PWS.docx

VA255-15-D-0210

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

Veterans’ Health Administration (VHA) Healthcare System Veterans Integrated Service Network (VISN) - 10 VISN-10 Esoteric Testing for Ohio Sites

Date:

VA-21

PWS Version Number: 1

Contents

Pathology and Laboratory Medicine Services

INTRODUCTION:

The Department of Veterans Affairs, Louis Stokes Cleveland VA Medical Center (VAMC), located within the Veterans Integrated Service Network (VISN) 10, is acquiring Referral Laboratory Testing Services for a board range of tests for esoteric testing on clinical and anatomical specimens for disease, diagnosis, treatment monitoring, and in general support of clinicians to provide essential patient care. The contractor shall provide the results appropriate to the standards outlined within this performance work statement. Period of service is one (1) base year plus four (4) option years.

BACKGROUND:

Louis Stokes Cleveland VAMC Pathology and Laboratory Medicine Service (P&LMS) is a state-of-the-art, fully accredited laboratory, and offers a full range of clinical laboratory and anatomical pathology services. The primary mission of P&LMS is to provide timely, accurate, and appropriate pathology services in support of patient care. While P&LMS provides a variety of services, additional laboratory testing is required to meet the needs of the Veterans it serves. These laboratory tests are not performed in-house for various reasons such as low testing volume or specialized equipment requirements that are not available at the VAMC.

SCOPE:

The Contractor shall provide reference laboratory testing for the VAMC. The test provided for the VAMC shall be varied and based on the VAMC needs and the test orders placed by the clinicians. The clinical referral laboratory testing services include all tests listed on Appendix A – Test Types and Quantities. The VAMC reserves the right to send these specimens to an alternate referral site when it better suits the needs of P&LMS or the patient. The contractor shall meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI), Veteran’s Health Administration (VHA), and The College of American Pathologists (CAP). The assessment shall cover requirements for many of the tests lined in (Appendix A) herein.

1. GENERAL REQUIREMENTS:

1.1 The Contractor shall be responsible for performing pre-analytic processing, analysis, and result interpretation for clinical and anatomical pathology specimens as requested by the VAMC.

1.2 The Contractor shall perform all the required tests listed in Appendix A – Test Types and Quantities in compliance with the College of American Pathology (CAP) and/or Joint Commission Standards. Any tests that are not specifically listed in Appendix A and identified as needed by the VAMC will be added to the contract through a modification on an as needed basis. The rate will be established in the same manner as the contract rates were established.

1.3 The Contractor shall provide a billing invoice system for tests that are requested but have not been added through a modification formally. Some testing is time sensitive and cannot wait for a modification process due to the impact of patient care.

1.4 The Contractor Shall Provide:

a. SUPPLIES. All necessary supplies which can included, but not limited to, special specimen containers, viral transport, DNA probe media, dry ice, chain of custody forms (if required), specimen transport request forms, shipping manifest and package and shipping kits.

(1) When supplies are needed, they are delivered within two business days of request or order under normal circumstances.

(2) When supplies are requested under emergency circumstances and determined as needed, they shall be delivered within an industry accepted timeframe for the circumstance.

b. TRANSPORTATION. The contractor shall be able to pick-up specimens at the VAMC within the requested timeframes in Attachment B – Scheduled Pick-Up Times and transport them.

(1) Collecting laboratory prepares for the transportation of specimens.

(2) Contractor will provide prelabeled Fed Ex labels to simplify and expedite shipping when feasible.

(3) STAT technical support shall be provided for any inconsistencies identified regarding transported contents and requisitions upon receipt of the package.

(4) The contractor shall immediately notify the VAMC of any problems or issues that transpire in route.

c. RESULTS REPORTING.

(1) The Contractor must have a discrete interchange with the current CA electronic medical record (VistA) and the new medical health medical record Cerner, which will be implemented at some point during the timeframe of this contract, if applicable.

(2) Secured web-based portal system, Intranet Laboratory Data Interchange (LEDI) system and other equipment, as necessary.

(3) The Contractor will provide a portal system for ordering and printing of results on demand.

(4) Provide reference laboratory testing and reporting with current reference ranges.

(5) The contractor will provide notice to test changes, to include methods and reference ranges, at least one month in advance.

d. CUSTOMER SERVICE & CONSULTATION. The Contractor shall provide customer support telephone service 24 hours, 7 days a week, 365 days a year.

(1) Support to include but not limited to specimen status, test results, technical issues, and test parameters, such as methodology, performance schedules, and reference ranges. Tracking and resolving related issues/problems that may arise in the performance under this contract.

(2) Physician consultation that is accessible with medical directors and pathologists in applicable areas of expertise, to assist with appropriate test ordering, additional recommended testing, disease management and patient results.

(3) Other consultation services shall include services that are consistent with services offered to other contracted customers without compensations.

(4) Contractor shall utilize genetic counselors to routinely review all complex (as defined by Contractor) germline genetic test orders to ensure proper utilization and prevent mis-ordering of genetic tests. If duplicate germline genetic test orders are identified, the contractor shall notify the VAMC by telephone to verify the duplicate test is needed.

(5) Routine inquiries, questions, and clarifications regarding collection requirements shall be addressed at the time of the initial call. Inquiries that require further research shall be addressed within ½ hour of the initial call.

(6) Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two (2) business hours of initial call.

(7) Result interpretation inquiries shall be addressed within four (4) business hours of initial call.

(8) Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four (24) business hours of the initial call.

e. REPORTS & TEST UTILIZATION ANALYSIS.

(1) The contractor shall provide a statistical analysis of the VAMC laboratory testing volumes to assist win the monitoring of ordering trends and utilization patterns and will make recommendations to the VAMC on mechanisms to reduce their costs including a monthly report of the facility’s top send-out tests with quantities and price totals.

(2) The VAMC should have access to generate on demand reports, download laboratory testing data to an electronic spreadsheet for further analysis, and create reports for presentations.

(3) A monthly report for the VAMC shall include at a minimum, through an appropriate electronic format (No PII/PHI can be included):

· Tests Ordered

· Number of unsatisfactory specimens

· Number of tests performed in current month

· Calendar year-to-date with Current Procedural Terminology (CPT) code and cost.

· All testing ordered for the calendar year.

· The report shall include FSS and BPA pricing.

· A report shall be provided for the VAMC to the COREsoteric testing supervisor, Service Chief, and Laboratory Manager on a monthly basis.

(4) Provide and maintain a user-friendly public website that allows for easy reference for researching test information (test number/CPT coding, patient preparation, test utility, result interpretive guidelines). For tests not listed on public website the Contractor shall provide access to their database for client research test information.

f. TEST RESULTS.

(1) The Contractor will provide a portal system for ordering and printing of results on demand.

(2) Routine test results will be reported to the VAMC within twenty-four (24) hours following test completion, except when specimens are picked up the day before a weekend or holiday (in which case the results shall be provided the following business day). The Contract shall notify the VAMC within two (2) hours of any critical values or results.

(3) The test results provided by the Contractor shall consist of a minimum:

· Two (2) full patient identifiers

· Physician’s name

· VAMC name

· Clinical Laboratory Improvement Amendments CLIA number (if requested)

· Account number

· Date/time specimen was collected

· Date/time specimen was received

· Date/time test was reported

· Test ordered

· Test result

· Flagged abnormal results

· Reference ranges

· Name of testing laboratory

· Type of Specimen

· Any additional comments related to test provided by submitting lab

· Any other information the laboratory has that may indicate a questionable validity of test results; and

· Unsatisfactory specimens shall be reported with regard to its unsuitability for testing.

(4) Alternative methods of reporting results in the event of electronic system failure may include results being faxed to (216) 707-7978

g. QUALITY REVIEWS.

(1) In accordance with VHA Handbook 1106, a 10% retrospective quality management peer review shall be completed. This review shall be completed by a second pathologist on at least a quarterly basis for a minimum of 10% of all surgical pathology cases, fine needle aspirates, cytopathology cases and gynecologic cases.

(2) This 10% review shall be performed by a pathologist certified in anatomic pathology.

(3) Reviews shall meet these review requirements:

· Under no circumstances shall a resident physician act as a second reviewer for a staff pathologist.

· Under no circumstances shall a staff pathologist review a resident physician’s diagnosis as this does not constitute a second review.

· Individuals performing a second review in GYN cytology shall have achieved a current successful GYN cytology competency assessment.

· The review process shall be random, shall include all types of specimens, and shall include a review of the entire case.

· At least 10% of the cytotechnologist’s cases that have been interpreted as negative are routinely rescreened and are diagnosed and documented as being negative by a qualified pathologist.

· Cases subjected for rescreening shall include some cases from high-risk patients, as well as random negative cases, based upon criteria established by the Chief or Director of Pathology and Laboratory Medical Services.

h. SLIDE STORAGE & SAMPLE SLIDES.

(1) The Contractor shall have de-identified specimens available for sale consistent with and at the same cost of samples sold to other contracted customers, to be used for in-house test validations, clinical trials, or related studies, proficiency testing, competency testing, or use a control material.

(2) The contractor shall return representative slides, anatomic, hematologic, etc., for quality control review when requested. Quality control slides shall represent duplicate copies of original slides prepared by the Contractor from permanent tissue blocks. The Contractor shall provide quality control slides to the VAMC at the same time the Contractor submits the final reports. The contractor shall prepare additional blocks and slides, in quantities specified by the VAMC for review by the Pathologists. For malignant cases, the Contractor shall call results to the submitting VAMC and prepare paraffin blocks and slides for review by the Joint Pathology Center (JPC) or other Government Pathology Organization (GPO). For benign cases, the contractor shall prepare slides for review by the VAMC. Upon provision of sample slides by the VAMC, the Contractor shall provide interpretation of sample slides. The sample shall include, at a minimum biopsy, and gynecology, non-gynecology cytology.

(3) The Contractor shall store all blood and fluid specimens after all testing has been completed in the event repeat or add on testing for one (1) week at conditions that shall maintain sample viability.

(4) Upon request, samples shall be returned to the VAMC via courier at conditions that shall maintain sample viability. All anatomical pathology specimens (i.e., slides, blocks, etc.) shall be returned within two (2) weeks of test completion.

(5) Contractor has the ability to provide validation samples for an additional fee.

i. TASK ORDERS. Services to be furnished under this contract shall be ordered by issuance of a task order by ordering activity for results to be delivered to the VAMC and in accordance with standards, clauses, and provisions of this document.

2. TECHNICAL REQUIREMENTS:

2.1 The contractor must have a broad range of tests available with accompanying Current Procedural Terminology (CPT) codes. Each Laboratory test shall meet acceptable turnaround times and have defined specimen requirements and specimen and shipping stability. These requirements should be available electronically.

2.2 The contractor must have experience in setting up successful bi-directional interfaces for large hospital systems, if applicable.

2.3 The contractor must provide a bi-directional internet-based system or electronic interface to allow for electronic order entry and transmission to the testing laboratory. Interfacing must be standard interface that does not conflict with VA firewall and must be able to completely be installed and coordinated between the contractor and VAMC with 98% of all results being interfaced in a period of 3 months or less, if applicable.

2.4 The bi-directional portal must meet VA requirements for encryption of sensitive patient information. The requirements that VA utilizes for these types of transmission shall be the Federal Information Processing Standard (FIPS) Publication 140-2. The Contractor shall be responsible for transmission of orders and test results, and the preventive and as-needed maintenance of the system. Contractor shall be available to train the VAMC staff on the use of the system, free of charge and as an as needed basis. The alternate method of sending orders and receiving results shall be in place in the event of system down time. A shipping manifest shall be generated that identifies the specimens sent to the reference laboratory, transportation conditions, and testing ordered, if applicable.

2.5 The Contractor shall be responsible for the purchase of any licenses for middleware products (e.g., Data Innovations) and hardware for any middleware or interface structure.

2.6 Due to the difficulties encountered with any major reference laboratory interfacing change or upgrade, Contractor shall temporarily provide a single knowledgeable point of contact for researching correct test information, point(s) of contact for developing, testing, and implementing a client/vendor interface, and then an ongoing point of contact for troubleshooting interface problems. Temporary service shall be in effect until interfacing change or upgrade has been completed.

2.7 The Contractor shall meet all Enterprise Cyber Security Infrastructure Project (ECSIP) requirements in order to establish an interconnection with the VA for transfer of laboratory test results directly into a VA computer system via the appropriate LEDI protocol. The ECSIP team shall have the ultimate decision on which connection type is appropriate.

2.8 The Contractor shall provide the following interfacing requirements: Laboratory Information Systems LIS physical connection and translation (drivers), any required (additional) interface connection license(s), provide documentation of successful interfacing with other VA Facility (provide two (2) VAMC references), and the Interface shall transmit test results to the host computer via automatic upload. The interface connection shall be tested and verified before putting into use.

2.9 The reference laboratory shall meet VA information security and Health Insurance Portability and Accountability Account of 1996 (HIPAA) requirements and shall be able to interface with the current or any new interface partner of the Laboratory Information System. The Contractor shall have all users with VA access complete the VHA privacy training prior to starting services.

2.10 The contractor shall provide training to government personnel on test ordering, shipping tissues, any programs or online systems utilized by providers, and all other provided services. Archived video training is desirable. On-site of on-line programs required, free of charge and as an as needed basis.

2.11 The vendor shall provide access to data elements necessary to populate the data tables associated with result reporting within the Veterans Affairs Hospital Information System (HIS) or current Government Laboratory Information System (LIS). This information, at a minimum, shall include the following data elements:

2.11.1 Ordering Code (Contractor’s Identification Code)

2.11.2 LOINC – Logical Observation Identifier Names and Code

2.11.3 CPT Code – Current Procedural Terminology

2.11.4 Interface Code/Test Mapping

2.11.5 Test methodology

2.11.6 Test Description, including reference ranges (when appropriate, age and sex adjusted) and units of measurement

2.11.7 Therapeutic or diagnostic reference ranges (when appropriate)

2.11.8 Specimen collection and handling requirements

2.11.9 Test result interpretation or interpretive remarks, if appropriate. Results must be able to flow directly to patient records and the interface must be bi-directional.

2.12 All testing shall be performed on the Contractor’s premises, or within the Contractor's network of laboratories (affiliate or qualified Subcontractor). Under no circumstances shall the Contractor allow any patient information or lab testing samples to be sent outside the confines of the internationally recognized borders of the United States of America. Contractor referrals to a secondary (Subcontractor) laboratory shall be kept to a minimum for control and uniformity purposes and shall be at the Contractor’s expense. Subcontractors shall be held to the same quality standards as specified in the contract.

2.13 Citizenship related Requirements: While performing services for the VA, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. The Contractor must return a signed certification at the time of proposal that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to the VA. This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001(http://uscode.house.gov/) and is applicable to the entire POP.

3. GENERAL QUALIFICATIONS:

3.1 Licensing and Accreditation

3.1.1 Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The Contractor/Subcontractor shall have all licenses, permits, accreditation and certificates required by law. The reference laboratory shall be licensed/accredited by the College of American Pathologists (CAP). In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988.

3.1.2 The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of all sanctions current or pending throughout the United States of America prior to contract award. In addition, the Contractor shall be responsible for providing written guarantee or evidence that all Subcontractors have appropriate licensure and accreditation to perform tests that the primary Contractor cannot perform prior to contract award and as requested by the Contracting Officer (CO). All proposed Subcontractor changes during the contract performance period must have prior approval by the CO. Changes to the requirements shall be addressed by bilateral modification.

3.1.3 Contractor Personnel assigned by the Contractor to perform the services covered by this contract shall be eligible to provide the services of this contract and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on this contract shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board.

3.1.4 Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPPA).

3.1.5 The Contractor shall notify the Contracting Officer in writing of all malpractice investigation or licensure or certification suspension that concerns the Contractor or Contractor personnel, or any discovery of any disciplinary action taken against laboratory(ies) performing under the contract within 24 hours of notification of an investigation or suspension.

3.2 Contractor Personnel: The Contractor shall maintain current accreditation and notify the Contracting Officer of all lapses in state license, Clinical Laboratory Improvement Amendments (CLIA) certification, or clinical pathology certification. The Contractor shall provide a copy of the renewed licenses/certificates to the Contracting Officer before expiration.

3.3 Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst.

3.4 The Contractor must have at least three years of experience providing laboratory services and must have at least one-year experience in transporting biomedical materials.

3.5 CLIA certifications shall include:

3.5.1 Histocompatibilty (010)

3.5.2 Bacteriology (110)

3.5.3 Mycobacteriology (115)

3.5.4 Mycology (120)

3.5.5 Parasitology

3.5.6 Virology (140)

3.5.7 Syphilis Serology (210)

3.5.8 General Immunology (220)

3.5.9 Routine Chemistry (310)

3.5.10 Urinalysis (320)

3.5.11 Endocrinology (330)

3.5.12 Toxicology (340)

3.5.13 Hematology (400)

3.5.14 Immunohematology ABO Group & Rh type (510)

3.5.15 Immunohematology Antibody Detection (transfusion) (520)

3.5.16 Immunohematology Antibody Detection (non-transfusion) (530)

3.5.17 Immunohematology Antibody Identification (540)

3.5.18 Immunohematology Compatibility Testing (550)

3.5.19 Histopathology (610)

3.5.20 Oral Pathology (620)

3.5.21 Cytology (630)

3.5.22 Radiobioassay (800)

3.5.23 Cytogenetics (900)

3.6 The Contractor is required to provide all technical advisory/recalls/alerts, prior to or simultaneously with field alerts, should be forwarded to the designated individuals determined at contract award.

3.7 The Government reserves the right to refuse the use of a subcontractor who fails to comply with evidence of accreditation(s) or licensures(s)

3.8 Authority: Public Law 104-262, Title 38 USC 8153, Health Care Resources (HCR) Sharing Authority, FAR Part 12 & 15, and VAAR 873.

3.9 Policy/Handbooks:

3.9.1 VHA Handbook 1100.17: National Practitioner Data Bank Reports - https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

3.9.2 VHA Handbook 1100.19 Credentialing and Privileging - https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

3.9.3 VHA Handbook 1907.01 Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

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

3.9.5 VHA Handbook 1106.01: Pathology and Laboratory Medicine Service (P&LMS) Procedures: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169

3.10 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.

3.10.1 BLS: Basic Life Support

3.10.2 CDC: Centers for Disease Control and Prevention

3.10.3 CDR: Contract Discrepancy Report

3.10.4 CERNER: Electronic Medical Record that will be replacing the current Computerized Patient Recordkeeping System – electronic health record system to be used by VA.

3.10.5 CMS: Centers for Medicare and Medicaid Services

3.10.6 Contracting Officer (CO) – 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.

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

3.10.8 CPARS: Contractor Performance Assessment Reporting System

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

3.10.10 Credentialing: Is the systematic process of screening and evaluating qualification and other credentials, including licensure, required education, relevant training and experience and current competence and health status.

3.10.11 DHHS: Department of Health and Human Services

3.10.12 HIPAA: Health Insurance Portability and Accountability Act

3.10.13 ISO: Information Security Officer

3.10.14 POP: Period of Performance

3.10.15 PWS: Performance Work Statement

3.10.16 QASP: Quality Assurance Surveillance Plan

3.10.17 LSCVAMC: Louis Stokes Cleveland VA Medical Center

3.10.18 TAT: Turnaround Time is defined as the time between pick-up of specimen and receipt of results by a Government facility.

3.10.19 VAMC: VA Medical Center

3.10.20 Veterans Integrated Services Network (VISN): The regional oversight for the VA medical centers in the VISN 10 geographic location.

4. KEY PERSONNEL

4.1 Conflict of Interest:

4.1.1 The Contractor and all contract personnel (s) 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 (Jan 2008).

4.2 Citizenship related Requirements:

4.2.1 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 Department of Veterans Affairs patient referrals;

4.2.2 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.

4.2.3 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.

4.2.4 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.

4.2.5 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.

4.3 Annual Office of Inspector General (OIG) Statement:

4.3.1 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.

4.3.2 Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site referenced above 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.

4.3.3 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.

4.4 Non-Personal Healthcare Services: The parties agree that the Contractor and all contract personnel (s) shall not be considered VA employees for any purpose.

4.5 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.

4.6 Inherent Government Functions: Contractor and Contract personnel (s) shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees (outside a clinical context), selection or non-selection of individuals for Federal Government employment 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.

4.7 No Employee status: The Contractor shall be responsible for protecting Contract personnel (s) 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:

4.7.1 Workers’ compensation

4.7.2 Professional liability insurance

4.7.3 Health examinations to include:

4.7.4 Annual TB Test and recent chest X-ray if there is a history of positive TB test

4.7.5 Evidence of Hepatitis B immunity (hepatitis immune titer, if the individual has had the series of shots; if no immunity, evidence that the individual has started the Hepatitis B vaccination series

4.7.6 Evidence of a Hepatitis C titer

4.7.7 Varicella titer if contracted employee has not had chicken pox

4.7.8 Income tax withholding, and

4.7.9 Social security payments

4.8 Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract personnel(s). When a Contractor or contract personnel (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 provider (s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

5. FACILITY ADMINISTRATIVE HOURS & FEDERAL HOLIDAYS:

5.1 Administrative hours for the VAMC are Monday through Friday, 8:00 a.m. - 4:30 p.m.

5.2 Federal Holidays observed by the Department of Veteran Affairs are identified below. Also any other day declared by the President of the United States to be a national holiday:

5.2.1 New Year’s Day;

5.2.2 Martin Luther King’s Birthday;

5.2.3 Presidents Day;

5.2.4 Memorial Day;

5.2.5 Juneteenth

5.2.6 Independence Day;

5.2.7 Labor Day;

5.2.8 Columbus Day;

5.2.9 Veterans Day;

5.2.10 Thanksgiving;

5.2.11 Christmas; and any other day specifically declared by the President of the United States to be a national holiday.

5.3 Off-Duty hours: Friday through Monday, 4:31 p.m. – 7:59 a.m.

6. CONTRACTOR’S RESPONSIBILITIES:

6.1 Procedure Guidance:

6.1.1 The testing methodology and reference ranges for a test must be defined in the Contractor’s laboratory user manual. The Contractor shall provide change notice prior to implementation of each new medical procedure and service. The Contractor’s laboratory user manual shall be made available to a Contracting Officer’s Representative if requested.

6.1.2 The Contractor shall ensure that all tests performed meet the currently acceptable standard deviations and that control materials are tested according to manufacturer’s and regulatory guidelines to determine testing accuracy. Upon request by the Contracting Officer (CO) or assigned Contracting Officer’s Representative (COR) for the VAMC and the Contractor shall make available quality assurance information on specific testing procedures for review.

6.1.3 Tests referred by the Contractor to another laboratory shall be at no additional transfer charge or confirmation charge to the Government.

6.2 Supplies: The Contractor shall provide all necessary supplies for testing including:

6.2.1 Requisition forms

6.2.2 Specimen containers

6.2.3 Dry ice and appropriate containers

6.2.4 Special instructions

6.2.5 Current list of tests with reference ranges and specimen requirements

6.2.6 Specimen carriers

6.2.7 All forms, to include Chain of Custody

6.2.8 Special media or tubes for samples

6.2.9 All supplies for special tests (e.g., viral studies, special swabs, special containers)

6.3 Transportation:

6.3.1 Sample Preparation: Each ordering activity shall prepare and package laboratory specimens in accordance with the requirements defined in the Contractor's laboratory user’s manual. These requirements shall be defined in the laboratory user manual. The Contractor shall be responsible for transporting in such a manner as to ensure the integrity of the specimen to outside testing facilities as needed. The Contractor shall supply any special preservatives required for specimen preservation. Each ordering activity is responsible for packaging the specimens.

6.3.2 Shipping Biological and Infectious Substances:

6.3.2.1 Regulatory Requirements. The regulations governing the packaging and shipment of biological, infectious, and hazardous substances are primarily found in 49 CFR parts 100-185 and 397. The parts of 49 CFR specifically dealing with biological and infectious specimens are 107, 171, 172, and 173. While the majority of shipments packaged and processed by the clinical laboratories are classified as diagnostic specimens, all specimens, as well as any select agents and toxins that are identified, must be packed and shipped in accordance with the applicable guidance provided in 49 CFR. Contractor or Subcontractors that package, transport, or ship biological, infectious, and hazardous substances shall comply with all laws, regulations, and policies of Federal, State, and Local governments, the Centers For Disease Control (CDC), Department of Transportation (DOT), International Air Transport Association (IATA), and the Department of Veterans Affairs.

6.3.2.2 Hazardous Materials and Security Training. Contractor or Subcontractors transporting or shipping hazardous materials (hazmat) must be aware of the potential use of hazmat for acts of terrorism and are required to have documented transportation security awareness training. As many biological specimens are now classified as hazmat, it is important for all personnel that are involved in the packing and shipping of laboratory specimens to have hazmat training. The Contractor shall ensure that all personnel who deal with specimen transportation and shipment have the training and certification required by law and regulation. Couriers must be trained to handle Biological Specimens. Evidence of such training shall be provided to the assigned COR and Contracting Officer for review after award and prior to performance. If a facility request vendor training, at any time during the contract, the vendor must provide documentation of their most current Courier training within five (5) business days upon request. Failure to maintain compliance shall be reason for the Government to terminate the contract.

6.3.2.3 The Contractor shall contact the assigned COR for the VAMC within a minimum of five (5) calendar days after award to coordinate the furnishing and delivery of specimen collection and transportation supplies, terminal or data fax and supplies, and the installation of equipment. The Contractor shall provide a mechanism for specimen pickup. The Contractor shall provide to the ordering VAMC the supplies and equipment within two (2) workdays after receipt of the task order. The assigned COR will request replenishment of supplies from the Contractor on an as needed basis.

6.4 Test Results:

6.4.1 Routine: The Contractor shall provide routine test results to the ordering activity in accordance with the testing specifications turnaround times defined in the PWS and Test Schedule. The turnaround times should be calculated from specimen pick-up time to result receipt time.

6.4.2 Test Result Reporting

6.4.2.1 Turnaround Times (TAT): Contractor shall provide electronic transmission (i.e., teleprinter, fax, or computer-to-computer via modem response) of all completed and partial test results to the VAMC within the turnaround times defined in the Contractor’s commercial specimen collection guide.

6.4.2.1.1 The turnaround times shall be calculated from specimen receipt (pick-up) time to test completion time and turnaround time report parameters should match times listed in the contractor’s published specimen collection guide.

6.4.2.1.2 Contractor shall provide an alternate route of transmission (i.e., telephone, fax, or courier service) for test ordering and resulting to the VAMC to be used in the case of a failure of the primary system. Specific information regarding when and how the system will be used will be provided to the assigned COR for the VAMC. The back-up plan is required to comply with all response times required by the contract.

6.4.2.2 Reporting of Results: Contractor shall provide all required hardware, software and related consumable supplies to support the transmission of electronic data for the VAMC at no additional charge. All necessary “connections” shall be the responsibility of the Contractor (including one commercial phone line for terminal/data fax connection if required).

6.4.2.3 Contractor shall provide electronic transmission (i.e. teleprinter, fax, or computer-to-computer via modem response) of all completed and partial test results to the ordering activity within the turnaround times defined in the Contractor’s commercial specimen collection guide. The turnaround times should be calculated from specimen receipt time to test completion time and turnaround time report parameters should match times listed in the Contractor’s published specimen collection guide. Contractor shall provide all required hardware, software and related consumable supplies and training to support the transmission of electronic data for each ordering activity at no additional charge.

6.4.2.4 If a computer to computer interface is not in place, the Contractor will provide portal account access to print and access reports on demand.

6.5 Retention of Specimens:

6.5.1 Upon completion of the testing, the Contractor shall retain all specimens as required by regulatory agencies (RA). Upon request by the ordering activity, the assigned COR for the VAMC, or designee, the Contractor shall provide a copy of the regulatory requirements for each participating RA. In the absence of RA requirements, the Contractor shall retain specimens after all testing has been completed in accordance with the most current versions of CAP guidelines GEN 20425 Record Retention Phase II and CAP ANP 12500 Record Retention Phase II. If the laboratory ceases operation, the specimens, slides, blocks, and documentation must be transferred to the VAMC where the testing was originally requested.

6.5.2 Rejection of Specimens: The Contractor shall provide its policies for dealing with inappropriate or compromised specimens.

6.5.3 Documentation: The Contractor shall ensure that all required documentation is timely, legible, and accurate. Contractor personnel shall indicate responsibility for the content and correctness of all prepared and transcribed reports by affixing the Contractor personnel’s own signature to the documents and validating their contents.

6.5.4 Quarterly cost savings reports are a significant condition of this contract. If the Contractor fails to provide a complete cost savings report within the allowable time frames, this contract may be terminated by the Government without cost or penalty. The Contractor shall provide a quarterly cost savings report showing the contract price, and total number of individual laboratory tests ordered quarterly to determine savings. The report is due within twenty (20) business days after the close of each quarter’s business. Reports shall be sent electronically to the following people: COR, Esoteric Testing Supervisor, Laboratory Manager, and Service Chief.

6.5.5 Report periods are as shown below:

6.6 FSS Schedule, Open Market Tests, and Emergency Test Process

6.6.1 This is an estimated quantity contract and pricing shall include all labor, materials, maintenance, technical support, project management and supervision, travel and expenses, training, software, software licenses, software updates, and support as identified herein that are necessary to furnish the required services.

6.6.2 The awarded agreement shall encompass the entire FSS schedule and any open market tests listed in the solicitation.

6.6.3 FSS Schedule shall be valid and in place for the entirety of the required period of performance (POP) of this requirement.

6.6.4 Contractor shall provide a new updated copy of their FSS Price Schedule each time the FSS is updated to include new or changed tests to the Contracting Officer, Contract Specialist, and COR(s).

6.6.5 The Government reserves the right, at any future date, via modification to add additional open market tests without competing each modification.

6.6.6 Open market tests not listed shall not be billed through this contract, task orders, or purchase orders until they are added via modification. Until open market tests not listed on this contract are added; all will be procured and paid for via government purchase cards or separate contract purchase orders prior to testing being authorized.

6.6.7 Contractor shall have the ability to create a second account number for each facility in order to accept, process, invoice/bill and obtain payment for non-contract tests.

7. ADMINISTRATIVE:

7.1 Service

7.1.1 The Contractor shall provide telephone number(s) and contact person to be used by the ordering activity to make specimen problem inquiries and provide problem solving at all times including weekends and holidays. The Contractor shall include names and telephone numbers of technical directors and pathologists available for consultation.

7.1.2 The Contractor agrees to maintain the minimum acceptable service, reporting systems and quality control as specified herein. Within 24 hours, notification must be given to the assigned COR for the VAMC and Contracting Officer upon adverse action by a regulatory agency. Contractor shall advise the VAMC of any changes in methodology, procedure, reference ranges and all new tests.

7.1.3 In the event that the Contractor changes the assay procedure or a critically important component of an assay (e.g., antibody, purified antigen, etc.), the Contractor shall notify the CO and assigned COR for the VAMC prior to the intended change. Changes in the assay materials or procedure shall be sufficient cause for changing to an alternate Contractor for the assay(s) for the duration of the contract.

7.2 Maintenance:

7.2.1 The Contractor shall provide preventive and as-needed maintenance on any installed equipment or system at the VAMC at no additional charge to the Government. The Contractor shall provide preventative (routine) maintenance within 72 hours of notification to the assigned COR for the VAMC or designee and respond to emergency maintenance calls within 24 hours.

7.2.2 Field Service Reports shall be provided to the COR electronically within 24 hours of preventive or corrective maintenance.

7.2.3 Telephone support shall be available 24/7 for technical support and troubleshooting.

7.2.4 All parts, travel, and labor and necessary upgrades are to be included in this contract.

7.3 Registration with Contractor Performance Assessment Reporting System (CPARS)

7.3.1 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.