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Clinical Reference Laboratory Testing Services

General Information

Document Type:SNOTE
Posted Date:Feb 05, 2019
Category: Medical Services
Set Aside:N/A

Contracting Office Address

ATTN: MCAA C BLDG 4197 2107 17TH Street Fort Sam Houston TX 78234-5015


The U.S. Army Health Contracting Activity (USAHCA), Health Readiness Contracting Office (HRCO), on behalf of the U.S. Army Medical Command (MEDCOM), has developed this Request for Information (RFI) to solicit market research information from industry to assist the Government with the analysis of a Government requirement and provide commercial insight on performance-based solutions, best practices, possible contractual arrangements, and potential issues. THIS IS A REQUEST FOR INFORMATION ONLY. This is not a Request for Proposal, a Request for Quotation, an Invitation for Bids, a Solicitation, or an indication that HRCO will contract for the items contained in the RFI. This RFI is part of a Government market research effort to determine the scope of industry capabilities and interest and will be treated as information only. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responses to this RFI are strictly voluntary and the Government will not pay respondents for information provided in response to this RFI. Responses to this RFI will not be returned and respondents will not be notified of the result of the review. If a solicitation is issued, it will be announced on the Federal Business Opportunities website http://www.fbo.gov at a later date, and all interested parties must respond to that solicitation announcement separately from any response to this announcement. This RFI does not restrict the Governments acquisition approach on a future Solicitation. The Governments requirement is to obtain two non-personal service single-award Indefinite-Delivery, Indefinite-Quantity (IDIQ) contracts to provide Clinical Reference Laboratory Testing services for U.S. Army, U.S. Air Force, U.S. Navy, U.S. Coast Guard, and Defense Health Agency (DHA) Medical Treatment Facilities (MTFs) worldwide. Services shall be provided in accordance with Army Regulation 40‐3 Medical, Dental, and Veterinary Care, Chapter 14, Medical Laboratory Management, in support of the patient care mission. The contractor(s) shall provide all required facilities, labor, equipment, materials, software interfaces, transportation, and services necessary for clinical reference laboratory testing. Clinical reference laboratory testing includes comprehensive support generally encompassing the American Medical Associations Current Procedural Terminology (CPT) coding within the range of 80047 to 88399, and includes, but is not limited to, support across multiple clinical and anatomic pathology disciplines to include chemistry, hematology and coagulation, urinalysis, transfusion medicine, microbiology, molecular, histology, cytology, and genetic testing. The contractor must be capable of providing comprehensive reference laboratory support for all tests listed on the attached fee schedules [Reference Performance Work Statement (PWS) Exhibit C - General Core Testing and Exhibit C - Specialized Testing]. These are unique, individually orderable tests and panels across all the aforementioned disciplines and must possess sufficient infrastructure to fully support the timely receipt, transport, processing, testing, and reporting of results for the total projected annual requirements across all agencies including both Continental United States (CONUS) and Outside of the Continental United States (OCONUS) MTFs. The Government is contemplating awarding two single-award IDIQ contracts for a ten- year ordering period (including a 6-month transition period). The North American Industrial Classification System (NAICS) code is 621511 and the small business size standard is $32.5M. The Government request you review the attached draft PWS (including Exhibits) and provide answers to the following questions: 1. What are the customary commercial practices for providing these types of services for non-governmental entities (i.e., contract types, pricing structures, commercial performance standards, etc.)? 2. Based on your experience, what is the most cost effective contract type and payment method (i.e., monthly firm fixed-price, separate price per service (price list), cost reimbursement, or combination, etc.)? 3. Is 30 calendar days sufficient time for you prepare your proposal (i.e., technical, past performance, and price proposal) using trade-off source selection procedures? If 30 calendar days is not sufficient, what is a reasonable time? 4. The Government requires a 6-month transition period for the contractor to perform pre-contract functions in order to be ready to begin full performance of the PWS by the contract start date. The transition period will be separately priced in the contract. The tasks to be performed during the transition period include, but are not limited to: personnel recruitment and hiring efforts, training, security requirements, familiarization with testing requirements, and completion of electronic interface in accordance with Dodi 8510.01, Risk Management Framework, requirements of the contract (see PWS paragraphs 1.7.10 through 1.7.11, and Exhibit D), and task order start-up requirements (see PWS paragraphs 8.14 through 8.14.6). Is a 6-month period a sufficient amount of time for the transition period? Based on your experience for similar efforts, should this period be shorter or longer and if so explain why? Does the transition requirement in the PWS address all the efforts that may be required to ensure a smooth transition? If not, what do you recommend? 5. Prior to initiation of performance by a new contractor, the contractors Laboratory Information System (LIS) must have an approved Business to Business (B2B) Agreement from the DHA B2B Program Management Office to connect to the Government via the Military Health Systems (MHS) B2B Gateway. Additionally, the reference laboratorys LIS must have approved interfaces to the Department of Defense (DoD) Electronic Health Records (EHR) (e.g., Composite Health Care System and MHS Genesis), in addition to obtaining the requisite Information Assurance (IA) approvals or Authority To Operate (ATO). Current DoD approved mechanisms for approval and/or ATO are via DoDI8510.01. Please briefly explain how you plan to meet the LIS requirements, to include the required B2B agreement, approved interfaces to the DoD EHR, IA approvals and Authority to Operate, within the 6-month transition period in order to start full performance. 6. The current acquisition approach will result in the award of two single-award IDIQ contracts for reference laboratory testing services; one contract for general core testing and another for specialized testing (see attached PWS Exhibit C, General Core Tests and Exhibit C, Specialized Tests). Both contracts will provide testing services for all of the facilities/locations listed in PWS Exhibit B, DoD Summary by Facility Name. What, if any, impact would result from a two-contract approach with regards to providing processing support, courier services, IT personnel, etc.? Do you have any recommendations regarding the two-contract approach and/or how the testing requirement could be divided? 7. Does your laboratory provide any onsite processor support for your commercial reference laboratory contracts, especially for the larger volume sites? If so, what factors do you use or recommend for use in determination of onsite processor support? Is there a workload threshold that is utilized to determine if a contractor employee will be physically placed in a hospital? 8. What issues do you foresee or have you encountered in providing onsite processor support, specifically within the context of separate contracts for General Core Testing and Specialized Testing, and potentially having two separate onsite contractors providing reference laboratory support? Are there any personnel or service conflict issues between your company and any other commercial reference laboratories? 9. Do you have a published commercial catalog(s) or price list(s) for the same or similar services? If so, please provide this information. 10. Does your company have standard commercial rates utilized for private industry contracts for these types of services? If so, please describe. If not, are you aware of other companies that have commercial rates for these types of services? If so, please explain. 11. Do you have a GSA schedule for this type of requirement? If so, regarding Exhibit B of the PWS, are there any performance locations that would not be included on the GSA schedule? 12. The contractor(s) must be capable of providing comprehensive reference laboratory support to include all unique, individually orderable tests and panels on the current fee schedule(s) (Reference. PWS Exhibit C, General Core Tests and PWS Exhibit C, Specialized Tests), and each test must be uniquely identified with a single test number that is standardized throughout the contractors network of laboratories. The contractor(s) must possess sufficient infrastructure to fully support the timely receipt, transport, processing, testing, and reporting of results for the total projected annual requirements across all agencies including both CONUS and OCONUS MTFs. A copy of the current fee schedules, to include test names, are attached. Is your company capable of providing all required clinical reference laboratory testing for one or both of the current fee schedules? Should you choose to propose on either of the required testing areas or submit separate proposals for both, is your company capable of providing your fee schedule(s) for all required tests to include, your test name, vendor unique test code/order number, identification of FDA Approved tests, CPT code(s), and Logical Observation Identifiers Names and Codes Code, LongName, Component, System, and Method? Is your company able to provide a firm fixed price for each test identified on the schedule(s) for a ten-year period? If not, what pricing arrangement would you recommend for a ten-year period? 13. Are the required performance measures in the Performance Requirements Summary (See Exhibit A of the PWS) achievable? If not, please be specific on which areas would not be and state the reasons why and provide recommendations. 14. Are there any innovative approaches used by your company in providing these types of services? If so, please explain. 15. What makes your company a market leader for this type of service? 16. Do you have past performance, within the past 3 years, for same or similar services in the attach PWS at multiple geographically dispersed locations? If so, please provide the following information for each relevant contract(s): (1) name of your customer; (2) contract number; (3) contract start date; (4) contract length; (5) total dollar value for all periods; (6) place of performance; (7) type of labor categories; and (8) a brief description of services (including the number of tests and locations). 17. For NAICS 621511 - Medical Laboratories, Small Business Size Standard $32.5M, is your company considered a small business? If your company is a small business, do you fall under any small business subcategory (SDB, SDVOSB, Hub Zoned, 8a, etc.)? If you are an 8a eligible company, please provide current status regarding your scheduled graduation date from the 8a program under this NAICS code. 18. If your company is a small business, can you comply with FAR Clause 52.219-14, Limitations on Subcontracting, required in contracts for small business set-asides? 19. If you are considered a large business, is there a possibility you may contemplate teaming with a small business for this requirement? Are there any subcontracting opportunities? If so, provide a list of services and supplies that your company would subcontract to small businesses? 20. What is your companys average revenue for the past 3 years? 21. What types of internal quality control performance assessment methods are commonly used by your company for clinical reference laboratory testing services? 22. Does your company currently possess adequate financial resources or the ability to obtain adequate financial resources to support all of the required locations? If so, please describe your capabilities. 23. Discuss any concerns, comments or recommendations you may have with the attached "draft" PWS or any related Attachments/Exhibits. Please reference the applicable PWS paragraph numbers with each comment. Request for Capability Statement: Respondents to this RFI are requested to describe their interest and ability/capability to perform the clinical reference laboratory testing services in the PWS enclosed with this notice by submitting a capability statement. Responses should contain your Company Name, Address, Point of Contact, Phone Number, Fax Number, CAGE Code, Size of Business pursuant to NAICS code 621511 (size standard $32,500,000). Please submit all responses through e-mail to both points of contact identified in the section below. Responses should be formatted as either MS Word (.doc) or Adobe Portable Document Format (.pdf) and should be limited to a maximum of five (5) pages (excluding price lists or catalogs). Proprietary/Competition Sensitive information (appropriately marked) will be protected from disclosure to the greatest extent practical; however, it is preferred that respondents do not provide proprietary or otherwise restricted responses. Responses should be submitted by e-mail to the POCs listed below no later than 4:00 PM CDST, 15 February, 2019. No faxes, courier delivered, or telephone inquiries/submissions will be accepted. Health Readiness Contracting Office POCs Contracting Officer: David Robledo, 210-221-5490 david.d.robledo.civ@mail.mil Contract Specialist: Anthony J. Smith, 210-221-3408 anthony.j.smith138.civ@mail.mil Contracting Office Address U.S. Army Health Contracting Activity Health Readiness Contracting Office 2199 Storage Street, Suite 68 JBSA Fort Sam Houston, TX 78234-5074 Enclosures : "Draft" Performance Work Statement (PWS) (Separately Attached) PWS Exhibits: Exhibit A - Performance Requirements Summary (PRS) Exhibit B - DoD Summary by Facility Name Exhibit C - "Draft" Fee Schedule - General Core Testing (Separately Posted) - "Draft" Fee Schedule - Specialized Testing (Separately Posted) Exhibit D - Risk Management Framework Requirements for DoD IT Exhibit E - List of Family Member Prefixes and Their Definitions Exhibit F - Army DEERS/RAPIDS System Procedures Exhibit G - Contract Administration Exhibit H - Wage Determinations NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (05-FEB-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.

Original Point of Contact

POC Anthony J. Smith, Contract Specialist, Phone 2102954631, - David D. Robledo, Contracting Officer, Phone 210-221-5490

Place of Performance

Reference attached PWS
, US
Link: Link To Document
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