Q301--Prostate Testing and Reporting for Salt Lake City VA Medical Center

Description

{"description":"Sources Sought Notice\n\nSources Sought Notice\n\nPage 3 of 4\nSources Sought Notice\n*= Required Field\nSources Sought Notice\n\nPage 1 of 4\nDESCRIPTION\n\nPage 4 of 4\nPage 1 of \nREQUEST FOR INFORMATION / SOURCES SOUGHT INQUIRY\n\nTHIS IS A SOURCES SOUGHT NOTICE ONLY. THIS IS NOT A REQUEST FOR PROPOSAL. The Department of Veterans Affairs Network Contracting Office (NCO) 19, Rocky Mountain Acquisition Center (RMAC) is seeking information and sources that can provide Prostate Testing and Reporting for Salt Lake City Regional VA Medical Center, located at 500 Foothill Blvd, Salt Lake City, UT 84148.\n\nThe NAICS code is 621511 Medical Laboratories and Small Business Size Standard is $41.5 Million. \n\nThe Contractor shall provide Prostate Testing and Reporting. The prostate test and report will be used to determine how likely the patient s cancer is to metastasize within the next five years. The test is performed on tissue samples obtained during biopsy or surgical removal of the prostate.\n\nThis is a request for information and sources only, which may or may not lead to a future solicitation! This is not a request for proposal (RFP). No questions will be answered. The VA will not pay for any information received resulting from this, sources sought notice. Information should be forwarded to the Contracting Officer and Contract Specialist. If your organization can provide these services and is interested in this opportunity, please respond to Devin Reichert, Contract Specialist via e-mail at devin.reichert@va.gov and NCO19LAB@va.gov with the above information requested. The response due date for this information is 9 AM Mountain Time, on Friday, November 28th, 2025.\n\nIn response to this announcement, please provide the information below: \nCompany Name:\nAddress:\nUEI (Unique Entity ID) Number:\nContact Name:\nPhone No.:\nEmail:\nBusiness Size Information - Select all that applies:\nSmall Business\nEmerging Small Business\nSmall Disadvantaged Business\nCertified under Section 8(a) of the Small Business Act\nHUBZone\nWoman Owned\nCertified Service-Disabled Veteran Owned Small\nVeteran Owned Small Business\nLarge Business\nFSS/GSA Contract Holder:\nYes No \nFSS/GSA Contract Number:\n\nEffective Date/ Expiration Date:\n\nProposed solution is listed and available on the above FSS/GSA Contract:\nYes No \nAvailable pricing structure of proposed solution (select all that are applicable below):\nPricing Model\nPlease Indicate Availability Below: (Yes / No / NA)\nAll on FSS\nOpen Market only\nMix of FSS & Open Market\n(CPRR) Cost Per Reportable Result \n\n\n\nCost Per Test(CPT)\n\n\n\nReagent Rental Agreement\n\n\n\nEquipment Rental with Reagent Purchase\n\n\n\nFixed Monthly Charge\n\n\n\nOther: (Please explain)\n\n\n\nFederal Acquisition Regulation (FAR) Market Rearch Questions:\nBuy American Act (FAR 52.225) What percentage of the proposed product (including leases) is a:\nDomestic end product? _____________ (%)\nForeign end product? _______________ (%)\nQuestions for Small Businesses ONLY:\nLimitations 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: __________\nIf subcontracting, what added value do you offer (FAR 52.215-23): _______________________________\n\nDEPARTMENT OF VETERANS AFFAIRS\nVA MEDICAL CENTER, SALT LAKE CITY, UT\nSTATEMENT OF WORK\n PROSTATE TESTING AND REPORTING\nIntroduction\nDepartment of Veterans Affairs, Veterans Health Administration, Salt Lake City VA Medical Center (VAMCSLC), 500 Foothill Drive, Salt Lake City, Utah 84148 has a requirement for reporting from prostate testing. The contract will be awarded as a firm fixed price contract as a blanket purchase agreement with a 5-year ordering period.\nScope of Work\nThe Contractor will provide Prostate Testing and Reporting. The prostate test and report are used to determine how likely the patient s cancer is to metastasize within the next five years. The test is performed on tissue samples obtained during biopsy or surgical removal of the prostate.\nDescription\nThe contractor shall be responsible for performing laboratory testing, analysis, and result interpretation on behalf of the VAMSLC facility in accordance with the terms, conditions, and provisions outlined thereof. The testing report will provide personalized treatment where the tumor analysis will identify patients at high versus low risk of progression of cancer.\nThe services performance shall include genomic testing with varying levels of support services depending on the unique characteristics presented by each individual ordering activity.\nThe contractor shall perform testing entirely upon their premises.\nTests will be performed and reported within established vendor turnaround times.\nThe contractor shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations as they pertain to a licensed clinical laboratory.\nThe contractor shall provide individual patient-chartable test result reports meeting Clinical Laboratory Improvement Amendments (CLIA) requirements.\nThe contractor shall provide all appropriate requisition forms and unique supplies needed for specialized collection of samples, at no additional charge.\nNotwithstanding, anything to the contrary in this Agreement or otherwise,The contractor shall not release patient records that include test results, without the specific written consent to release such information as provided by the patient, to any person other than the ordering healthcare provider or designee. All patient records shall be treated as confidential so as to comply with all state and federal laws regarding the confidentiality of patient's records. This provision shall survive termination of this Agreement.\nThe required highly specific molecular testing reference laboratory services include but are not limited to the identified required test menu testing, specimen preparation and storage of clinical laboratory specimens, performance of analytical testing; reporting of analytical test results; and consultative services. \nSALIENT CHARACTERISTICS (TECHNICAL SPECIFICATIONS)\nDynamic Report\nA report must be generated with the Patient Information, Specimen Information, Ordering Physician, Clinical and Pathology Details, Genomic Score, Genomic Score Interpretation, Risk Graph, Risk Estimates, Risk Graph Interpretation, Clinical Findings, Test Description, Intended Use, Confidence Interval, and References. \nGenomic Score\nA Genomic Score must be generated based off of the genomic risk of metastasis, tumor biology alone, independent of clinical & pathological factors (e.g., Gleason, PSA), the 22 genes, 7 biological pathways, and continuous genomic risk score classified as low, intermediate or high. \nGenomic Score Interpretation\n Provide a summary based on this patient s genomic risk & relevant clinical findings.\nRisk Estimates\n Provide the risk estimates of the patient with standard therapy. \nRisk Graph\n Provide a Graph to show the patient their risk compared to patients with similar clinical and pathological features. \nRisk Comparison \nProvide a comparison of the patient and their risk compared to patients with similar clinical and pathological features. \nRisk Graph Interpretation \nExplains risk comparison graphic.\nProvides this patient s percentile rank in the tested population.\nClinical Findings\nProvide clinical study results relevant to this patient.\nTest Description\nProvide a summary of testing platform technology.\nRisk estimates. \nProvide cut points separating low, intermediate & high risk.\nIntended Use\nProvide a summary of the intended use in biopsy specimens from patients.\nConfidence Interval Confidence Intervals\nProvide a confidence interval for each risk estimate.\nReferences\n Provide references for each of the clinical studies cited in the report.\nThese tests will need to be provided to ensure efficient evaluation and management of prostate cancer. \n- Prolaris (Myriad Genetics) \nPurpose: Predicts cancer aggression and ideal treatment path. \n- Promark (Metamark Genetics) \n Purpose: Predicts cancer aggression and recurrence. \n- Benign Prostate Tissue Evaluation:\n Purpose: Evaluates tissue deemed benign (no malignancy found) to assess the risk of future malignancy. \n- Oncotype DX (Genomic Health) \n Purpose: Utilized for breast or colon cancer assessment. \nSchedule of Services\nEvery test must include \nPatient Information\nSpecimen Information\nOrdering Physician, \nClinical and Pathology Details\nGenomic Score\nGenomic Score Interpretation\nRisk Graph, Risk Estimates\nRisk Graph Interpretation\nClinical Findings\nTest Description\nIntended Use\nConfidence Interval\n References. \nGeneral Requirements\nThe contractor s standard price list of all testing services available along with the price to be billed to the VHA for each testing service shall reflect that which is listed in their GSA price list. \nThe price list, at a minimum, shall include the following data elements:\nCPT code\nProduct Name/Description \nPrice\nTest description, including reference ranges and units of measurement\nMaximum turn-around-time (TAT) shall not exceed three weeks from specimen submission.  \n\nTest Result Reporting\n\nThe Contractor shall provide encrypted and/or secured electronic transmission (i.e., fax and/or on-line web access) of all completed and/or partial test results to the ordering activity within published turnaround time of fifteen days. \n \nAll payments shall be made in arrears (30 days) upon receipt of a proper invoice. Invoices must contain at a minimum the following information. The contractor shall provide this information on one original invoice:\n\ni. Invoice Number\nii. Date of Service\niii. Test Description and CPT Code\niv. Unit cost\nv. Total cost\n\nMandatory Requirements\nLicensing and Accreditation: Only fully licensed and accredited laboratories actively engaged in providing the specific services and laboratory testing outlined. The contractor shall have all the licenses, permits, accreditation and certificates required by law. The reference laboratory must be licensed and accredited by the College of American Pathologists (CAP) and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Amendments of 1988.\nThe contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America prior to contract award. In addition, the contractor shall be responsible for providing a 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. Any proposed subcontractor changes during the contract performance period must have prior approval by the Local VA Point of Contact (POC). \nThe Contractor policies and procedures shall comply with the Health Insurance Portability and Accountability Act (HIPAA).\nThe contractor will provide and maintain quality assurance programs which meet federal regulations for laboratory operations. The contractor will be certified by the College of American Pathologist under the CLIA.\nThe contractor shall notify the POC in writing of any malpractice investigation or licensure or certification suspension which concerns the contractor or any employees, within 24 hours of notification of an investigation or suspension.\nContractor Personnel: The contractor shall maintain current accreditation and notify the POC of any lapse in state license, CLIA certification, or clinical pathology certification. The contractor shall provide a copy of renewed licenses/certificates to the POC before expiration.\n\nContractors Responsibilities\nProcedure Guidance:\nThe testing methodology and reference ranges for a test must be defined and available electronically. The contractor shall provide change notice prior to implementation of any new medical procedures and services.\nThe contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy. Upon request by the Laboratory Point of Contact (POC), the contractor will make available quality assurance information on specific testing procedures for review.\nIn the event of tests being referred to another laboratory, there shall be no additional transfer charge or confirmation charge to the government.\n Reporting of Results:\nA testing report is defined as a printed final copy of laboratory testing results. The report(s) shall be available on an encrypted and/or secured electronically with on-line web access and /or secured facsimile (Fax). \n\nEach test report shall at minimum indicate the following information:\ni. Patients name and/or identification code (social security number) PII Safety Protocols must be Enacted.\nii. Physician s name (if supplied)\niii. Date/time specimen received in reference lab\niv. Test ordered\nv. Date/time of specimen collection (when available)\nvi. Date test completed\nvii. Test result\nviii. Flag abnormal\nix. Reference range\nx. Toxic and/or therapeutic range where applicable\nxi. Testing laboratory specimen number\nxii. Name of testing laboratory and address (contractor and/or subcontractor)\nxiii. Type of specimen\nxiv. Unsatisfactory specimen shall be reported with regard to its unsuitability for testing\n\nRetention of Specimens:\n\nUpon completion of the testing procedures, the contractor shall retain all specimens as required by regulatory agencies. Upon request by the ordering activity POC or designee, the contractor shall provide a copy of the regulatory requirements for each participating regulatory agency. In the absence of regulatory agency requirements, the contractor shall retain specimens, after all testing has been completed for clinical specimens (7) days.\n\nSpecial Contract Requirements\n\nServices:\n\nThe services specified herein may be changed by written modification to the BPA. The VA POC will prepare the modification and, prior to becoming effective, must be signed by both parties. \n\nOnly the POC is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this agreement. In the event the contractor affects any such change at the direction of any person other than the POC, the change shall be considered unauthorized, and no adjustment will be made to the contract price to cover any increase in costs incurred as a result thereof.\n\nThis is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the contractor or the contractor s employee(s). Contractor personnel are not subject to the supervision and control of a government officer or employee. Rather, contractor personnel perform their duties in accordance with the Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. The healthcare provider who furnishes services under this contract is subject to Government technical oversight of the services. The Government retains the right to reject services for contractual non-performance. \n\nThe Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered. \n\nContractor is required to maintain medical liability insurance for the duration of this contract. Medical Liability insurance must cover the provider(s) for services in all states where services are rendered by the provider. Contractor must indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance. \n\nContractor shall, in writing, keep the POC informed of any unusual circumstances in conjunction with the contract. \n\nContractor shall not, under any circumstances, furnish reports directly to patients. \n \nTerm of the Contract\n\nThe contract will be awarded as a firm fixed price contract as a blanket purchase agreement with a 5-year ordering period.\n\nFederal Holidays\n\nThe contractor is not required to provide these laboratory services on federal holidays. The 10 holidays observed by the Federal Government are: \nNew Year s Day (January 1st)\nMartin Luther King s Birthday (3rd Monday in January)\nPresidents Day (3rd Monday in February)\nMemorial Day (last Monday in May)\nIndependence Day (July 4th)\nLabor Day (1st Monday in September)\nColumbus Day (2nd Monday in October)\nVeterans Day (November 11)\nThanksgiving Day (4th Thursday in November)\nChristmas Day (December 25th) \nAny other day specifically declared by the President of the United States to be a national holiday.\n\nWhen one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies.\n\nQualifications/Requirements of Laboratory & Contractor Personnel\n\nLaboratory: \n\nThe contractor to including 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 CLIA of 1988, or must demonstrate accreditation by a regulatory agency(s) with deemed status from the College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The reference laboratory must maintain valid certifications during the entire performance period of this contract.\nCopies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America must be supplied in response to this procurement action. In addition, as these documents are re-issued or re-awarded, the awarded contractor must supply a copy to the POC assigned to the servicing Government facility. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary contractor. \n\nThe contractor must notify immediately the POC in writing, upon its loss of any required certification, accreditation, or licensure.\n\nThe 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.\n\nEnd of Statement of Work\n"} Solicitation Number: 36C25926Q0028 Type: Sources Sought Base Type: Sources Sought NAICS: 621511 Classification Code: Q301 Response Deadline: 2025-11-28T09:00:00-07:00 Office Address: Greenwood Village, CO POC: Devin Reichert, Devin.Reichert@va.gov, 303-712-5709 {"description":"Sources Sought Notice\n\nSources Sought Notice\n\nPage 3 of 4\nSources Sought Notice\n*= Required Field\nSources Sought Notice\n\nPage 1 of 4\nDESCRIPTION\n\nPage 4 of 4\nPage 1 of \nREQUEST FOR INFORMATION / SOURCES SOUGHT INQUIRY\n\nTHIS IS A SOURCES SOUGHT NOTICE ONLY. THIS IS NOT A REQUEST FOR PROPOSAL. The Department of Veterans Affairs Network Contracting Office (NCO) 19, Rocky Mountain Acquisition Center (RMAC) is seeking information and sources that can provide Prostate Testing and Reporting for Salt Lake City Regional VA Medical Center, located at 500 Foothill Blvd, Salt Lake City, UT 84148.\n\nThe NAICS code is 621511 Medical Laboratories and Small Business Size Standard is $41.5 Million. \n\nThe Contractor shall provide Prostate Testing and Reporting. The prostate test and report will be used to determine how likely the patient s cancer is to metastasize within the next five years. The test is performed on tissue samples obtained during biopsy or surgical removal of the prostate.\n\nThis is a request for information and sources only, which may or may not lead to a future solicitation! This is not a request for proposal (RFP). No questions will be answered. The VA will not pay for any information received resulting from this, sources sought notice. Information should be forwarded to the Contracting Officer and Contract Specialist. If your organization can provide these services and is interested in this opportunity, please respond to Devin Reichert, Contract Specialist via e-mail at devin.reichert@va.gov and NCO19LAB@va.gov with the above information requested. The response due date for this information is 9 AM Mountain Time, on Friday, November 28th, 2025.\n\nIn response to this announcement, please provide the information below: \nCompany Name:\nAddress:\nUEI (Unique Entity ID) Number:\nContact Name:\nPhone No.:\nEmail:\nBusiness Size Information - Select all that applies:\nSmall Business\nEmerging Small Business\nSmall Disadvantaged Business\nCertified under Section 8(a) of the Small Business Act\nHUBZone\nWoman Owned\nCertified Service-Disabled Veteran Owned Small\nVeteran Owned Small Business\nLarge Business\nFSS/GSA Contract Holder:\nYes No \nFSS/GSA Contract Number:\n\nEffective Date/ Expiration Date:\n\nProposed solution is listed and available on the above FSS/GSA Contract:\nYes No \nAvailable pricing structure of proposed solution (select all that are applicable below):\nPricing Model\nPlease Indicate Availability Below: (Yes / No / NA)\nAll on FSS\nOpen Market only\nMix of FSS & Open Market\n(CPRR) Cost Per Reportable Result \n\n\n\nCost Per Test(CPT)\n\n\n\nReagent Rental Agreement\n\n\n\nEquipment Rental with Reagent Purchase\n\n\n\nFixed Monthly Charge\n\n\n\nOther: (Please explain)\n\n\n\nFederal Acquisition Regulation (FAR) Market Rearch Questions:\nBuy American Act (FAR 52.225) What percentage of the proposed product (including leases) is a:\nDomestic end product? _____________ (%)\nForeign end product? _______________ (%)\nQuestions for Small Businesses ONLY:\nLimitations 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: __________\nIf subcontracting, what added value do you offer (FAR 52.215-23): _______________________________\n\nDEPARTMENT OF VETERANS AFFAIRS\nVA MEDICAL CENTER, SALT LAKE CITY, UT\nSTATEMENT OF WORK\n PROSTATE TESTING AND REPORTING\nIntroduction\nDepartment of Veterans Affairs, Veterans Health Administration, Salt Lake City VA Medical Center (VAMCSLC), 500 Foothill Drive, Salt Lake City, Utah 84148 has a requirement for reporting from prostate testing. The contract will be awarded as a firm fixed price contract as a blanket purchase agreement with a 5-year ordering period.\nScope of Work\nThe Contractor will provide Prostate Testing and Reporting. The prostate test and report are used to determine how likely the patient s cancer is to metastasize within the next five years. The test is performed on tissue samples obtained during biopsy or surgical removal of the prostate.\nDescription\nThe contractor shall be responsible for performing laboratory testing, analysis, and result interpretation on behalf of the VAMSLC facility in accordance with the terms, conditions, and provisions outlined thereof. The testing report will provide personalized treatment where the tumor analysis will identify patients at high versus low risk of progression of cancer.\nThe services performance shall include genomic testing with varying levels of support services depending on the unique characteristics presented by each individual ordering activity.\nThe contractor shall perform testing entirely upon their premises.\nTests will be performed and reported within established vendor turnaround times.\nThe contractor shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations as they pertain to a licensed clinical laboratory.\nThe contractor shall provide individual patient-chartable test result reports meeting Clinical Laboratory Improvement Amendments (CLIA) requirements.\nThe contractor shall provide all appropriate requisition forms and unique supplies needed for specialized collection of samples, at no additional charge.\nNotwithstanding, anything to the contrary in this Agreement or otherwise,The contractor shall not release patient records that include test results, without the specific written consent to release such information as provided by the patient, to any person other than the ordering healthcare provider or designee. All patient records shall be treated as confidential so as to comply with all state and federal laws regarding the confidentiality of patient's records. This provision shall survive termination of this Agreement.\nThe required highly specific molecular testing reference laboratory services include but are not limited to the identified required test menu testing, specimen preparation and storage of clinical laboratory specimens, performance of analytical testing; reporting of analytical test results; and consultative services. \nSALIENT CHARACTERISTICS (TECHNICAL SPECIFICATIONS)\nDynamic Report\nA report must be generated with the Patient Information, Specimen Information, Ordering Physician, Clinical and Pathology Details, Genomic Score, Genomic Score Interpretation, Risk Graph, Risk Estimates, Risk Graph Interpretation, Clinical Findings, Test Description, Intended Use, Confidence Interval, and References. \nGenomic Score\nA Genomic Score must be generated based off of the genomic risk of metastasis, tumor biology alone, independent of clinical & pathological factors (e.g., Gleason, PSA), the 22 genes, 7 biological pathways, and continuous genomic risk score classified as low, intermediate or high. \nGenomic Score Interpretation\n Provide a summary based on this patient s genomic risk & relevant clinical findings.\nRisk Estimates\n Provide the risk estimates of the patient with standard therapy. \nRisk Graph\n Provide a Graph to show the patient their risk compared to patients with similar clinical and pathological features. \nRisk Comparison \nProvide a comparison of the patient and their risk compared to patients with similar clinical and pathological features. \nRisk Graph Interpretation \nExplains risk comparison graphic.\nProvides this patient s percentile rank in the tested population.\nClinical Findings\nProvide clinical study results relevant to this patient.\nTest Description\nProvide a summary of testing platform technology.\nRisk estimates. \nProvide cut points separating low, intermediate & high risk.\nIntended Use\nProvide a summary of the intended use in biopsy specimens from patients.\nConfidence Interval Confidence Intervals\nProvide a confidence interval for each risk estimate.\nReferences\n Provide references for each of the clinical studies cited in the report.\nThese tests will need to be provided to ensure efficient evaluation and management of prostate cancer. \n- Prolaris (Myriad Genetics) \nPurpose: Predicts cancer aggression and ideal treatment path. \n- Promark (Metamark Genetics) \n Purpose: Predicts cancer aggression and recurrence. \n- Benign Prostate Tissue Evaluation:\n Purpose: Evaluates tissue deemed benign (no malignancy found) to assess the risk of future malignancy. \n- Oncotype DX (Genomic Health) \n Purpose: Utilized for breast or colon cancer assessment. \nSchedule of Services\nEvery test must include \nPatient Information\nSpecimen Information\nOrdering Physician, \nClinical and Pathology Details\nGenomic Score\nGenomic Score Interpretation\nRisk Graph, Risk Estimates\nRisk Graph Interpretation\nClinical Findings\nTest Description\nIntended Use\nConfidence Interval\n References. \nGeneral Requirements\nThe contractor s standard price list of all testing services available along with the price to be billed to the VHA for each testing service shall reflect that which is listed in their GSA price list. \nThe price list, at a minimum, shall include the following data elements:\nCPT code\nProduct Name/Description \nPrice\nTest description, including reference ranges and units of measurement\nMaximum turn-around-time (TAT) shall not exceed three weeks from specimen submission.  \n\nTest Result Reporting\n\nThe Contractor shall provide encrypted and/or secured electronic transmission (i.e., fax and/or on-line web access) of all completed and/or partial test results to the ordering activity within published turnaround time of fifteen days. \n \nAll payments shall be made in arrears (30 days) upon receipt of a proper invoice. Invoices must contain at a minimum the following information. The contractor shall provide this information on one original invoice:\n\ni. Invoice Number\nii. Date of Service\niii. Test Description and CPT Code\niv. Unit cost\nv. Total cost\n\nMandatory Requirements\nLicensing and Accreditation: Only fully licensed and accredited laboratories actively engaged in providing the specific services and laboratory testing outlined. The contractor shall have all the licenses, permits, accreditation and certificates required by law. The reference laboratory must be licensed and accredited by the College of American Pathologists (CAP) and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Amendments of 1988.\nThe contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America prior to contract award. In addition, the contractor shall be responsible for providing a 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. Any proposed subcontractor changes during the contract performance period must have prior approval by the Local VA Point of Contact (POC). \nThe Contractor policies and procedures shall comply with the Health Insurance Portability and Accountability Act (HIPAA).\nThe contractor will provide and maintain quality assurance programs which meet federal regulations for laboratory operations. The contractor will be certified by the College of American Pathologist under the CLIA.\nThe contractor shall notify the POC in writing of any malpractice investigation or licensure or certification suspension which concerns the contractor or any employees, within 24 hours of notification of an investigation or suspension.\nContractor Personnel: The contractor shall maintain current accreditation and notify the POC of any lapse in state license, CLIA certification, or clinical pathology certification. The contractor shall provide a copy of renewed licenses/certificates to the POC before expiration.\n\nContractors Responsibilities\nProcedure Guidance:\nThe testing methodology and reference ranges for a test must be defined and available electronically. The contractor shall provide change notice prior to implementation of any new medical procedures and services.\nThe contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy. Upon request by the Laboratory Point of Contact (POC), the contractor will make available quality assurance information on specific testing procedures for review.\nIn the event of tests being referred to another laboratory, there shall be no additional transfer charge or confirmation charge to the government.\n Reporting of Results:\nA testing report is defined as a printed final copy of laboratory testing results. The report(s) shall be available on an encrypted and/or secured electronically with on-line web access and /or secured facsimile (Fax). \n\nEach test report shall at minimum indicate the following information:\ni. Patients name and/or identification code (social security number) PII Safety Protocols must be Enacted.\nii. Physician s name (if supplied)\niii. Date/time specimen received in reference lab\niv. Test ordered\nv. Date/time of specimen collection (when available)\nvi. Date test completed\nvii. Test result\nviii. Flag abnormal\nix. Reference range\nx. Toxic and/or therapeutic range where applicable\nxi. Testing laboratory specimen number\nxii. Name of testing laboratory and address (contractor and/or subcontractor)\nxiii. Type of specimen\nxiv. Unsatisfactory specimen shall be reported with regard to its unsuitability for testing\n\nRetention of Specimens:\n\nUpon completion of the testing procedures, the contractor shall retain all specimens as required by regulatory agencies. Upon request by the ordering activity POC or designee, the contractor shall provide a copy of the regulatory requirements for each participating regulatory agency. In the absence of regulatory agency requirements, the contractor shall retain specimens, after all testing has been completed for clinical specimens (7) days.\n\nSpecial Contract Requirements\n\nServices:\n\nThe services specified herein may be changed by written modification to the BPA. The VA POC will prepare the modification and, prior to becoming effective, must be signed by both parties. \n\nOnly the POC is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this agreement. In the event the contractor affects any such change at the direction of any person other than the POC, the change shall be considered unauthorized, and no adjustment will be made to the contract price to cover any increase in costs incurred as a result thereof.\n\nThis is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the contractor or the contractor s employee(s). Contractor personnel are not subject to the supervision and control of a government officer or employee. Rather, contractor personnel perform their duties in accordance with the Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. The healthcare provider who furnishes services under this contract is subject to Government technical oversight of the services. The Government retains the right to reject services for contractual non-performance. \n\nThe Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered. \n\nContractor is required to maintain medical liability insurance for the duration of this contract. Medical Liability insurance must cover the provider(s) for services in all states where services are rendered by the provider. Contractor must indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance. \n\nContractor shall, in writing, keep the POC informed of any unusual circumstances in conjunction with the contract. \n\nContractor shall not, under any circumstances, furnish reports directly to patients. \n \nTerm of the Contract\n\nThe contract will be awarded as a firm fixed price contract as a blanket purchase agreement with a 5-year ordering period.\n\nFederal Holidays\n\nThe contractor is not required to provide these laboratory services on federal holidays. The 10 holidays observed by the Federal Government are: \nNew Year s Day (January 1st)\nMartin Luther King s Birthday (3rd Monday in January)\nPresidents Day (3rd Monday in February)\nMemorial Day (last Monday in May)\nIndependence Day (July 4th)\nLabor Day (1st Monday in September)\nColumbus Day (2nd Monday in October)\nVeterans Day (November 11)\nThanksgiving Day (4th Thursday in November)\nChristmas Day (December 25th) \nAny other day specifically declared by the President of the United States to be a national holiday.\n\nWhen one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies.\n\nQualifications/Requirements of Laboratory & Contractor Personnel\n\nLaboratory: \n\nThe contractor to including 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 CLIA of 1988, or must demonstrate accreditation by a regulatory agency(s) with deemed status from the College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The reference laboratory must maintain valid certifications during the entire performance period of this contract.\nCopies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America must be supplied in response to this procurement action. In addition, as these documents are re-issued or re-awarded, the awarded contractor must supply a copy to the POC assigned to the servicing Government facility. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary contractor. \n\nThe contractor must notify immediately the POC in writing, upon its loss of any required certification, accreditation, or licensure.\n\nThe 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.\n\nEnd of Statement of Work\n"}