Q301--Intent to Sole Source CBOC CAP Laboratory Accreditation for the Louisville VAMC.

36C249-19-AP-2625 The Department of Veterans Affairs, Network Contracting Office 9, intends to award a sole-source, contract to The College of American Pathologists (CAP), 325 Waukegan Rd, Winnetka, IL, 60093 for the Louisville VA Health Care System, Robley Rex VAMC 800 Zorn Ave, Louisville KY 40206. This contract will be awarded as 36C24920Q0079, CBOC CAP Accreditation FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, applies to this procurement." The contract is expected to be awarded under FAR 13.106-1 (b). Period of Performance: 05-01-2020-04-30-2025 NACIS: 541380 PSC: Q301 Size Standard: 16.5 M $22 M Statement of Work Pathology and Laboratory Accreditation Section 1. SCOPE OF WORK: This is a requirement for non-personal service to provide Accreditation of Laboratory Services for all CLIA (Clinical Laboratories Improvement Amendment) certified, and FDA defined complexity levels (high, moderate, waived) testing sites identified for Louisville VAMC. All testing sites that perform laboratory tests for patient care within the VHA must be in compliance with CFR Part 493 and must maintain accreditation by a nationally recognized, a VA designated laboratory accrediting agency/program with deemed status from the Center for Medicare and Medicaid Services (CMS). Description of Services/Introduction: The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, and other items and non-personal necessary to perform Accreditation of Laboratory Services as defined in this Work Statement. The Contractor shall be identified by Centers for Medicare and Medicaid Services (CMS) as an accrediting agency under the Clinical Laboratories Improvement Amendment (CLIA) and identified by The Joint Commission (TJC) as having a comparative agreement pursuant to the Cooperative Accreditation Initiative. The laboratory accreditation process is a complex system of related and dependent activities. It includes pre-inspection/review activities (e.g., on-site inspection/reviews, inspection/review notification to Laboratory Director/Chief and VA National Enforcement Office (NEO) Representative, inspection/review validation/notification process); post-inspection/review report(s) in an exportable format (access compatible); data measurement, complaint management program and reporting requirements and data submissions. Maintaining laboratory accreditation is directed by: Veterans Health Administration (VHA) Handbook 1100.16 which establishes policy and responsibilities in obtaining and retaining The Join Commission (TJC) accreditation VHA Handbook 1106.01 which establishes policy and responsibilities for Pathology and Laboratory Medicine Service (P&LMS) 1.2 Objectives: The objective of this requirement is to supply accreditation services for specified Louisville VA clinical laboratories and community-based outpatient centers (CBOCs). Maintaining laboratory accreditation is consistent with one of Pathology and Laboratory Medicine Services (P&LMS) strategies under quality improvement. Laboratory accreditation confers recognition that a laboratory meets firm standards of quality and safety and confers deemed compliance with healthcare quality standards of payors, both public (e.g., Medicare) and commercial. Annual Lab Accreditation 1.3 Scope: This requirement includes inspection, quality assessment and laboratory accreditation services for all FDA defined complexity levels (high, moderate, waived), at specified Louisville VHA laboratories and CBOCs, where patient testing is performed. Specialties/subspecialties (in language/terms reference on CMS, Clinical and Laboratory Standards Institute (CLSI), and Good Laboratory Practices (GLP) public websites) that fall under this requirement include: Specialties Chemistry, Hematology, Immunohematology (Blood Bank), Microbiology, Anatomic Pathology, Point-of-Care Testing, Subspecialties Transfusion Medicine, Toxicology, Coagulation, Immunology, Urinalysis, Histology, Cytopathology, Molecular Pathology, Bacteriology, Blood Gas, Cytology, Histopathology, General Immunology, Immunochemistry, Molecular Microbiology, Mycobacteriology, Mycology, Point-of-Care Testing, Routine Chemistry, Syphilis Serology Quality Oversight Lab General, Team Leader Assessment of Director & Quality, All Common, Safety, Specimen Collection, Laboratory Computer Services, Environment, Communications, Laboratory Director Responsibilities; Quality Improvement, Complaint Review, and Autopsy 1.4 Period of Performance: The period of performance shall be for one (1) base period with four (4) Option Years. The Period of Performance reads as follows: Base Year: 1 May 2020 through 30 April 2021 Option Year 1 1 May 2021 through 30 April 2022 Option Year 2 1 May 2022 through 30 April 2023 Option Year 1 1 May 2023 through 30 April 2024 Option Year 1 1 May 2024 through 30 April 2025 1.5 Recognized Holidays: The contractor is not required to perform services on the following Federal Holidays: New Year s Day Labor Day Martin Luther King Jr. s Birthday Columbus Day President s Day Veteran s Day Memorial Day Thanksgiving Day Independence Day Christmas Day 1.6 Hours of Operation: The Contractor is responsible for conducting business between the hours of 07:30 4:00 (ET - standard local time for the facility being accredited), Monday thru Friday, except Federal Holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. 1.7 Place of Performance: The work to be performed under the resulting contract will be performed at VHA facilities requiring accreditation as set forth on Technical Exhibit A and at the contractor facilities. Currently, there are eight Louisville VA patient testing sites (One major hospital clinical laboratory, and seven CBOCs) that utilize inspection, quality assessment, and laboratory accreditation services under this requirement. One is highly complexity, and seven are waived as categorized by the FDA. Complexity testing is determined by the needs of each site and can change. During this contract s period of performance, the total number of inspections, quality assessments, and laboratory accreditation sites is not expected to change more than 10%, as long as the facilities needs comply with the testing complexity defined by the FDA. In the performance of the tasks associated with this Performance Work Statement, the Contractor shall comply with the following: Main Facility Robley Rex VAMC Path & Lab Med 113 800 Zorn Ave Louisville, KY 40206 7 CBOC Clinics VA Healthcare Center Carroll Path & Lab Med 113 1911 US Highway 227 Carrollton, KY 41008-8037 VA Healthcare Center Grayson Path & Lab Med 113 619 W Main Street Clarkson, KY 42726-7044 VA Healthcare Center New Albany Path & Lab Med 113 4347 Security Parkway New Albany, IN 47150-6419 VA Healthcare Center Newburg Path & Lab Med 113 3430 Newburg Road, Suite 200 Louisville, KY 40218-3483 VA Healthcare Center Scott Path & Lab Med 113 1467 N. Scott Valley Drive Scottsburg, IN 47170-7795 VA Healthcare Center Shively Path & Lab Med 113 3934 Dixie Hwy Suite 210 Louisville, KY 40216-4176 VA Healthcare Center Stonybrook Path & Lab Med 113 9208 Taylorsville Road Louisville, KY 40299 Section 2 Description of Duties. The Contractor shall when needed: 2.1 Provide Laboratory Accreditation Program Services. The program shall include supporting services and a contractor developed quality oversight program or contractor CAP Annual Lab Accreditation. Supporting Services shall include: i. A contact for contractor who shall have ability to act for the contractor (i.e., resolve disputes, sign documents, etc.) on all matters relating to this contract which includes overseeing the performance of the contract. The name and contact information shall be designated in writing to the Contracting Officer and COR. Contact shall be available during normal business hours. ii. Providing a method for VHA general laboratory staff to receive live (not automated) technical support and/or customer service from the contractor, during normal business hours. iii. Providing a method for VHA general laboratory staff to access/obtain contractor-published laboratory accreditation material, documents, forms, educational opportunities during and outside of normal business hours. iv. Providing a method for the contractor to notify the laboratory director/manager, regional medical technologists in writing (mailed or electronic) if any new standards, revised, or updated accreditation information become available. v. Providing an electronic method (i.e., secure website, fax, email) for receipt of VA furnished correspondence. Quality Oversight/Quality Standards shall include: i. Processes equivalent to those submitted to and approved by CMS for which contractor obtained laboratory accreditation "granting" authority. ii. Hard (non-electronic) master copies of laboratory accreditation material provided by the contractor and electronic master copies in Microsoft Word compatible format. iii. Standardized written document identifying any deficient finding for any (identified) standard or requirement for all on-site inspections. iv. Standardized documents serving as written notification of contractor's decision to accredit (a laboratory). The document must identify, at minimum, the laboratory's name and address, the contractor's assigned laboratory identifier, and the laboratory's accreditation expiration date. v. Standardized written formats (for VHA specialties/subspecialties) for laboratory accreditation materials provided by the contractor. This includes language used and general/common laboratory requirements (i.e., safety, laboratory automation and informatics, quality management, method evaluation, personnel, equipment). vi. Method to obtain and resolve concerns initiated by Louisville VHA general laboratory staff regarding quality of services performed by the contractor and/or quality of services/testing performed in any specialty/subspecialty of the laboratory where patient testing is performed during the period of performance. vii. Method for providing electronic deliverables. viii. Process to maintain, query, analyze, and/or generate reports for any work performed or any (facility) information/data furnished by the government under this requirement. 2.2. Perform ON CYCLE INSPECTION, QUALITY ASSESSMENT, AND LABORATORY ACCREDITATION SERVICES, prior to the accreditation expiration date provided by the Government (current listing provided in Technical Exhibit B) utilizing INSPECTION TEAM assembled in accordance with established criteria. 2.3. Provide a transition plan sufficient to provide continuous accreditation and service and to ensure all laboratories are inspected for accreditation prior to their current accreditation expiration date. The plan must include a transition process for immediate remediation in the even a laboratory may have been identified as an at-risk laboratory during the transition. 2.4. Deliverables A. One Time i. Provide contact information contractor account manager (and alternate) within 30 days of contract award. ii. Provide master copies of laboratory accreditation material to each VHA laboratory or CBOC within 60 days of contract award or make available electronically. B. Recurrent i. Provide written notification (contractor letterhead document or certificate, etc.) of contractor decision to (re)accredit, revoke, or deny accreditation to the inspected laboratory no more than 90 calendar days from date of onsite inspection. ii. Provide information regarding new standards, revised, or updated accreditation information within 30 days of contractor's publication. iii. Provide written document identifying any deficient finding for any (identified) standard or requirement to the inspected laboratory within 30 days of on-site inspections. Section 3: OPERATING CONSTRAINTS. 3.1. The contractor shall have a Business Associate Agreement (BAA) with VHA. 3.2. The Contractor shall allow each VA facility to select 10 avoid dates in addition to those mandated by federal law such as holidays. 3.3. Scheduling of an inspections/reviews shall avoid all Federal holidays, including Veterans Day. 3.4. The Contractor shall have no access to the VA computer network. 3.5 The Contractor shall be identified by Centers for Medicare and Medicaid Services (CMS) as an accrediting agency under the Clinical Laboratories Improvement Amendment (CLIA) and identified by The Joint Commission (TJC) as having a comparative agreement pursuant to the Section 4: Cooperative Accreditation Initiative. The Contractor shall have the capability of providing inspection, quality assessment and laboratory accreditation services for all laboratory complexity levels (defined by FDA) in the following: Specialties Chemistry, Hematology, Immunohematology (Blood Bank), Microbiology, Anatomic Pathology, Point-of-Care Testing, Subspecialties Transfusion Medicine, Toxicology, Coagulation, Immunology, Urinalysis, Histology, Cytopathology, Molecular Pathology, Bacteriology, Blood Gas, Cytology, Histopathology, General Immunology, Immunochemistry, Molecular Microbiology, Mycobacteriology, Mycology, Point-of-Care Testing, Routine Chemistry, Syphilis Serology Quality Oversight Lab General, Team Leader Assessment of Director & Quality, All Common, Safety, Specimen Collection, Laboratory Computer Services, Environment, Communications, Laboratory Director Responsibilities; Quality Improvement, Complaint Review, and Autopsy THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTES. However, all responsible sources may submit a capability statement or quotation, which shall be considered by the agency on or before February 11, 2020, 10:30am Central Time to [email protected]. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. The Department of Veterans Affairs will NOT be responsible for any costs incurred by interested parties in responding to this notice of intent. Only written responses will be considered. All responses from responsible sources will be fully considered. As a result of analyzing responses to this notice of intent, the Government shall determine if a solicitation will be issued. Any prospective contractor must be registered in the System for Award Management (SAM) in order to be eligible for award. Interested parties are encouraged to furnish information by email only with RESPONSE TO INTENT TO SOLE SOURCE CBOC CAP Accreditation in the subject line. All documents submitted will not be returned. All interested parties shall submit clear and convincing documentation demonstrating their capabilities including documented proof the quoter is authorized by the OEM to accomplish software programming changes to satisfy the requirements listed above to the Contracting Specialist, Michael Brown by email at [email protected]. The capability documentation should include general information and technical background describing in detail the prospective contractor's capabilities and experience that will demonstrate the ability to support these requirements, including proof of training and certification for performing maintenance and service on the listed equipment and systems. Point of Contact: Michael Brown, [email protected].