evidence of Infection Control Compliance:

Statement confirming OSHA

Upon proposal and annually COR

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

Cybersecurity & Privacy Training Certificates:

VA Privacy and Information Security Awareness and HIPAA training

Before VA network access and annually

Contracting Officer

Certification that staff list have been compared to OIG list

Upon proposal and upon new hires.

Contracting Officer

Proof of Indemnification and Medical Liability Insurance

Upon proposal and upon renewals.

Contracting Officer

Certificates of Completion for Cyber Security and Patient Privacy Training Courses

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

Contracting Officer

BLS (Basic Life Suport) Certification Upon award and every two years after award.

COR

Contingency plan fo replacing key personnel to maintain services as required under the terms of the contract

Upon proposal and as updated COR

8.2 Billing:

8.2.1 Invoice requirements and supporting documentation: Supporting documentation and invoice must be submitted no later than the 5th workday of the following month in which services were rendered. Invoices must be submitted via Electronic Funds Transfer banking system such as Tungsten. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include the following for Venipuncture Services if applicable:

8.2.1.1 Name and Address of Contractor

8.2.1.2 Invoice Date and Invoice Number

8.2.1.3 Contract Number and Purchase/Task Order Number

8.2.1.4 Month/Date of Service

8.2.1.5 Total number of Venipunctures performed

8.2.1.6 Total price

If Off-site Per-Procedure:

Invoice requirements and supporting documentation: Supporting documentation and invoice must be submitted no later than the 5th workday of the following month in which services were rendered. Payment to the Contractor shall be made monthly, in arrears, upon receipt of a properly prepared invoice. Payment for services will be at the rates specified in the Schedule of Services. The Contractor shall submit invoices using CMS Uniform Billing (UB-04) forms covering the services performed under this contract. The invoices shall contain the following information:

• Contract Number and Purchase Order Number (if applicable)

• Name of Beneficiary and last four digits of the Social Security Number

• Itemized statement of services rendered by CPT Code and Rates

• Total Price

8.2.2 Vendor Electronic Invoice Submission Methods

Invoices will be electronically submitted to the Tungsten website at https://www.tungstenautomation.com/. Tungsten Automation direct vendor support number is 877-489- 6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten Automation will confirm your Taxpayer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. To successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten Automation to the VA-FSC should mirror the current submission of Invoice.

Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). Payment will only be made for actual services rendered. Payments shall be made monthly in arrears. The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements. The contractor shall be reimbursed upon receipt of a proper invoice. For additional information, please contact:

Tungsten Support Phone: 1-877-489-6135 Website: https://www.tungstenautomation.com/

Department of Veterans Affairs Financial Service Center https://www.fsc.va.gov/einvoice.asp https://www.tungstenautomation.com/ https://www.tungstenautomation.com/ https://www.fsc.va.gov/einvoice.asp

8.3 Reduction in Services: This is a fixed quantity contract for a specified number of hours. If, at the end of the period of performance, the government has not utilized the total number of hours required under this contract because of a change in its requirements, the parties agree that they will attempt to negotiate in good faith a contract modification reducing the scope of the contract with a corresponding adjustment in the total contract price. In no event will the VA pay for hours that exceed the total number of hours specified in the contract for the period of performance.

8.4 Payments in full/no billing VA beneficiaries: The Contractor shall accept payment for services rendered under this contract as payment in full. VA beneficiaries shall not under any circumstances be charged nor their insurance companies charged for services rendered by the Contractor, even if VA does not pay for those services. This provision shall survive the termination or ending of the contract.

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

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

8.5 Contractor Security Requirements (VA Handbook 6500.6) -

1. ADMINISTRATIVE MATTERS – DEFINITIONS

a. CONTRACTING OFFICER: The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under the resultant contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes which will affect price, quantity, quality or performance of the resultant contract.

b. CONTRACTING OFFICER’S REPRESENTATIVE (COR): a VA official who will provide the daily administration and coordination of the contract. Any technical questions pertaining to the resultant contract should be directed to the COR as delegated by the Contracting Officer (refer to Delegation of Authority Memo issued after award). The COR duties and limited responsibilities are detailed in the Delegation of Authority, which the Contractor is advised to read.

c. In the event the Contractor affects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment to the contract price will be made to cover the increase in cost incurred as a result thereof.

d. Items collected and processed must have Personally Identifiable Information (PII) such as full name, full Social Security number, etc., and/or Protected Health Information (PHI) such as medical test information, test results, etc. All such information must be secured by contractor in a secure location.

e. The names of the Contractor’s main Point of Contact and an alternate, or alternates, who shall act for the Contractor when the POC is absent, shall be designated in writing to the Contracting Officer. Contractor shall provide updated listings if any changes in personnel occur.

f. The Contractor’s personnel performing services to the Government shall, always, conduct themselves in a professional manner, present a neat appearance and be easily recognized as a contract employee.

g. The Contractor shall direct all questions and problems regarding this contract to the Government CO.

The CO is the sole authority to amend the terms and conditions of this requirement. All changes will be issued by the Government via modifications in writing from the CO to the Contractor.

h. The Contractor shall notify the Government CO and COR within two (2) hours, via phone and email of Contractor’s knowledge of any conditions which may adversely affect the Contractor’s ability to perform under the terms and conditions as stated in the specifications of this requirement.

l. The Contractor shall be required to maintain a record and/or log of courier pickups, indicating time and date of pickups, along with signatures.

m. The Government reserves the right to restrict any Contractor employee from performing services under this contract who do not meet the required qualifications, or who violates Federal regulations or are identified as a potential threat to the security, safety, health and/or operational mission of the VA and its veteran population. The restriction of such Contractor personnel shall not relieve the Contractor from performing all the required services in accordance with all terms, conditions and schedules contained herein.

2. QUALITY CONTROL: The Contractor shall develop and maintain a quality control program that ensures specimen collection and processing are performed in accordance with these specifications. The Contractor shall develop and implement procedures to track, identify, prevent, remedy, and ensure non-recurrence of defective services. The Contractor shall provide a method to accept and resolve Government VA Personnel complaints and notify the Government of the resolution.

The Contractor shall immediately notify the Government CO upon receipt of a VA personnel complaint so joint validation may be accomplished. The Contractor shall be responsible for quality control and specification compliance.

3. QUALITY ASSURANCE: The Government will evaluate the Contractor’s performance using customer complaint, periodic on-site inspection, and may at the Government’s discretion, inspect each task to incur conformance and acceptance prior to payment.

4. RECORDS MANAGEMENT:

a. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33;

Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

b. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

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

d. 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 by the Freedom of Information Act.

e. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

f. The Government Agency owns the rights to all data/records produced as part of this contract.

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

h. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974.

These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

i. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

j. 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, this contract. The

Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.