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PERFORMANCE WORK STATEMENT for ANATOMIC PATHOLOGY SERVICES Western Colorado Health Care System (WCHCS) Grand Junction VA Medical Center 2121 North Avenue Grand Junction, CO. 81501 Background The purpo... PERFORMANCE WORK STATEMENT for ANATOMIC PATHOLOGY SERVICES Western Colorado Health Care System (WCHCS) Grand Junction VA Medical Center 2121 North Avenue Grand Junction, CO. 81501 Background The purpose of this Statement of Work (SOW) is to procure Anatomic Pathology Services from a qualified Reference Laboratory (hereafter Contractor) for the Western Colorado Health Care System (WCHCS), Pathology and Laboratory Medicine Services (P&LMS). The period of service is October 1, 2025, to September 30, 2026, with four consecutive option years. Services will be provided by the Contractor at both the Contractor s facility and on-site at WCHCS. WCHCS does not have an Anatomic Pathology department and needs a service that will provide a licensed consulting pathologist for surgical specimen processing with interpretation, cytological specimen processing with interpretation, and autopsy services. The Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide reference laboratory services to the WCHCS described herein. Contractor shall also have an existing VISTA connection. Reference laboratory services include, but are not limited to: specimen preparation and storage. transportation of clinical laboratory specimens, microbiology cultures, and stocks; performance of analytical testing; reporting of analytical test results; consultative services. Quality control activities. All Contractor s 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 on all biomedical materials. Specimen Testing The Contractor shall pick up, process, embed, stain, cut, and coverslip the specimens, provide pathological analysis, and report findings in a reasonable time frame, as noted below. Surgical specimens shall be reported in less than or equal to two (2) days. Procedures include, but are not limited to, the following (by CPT code) performed at the Contractor s laboratory: 85060: Blood Smear, Peripheral, Interpretation by Physician 85097: Bone Marrow, Smear Interpretation 87624: Infectious Agent Detection by Nucleic Acid (DNA or RNA) 88164: Cytopathology, Slides, Cervical or Vaginal 88300: Level 1 Tissue Exam By Pathologist 88302: Level 2 Tissue Exam By Pathologist 88304: Level 3 Tissue Exam By Pathologist 88305: Level 4 Tissue Exam By Pathologist 88307: Level 5 Tissue Exam By Pathologist 88309: Level 6 Tissue Exam By Pathologist 88311: Decalcification Procedure 88312: Special Stains Group 1, including Interpretation and Report 88313: Special Stains Group 2, including Interpretation and Report 88321: Consultation and Report on Referred Slides Prepared 88323: Consultation and Report on Referred Material 88341: Immunohistochemistry or Immunocytochemistry, per Specimen 88342: Immunohistochemistry or Immunocytochemistry + Immunoperoxidase Stain 89060: Crystal Identification by Light Microscopy Non-GYN Cytology Specimens. Shall be reported in less than two (2) business days. Procedures include, but are not limited to, the following (by CPT code) performed at the Contractors laboratory: 88108: Cytopathology Concentration Technique 88112: Cytopathology, Selective Cellular Enhancement Technique GYN Cytology Specimens. Shall be reported in less than two (2) days. Procedures include, but are not limited to, the following (by CPT code) performed at the Contractors laboratory: 88141: Cytopathology, Cervical or Vaginal, GYN Physician Interpretation 88142: Cytopathology, Cervical or Vaginal, GYN auto Frozen Sections. Shall be processed and the initial report received at WCHCS within 20 minutes or less from the time the specimen is received at the Contractor s place of business. Procedures include, but are not limited to, the following (by CPT code) performed at the Contractors laboratory: 88331: Pathology Consultation During Surgery, Frozen Section 88332: Pathology Consultation During Surgery, Frozen Section Add Rush Block Fine Needle Aspirates. Immediate evaluations are performed at bedside at WCHCS for Fine Needle Aspirates and Core Biopsies to determine if the specimens are adequate and to provide a preliminary report. Specimens are then treated as surgical and Non-GYN cytology specimens. Procedures include, but are not limited to the following (by CPT code): 88172: Cytopathology, Evaluation of Fine Needle Aspirate + Fine Needle Consult 88173: Cytopathology, Evaluation of Fine Needle Aspirate 88333: Pathology Consultation During Surgery, Cytologic Examination + Misc. AP test Autopsies. Shall be processed and completed within sixty (60) days. A provisional diagnosis shall be received within two (2) business days. A post-mortem Quality Assurance Survey must be completed within thirty (30) days. Procedures include, but are not limited to, the following (by CPT code) performed at the Contractors laboratory: 88020: Necropsy (Autopsy), Limited, Gross and/or Microscopic, Without CNS 88025: Necropsy (Autopsy), Gross and Microscopic, with brain 88036: Necropsy (Autopsy), Limited, Gross and/or Microscopic Histology. The contractor shall embed, stain, cut, and coverslip to the specimens and then return the specimen to WCHCS. This could be called a Block and stain service for Anatomic pathology specimens should a special circumstance arise. Staining. Upon receipt of tissue specimens, the Contractor shall embed, perform a Hematoxylin & Eosin (H&E) stain, perform a single cut of the specimen, and affix it so a slide with coverslip. Staining. Upon receipt of tissue specimens, the Contractor shall embed, perform a Hematoxylin & Eosin (H&E) stain, perform a single cut of the specimen, and affix it so a slide with coverslip. NOTE: The Contractor must offer the Technical Component separately form the Professional Component on both their test menu and the bill of charges. NOTE: New tests not listed must be added to the contract though modification by the Contracting Officer prior to the specimen being tested. The Contractor shall notify the Contracting Officer and the Contracting Officer s Representative (COR) or designee of any test information modifications no earlier than two weeks prior to the desired implementation date of the test change. Specimen Preparation, Storage, and Retention for Reference Testing Specimens The Contractor shall provide all materials necessary to collect and preserve specimens that are destined to the commercial reference laboratory for testing. These materials include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory. The Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen. All Anatomic Pathology materials (e.g., histology blocks, slides or other diagnostic material) generated by the VA shall be returned within 2 days after final diagnosis is reported. The Contractor shall be responsible for storing specimens in such a manner to insure the integrity of the specimen. Transportation Services for Reference Testing Specimens The Contractor shall provide transportation of primarily biomedical materials that include patient specimens, originating from the WCHCHS and destined to their contracted reference laboratory facility. These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents. Transportation shall be done in such a manner that the safety and integrity of the biomedical material is maintained. NOTE: The WCHCHS will NOT employ the use of their own courier services for this contract. Routine transportation services shall occur a minimum of once per day: New specimens shall be picked up from the WCHCHS no later than 5:30 pm each business day, Monday through Friday, not including government holidays. Emergency Transportation arrangements shall be made by WCHCHS. Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor s laboratory. These supplies shall include, but may not be limited to: Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor s laboratory. Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates. Test request forms. Specimen Retention All Anatomic Pathology materials (e.g., histology blocks, slides or other diagnostic material) generated by the VA shall be returned within 2 days after final diagnosis is reported. Reporting of Results The results of testing shall be reported within the prescribed turnaround times provided by WCHCS as part of the test information. The Anatomic Pathology report must be issued as an electronic final copy. The Contractor shall deliver reports electronically preferably though the Veterans Administration VISTA HL7 interface. Contractor must provide IT support for current and/or future connectivity to VISTA. Accessibility to WCHCHS reports must be available via web-based programs at any time. 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 Test(s) ordered Date/time of specimen collection Collection site Brief patient history that is provided Date/time test completed Test result CPT code SNOMED code Reference laboratory accession number if applicable 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. Customer Service The Contractor shall provide customer service that is accessible by telephone service Monday through Friday, 8:00 am 4:00 pm Mountain Time, in order to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period: Telephone Inquiries Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the Government s minimum time expectation for meeting this service. Specimen Collection Routine inquiries, questions and clarifications regarding collection requirements shall be addressed at the time of the initial call. Esoteric inquiries, questions and clarifications regarding collection requirements that require further research shall be addressed within ½ hour of the initial call. Testing Inquiries regarding the status of pending orders shall be addressed at the time of the initial call. Esoteric inquiries when information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial call. Technical Expertise Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two business hours of initial call. Result interpretation inquiries shall be addressed within four business hours of initial call. Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four business hours of the initial call. Account follow-up Information general in nature yet specific to the account, e.g. test pricing, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial call. The Contractor shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc. Consultative Services/Utilization Reports Contractor shall prove consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation. Contractor shall provide a statistical analysis of the Government facilities workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the facilities on mechanisms to reduce their costs. Contractor shall provide a cumulative workload summary report of tests performed. The summary must include the test name/description, monthly test volume, year-to-date test volume, unit test cost, monthly test expenditures and year-to date test expenditures. The report shall be delivered electronically to the COR or designee by the 10th of the month following the close of the reporting month. All reports shall be submitted in electronic spreadsheet format. 9.0 Special Contract Requirements Services Monitoring of contractor s performance shall be demonstrated through clinical and administrative record reviews. The COR will be responsible for verifying contract compliance. The COR will monitor services through one or a combination of the following mechanisms: The COR will monitor Contractor performance to ensure that services called for in the PWS 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 Contracting Officer. Documentation of services performed will be reviewed prior to certifying payment. The COR will perform periodic spot checks on all documents and record all findings. VA will pay only for services actually provided. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided. The COR will provide a written statement annually to the Contracting Officer 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 45 days prior to expiration of contract (and/or prior to election of option year renewals, if applicable). The Contractor shall not, under any circumstances, furnish reports directly to patients. The Contractor shall be CLIA certified and confirm that they are a covered entity. The Contractor must comply with all Joint Commission, College of American Pathologists, and VHA Handbook 1106.01 requirements. Federal Holidays The Contractor is not required to provide transportation of specimens on federal holidays. The 10 holidays observed by the Federal Government are: New Year s Day Martin Luther King s Birthday Presidents Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day *and any other day specifically declared by the President of the United States to be a national holiday. Qualifications/Requirements of Laboratory & Contractor Personnel Laboratory In accordance with VA Directive and Handbook 6500.6, Appendix A, a Business Associate Agreement is required. The Contractor must comply with all Joint Commission, College of American Pathologists, and VHA Handbook 1106 requirements. The Contractor shall 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 Contractor must maintain valid certifications during the entire performance period of this contract. The 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 The Contractor shall ensure all testing and supervisory personnel at the reference laboratory 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. The Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification. Any new requirements for mandatory education and/or competency reassessment, which occur during the contract period, must be completed by the individual contractor employee(s) within VA established timeframes. The Contractor couriers entering any Government facility shall prominently display a contractor-issued identification badge. The work will be performed at the contractor s location of business, excluding any specialized testing requiring specimens to be sent out. HIPAA Compliance Contractor shall 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 Contractor shall prove to the GJVAMC that they are identified as healthcare providers, and that the PHI is being disclosed and/or used for treatment. Contract Performance Monitoring Monitoring of contractor s performance shall be demonstrated through clinical and administrative record reviews. The COR will be responsible for verifying contract compliance. The COR will monitor services through one or a combination of the following mechanisms: The COR will monitor Contractor performance to ensure that services called for in the PWS 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 Contracting Officer. Documentation of services performed will be reviewed prior to certifying payment. The COR will perform periodic spot checks on all documents and record all findings. VA will pay only for services actually provided. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided. The COR will provide a written statement annually to the Contracting Officer 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 45 days prior to expiration of contract (and/or prior to election of option year renewals, if applicable). Quality Control Program The Contractor shall maintain a Quality Control Program related to Reference Laboratory services covered under this contract. 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. The contractor will meet or communicate with the WCHCS staff for process review and improvement of contract performance on an as needed basis. The Contractor will notify the performing provider and WCHCS Laboratory Leadership for all new malignancies within 2 business days. The new malignancy report will contain all required SNOMED and P codes in accordance with VA Handbook 1106. The Contractor will provide monthly quality assurance reports. The Contractor will provide an annual evaluation of statistical data to include: Cytology cases examined. Specimens processed by specimen type. Patient cases reported by diagnosis. Gynecologic cases where cytology and histology are discrepant. Security Requirements Contractor shall 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 Contractor shall prove to the GJVAMC that they are identified as healthcare providers and that the PHI is being disclosed and/or used for treatment. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). VA WCHCS will provide the Electronic Health Record for issuing pathology reports. Other Pertinent Information or Special Considerations. Specimens may require additional specialized staining. Identification of Possible Follow-on Work: Community Hospital Pathologists may encounter the need to order follow-on testing and have tissue blocks and/or slides sent to another reference laboratory for additional analysis. Identification of Potential Conflicts of Interest (COI). None identified Identification of Non-Disclosure Requirements. All correspondence must be encrypted. The contractor must not disclose pricing to other vendors or entities outside of the WCHCS contracting and laboratory departments. Packaging, Packing and Shipping Instructions. The Contractor shall provide transportation of primarily biomedical materials that include patient specimens, originating from the GJVAMC and destined to their contracted reference laboratory facility. These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents. Transportation shall be done in such a manner that the safety and integrity of the biomedical material is maintained. NOTE: The GJVAMC will not employ the use of their own courier services for this contract. Routine transportation services shall occur a minimum of once per day: New specimens shall be picked up from the GJVAMC no later than 5:30 pm each business day, Monday through Friday, not including government holidays. Emergency Transportation arrangements shall be made by GJVAMC. Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor s laboratory. These supplies shall include, but may not be limited to: Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor s laboratory. Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates. Test request forms. Inspection and Acceptance Criteria. The COR is responsible for certifying that the work done under the contract is performed to time and standard. They are also responsible to assure the inspection and acceptance of products provided incidental to services. A demo period or trial is not inspection of a product. Rick Control The contractor may be exposed to hazardous chemicals. The contractor is responsible for keeping up to date on Safety Data Sheets and procedures for mitigation of exposure. Place of Performance. 10/01/2025 through 09/31/2026. This will be a base plus four option years firm fixed price contract. Delivery Schedule. Task 1: Surgical specimens. Shall be reported in less than or equal to two (2) days. Task 2: Non-GYN Cytology Specimens. Shall be reported in less than two (2) business days. Task 3: GYN Cytology Specimens. Shall be reported in less than two (2) days. Task 4: Frozen Sections. Shall be processed and the initial report received at WCHCS within 20 minutes or less from the time the specimen is received at the Contractor s place of business. Task 5: Fine Needle Aspirates. Immediate evaluations are performed at bedside at WCHCS for Fine Needle Aspirates and Core Biopsies to determine if the specimens are adequate and to provide a preliminary report. (End of Statement of Work) In response to this announcement, please provide the information below. If this information is not provided, then it will be assumed the entire requirement cannot be met: NAICS Code: 621511 Company Name: Address: UEI (Unique Entity ID) Number: Contact Name: Phone No.: Email: Business Size Information - Select all that applies: Small Business Emerging Small Business Small Disadvantaged Business Certified under Section 8(a) of the Small Business Act HUBZone Woman Owned Certified Service-Disabled Veteran Owned Small Veteran Owned Small Business Large Business FSS/GSA Contract Holder: Yes No FSS/GSA Contract Number: Effective Date/ Expiration Date: Proposed solution is listed and available on the above FSS/GSA Contract: Yes No Available pricing structure of proposed solution (select all that are applicable below): Pricing Model Please Indicate Availability Below: (Yes / No / NA) All on FSS Open Market only Mix of FSS & Open Market (CPRR) Cost Per Reportable Result Cost Per Test(CPT) Reagent Rental Agreement Equipment Rental with Reagent Purchase Fixed Monthly Charge Other: (Please explain) Federal Acquisition Regulation (FAR) Market Rearch Questions: Buy American Act (FAR 52.225) What percentage of the proposed product (including leases) is a: Domestic end product? _____________ (%) Foreign end product? _______________ (%) Questions for Small Businesses ONLY: Limitations on Subcontracting (FAR 52.219-14) What percentage of the work would be subcontracted to another company? ________ If > 0, what is company s business size: __________ If subcontracting, what added value do you offer (FAR 52.215-23): _______________________________ Nonmanufacturer Rule (FAR 52.219-33): Does your company manufacturer these proposed items? [ ] yes [ ] no Does your company exceed 500 employees? [ ] yes [ ] no If yes, list # of employees: _________ Does your company primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied? [ ] yes [ ] no Does your company take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice? [ ] yes [ ] no Does your company supply the end item of a small business manufacturer, processor or producer made in the United States, or obtains a waiver of such requirement pursuant to paragraph (b)(5) CFR 121.406. [ ] yes [ ] no If yes, what is the manufacturer s name? ________________ The information submitted shall contain the company s business size status. This is a request for information and sources only, which may or may not lead to a future solicitation. This is not a request for quote (RFQ). No questions will be answered. The VA will not pay for any information received resulting from this sources sought notice. Requests for copies of a solicitation shall not be honored or acknowledged. Information should be forwarded to the Contracting Officer. If your organization can provide all services of this potential requirement and is interested in this opportunity, please respond to Lindsey Zwaagstra, Lindsey.Zwaagstra@va.gov, Contracting Officer, Department of Veterans Affairs, NCO 19, 6162 S. Willow Drive, Suite 300, Greenwood Village, Colorado 80111 and NCO19lab@va.gov  with a statement describing your capabilities and completed table above. The capability statement shall include a point of contact, complete mailing address, telephone number, email address and state the company s business size status. The deadline for this information to be received is 16:00 PM Mountain Time, 02/14/2024.