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Page 3 of 3 THIS IS A SOURCES SOUGHT NOTICE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The purpose of this Sources Sought Notice is to obtain information ... Page 3 of 3 THIS IS A SOURCES SOUGHT NOTICE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The purpose of this Sources Sought Notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. The responses received from interested contractors will assist the Government in determining the appropriate acquisition method. The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 20, is conducting market research to identify potential sources which can provide the following services: Pathology and cytology reference laboratory testing services for the Spokane VAMC Potential sources having the capabilities necessary to provide the above services which meet all the requirements as defined in the attached Statement of Work are invited to respond to this Sources Sought Notice via e-mail to Charles.Hartwick@va.gov no later than 3/16/2020. No telephone inquiries will be accepted. Responses should include the following information: Capability statement addressing technical requirements as outlined in attached SOW Documentation of established EHR IT interface with Cerner NAICS Code 621511 is applicable to determine business size standard. Disclaimer and Important Notes: This Sources Sought Notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. The Government will treat any information received as proprietary and will not share such information with other companies. Any organization responding to this Sources Sought Notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government may or may not issue a solicitation as a result of this announcement. There is no solicitation available at this time. STATEMENT OF WORK Surgical Pathology and Cytology Reference Laboratory Testing Services For the Department of Veterans Affairs Spokane VA Medical Center Laboratory (113) Assembly Street Spokane, WA 99205-6197 BACKGROUND The Spokane VA Medical Center (VAMC) Laboratory Department requires Surgical Pathology and Cytology reference laboratory testing services. This reference lab services requirement will provide testing supplies, customer service, courier services and system interfaced lab result reporting services. This requirement will ensure accurate and timely test results are made available to the Spokane VAMC healthcare providers which will ensure high quality healthcare is provided to the Veterans at the Spokane VAMC. SCOPE The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient specimen testing for the specific range of referral testing within their capability. Services shall include the performance of analytical testing as defined by the Laboratory's reference test manual, the reporting of analytical test results and consultative services as required assimilating the full scope of its laboratory operations to Mann Grandstaff VA Laboratory Services. All requirements and provisions defined in the specifications of this solicitation will apply to any laboratory, i.e. branch, division, sub-contractor, etc. performing reference testing on behalf of the Reference Laboratory. The VA Facilities will be responsible for specimen collection and will provide laboratory specimens prepared according to the Reference Laboratory's laboratory user s manual, identified, and labeled for testing. SPECIFIC TASKS Surgical Pathology/Cytology: If required the Reference Laboratory shall perform the technical components (specimen grossing, processing, embedding, cutting and routine/special/ immunohistochemical staining) and professional component, for anatomical pathology and cytology specimens as requested by the Mann-Grandstaff VA Medical Center, Spokane, WA. If required the Reference Laboratory shall transport created slides to Mann-Grandstaff to perform professional component (slide reading, interpretation, and report generation). Contractor shall provide the necessary pathology specimen processing and additional testing services at vendor site. The contractor shall provide following consumables and pathology materials: Furnish Specimen containers for Pathology specimen collection and processing including but not limited to 10% buffered Formalin in various sizes, Cytology transport solutions for various specimen types, specialized immunofluorescence and other transport/collections media, PAP liquid based Gynecologic Cytology (e.g., Thin prep or other) media and collection devices as required and furnish courier bags and absorbent material and manifest forms for transport of specimens. Furnish all Requisition forms. Surgical pathology prep-op and post-op, Systematized Nomenclature of Medicine (SNOMED) and CPT coding shall be noted on each report. Surgical pathology prep-op verses post-op discrepancy report shall be provided quarterly. Any discrepancy shall require secondary review. Full testing of Oncology patients to include: Pathology and Cytogenetic/Flow testing. Provide names and DOB of staff who will be performing slide reviews for verification purpose in VA laboratory system at least two weeks in advance of work being performed. Provide retrospective random review of ten (10) percent of all surgical pathology, cytology and fine needle aspirate cases for the VA facility. ELECTRONIC INTERFACE If awarded the Reference Laboratory agrees to a transition period for providing a fully functioning interconnection for exchanging data between upcoming Electronic Health Record (Cerner) and the Reference Laboratory's electronic lab information system. During this time the Reference Laboratory will supply the VA Facility with available test menu and agrees to receive test orders as they are transitioned until full menu implementation. System drivers must be compatible with Cerner. The server and interface software will be owned and maintained by the Reference Laboratory. This interconnection shall be protected through the use of VA approved encryption algorithms and products as required and in compliance with HIPPA guidelines. Connections at each end shall be located within a controlled access facility. All access shall be controlled by authentication methods to validate approved users. TESTING METHODOLOGY, REFERENCE AND TURN AROUND TIME Routine test results shall be reported within the specified turnaround time (TAT) which is defined from time of specimen pickup to when results are available. TAT is established by the VA facility. In general, Surgical Pathology and Cytology specimens should be completed within 1-2 days, see attachment for details. If testing is not within TAT, notify the VA Facilities of the new estimated TAT within 12 hours. Stat test results shall be reported within 2 hours of specimen pickup to when results are available. Stat testing would include Frozen sections. Reference Laboratory agrees to maintain the minimum acceptable service, reporting systems and quality control. Reference Laboratory shall advise facility of any changes in methodology, procedure, reference ranges and any new tests introduced. Exception handling: Reference Laboratory will notify VA Facilities Laboratory Service within 12 hours of any problems with specimens received. The VA Facilities will provide laboratory specimens prepared according to the Reference Laboratory's user s manual, identified, and labeled for testing. Critical Value test results shall be reported immediately. Telephoned results will be confirmed with a follow-up by vendor via fax. CUSTOMER SERVICE The Reference Laboratory will provide VA Laboratory with a means of communication to permit immediate inquiry regarding the status of pending tests or specimen problem, 24 hours per day, 7 days per week. The Reference Laboratory shall provide names and telephone numbers of technical Directors and Pathologists available to provide information. COURIER SERVICES The Reference Laboratory shall be responsible for transporting and storing specimens in such a manner as to ensure the integrity of the specimen where applicable. Reference Laboratory shall supply any special preservatives required for specimen preservation. Transport samples in such a manner as to ensure the integrity of the specimen. Reference Laboratory shall supply any special preservatives required for specimen preservation. Reference Laboratory shall notify VA Facilities of any specimen problems or discrepancies from the submitted manifest within 24 hours after shipping. The Reference Laboratory shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA facilities but not less than once a day. The VA Facilities laboratory manager or designee shall notify the Reference Laboratory during weekends and federal holidays, via telephone, when a pick-up courier is required. DELIVERY AND REPORTING Billing summaries shall begin the first day of the month and include the last day of the month. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the government. Deliveries must be accompanied by a delivery ticker or sales slip that contains the following information as a minimum: Vendor Name Applicable contract number Task order number, and Purchase Order number Date of Purchase Date of Shipment Description of item Quantity of each item Unit price and extended (quantity x unit price) price for each item Provide data on tests not performed due to issues such as sample type, quantity, or stability. PERFORMANCE MONITORING At the time of contract award the Contracting Officer will appoint a Contracting Officer Representative (COR) to assist with the contract monitoring requirements. The COR or designee will monitor such items as quality of service, contractor's ability to meet TAT's, correct billing, customer service, and review of the contractor's proficiency program. Contractor shall provide to the COR or designee no later than Ninety (90) days prior to the end of each contract period a proficiency report. The COR or designee shall review the proficiency results. The contractor shall maintain a minimum of 95% success rate for proficiency testing to be considered successful. Failure to achieve 95% success rate two periods in a row could be grounds for Termination for Cause. The COR or designee will ensure that services performed are in accordance with all terms and conditions of the contract. The delegated COR or designee will notify the Contracting Officer of any non-compliance immediately upon his/her gaining knowledge of any such situation or incident. After such communication, the COR or designee will provide a written statement to the contracting officer along with any supporting documentation regarding the performance failure noted. Upon receipt of a proper invoice, the COR or designee shall certify that the services identified have been performed. Once certification has been made, the invoice will be forward through the proper billing channels and payment shall be made to the Contractor. It is the intention of both parties to conduct joint reviews prior to the expiration date of the contract to determine and evaluate if services being provided are in accordance with the contract terms, payments and billings are being properly handled and to jointly determine if this agreement is satisfactory to both parties in terms of services provided and consideration being received. This review may include. but not be limited to: analyze all billings, payments, costs, administrative issues, patient satisfaction, quality of care and other related documentation that identities that services had been received. Upon conclusion of the initial contract period, and in coordination with the Contracting Officer, the using service shall provide a statement to the Contracting Officer providing a summary of contractor actions and a statement that all requirements of the contract were fulfilled as agreed. This information shall be forwarded by the COR or designee to the Contracting Officer prior to exercising any extension of this agreement (at least 60 days prior to contract expiration). LICENSING AND ACCREDITATION Reference Laboratory shall provide copies of all licenses, permits, accreditation and certificates required by law. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst. All medical facilities providing laboratory services under the contract must possess a valid state license and meet JC standards as well as CLIA requirements and standards of the College of American Pathologists (CAP). Contractor shall provide copies of all licenses, permits, accreditation and certificates required by law. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst. PERSONNEL The Reference Laboratory shall make sure employees have current and valid professional certifications before starting work under this contract. Technologist, medical technicians, and cytotechnologist shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. The Government s reserves the right to request information or certification from the contractor verifying they comply with this contract requirement. If discovered the contractor is not in compliance with this requirement the contract shall be terminated for cause in accordance with clause 52.212-4. HOURS OF OPERATION The Mann Grandstaff VA is open 24 hours a day, 7 days a week, 12 months of the year and may require services during those times. PERIOD OF PERFORMANCE Contract will be one Base Period plus Four (4) Option Years: Base Period: 5/29/2020-4/30/2021 Option Year One (1): 5/1/2021-4/30/2022 Option Year Two (2): 5/1/2022/4/30/2023 Option Year Three (3): 5/1/2023-4/30/2024 Option Year Four (4): 5/1/2024-4/30/2025 PATIENT INFORMATION SAFETY The Reference Laboratory shall not use or disclose Protected Health Information (PHI) other than as permitted or required by the agreement or as required by law. The Reference Laboratory shall use appropriate safeguards to prevent use or disclosure of the PHI other than is provided for by this agreement. The Reference Laboratory shall report immediately any breach of safeguards and mitigate any harmful effects related to the use or disclosure of PHI by the Reference Laboratory or any of its agents, including sub-contractors. SECURITY REQUIREMENTS The Reference Laboratory shall be responsible for adhering to the following statements as they relate to the contract. Mann Grandstaff VA in coordination with their site Information Security Officer (ISO) shall monitor the work performed by contractor personnel, including sub-contractors, on a periodic basis to make sure contractor personnel are following the stated security requirements. Quality Assurance Surveillance Program SOW Task# Quality Monitor Format Calendar Days After CO Start Acceptability Level 1 Licensures/Certificates Copies At initial award, and when renewed 100% Received 2 Monthly Test Summary One electronic copy Monthly by the 10th work day 100% Received 3 Contact Phone List One electronic copy At initial award, and when changes occur 100% Received 4 Turn Around Time One electronic copy Monthly 95% meets established limits 5 Proficiency Testing One electronic copy 90 days prior to the end of contract period 95% meets success rates 6 Pre-op/Post-op One electronic copy Quarterly 100% Received Attachment: VA Turn Around Times for most common orders but not inclusive of all orders PathTestName CPTCode Turn Around Time (days) ABDOMINAL FLUID CYTO 88112 - 1 1 day ANAL(RECTAL) CYTOLOG 88112 - 1 1 day CONSUL+REP/REF SLIDE 88321 - 1 1 day CONSULT+REP/REFERRED 88323 - 1 Case by case basis, anywhere from 3-14 days. DECALCIFICATION, 1ST 88311 - 1 2 days DECALCIFICATION, 2ND 88311 - 1 2 days DECALCIFICATION, 3RD 88311 - 1 2 days FINE-NEEDLE ASPIRATI 88173 - 1 1 day HPV, LOW VOLUME RFX 87624 - 1 1 day IHC EA ADDL AB STAIN 88341 - 1 1 day IHC 1ST AB STAIN X1 88342 - 1 1 day IHC 1ST AB STAIN X2 88342 - 2 1 day IHC 1ST AB STAIN X3 88342 - 3 1 day IHC 1ST AB STAIN X4 88342 - 4 1 day IN SITU HYBRIDIZATIO 88365 - 1 1 day MISCELLANEOUS FLUID 88112 - 1 1 day MORP ANA,TUMOR IMMUN 88360 - 1 1 day PAP LB, HPV-HR 88142 - 1,87624 - 1 1 day PAP LB, RFX HPV ALL 88142 - 1 2 day PHYSICIAN READ PAP 88141 - 1 1 day PLEURAL FLUID CYTOLO 88112 - 1 1 day SPEC-STAIN,GRP I-MIC 88312 - 1 1 day SPEC-STAIN,GRP II-AL 88313 - 1 1 day SPUTUM CYTOLOGY 88108 - 1 1 day URINE CYTOLOGY 88112 - 1 1 day 88300 SURGICAL PATHO 88300 - 1 1 day 88302 SURGICAL PATHO 88302 - 1 1 day 88304 SURGICAL PATH- 88304 - 1 1 day 88305 SURG PATH-1ST 88305 - 1 1 day 88305 SURG PATH-2ND 88305 - 1 1 day 88305 SURG PATH-3RD 88305 - 1 1 day 88305 SURG PATH-4TH 88305 - 1 1 day 88305 SURG PATH-5TH 88305 - 1 1 day 88305 SURG PATH-6TH 88305 - 1 1 day 88305 SURG PATH-7TH 88305 - 1 1 day 88305 SURG PATH-8TH 88305 - 1 1 day 88305 SURG PATH-9TH 88305 - 1 1 day 88307 SURGICAL PATHO 88307 - 1 2 days