MEDICAL LABORATORY TESTING SERVICES
SOURCES SOUGHT NOTICE DESCRIPTION: This is a source sought to determine the availability of potential sources having the skills and capabilities necessary to provide the SPECIFIED REQUIREMENT. All interested vendors are invited to provide information to contribute to this market survey/sources sought including commercial market information. THIS IS NOT A SOLICITATION ANNOUNCEMENT. This is a Sources Sought Synopsis only. Questions should be submitted by email to Janica.Francis@va.gov. Provide only the requested information below. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classifications (Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), Hub zone, 8(a), small, small disadvantaged, woman owned small business, FSS/GSA contract schedule holders or large business) relative to NAICS 622110, General Medical and Surgical Hospitals (size standard $38.5 million). Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this source sought synopsis, a solicitation announcement may be published on the FBO website. Responses to this source sought synopsis are not considered adequate responses to the solicitation announcement. All interested offerors must respond to the solicitation announcement in addition to responding to this source sought announcement. SPECIFIED REQUIREMENT: Network Contracting Office 7, Charleston, SC is seeking sources for a potential contractor to perform the following type of service: This block will not print. Cleaned up by Gayle 3/7/96. MEDICAL UNIVERSITY HOSPITAL AUTHORITY (MUHA) REFERENCE LABORATORY TESTING PERFORMANCE BASED WORK STATEMENT DESCRIPTION OF WORK: The contractor shall provide laboratory testing service for patient specimens that are urgent/emergent, and/or have limited viability, and not performed at the Ralph H. Johnson VA Medical, Charleston, SC. Testing includes, but is not limited to, Mycobacteria Stains, Immunoperoxidase Stains, Therapeutic Drugs, and Clotting Factor assays. Turnaround time for STAT/emergent testing is 24 hours, or less, as indicated for patient care. PERFORMANCE MEASURES: Performance measures, indicated in the Quality Assurance Surveillance Plan(QASP), are based on acceptable turnaround times, test completion, and error rates (Corrected Reports). QUALIFICATIONS Current/Valid CMS CLIA Certificate for High Complexity Testing and Current/Valid Laboratory Accrediting Agency Certificate, i.e., College of American Pathologists(CAP), or The Joint Commission(TJC) HOURS OF PERFORMANCE: The contracting laboratory must be available to accept specimens seven (7) days a week, and must have testing services available 24 hours a day, for those tests that can be ordered with STAT urgency. CONTRACTOR FURNISHED PROPERTY AND PERSONNEL SERVICES. Specimen Courier Special Collection Kits/Containers/Media/Biohazard Bags for tests performed by the contractor. SPECIFIC TASKS. The contractor will perform accurate laboratory testing. The contractor will provide test results within acceptable time frames for the testing specified. Finalized laboratory results/reports are faxed to the P & LMS administrative office; hard copies of reports are also delivered to the P & LMS administrative office. The contractor s specimen courier will pick up laboratory specimens Monday Friday, twice a day, at approximately 09:00a.m. and again at approximately 16:00p.m. The contractor s specimen courier will pick up laboratory specimen s, upon request, for nights and weekends. MONITORING: The Contracting Officer s Representative (COR), and the VAMC Laboratory Manager will monitor contractor performance as indicated in the Quality Assurance Surveillance Plan(QASP). PAYMENT: Payment will be made monthly in arrears for services rendered after receipt of a proper invoice. The VA Medical Center will establish and maintain a contract file. The Contractor must actually perform the required services in accordance with contract specifications in order to receive compensation. Invoices must contain the following information: (a) Contract Number (b) Dates of Services (c) Patient Name and Medical Record Number (d) LaboratoryTest Name (e) Test Charge/Price/CPT code DATA SECURITY: Information, including, but not limited to, veteran individually-identifiable information (iii) and personal healthcare information (PHI), gathered or created by the Contractor in the performance of this contract is the exclusive property of VA and must be received, gathered, stored, backed up, maintained, used, disclosed and disposed of in accordance with the terms of this contract and applicable federal and VA information confidentiality and security laws, regulations and policies, including VA Directive and Handbook number 6500. The Contractor shall provide access to VA information to employees, subcontractors, and affiliates only: (1) to the extent necessary to perform the services specified in this contract, (2) to perform necessary maintenance functions for electronic storage or transmission media necessary for performance of this contract, and (3) only to individuals who first satisfy the same conditions, requirements and restrictions that comparable VA employees must meet in order to have access to the same VA information. These restrictions include the same level of background investigations, where applicable. The Contractor shall immediately (on the date of discovery of the incident) report any incident of theft, loss or comprise of VA sensitive information to the Contracting Officer, the Contracting Officer s Technical Representative and any other VA Official designated by the Contracting Officer.A This report shall be in writing and contain the fullest explanation possible and all the details of the incident available to the contractor.A VA must receive notice for the contractor on the date contractor discovers incident. HIPPA Compliance. The 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). CONTRACT ADMINISTRATION DATA: The contracting officer is the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will 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 to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. DESIGNATION OF CONTRACTING OFFICER S REPRESENTATIVE (COR): A VA Medical center representative of the Contracting Officer (COR) shall be designated to represent the Contracting Officer in furnishing technical guidance and advice regarding the work being performed under this task order. The foregoing is not to be construed as authorization to interpret or furnish advice or information to the Contractor relative to the financial or legal aspects of the task order. Enforcement of these segments is vested and the sole responsibility of the Contracting Officer. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) LABORATORY TESTING SERVICES TABLE OF CONTENTS 1 INTRODUCTION 1 1.1 Purpose 1 1.2 Performance Management Approach 1 1.3 Performance Management Strategy 1 2 ROLES AND RESPONSIBILITIES 2 2.1 The Contracting Officer 2 2.2 The Contracting Officer s Technical Representative 2 3 IDENTIFICATION OF REQUIRED PERFORMANCE STANDARDS/QUALITY LEVELS 2 4 METHODOLOGIES TO MONITOR PERFORMANCE 2 4.1 Surveillance Techniques 2 4.2 Customer Feedback 3 4.3 Acceptable Quality Levels 3 5 QUALITY ASSURANCE DOCUMENTATION 3 5.1 The Performance Management Feedback Loop 3 5.2 Monitoring Forms 3 6 ANALYSIS OF QUALITY ASSURANCE ASSESSMENT 4 6.1 Determining Performance 4 6.2 Reporting 4 6.3 Reviews and Resolution 4 ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY 5 ATTACHMENT 2: QUALITY ASSURANCE MONITORING FORM 6 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) INTRODUCTION: This quality assurance surveillance plan (QASP) is pursuant to the requirements listed in the Performance Work Statement (PWS) entitled MUHA Laboratory Testing Services. This plan sets forth the procedures and guidelines Pathology and Laboratory Services will use in ensuring the required performance standards or services levels are achieved by the `contractor. Purpose: The purpose of the QASP is to describe the systematic methods used to monitor performance and to identify the required documentation and the resources to be employed. The QASP provides a means for evaluating whether the contractor is meeting the performance standards/quality levels identified in the SOW and the contractor s quality control plan (QCP), and to ensure that the government pays only for the level of services received. This QASP defines the performance objectives, defines the methodologies used to monitor and evaluate the contractor s performance, describes quality assurance documentation requirements, and describes the analysis of quality assurance monitoring results. Performance Management Approach: The PWS structures the acquisition around what service or quality level is required, as opposed to how the contractor should perform the work (i.e., results, not compliance). This QASP will define the performance management approach taken by Pathology and Laboratory Services to monitor and manage the contractor s performance to ensure the expected outcomes or performance objectives communicated in the SOW are achieved. Performance management rests on developing a capability to review and analyze information generated tough performance assessment. The ability to make decisions based on the analysis of performance data is the cornerstone of performance management; this analysis yields information that indicates whether expected outcomes are being achieved by the contractor. Performance management represents a significant shift from the more traditional quality assurance (QA) concepts in several ways. Performance management focuses on assessing whether outcomes are being achieved and to what extent. This approach migrates away from scrutiny of compliance with the processes and practices used to achieve the outcome. A performance-based approach enables the contractor to play a large role in how the work is performed, as long as the proposed processes are within the stated constraints. The only exceptions to process reviews are those required by law (federal, state, and local) and compelling business situations, such as safety and health. A results focus provides the contractor flexibility to continuously improve and innovate over the course of the contract as long as the critical outcomes expected are being achieved and/or the desired performance levels are being met. Performance Management Strategy: The contractor is responsible for the quality of all work performed. The contractor measures that quality tough the contractor s own quality control (QC) program. QC is work output, not workers, and therefore includes all work performed under this contract regardless of whether the work is performed by contractor employees or by subcontractors. The contractor s QCP will set forth the staffing and procedures for self-inspecting the quality, timeliness, responsiveness, customer satisfaction, and other performance requirements in the PWS. The contractor will develop and implement a performance management system with processes to assess and report its performance to the designated government representative. The contractor s QCP will set forth the staffing and procedures for self-inspecting the quality, timeliness, responsiveness, customer satisfaction, and other performance requirements in the SOW. This QASP enables the government to take advantage of the contractor s QC program. 1.3.2 The government representative(s) will monitor performance and review performance reports furnished by the contractor to determine how the contractor is performing against communicated performance objectives. The contractor will be responsible for making required changes in processes and practices to ensure performance is managed effectively. ROLES AND RESPONSIBILITIES The Contracting Officer: The contracting officer (CO) is responsible for monitoring contract compliance, contract administration, and cost control and for resolving any differences between the observations documented by the Pathology and Laboratory Services contracting officer's representative (COR) and the contractor. The CO will designate one full-time COR as the government authority for performance management. The number of additional representatives serving as technical inspectors depends on the complexity of the services measured, as well as the contractor s performance, and must be identified and designated by the CO. The Contracting Officer s Technical Representative: The contracting officer s representative (COR) is designated in writing by the CO to act as his or her authorized representative to assist in administering a contract. COR limitations are contained in the written appointment letter. The COR is responsible for technical administration of the project and ensures proper government surveillance of the contractor s performance. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the government s behalf. Any changes that the contractor deems may affect contract price, terms, or conditions shall be referred to the CO for action. The COR will have the responsibility for completing QA monitoring forms used to document the inspection and evaluation of the contractor s work performance. Government surveillance may occur under the inspection of services clause for any service relating to the contract. IDENTIFICATION OF REQUIRED PERFORMANCE STANDARDS/QUALITY LEVELS The required performance standards and/or quality levels are included in the SOW and in Attachment 1, Performance Requirements Summary. If the contractor meets the required service or performance level, it will be paid the amount agreed on in the contract. Failure to meet the required service will result in nonpayment of the amount agreed on in the contract. METHODOLOGIES TO MONITOR PERFORMANCE Surveillance Techniques: In an effort to minimize the performance management burden, simplified surveillance methods shall be used by the government to evaluate contractor performance when appropriate. The primary methods of surveillance are: Random monitoring, which shall be performed by the COR. 100% Invoice Inspection Each quarter, the COR, shall review the generated invoices and enter summary results into the QASP Spreadsheet. Customer Feedback: The contractor is expected to establish and maintain professional communication between its employees and customers. The primary objective of this communication is customer satisfaction. Customer satisfaction is the most significant external indicator of the success and effectiveness of all services provided and can be measured tough customer complaints. The contractor shall address customer complaints and investigate issues and/or problems, but the customer always has the option to communicate complaints to the COR as opposed to the contractor. Customer complaints, to be considered valid, must set forth clearly and in writing the detailed nature of the complaint, and must be forwarded to the COR. The COR will accept those customer complaints and initiate an investigation. Acceptable Quality Levels: The acceptable quality levels (AQLs) included in Attachment 1, Performance Requirements Summary Table, for contractor performance are structured to allow the contractor to manage how the work is performed. QUALITY ASSURANCE DOCUMENTATION The Performance Management Feedback Loop: The performance management feedback loop begins with the communication of expected outcomes. Performance standards are expressed in the SOW and are assessed using the performance monitoring techniques shown in Attachment 1. Monitoring Forms: The government s QA surveillance, accomplished by the COR, will be reported using the monitoring form in Attachment 2. The form, when completed, will document the government s assessment of the contractor s performance under the contract to ensure that the required results are being achieved. The COR will retain a copy of all completed QA surveillance forms. ANALYSIS OF QUALITY ASSURANCE ASSESSMENT Determining Performance: Government shall use the monitoring methods cited to determine whether the performance standards/service levels/AQLs have been met. If the contractor has not met the minimum requirements, it may be asked to develop a corrective action plan to show how and by what date it intends to bring performance up to the required levels. Reporting: At the end of each Quarter, the COR will prepare a written report summarizing the overall results of the quality assurance surveillance of the contractor s performance. This written report and the completed quality assurance monitoring form (Attachment 2), will become part of the QA documentation. It will enable the government to demonstrate whether the contractor is meeting the stated objectives and/or performance standards, including cost/technical/scheduling objectives. Reviews and Resolution: The COR may require the contractor s project manager, or a designated alternate, to meet with the COR and other government personnel as deemed necessary to discuss performance evaluations. The agenda of the reviews may include: Monthly performance assessment data and trend analysis Issues and concerns of both parties Projected outlook for upcoming months and progress against expected trends, including a corrective action plan analysis Recommendations for improved efficiency and/or effectiveness The COR must coordinate and communicate with the contractor to resolve issues and concerns regarding marginal or unacceptable performance. The COR and contractor should jointly formulate tactical and long-term courses of action. Decisions regarding changes to metrics, tesholds, or service levels should be clearly documented. Changes to service levels, procedures, and metrics will be incorporated as a contract modification at the convenience of the PCO/ACO. ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY Required Services (Tasks) Performance Standards Acceptable Quality Levels Methods of Surveillance Reference Laboratory Testing Services Completion Rate. 100% Complete 100% Complete Random Monitoring Reference Laboratory Testing Services Error Rate(Corrected Reports) No Corrected Reports/Results No Corrected Reports/Results All reported instances ATTACHMENT 2: QUALITY ASSURANCE MONITORING FORM SERVICE or STANDARD: SURVEY PERIOD: SURVEILLANCE METHOD (Check): r Random Sampling r 100% Inspection r Periodic Inspection r Customer Complaint LEVEL OF SURVEILLANCE (Check): r Monthly r Quarterly r As needed PERCENTAGE OF ITEMS SAMPLED DURING SURVEY PERIOD: ______ % ANALYSIS OF RESULTS: Observed Service Provider Performance Measurement Rate: ______% Service Provider s Performance (Check): r Meets Standards r Does Not Meet Standards Narrative of Performance During Survey Period: PREPARED BY: ___________________________________ DATE: _________________ ------END OF STATEMENT OF WORK------ REQUESTED INFORMATION: (1) STATEMENT OF CAPABILITY: Submit a brief description, five (5) pages or less, that demonstrates how your company has the supervision, facilities, labor and experience to provide Omnicell Pharmacy Storage and Dispensing Equipment Maintenance and Repair at the Ralph H Johnson VA Medical Center. Include past experience in performing these services to the VA, other Government (Federal or State) agency, or for a private facility. Please specify your availability to start date and your address. (2) BUSINESS SIZE AND SOCIO-ECONOMIC STATUS: (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Hub-zone firm (e) Indicate if your firm is a woman-owned or operated business (f) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) (g) Include the DUNS number of your firm. (h) State whether your firm is registered with the System for Award Management (SAM) at https://www.sam.gov/portal/public/SAM/ and the VetBiz Registry at http://vip.vetbiz.gov/. If not, please (i) NOTE that any future solicitation could only be awarded to a contractor who is registered in SAM and to receive award based on VOSB or SDVOSB status you must be registered in the VetBiz Registry. Responses must be emailed to Janica.Francis@va.gov no later than 10:00 am EST, July 21st, 2018. Please place "(STAT Urgent/Emergent Laboratory Testing Service for Patient Specimens) in the subject line of your email. Your response must include your STATEMENT OF CAPABILITY and BUSINESS SIZE AND SOCIO-ECONOMIC STATUS information as explained above, and the completed Market Research Questionnaire. MARKET RESEARCH QUESTIONNAIRE Response to Questionnaire is required from all interested parties. Company Name, Address & Telephone#___________________________________________ Email Address for designated POC ____________________________________________ DUNS#____________________________________________ GSA or NAC Contract # (if applicable) ____________________________________________ Indicate your business size & socio-economic status under NAICS code 238210: [ ] yes [ ] no Small Business (SB) [ ] yes [ ] no Certified HUBZone [ ] yes [ ] no Certified Small Business 8(a) [ ] yes [ ] no Small Disadvantaged Business (SDB) [ ] yes [ ] no Economically-Disadvantaged Women-Owned Small Business (EDWOSB) [ ] yes [ ] no Women-Owned (WO) Small Business [ ] yes [ ] no Certified Service Disabled Veteran Owned Small Business (SDVOSB) [ ] yes [ ] no Veteran Owned Small Business (VOSB) [ ] yes [ ] no Other (please specify) [ ] yes [ ] no Registered with the System for Award Management (SAM) @ https://www.sam.gov [ ] yes [ ] no Registered in VetBiz Registry @ http://vip.vetbiz.gov/ RISK: Address any potential risk to the Government to include technical; cost, schedule and performance that may have a direct impact on the acquisition of this service. A SOLICITATION HAS NOT BEEN ISSUED. After review of responses, a solicitation may be published at a later date. Responses to this Market Research Questionnaire will not be considered as submission of an offer for future solicitation announcements. All interested parties must respond to future that solicitation announcement separately or in addition to this Market Research Questionnaire. Contract award resulting from any future solicitation can only be made to a contractor who is registered in SAM. This notice is to assist the VA in determining sources only. A SOLICITATION IS NOT CURRENTLY AVAILABLE. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement.
36C24718Q9306 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 7
7/12/18, 3:26 PM