Inactive

B.3 STATEMENT OF WORK 1. Scope: Contractor shall provide all labor, supplies, equipment, maintenance, information technology, transportation, and supervision necessary to provide Cytogenetic and Esote... B.3 STATEMENT OF WORK 1. Scope: Contractor shall provide all labor, supplies, equipment, maintenance, information technology, transportation, and supervision necessary to provide Cytogenetic and Esoteric Rapid Response and STAT Laboratory Testing Services to the Clement J. Zablocki VAMC, located in Milwaukee, WI. Cytogenetic and Esoteric Rapid Response Laboratory Testing Services include but are not limited to: specimen preparation and storage, transportation of clinical laboratory specimens, performance of analytical testing, reporting of analytical test results, specimen retention and consultative services. 2. Specific Tasks and Deliverables a. Specimen Preparation and Storage for Reference Testing Specimens The Contractor shall provide the Government facility with its current commercial laboratory reference test manual (Hard Copy) to ensure that the collection and storage of specimens are in accordance with Contractor s requirements. If the Contractor requires specialized specimen collection containers/media, the Contractor shall supply the Government facility with the appropriate collection container/media and Safety Data Sheets (SDS) to ensure proper specimen integrity and chemical spill clean-up efforts. The Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen. b. Specimen Transportation/Testing Laboratory Locations The Contractor shall be responsible for all services related to the transportation of the specimens from the Milwaukee VAMC Laboratory to the commercial testing laboratory. The Contractor or Subcontractor shall have at least one (1) year of experience in providing transportation of biomedical materials. Due to the critical importance of maintaining the viability of the specimen cells, the specimens must arrive at the Contractor s/Subcontractor s testing facility within eight (8) hours of the telephone request by the Government facility. The Government shall request specimen transportation services via telephone to the Contractor or designee on an as needed basis, Monday through Friday, twenty-four (24) hours a day, including Holidays. Historically, the Milwaukee VAMC requests specimen testing pick up once a day (Monday through Friday) but on occasion it can be two (2) or three (3) times in a day. The Contractor shall implement and maintain specimen transportation services in accordance with the transportation plan submitted with the offer, for the transportation of specimens from the Milwaukee VAMC Laboratory to the Contractor s/Subcontractor s testing facility. The Contractor shall receive a copy of the orders following notification by the Government. The orders shall be provided via a secure fax to the contractor. Contractor s fax machine receiving these orders shall be in a secure location. The orders shall contain, at a minimum, the following information below: Patient s Full Name Patient s identification number, e.g. social security number (SSN) Physician s name Test(s) ordered Date/time of specimen collection Specimen type The Contractor shall have laboratory personnel available on Saturday to accept and process specimens, for when a telephone request is initiated on a Friday. c. Specimen Testing The Contractor and/or Subcontractor shall provide the full range of clinical and/or anatomic pathology diagnostic testing capabilities to execute all required tests as annotated in Attachment B. Contractor shall make available the test information below: Requisition form requirements Alphabetized test name list Test order code Specimen collection and preservation requirements Test method employed (indicate if testing performed in duplicate) Test reference intervals adjusted for age, sex or race, when required Test specific sensitivity, specificity and interferences, when required Test critical values, if any Policy for critical value notification CPT coding Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between receipt of specimen by the Contractor/Subcontractor and receipt of results by a Government facility Schedule of test performance (specific days of week indicated) Location of test performance by test name (i.e. name of primary laboratory, name of separate branch/division of primary lab, name and address of secondary (sub-contracted) laboratory must be cited) d. Preliminary Result Interpretation The Contractor shall provide preliminary test result interpretation of the ordered test. The Contractor shall provide recommendations for reflex testing and/or cancellation of Government requested testing. Contractor shall notify the Contracting Officer (CO) and the COR of any test information modifications no later than two (2) weeks prior to the implementation date of the test change. Any new test(s) not listed in Attachment B shall be identified to the CO within seventy-two (72) hours of laboratory identification. The notification shall include all information identified above and include the cost of specimen testing. The Contractor shall not be reimbursed for any new services or testing unless the required notification is provided. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee. The Contractor shall ensure the accurate and timely performance of laboratory testing services. e. Specimen Retention The Contractor shall store the specimens a minimum of three (3) days after the test is reported or in accordance with the retention requirements of their regulatory body, whichever is longer, in the event that subsequent action is necessitated, e.g. problem solving and/or repeat testing. All anatomic pathology materials (e.g., histology blocks, slides, or other anatomic pathology material) generated by the VA shall be returned within seven (7) calendar days after final report is issued. f. Reporting of Results Contractor shall provide timely and appropriate testing of patient specimens as requested by the Government facility. Due to the criticality of the diagnostic information that results from this testing, the turnaround times (defined as the time from receipt of the specimen in the testing laboratory to the receipt of test results by the Milwaukee VAMC and based on specimen type) shall be minimal and are defined in Attachment B. A final report of laboratory testing results must be issued as a printed hard copy within twenty-four (24) hours from the time the sample is picked up at the government facility. Contractor shall deliver the reports without an additional charge by expedited overnight courier shipping, mailing, and/or transportation services by hand, or by telephone facsimile to a protected machine identified to the Contractor by the VA. Contractor s fax machine to transmit the test results shall be in a secure location. Delivery by electronic mail, i.e. MS Outlook, etc., is prohibited. Each test report shall, at minimum, include the following information: Patient's full name Patient s identification number, e.g. social security number (SSN) Physician s name (if supplied) Government laboratory accession number (if supplied) Submitting facility name Submitting facility account number Patient's location (clinic/ward) (if supplied) Test(s) ordered Date/time of specimen collection (when available) Date and time specimen was received at the testing facility Date/time test completed Test result Reference intervals (adjusted for age, sex or race, when appropriate) Toxic and therapeutic ranges, if applicable Flagged abnormal results Reference laboratory accession number Name and address of testing laboratory Any other information the laboratory has that may indicate a questionable validity of test results Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing Test results determined by the contractor to be critical, shall be communicated by telephone to a designated Government contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by a final report issued as a printed (hard) copy as required above. g. Consultative Services/Utilization Reports Contractor shall provide professional consultative services that are consistent with the services offered commercially to other customers at no cost to the Government. These services may include consultations by laboratory professionals or experienced physicians/PhD on test or methodology selection or test result interpretation. Contractor shall provide direct communication with the VA Pathologist in order to provide additional assistance in the interpretation, recommendation of additional testing, and assist in the diagnosis of clinical illnesses. Contractor shall provide, to the COR, a monthly report detailing the date and time of specimen receipt at the testing laboratory. Customer Service Contractor shall provide customer service twenty-four (24) hours a day, six (6) days a week (Monday through Saturday), that is accessible by telephone service to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract. The Contractor shall notify the Milwaukee VAMC laboratory, by telephone, of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc. Government notification shall be provided within twenty-four (24) hours from when the specimen was received at the testing laboratory. Record Keeping Contractor Contractor shall establish a record keeping system of all tests performed. 3. Hours of Operation Normal hours of coverage are Monday through Friday from 7:30 am to 4:30 pm Central Time, including holidays. When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a Federal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a Federal holiday. Federal Holidays include: New Years' Day Labor Day Martin Luther King Day Columbus Day Presidents' Day Veterans' Day Memorial Day Thanksgiving Day Independence Day Christmas Day And any other day specifically designated as a national holiday by the President of the United States. 4. Place of Performance Clement J. Zablocki VA Medical Center 5000 W. National Ave. Milwaukee, WI 53295 5. Period of Performance Base Year: October 1, 2021 through September 30, 2022 Option Year 1: October 1, 2022 through September 30, 2023 Option Year 2: October 1, 2023 through September 30, 2024 Option Year 3: October 1, 2024 through September 30, 2025 Option Year 4: October 1, 2025 through September 30, 2026 6. Other Pertinent Information Government-Furnished Equipment (GFE): None Start of Work Meeting The Contractor shall attend a Start of Work meeting to be held at the Milwaukee VAMC within fifteen business days following contract award. The Contractor shall have the following representation at the Start of Work Meeting: Customer Service Representative Contracting Representative The Contractor shall be given at least a five (5) business day notice of the time, date, and location of the Start of Work Meeting. The Contractor shall be limited to five (5) individuals representing the Contractor at the Start of Work Meeting due to limited space. Three (3) days following the receipt of the Government s Start of Work Meeting notification, the Contractor shall provide the names, titles, and email addresses of the individuals who shall be attending the Start of Work Meeting to the Contracting Specialist. Qualifications/Requirements of Laboratory & Contractor Personnel Laboratory Contractor must have at least three (3) years of experience in providing Cytogenetic and Esoteric Rapid Response and STAT Laboratory Testing Services. Contractor, including all subcontractor(s), must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency(s) with deemed status from the Centers for Medicare & Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The reference laboratory (ies) must maintain valid certifications during the entire performance period of this contract. Upon reissue or re-certification, the Contractor must supply a copy of the certification(s) referenced above to the Contracting Officer s Representative (COR) assigned to the contract. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary Contractor. Contractor must immediately notify the COR, in writing, upon loss of any required certification, accreditation, or licensure. Contractor shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA) and the Center for Disease Control (CDC) and Prevention. Personnel Contractor shall ensure all testing and supervisory personnel at all Contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations, the College of American Pathology (CAP) accreditation standards, or other accrediting organizations and State standards. Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification. Personnel assigned by the Contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402). Any new requirements for mandatory education and/or competency reassessment, which occur during the contract period, shall be completed by the individual contractor employee(s), documented, and available upon request. Contractor/Subcontractor representatives (i.e. courier) entering any Government facility must be attired in a Contractor/Subcontractor issued uniform that bears the name of the Contractor/Subcontractor s company. In addition, Contractor/Subcontractor representatives shall prominently display a Contractor-issued identification badge. Medical Records Clinical or other medical records (i.e. test results) of VA veteran patients treated by Contractor under this contract are owned by the VA and the Contractor is not authorized to release or utilize this data for any use other than contract performance. If requested, test results will be mailed to the VA at no additional cost to the Government. Mail shall be sent in accordance with VA Directive 6609, Mailing of Sensitive Personal Information. Contractor may obtain a copy of VA Directive 6609 at the following website: http://www1.va.gov/vhapublications/index.cfm. If a subpoena or court order is received for the production of a medical record/test result, the contractor shall notify the CO that a subpoena or court order was received. 7. Contract Performance Monitoring Monitoring of contractor s performance shall be demonstrated through clinical and administrative record reviews. COR will be responsible for verifying contract compliance. The COR will designate appropriate VA personnel to monitor services through one or a combination of the following mechanisms below. Departments being served will monitor Contractor performance to ensure that services called for in the contract have been received by VA in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the CO. Documentation of services performed will be reviewed prior to certifying payment. The COR will perform periodic spot checks and document with the using service to ensure records monitoring. VA will pay only for services actually provided, and in strict accordance with the Price Schedule/Attachment 1. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided. Departments being served, through the COR, will provide a written statement annually to the CO to include a summary of Contractor actions and a statement that all requirements of the contract have been fulfilled as agreed. This summary evaluation will be submitted forty-five (45) days prior to expiration of contract (and/or prior to election of option year renewals, if applicable). 8. Quality Assurance Monitoring Contractor shall maintain a Quality Assurance Program related to Cytogenetic Laboratory services covered under this contract. Contractor shall also participate in a joint quality assurance surveillance program (QASP) with the Government facility. This program must minimally address the quality aspects representative to the testing process, i.e. pre-analytical, analytical, and post-analytical variables and include a description of monitoring and evaluation activities. There must be a mutually agreed upon procedure for responding to issues, problems and/or concerns identified by the Government with details as to whom and in what timeframe the matters will be reconciled. The issues that may need to be addressed may be general in nature or specific to an incident or event. The contractor will meet or communicate with the facility staff for process review and improvement of contract performance on an as needed basis. Copies of licensure/certifications are also required to be submitted upon request by the VA. Quality factors that VA may consider when monitoring quality of care may include, but are not limited to: patient medical records, security/privacy, adverse event reporting, turn-around times, timeliness to customer service requests, adherence to transportation requirements. These monitoring procedures and disincentives for contractor s failure in meeting these tasks are further illustrated in the following Performance Requirements Summary Matrix below. 9. General Instructions Designation of Contracting Officer Representative. The Milwaukee Staff Support Supervisor will be designated as the COR to represent the CO in furnishing guidance and advice regarding the work being performed under this contract. The COR will provide technical guidance, verify services were actually performed, and also verify that documentation for services performed is received prior to certifying payment. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the CO. The extent and limitations of the COR designation will be provided in the COR Delegation Memo. VA Contact Person(s): COR: To be named at the time of award. Facility Check-In Requirement. The Contractor shall report to the Laboratory, Building 111, 2nd Floor, Room 2600 to check in, pick up and drop off specimens that will be analyzed under this contract. This check in is mandatory. Identification, Parking, Smoking & VA Regulations. No contractor or sub-contractor employee shall be permitted to perform work or access non-public areas unescorted without an ID card obtained from the VA Police. Contractor's and any Subcontractor's employees will be required to provide 2 forms of ID and be accompanied by the COR to obtain ID. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VAMC will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Effective January 1, 2019, smoking is prohibited both inside and outside (entire campus) at the VAMC. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court. 10. HHS/OIG . To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract. 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. During the performance of this contract the contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. Any healthcare provider or entity that employ or enter into contracts with excluded individuals or entities may have a Civil Monetary Penalty (CMP) imposed against them. By signing this offer, the Contractor certifies that all persons or entities listed in the contractor s offer have been compared against the OIG list and are NOT listed as of the date the offer was signed. 11. HIPAA Compliance. Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). The VA has recognized Diagnostic Laboratory Facilities as healthcare providers and that the PHI is being disclosed and/or used for treatment. Therefore, no BAA is required for Cytogenetic Laboratory Services.