P09 - PWS Autopsy Service for VAPAHCS.docx

Performance Work Statement

Autopsy Services For VA Palo Alto Health Care System

1. GENERAL: This is a non-personnel services contract to provide Autopsy Services. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1. Services Provided: The Contractor shall provide accredited Pathology Physician Services off-site for the Department of Veterans Affairs, Palo Alto Health Care System (hereinafter referred to as VAPAHCS) located at 3801 Miranda Avenue, Palo Alto, California 94304, to perform anatomical autopsy services in accordance with the specifications contained herein to beneficiaries of the VAMC. All physician(s) shall be board certified in Anatomic Pathology or Forensic Pathology by the American Board of Pathology or the American Osteopathic Board of Pathology and the autopsy must be performed at a facility with an autopsy suite and laboratory accredited by either the College of American Pathologists (CAP), the National Association of Medical Examiners (NAME) or an equivalent agency. All services provided by the Contractor shall meet or exceed all applicable standards of The Joint Commission (TJC).

1.2. Place of Performance: Services shall be provided within 50 miles of VAPAHCS off site at the Contractor’s location.

1.3. Period of Performance: This contract is for a base year plus four (4) option years.

1.4. Authority: Title 38 United States Code (U.S.C.) § 8153 – Sharing of Health Care Resources (HCR).

1.5. Policy/Handbooks: The Contractor shall be subject to the following policies, including any subsequent updates during the period of performance.

1.5.1 VA Directive 1663: Health Care Resources Contracting- Buying-http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347

1.5.2 VHA Handbook 1100.17: National Practitioner Data Bank Reports-http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

1.5.3 VHA Handbook 1100.18: Reporting and Responding To State Licensing Boards http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

1.5.4 VHA Handbook 1400.05: Disbursement Agreements Procedures http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1769

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

1.5.6 Privacy Act of 1974 (5 U.S.C. § 552a) as amended

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

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

1.6.1 ABP: American Board of Pathology

1.6.2 ACS: Administrative Contract Specialist. Contract Specialist who administers the contract.

1.6.3 AOD: Administrative Officer of the Day

1.6.4 CAP: College of American Pathologists

1.6.5 CDC: Centers for Disease Control and Prevention

1.6.6 CDR: Contract Discrepancy Report

1.6.7 CEU: Certified Education Unit

1.6.8 CLIA: Clinical Laboratory Improvement Amendments

1.6.9 CME: Continuing Medical Education

1.6.10 CMS: Centers for Medicare and Medicaid Services

1.6.11 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.

1.6.12 COR: Contracting Officer 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.

1.6.13 Contractor: a person or entity that enters into a contract. Includes contract physician(s).

1.6.14 COS: Chief of Staff

1.6.15 CPARS: Contractor Performance Assessment Reporting System

1.6.16 CS or ACS: Administrative Contract Specialist. Contract Specialist who administers the contract.

1.6.17 FAD: Final Anatomic Diagnosis.

1.6.18 FAR: Federal Acquisitions Regulations.

1.6.19 FSMB: Federation of State Medical Boards

1.6.20 HHS: Department of Health and Human Services

1.6.21 HICPAC: Healthcare Infection Control Practices Advisory Committee

1.6.22 HIPAA: Health Insurance Portability and Accountability Act

1.6.23 ISO: Information Security Officer

1.6.24 MOD: Medical Officer of the Day

1.6.25 NAME: National Association of Medical Examiners

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

1.6.27 NPPES: National Plan and Provider Enumeration System

1.6.28 PAD: Provisional Anatomic Diagnosis

1.6.29 POP: Period of Performance

1.6.30 PWS: Performance Work Statement

1.6.31 QASP: Quality Assurance Surveillance Plan

1.6.32 ROI: Release of Information

1.6.33 TJC: The Joint Commission

1.6.34 VA: Department of Veterans Affairs

1.6.35 VAMC: Veteran’s Affairs Medical Center. Unless identified with the name of a different VAMC, for purposes of this contract, this term shall mean the VAPAHCS.

1.6.36 VAPAHCS: Veterans Affairs Palo Alto Health Care System

1.6.37 VHA Veterans Health Administration. The central office for administration of the VAMC throughout the United States. The VHA is located in Washington, D.C.

1.6.38 VISN: Veterans Integrated Services Network. The regional oversight for the VAMC.

2. SCOPE:

2.1 Contractor shall be responsible for providing either a partial or full autopsy (as indicated on the Authorization for Autopsy form), including standard gross and microscopic samplings, photography, neuropathology and toxicology on cadavers prepared for transportation to the Contractor’s facility. Cadavers shall be transported from the VAMC location or VAMC contracted facility to the Contractor’s location by the Contractor.

2.1 1 Contractor shall not accept a cadaver without copies of appropriate medical records prepared by the VAMC and a signed, legal and complete autopsy permit. The VA shall deliver the cadaver to the Contractor’s location. Upon receipt at the Contractor’s location, the cadaver shall be logged in. The medical records shall be kept with the cadaver. When the body is removed, the medical records shall be provided to the physician(s) performing the autopsy. Following the autopsy, the medical records shall be locked in a secured location for review. Upon the physician(s) completion of the medical records review, the physician(s) shall submit the medical records to the contractor’s Records Supervisor or designee who will shred the documents.

2.1 2 Prior to the VA making arrangements for the cadaver transportation from the VAMC or VAMC contracted facility location to the contractor’s facility, a primary investigator from the VA shall contact the Contractor to discuss the need for the autopsy and/or any restrictions/limitations placed on the autopsy.

2.2 Special Registry autopsies:

2.2.1 The P&LMS physician staff at the VAMC shall determine if special registry protocols apply and shall verify that additional consent has been obtained to approve the inclusion of the autopsy in a special registry for research purposes and shall communicate this information to Contractor.

2.2.2 Special registry autopsy protocols apply to any of the following:

2.2.2.1 Former Prisoners of War (POW)

2.2.2.2 Agent Orange/Vietnam Service (AGO)

2.2.2.3 Kuwait/Persian Gulf War Service 1990-1991 (KUW)

2.2.2.4 Operation Iraqi Freedom/Iraq Service 2003-2011 (IRQ)

2.2.2.5 Operation Enduring Freedom/Afghanistan Service 2001-Present (AFG)

2.2.3 Special registry autopsy protocols include the following: Additional wet tissue (in addition to tissue collected, examined and reported in the customary manner for the autopsy by the contracting facility) must be collected and placed in formalin, including:

2.2.3.1 The intact brain and spinal cord

2.2.3.2 Peripheral nerve (e.g., sciatic), skeletal muscle (e.g., psoas), and dorsal root ganglia (may be harvested with adjacent psoas muscle)

2.2.3.3 Specimens from the Testes, Prostate, Bladder and Kidneys:

2.2.3.4 Half of each testis

2.2.3.5 Material from the prostate should include the capsule and the urethra. The sample should include as much of the gland as is practical and any focal lesions.

2.2.3.6 Sections from the bladder should include any obvious lesions. If there is none, the sample should include the trigone.

2.2.3.7 Sections from the kidney should include cortex and pelvis

2.2.3.8 Lung sections: should include: one peripheral section from each lobe, preferably after one lung is inflated. It is helpful to record postmortem lung weights and to sample any palpable or visible focal lesions; this includes those of the parietal pleura and diaphragm. At least one section should include a medium sized bronchus, and one a mediastinal lymph node.

2.2.4 The contractor shall ensure that all additional wet tissue along with a duplicate set of slides and blocks used for the autopsy, and a copy of the autopsy report from the contracted facility shall be submitted to the Laboratory Director or Designee at VAPAHCS for submission to the Joint Pathology Center (JPC). The additional tissue and duplicate set of slides and blocks used for the autopsy must be submitted as soon as possible by via FedEx, UPS, or courier but no later than ten (10) business days after completion of the final report and/or conference presentation, if applicable.

2.2.5 Physician(s) shall provide the VAMC with preliminary anatomical diagnosis within three (3) business days for a partial autopsy. A full autopsy report shall be provided within sixty (60) business days.

Copies of these reports which shall include the Final Anatomical Diagnosis (FAD) shall be faxed to

(650) 496-2574 addressed to the VAPAHCS Laboratory Director as soon as they are available.

Originals shall be mailed to the VAMC at: Chief, Pathology & Laboratory Medicine Service (P&LMS) (113), 3801 Miranda Avenue, Room E4-332, California, 94304. Any mailed documents shall be trackable by a tracking number system.

2.2.6 Following completion of an autopsy, the contractor shall contact VAPAHCS’ Decedent Affairs Office at (650) 858-3980 regarding instructions for the disposition of the cadavers and Corresponding transportation arrangements. The after-hours contact and phone number are the same.

2.2.7 Upon mutual agreement of both the VAMC and the Contractor, the Contractor shall present Autopsy findings at clinical conferences provided with at least ten (10) calendar days of advance notice by the VAMC.

1.2.8 A Clinicopathological correlation will be included in all reports.

3. QUALIFICATIONS

3.1 Staff/Facility:

3.1.1 License: Physician(s) assigned by the Contractor to perform the services covered by this contract shall have a current license to practice medicine in any State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by the personnel working on this contract shall be full and unrestricted licenses. Physician(s) who have current, full and unrestricted licenses in one or more states, but who have, or ever had, a license restricted, suspended, revoked, voluntarily revoked, voluntarily surrendered pending action or denied upon application will not be considered for the purposes of this contract.

3.1.2 Board Certification: All physician(s) shall be:

3.1.2.1 American Board of Pathology board certified/board eligible in Anatomic Pathology, Anatomic & Clinical Pathology or Forensic Pathology, or

3.1.2.2 American Osteopathic Board of Pathology certified in Anatomic Pathology or Forensic Pathology 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 VAMC COR upon request.

3.1.3 Technical Proficiency: Physician(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO 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 physician(s).

3.1.4 Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements: Contractor shall provide the COR copies of current CMEs as required or requested by the VAMC. Physician(s) registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current.

3.1.5 National Provider Identifier (NPI): NPI is a standard, unique ten (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). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the Centers for Medicare and Medicaid Services (CMS) National Plan and Provider Enumeration System (NPPES) and provide these to the CO with the proposal.

3.1.6 Conflict of Interest: The Contractor and all physician(s) shall identify and communicate to the CO and COR conflicts of interest that exist 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 who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

3.1.7 Citizenship Related Requirements:

3.1.7.1 The Contractor certifies that the physician(s) 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 VAMC.

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

3.1.7.3 If the Contractor fails to comply with any requirements outlined in the preceding paragraphs, the VAMC may, at its discretion, require that foreign nationals 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, stop performing services under this contract. Failure to comply with paragraph 2.1.10. and its subparagraphs shall form the basis for termination of this contract breach.

3.1.7.4 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.

3.1.8 Annual Office of Inspector General (OIG) Statement: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the 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.

3.1.8.1 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 and shall not provide physician(s) named on that list. 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 employs or enters into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

3.1.8.2 By submitting their proposal, the Contractor certifies that the HHS OIG List of Excluded Individuals/Entities has been reviewed and that the Contractor and its proposed contract physician(s) are not listed as of the date the offer/bid was signed.

4. HOURS OF OPERATION

4.1 VAMC Business Hours: The normal business hours for the VAMC are 0730 to 1600 Monday through Friday excluding federal holidays.

4.2 Federal Holidays: The following holidays are observed by the VHA:

1. New Year’s Day

1. Martin Luther King, Jr. Birthday

1. Washington’s Birthday

1. Memorial Day

1. Juneteenth Day

1. Independence Day

1. Labor Day

1. Columbus Day

1. Veterans Day

1. Thanksgiving Day

1. Christmas Day

1. Any day specifically declared by the President of the United States to be a national holiday.

5. CONTRACTOR RESPONSIBILITIES

5.1 Clinical Personnel Required: The Contractor shall provide physician(s) who are competent, qualified per this PWS and adequately trained to perform assigned duties.

5.1.1 Contractor shall ensure that only qualified, licensed, board certified pathologists provide the final written diagnosis for gross and microscopic post-mortem examination findings. If a resident/fellow signs the autopsy report, a licensed pathologist who meets the identified criteria shall countersign it. (see 3.1.2 for board certification requirements)

5.1.2 The Contractor shall ensure that the physician(s) close all autopsy cases within the timeframe defined in section 2.1.1.3. The COR shall be 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.

5.1.3 All sections of the autopsy report shall be finalized before the autopsy can be closed. This includes when the brain is included as part of the autopsy at the contractor’s facility, but does not apply when the brain is sent to VAPAHCS for submission to the JPC.

5.1.4 Contractor shall provide adequate space for storage of all materials associated with the VAMC’s autopsy cases. The storage locations shall be locked and dry.

5.1.5 Retention requirement shall follow VHA directive 1106.01 or subsequent successive directive, as stated below:

5.1.5.1 Accession log records (paper or electronic): retain for 2 years after the Final Anatomic Diagnosis (FAD).

5.1.5.2 Autopsy consent: The longer of institutional medical record retention policy or 10 years after the FAD.

5.1.5.3 Wet tissue (refers to small portions of organs that are saved in a small container. There is no requirement for retention of whole or large portions of organs): 3 months after the FAD.

5.1.5.4 Paraffin blocks: 10 years after the FAD.

5.1.5.5 Glass slides: 25 years after the FAD.

5.1.5.6 Reports (Provisional, Final, Modified): 25 years after the last report issued.

5.1.5.7 Contractors shall pull materials from storage, when necessary, for additional sectioning/review for any clinically appropriate purpose, including but not limited to, quality assurance review and teaching purposes.

5.2 Standards of Care: The physician(s) care shall cover the range of Pathology 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 national standards as established by:

5.2.1 VA Standards: VHA Directive 2006-041 “Veterans’ Health Care Service Standards” (expired but still in effect pending revision) https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443

5.2.2 The professional standards of The Joint Commission (TJC) http://www.jointcommission.org/standards_information/hap_requirements.aspx

5.2.3 The standards of the American Hospital Association (AHA) http://www.hpoe.org/resources?show=100&type=8 and;

5.2.4 The requirements contained in this PWS.

5.3 MEDICAL RECORDS

5.3.1 Authorities: Physician(s) providing healthcare services to the VAMC patients shall be considered as part of the Department Healthcare Activity. Contractor shall ensure its physician(s) comply with the 47 U.S.C. § 551(a) (Protection of Subscriber Privacy), 38 U.S.C. § 5701 (Confidential Nature of Claims), 5U.S.C. § 552 (Freedom of Information Act), 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).

5.3.2 HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and does not require a Business Associate Agreement (BAA). Treatment and administrative patient records generated by this contract or provided to the Contractors by the VAMC are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA19). Contractor generated VA patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services that are in its possession are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at their expense. Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

5.3.3 Disclosure: Physician(s) may have access to patient medical records; however, the Contractor shall obtain permission from the VAMC before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or its designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to the VAMC records, at the place of business on request during normal business hours, to inspect and review and make copies of such records. The VAMC will provide the Contractor with a copy of VHA Directive 1907.1, VHA Health Information Management and Health Records and VHA Directive 1605.01, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations listed in paragraph 4.4.1 apply to the Contractor.

5.3.4 Professional Standards for Documenting Care: Contractor shall ensure that medical care is provided under this contract is appropriately documented in medical records in accordance with standard commercial practice and in accordance with guidelines established by VHA Directive 1907.01 Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235, as well as all guidelines provided by the VAMC.

5.3.5 Release of Information: The VAMC shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements.

5.3.6 Contractor will have no National Security or Public Trust duties at any time during the contract terms. Contractor’s Position Designation shall be Non-Sensitive Low Risk Tier 1.

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

5.3.7.1 Contractor shall ensure that autopsy equipment is maintained in good working order and in accordance with manufacturer’s specifications.

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

5.4.1 Quality Management/Quality Assurance Surveillance: Contractor personnel shall be subject to Quality Management measures. Contractor performance shall be monitored by the government using the standards as outlined in this 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. A Quality Assurance Plan (QAP) from the Contractor is required. The QAP shall describe the strategy and methods the Contractor will deploy to ensure that the items identified in the QASP are met.

5.4.2 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 Contractor personnel involved in the complaint. This does not preclude refusal in the event of incidents involving physical or verbal abuse.

5.4.3 Performance Standards:

5.4.3.1 Measure: Timeliness of Autopsy Reports

Performance Requirement: Exams read in timely fashion, interpretation signed and faxed to VAMC Pathology & Laboratory Service.

Standard: Preliminary autopsy diagnosis must be read within 3 business days of exam completion. Final autopsy diagnosis must be provided within 60 business days of exam completion.

Acceptable Quality Level: 90% of above standard read during the month.

Surveillance Method: Direct Observation and Validated User/Customer Complaints Frequency: Monthly, in each month that an autopsy is performed.

Incentive: Positive Evaluation of Contractor’s Performance Disincentive: Unfavorable Evaluation of Contractor’s Performance and a Letter of Concerns shall be issued to the Contractor.

5.4.3.2 Measure: Maintains Patient Privacy Confidentiality/Adheres to all HIPPA requirements

Frequency: Quarterly Incentive: Positive Evaluation of Contractor’s Performance Disincentive: Unfavorable Evaluation of Contractor’s Performance. Removal from contract.

5.4.3.3 Measure: Maintains Appropriate Qualifications and licensure/certifications requirements Performance Requirement: All physician(s) shall be board certified in accordance with section 3.1 of this contract and perform within their individual scopes of practice/privileging.

Frequency: Yearly Incentive: Positive Evaluation of Contractor’s Performance Disincentive: Unfavorable Evaluation of Contractor’s performance. Removal from contract.

6. GOVERNMENT RESPONSIBILITIES

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

6.1.1 CO Responsibilities:

6.1.1.1 The CO and ACS are the only people authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the ACS on all matters pertaining to contract administration. Only the CO or ACS 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.

6.1.1.2 The ACS 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 ACS without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

6.1.1.3 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.

6.1.2 COR Responsibilities:

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

6.1.2.2 The COR will be responsible for monitoring the Contractor’s performance against the contract requirements.

6.1.2.3 The COR shall establish and maintain a record keeping system that will record work performed by the Contractor physician(s).

6.1.2.4 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.

6.1.3 VAMC Responsibilities:

6.1.3.1 VAMC location or VAMC contracted facility shall place the cadaver in sealed body bags and shall mark the outside of the bag with the information, if applicable, pertaining to the possibility of infectious disease (HIV, TB, HEP-C). Cadavers shall be accompanied by autopsy consent, full identification and medical records.

6.1.3.2 VAMC shall provide the Contractor with the name and address of the funeral home that shall receive the deceased.

6.1.3.3 VAMC shall provide the Contractor with completed autopsy request form “OP 113-002 VAMC Authorization for Autopsy” prior to the Contractor being notified of a pending autopsy request. A copy of the beneficiary’s medical record along with the death summary shall be furnished to Contractor. With each referral case, a VAMC physician shall be the primary contact for Contractor. Telephone numbers and pager numbers will be furnished with each case. The P&LMS administration may also be contacted for any additional concerns.