Q301--Microbiological Testing

B.3 STATEMENT OF WORK (SOW) Specialized Microbiological Diagnostic Testing Services Scope of Work: The contractor shall provide specialized diagnostic testing for microbiological organisms from biological samples for the Pathology & Laboratory Medicine Service at Department of Veterans Affairs, Black Hills VA Health Care System (BHVAHCS) which consist of Fort Meade VA Medical Center, Hot Springs VA Medical Center, and Rapid City VA Clinic. Services shall include specimen pick-up from the above named locations, transport, laboratory testing, consultation, and reporting. The contractor is responsible for ensuring specimen integrity, timely transportation, and testing, with specific turnaround times for various tests. The contract also outlines requirements for compliance with federal regulations, confidentiality, and quality assurance monitoring. Contractor Responsibilities: Laboratory Testing: Perform culture, isolation, count, identification, and susceptibility testing of microorganisms. Analyze the full range of micro specimens as specified in the Laboratory User’s Manual. Specimen Transport: Provide courier service for specimen pickup from the VA Health Care System laboratory or designated location (excluding STAT specimens). Supply lab test request forms and special instructions for specimen handling. Consultation: Advice on test selection, specimen collection, transportation, and result interpretation as needed. Reporting: Fax or electronically report results to the VA Laboratory. Provide a printed final copy of pathology interpretive consults. Include the following in each report: Patient’s name Physician’s name (if supplied VA Facility name Patient’s location (if supplied) Test ordered Date/time of specimen collection and receipt Date test completed Test result Name of testing laboratory (contractor/subcontractor) Testing laboratory specimen number Type of specimen Comments from submitting lab Notation of questionable validity or unsatisfactory specimens Documentation: Provide a Laboratory User’s Manual detailing: List of available tests and methodologies Testing schedules Specimen requirements and special handling instructions Billing: Submit monthly billing for tests provided in the preceding month. Communication: Maintain a means of immediate inquiry regarding test status. Provide contact information for specimen inquiries and technical/pathologist consultation. Licensing and Accreditation: Ensure compliance with all federal and state laws, including required licenses, permits, accreditations, and professional certifications. Maintain accreditation by the College of American Pathologists (CAP), The Joint Commission, Clinical Laboratory Improvement Amendment (CLIA), or equivalent. Provide copies of current accreditation upon request. Personnel Qualifications: Pathologists overseeing the laboratory must hold an unrestricted license to practice medicine in the United States or District of Columbia Laboratory personnel must be highly skilled and trained; qualifications are subject to review by the VA Medical Center Laboratory Director. Quality Control: Provide annual summaries and proficiency testing data upon request. Allow VA representatives to examine facilities, methodologies, and quality control procedures at any time. Notify VA within 24 hours of any adverse regulatory action. Maintain minimum acceptable service, reporting systems, and quality controls as specified. Change Management: Notify VA Laboratory Manager in advance of any changes in assay methodology, procedures, or introduction of new tests. Performance Metrics: Adhere to designated turnaround times for testing (e.g., ASAP, STAT, or as specified in the Laboratory User’s Manual). Monitor and report on performance indicators such as turnaround time, error rates, and customer satisfaction. Contact Information: Specimen Inquiries: ___________________________ Lab Technical Director/Pathologist: ___________________________ Test Menu & Timeframes Test Name/Description CPT Code Urgency Timeframe Aerobic Culture "any source" 87070 N/A 48 HOURS Anaerobic culture "any source" 87075 N/A 48 HOURS Micro Bacterial Culture 87077 N/A 48 HOURS Blood Culture 87040 N/A 48 HOURS Blood Culture POS ID 87150 N/A 24 HOURS Urine Culture 87088 N/A 24 HOURS Bacterial MIC 87186 N/A 24 HOURS Yeast ID 87106 N/A 24 HOURS Gram Stain 87205 N/A 24 HOURS Blac Beta Lactamase 87185 N/A 24 HOURS Security Requirements: The contractor and contractor personnel performing the duties shall comply with Black Hills VA Health Care System security requirements. Complete a Fingerprint Resource Form Complete the following Talent Management System (TMS) training courses: TMS 20939: VA Privacy Training without Access to VA Computer Systems or Direct Access Once courses are complete the Contractor is responsible for providing signed TMS certificates to the BHVAHCS Contracting Officer Representative (COR)/designee Ensure all personnel assigned to this contract adhere to the following sections of the IT Contract Security Clause: General (Section 1) VA Information Custodial Language (Section 2) Training (Section 4) Security Incident Investigation (Section 5) National Archives and Records Administration (NARA): Contractor and personnel performing the work on this contract shall adhere to the NARA language below: Records Management Obligations Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preser…