BIDD SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C26318Q0590 Posted Date: 05/25/2018 Original Response Date: 06/27/2018 Current Response Date: 06/27/2018 Product or Service Code: Q301 Medical Laboratory Testing Set Aside (SDVOSB/VOSB): VOSB NAICS Code: 621511 Medical Laboratories Contracting Office Address
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BIDD SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C26318Q0590 Posted Date: 05/25/2018 Original Response Date: 06/27/2018 Current Response Date: 06/27/2018 Product or Service Code: Q301 Medical Laboratory Testing Set Aside (SDVOSB/VOSB): VOSB NAICS Code: 621511 Medical Laboratories Contracting Office Address Department of Veterans Affairs Network Contracting Office 23 Warren E. Burger Federal Building and U.S. Courthouse 316 Robert Street N.; Suite 506 St. Paul, MN 5101 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document is also attached. This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005-97 effective 01/24/2018. The associated North American Industrial Classification System (NAICS) code for this procurement is 621511, with a small business size standard of $32.5 Million. The Network Contracting Office 23, Warren E. Burger Federal Building and U.S. Courthouse 316 Robert Street N.; Suite 506; St. Paul, MN 5101 is seeking to purchase Anatomic Pathology Testing Services for the Fargo VA Health Care System (FVAHCS). All interested companies shall provide quotations for the following: SCOPE Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide Reference Laboratory Services to the Fargo VA Health Care System. 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; and consultative services. Specimen Preparation and Storage for Reference Testing Specimens Contractor shall supply each Government facility with its commercial laboratory reference test manual to insure that the collection and storage of specimens are in accordance with Contractor s requirements. Contractor shall be responsible for storing specimens in such a manner to insure the integrity of the specimen. Transportation Services for Reference Testing Specimens Contractor shall provide transportation of primarily biomedical materials that include patient specimens and microbiology cultures and stocks, originating from Government facilities and destined to the contracted commercial reference laboratory. 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. Routine transportation services shall occur at a minimum of once per day excluding weekends and Government Holidays from the Fargo VA Health Care System. Specimen pick-up times will be negotiated after contract award. 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: Test request forms Test request forms for specialized testing (i.e. cytogenetics, tissue, etc.). Transportation beyond routine pick-up: services shall be available 24 hours per day, seven days per week including Government holidays. Response time for emergency transportation services shall be within 1 hour. This response time refers only to the transportation of the specimen(s) and does not include the time for test performance. Specimen Testing The Contractor and/or subcontractor shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to execute all required tests as annotated in Attachment 1 CPT Code Listing Local Reference Lab. Contractor shall make available the following test information: Requisition form requirements Alphabetized test name list Test order code Specimen collection and preservation requirements Test method employed (indicate if testing performed in duplicate) and interpretations Test reference intervals adjusted for age, sex or race, when required Test specific sensitivity, specificity and interferences, when required Test critical values, if any CPT coding Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between pick-up of specimen by the Contractor 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) Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change. Any new test(s) not listed in Attachment 1 CPT Code Listing Local Reference Lab must be added to the contract through modification by the Contracting Officer (CORs and Government facility representatives do not have this authority) prior to specimen being tested. 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 (defined in Section 5.1.10) of laboratory testing services on the biomedical materials. Specimen Retention A medico legal specimen shall be retained indefinitely. This type of specimen will be identified by the Government in writing or through telephone communication. All anatomic pathology materials (e.g., histology blocks, slides or other diagnostic material) generated by the VA shall be returned within 7 days after final diagnosis is reported. Reporting of Results The results of testing shall be reported within the prescribed turnaround times provided by the Contractor as part of the test information (defined in Section 5.1.10). A report of laboratory testing results must be issued either as a printed final copy or through the host to host electronic transmission of the test results. The results can be faxed to the Fargo VA secure fax phone number 701-237-2646. 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) Submitting facility name Test(s) ordered Date/time of specimen collection (when available) 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 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 an electronic transmission. Customer Service Contractor shall provide customer service that is accessible by toll-free telephone service 24 hours per day, 7 days per week 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. Testing Inquiries regarding the status of pending orders shall be addressed at the time of the initial call. Technical Expertise Result interpretation inquiries shall be addressed within four business hours of 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. A copy of the report shall be delivered electronically to the Contracting Officer, Lead COR, and each Government facility COR by the 10th of the month following the close of the reporting month. SPECIAL CONTRACT REQUIREMENTS Services The services specified herein may be changed by written modification to this contract. The VA Contracting Officer will prepare the modification (reference FAR clause 52.212-4(c), Changes) and, prior to becoming effective, shall be signed by both parties. Only the Contracting Officer is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. This 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. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered. Contractor 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. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract. Contractor shall not, under any circumstances, furnish reports directly to patients. Federal Holidays Contractor is not required to provide routine daily transportation of specimens on federal holidays. The 10 holidays observed by the Federal Government are: New Year s Day (January 1st), Martin Luther King s Birthday (3rd Monday in January), Presidents Day (3rd Monday in February), Memorial Day (last Monday in May), Independence Day (July 4th), Labor Day (1st Monday in September), Columbus Day (2nd Monday in October), Veterans Day (November 11), Thanksgiving Day (4th Thursday in November), Christmas Day (December 25th) and any other day specifically declared by the President of the United States to be a national holiday. When 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. Qualifications/Requirements of Laboratory & Contractor Personnel Laboratory Offeror must have at least three years of experience in providing laboratory testing services and must have at least one year experience in transporting biomedical materials. Offerors, 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 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. Copies 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 solicitation. In addition, as these documents are reissued or re-awarded, the awarded Contractor must supply a copy to the Contracting Officer s Representative assigned to each Government facility. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary Contractor. Contractor must notify immediately the Contracting Officer s Representative (COR) at each of the Government facilities in writing, upon its 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). Contractor couriers entering any Government facility must be attired in a contractor-issued uniform that bears the name of the Contractor s company. In addition, the Contractor representative shall prominently display a contractor-issued identification badge. Record Keeping Contractor Contractor must establish a record keeping system of all tests performed. Medical Records Clinical or other medical records (ie. test results) of VA veteran patients treated by Contractor under this contract are owned by the VA. If requested, test results will be mailed to the VA at no additional cost. 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 Contracting Officer that a subpoena or court order was received. Confidentiality of Patient Records The Contractor is a VA contractor and will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. Contractor is considered to be a VA contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7332. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the sharing agreement, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA s records, at VA s place of business on request during normal business hours, to inspect and review and make copies of such records. 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 Reference Laboratory Services. Designation of Contract Representatives The Laboratory Manager VISN 23 Pathology & Laboratory Medicine Services (P&LMS), Fargo, ND, will be designated as the Contracting Officer Representative (COR) to represent the Contracting Officer in furnishing guidance and advice regarding the work being performed under this contract. 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 Contracting Officer. The extent and limitations of the COR designation will be provided in the COR Delegation Memo. Contract Performance Monitoring Contractor's employee(s) shall report to the front desk, upon arrival at the VA for specimen pickup. Monitoring of contractor s performance shall be demonstrated through clinical and administrative record reviews. COR will be responsible for verifying contract compliance. Contracting Officer's Representative(s) (COR) will designate appropriate VA personnel to monitor services through one or a combination of the following mechanisms: 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 Contracting Officer. 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 Schedule of Services / Attachment 1 CPT Code Listing Local Reference Lab. 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(s), 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 Assurance Monitoring Contractor shall maintain a Quality Assurance Program related to Reference Laboratory services covered under this contract. Contractor shall also participate in a joint quality assurance surveillance program (QASP) with the Government facilities. 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/VISN 23 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: security/privacy, adverse event reporting, turn-around times, timeliness to customer service requests, missed/delayed routes, etc. and can be found in Attachment 2 QASP Local Reference lab. CONTRACT SECURITY REQUIREMENTS General Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. Contractor Personnel Security Requirements Failure to comply with the contractor personnel security requirements may result in termination of the contract for default. Contractor shall certify that all its employees and subcontractor employees having access to VA sensitive information (ie. laboratory technicians, administrative personnel) during the performance of this contract have successfully passed a contractor employee background check. Position Sensitivity - The position sensitivity has been designated as Low Risk. Background Investigation - The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries. Contractor Responsibilities The contractor shall bear the expense of obtaining background investigations. If the Office of Personnel Management (OPM) conducts the investigation, the contractor shall reimburse VA within 30 days. If timely payment is not made within 30 days from date of bill for collection, then VA shall deduct the cost incurred from the contractors 1st month s invoice(s) for services rendered. The anticipated period of performance is October 1, 2018 through September 30, 2019 with four 12-month option periods (See Schedule of Services). Base Period 10/01/2018 09/30/2019 CLIN No. SUB-CLIN Description Estimated Qty. Unit Unit Cost Total Estimated Cost 0001 None CPT Code rates (all inclusive) and quantities as described in Attachment 1 CPT Code Listing Local Reference Lab. 1 Lot DO NOT PRICE $_______________ Place of Performance: Contractor s Facility Award shall be made to the offeror whose proposal offers the best value to the government, considering Technical Capability, Past Performance, and Price. The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Items JAN 2017 VAAR 852.252-70 Solicitation Provisions or Clauses Incorporated by Reference JAN 2008 FAR 52.204-16 Commercial and Government Entity Code Reporting JUL 2016 VAAR 852.270-1 Representatives of Contracting Officers JAN 2008 VAAR 852.271-70 Nondiscrimination in Services Provided to Beneficiaries JAN 2008 FAR 52.212-2 Evaluation Commercial Items FAR 52.212-3, Offerors Representations and Certifications Commercial Items NOV 2017 Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Items JAN 2017 To include the following Addenda: 52.216-18 Ordering OCT 1995 52.216-19 Ordering Limitations OCT 1995 52.216-22 Indefinite Quantity OCT 1995 52.217-8 Option to Extend Services NOV 1999 52.217-9 Option to Extend the Term of the Contract MAR 2000 52.232-19 Availability of Funds for the next Fiscal Year APR 1984 852.203-70 Commercial Advertising JAN 2008 852.19-11 VA Notice of Total Veteran-Owned Small Business Set-Aside JUL 2016 852.232-72 Electronic Submission of Payment Requests NOV 2012 852.237-70 Contractor Responsibilities APR 1984 52.204-18 Commercial and Government Entity Code Maintenance JUL 2016 52.224-1 Privacy Act Notification APR 1984 52.224-2 Privacy Act APR 1984 52.227-14 Rights in Data General MAY 2014 52.232-40 Providing Accelerated Payments to Small Business Sub-Contractors DEC 2013 FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders JAN 2018 The following subparagraphs of FAR 52.212-5 are applicable: Subsection (a) in its entirety Subsection (b): (4) 52.204 10, Reporting Executive Compensation and First-Tier Subcontract Awards (OCT 2016) (Pub. L. 109 282) (31 U.S.C. 6101 note). (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (OCT 2015) (31 U.S.C. 6101 note). (22) 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C 632(a)(2)). (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755). (27) 52.222-21, Prohibition of Segregated Facilities (APR 2015). (28) 52.222 26, Equal Opportunity (SEP 2016) (E.O. 11246). (30) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793). (33)(i) 52.222-50, Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627). (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (45) (i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a). (49) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). (55) 52.232-33, Payment by Electronic Funds Transfer System for Award Management (Jul 2013) (31 U.S.C. 3332). Subsection (c): (2) 52.222-41, Service Contract Labor Standards (MAY 2014) (41 U.S.C. chapter 67). (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards Price Adjustment (Multiple Year and Option Contracts) (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). (8) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015). (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706). Subsection (d) in its entirety Subsection (e) in its entirety All Vendors shall submit the following: See Proposal Submittal Instructions within the attached Solicitation. All quotations shall be sent to: See Proposal Submittal Instructions within the attached Solicitation. This is an open-market combined synopsis/solicitation for Anatomic Pathology Testing services as defined herein. The government intends to award a contract as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoter shall list exception(s) and rationale for the exception(s). Submission shall be received not later than 1:00pm CST on 06/27/2018 via email to email@example.com. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Contracting Officer at firstname.lastname@example.org. Point of Contact Scott Hendrix at email@example.com.