U010--Clinical laboratory testing services - anatomic pathology surveys

This is a SOURCES SOUGHT NOTICE ONLY. This SOURCE SOUGHT NOTICE is for the purpose of Market Research. Response to this notice will be used for information and planning purposes. No proposals or quotes are being requested or accepted with this notice. THIS IS NOT A SOLICITATION FOR PROPOSALS or QUOTES and NO CONTRACT SHALL BE AWARDED FROM THIS NOTICE. This notice shall NOT be construed as solicitation or as an obligation on the part of the Department of Veterans Affairs (VA). Responses to this notice is not a request to be added to a prospective bidders list or to receive a copy of the solicitation. The Network Contracting Office (NCO) 16 is seeking preferably Service Disabled Veteran Owned Small Businesses, or Small Businesses (but will accept other than small business for market research purposes), capable of performing clinical laboratory testing services, and anatomic pathology surverys, for the Gulf Coast Veterans Health Care System, Biloxi, MS. See DRAFT Scope of Work for detailed description of services. The NAICS code is 611310 Certifications and Accreditations for Educational Institutes Services and the Size Standard is $30.0M. Responses must be received by no later than 12:00 p.m. Central Time, Thursday, July 3, 2020. Responses shall be emailed to contact@example.gov. Responses shall include Capabilities Statements, DUNS number, and whether the requirement is on GSA/FSS schedule or Open Market. Facsimile or Telephonic responses will not be accepted. Note: All interested parties are reminded to be registered, active and verified in the following to be considered for Award. SAM: https://sam.gov/SAM/ VETBIZ: https://www.vip.vetbiz.va.gov/ Vet 4212 (Veteran owned small Business are reminded of Reporting Requirements) https://www.dol.gov/agencies/vets/progams/vets4212 DRAFT - Statement of Work A. Background As required by VHA Handbook 1106.01, 1. All Department of Veterans Affairs (VA) s Pathology and Laboratory Medicine Service laboratories and all Ancillary Testing Sites that perform testing on patients must subscribe to an external proficiency testing program that meets Clinical Laboratory Improvement Act 1988 and amendments (CLIA)1988 requirements to: a) ensure reliability of patient testing in the laboratory, and b) meet accreditation requirements 2. All laboratories must successfully participate in a Centers for Medicare and Medicaid Services (CMS)- Clinical Laboratory Improvement Amendments (CLIA) approved PT program. 3. External Proficiency Testing (PT) Program: As an enhancement to the internal Quality Control Program, to ensure reliability of patient testing in the laboratory, and to maintain accreditation requirements, each Pathology and Laboratory Medicine Service and all Ancillary Testing Sites must subscribe to external PT programs that meet CLIA 88 requirements for all analytes for which PT is available, including waived testing, Provider Performed Microscopy (PPM), and unregulated analytes. 4. Laboratories that perform clinical diagnostic tests on human specimens and fail to meet the PT requirements as described in 42 CFR 493, Subpart H, or who have demonstrated deficiencies which pose a direct threat to patients may be instructed to terminate those processes. CMS has determined the analyte-specific evaluation criteria and target values used to grade proficiency testing results for regulated analyte. CLIA approved proficiency testing providers may specify grading criteria for other-than-regulated analytes. CLIA categorization is determined after the FDA has cleared or approved a marketing submission. The FDA determines the test s complexity by reviewing the package insert test instructions, and using a criteria scorecard to categorize a test as moderate or high complexity. B. Scope The overall purpose of this requirement is to obtain a contractor to provide a CLIA 88 approved proficiency testing program so that all VHA medical laboratories and ancillary testing sites that perform patient testing are in compliance with VHA Handbook 1106.01 proficiency testing requirements. Currently there are approximately 980 VHA patient testing sites. A current listing of VA facilities can be found on Attachment 1. The sites are located in the contiguous 48 states as well as Alaska, Hawaii, and Puerto Rico. VHA medical laboratories and ancillary testing sites perform patient testing in the following CLIA specialties/subspecialties: Microbiology, Bacteriology, Mycobacteriology, Mycology, Parasitology, Virology, Diagnostic Immunology, Syphilis, General Immunology, Immunoglobulins, Chemistry (routine), Blood Gases, Endocrinology, Toxicology, Hematology, Immunohematology, Histocompatibility, and Cytology. Proficiency testing shall be performed at each medical laboratory or ancillary testing site that performs patient testing in accordance with calendar of events or shipping table provided by the contractor. Each site must perform proficiency testing on every instrument (including backups) for the primary test method, for each test (assay) performed on-site. The proficiency testing program must be CLIA approved for all aforementioned CLIA specialties/subspecialties. Pertinent proficiency testing information will be internally managed via Microsoft Access database. C. Period of Performance The contract period of performance shall be October 01, 2019 September 30, 2024 which includes 4 option years that may be unilaterally exercised at the Government s discretion. Place of performance is each VHA medical laboratory. D. Type of Contract The Government intends to award a Firm Fixed Price, Indefinite Delivery Indefinite Quantity (IDIQ) contract. E. Tasks Task 1: Implement a Proficiency Testing program 1. The contractor s program must be a CLIA approved proficiency testing program. The proficiency testing program must: Be administered as specified in package submitted for CLIA proficiency testing program approval. Provide, at minimum, specimens for all CLIA specialties/subspecialties for which patient testing is performed in VHA clinical laboratories which include: Microbiology, Bacteriology, Mycobacteria, Mycology, Parasitology, Virology, Diagnostic Immunology, Syphillis, General Immunology, Immunoglobulins, Chemistry (routine), Blood Gases, Endocrinology, Toxicology, Hematology, Immunohematology, Histocompatibility, and Cytology. iii. Include a mechanism for the contractor to notify the government if proficiency testing updates become available and promptly notify each proficiency testing laboratory and COR, in writing (mailed or electronic), of such updates. iv. Include a contractor established event calendar and/or shipping table that identifies the date each proficiency testing deliverable is scheduled to be shipped to the testing laboratory v. Have a method that allows each individual laboratory to transmit proficiency testing results electronically (i.e., secured website, secure direct interface capability, facsimile, etc). vi. Meet, or be more restrictive than, evaluation criteria (allowable limits and target values) determined by CMS for each regulated analyte. For other-than-regulated analytes, the grading criteria may be determined by the contractor. vii. Include formal evaluation of results for each test. Formal evaluations reports must include: a) A mechanism for each laboratory to compare its proficiency testing performance and/or results against peer laboratories using the same instrument/reagent system (when available) b) A summary of the individual laboratory s historic performance over the past three proficiency testing events for each regulated analytes c) Overall performance summary report for each regulated analyte that indicates whether current performance is satisfactory, at risk pending future performance, or unsatisfactory. d) A summary of peer participant results e) As applicable for each analyte: analyte tested, test methodology, reported results, graded score, peer statistics (such as mean standard deviation) and contractor determined intended result f) The reason any proficiency testing result was not scored/graded viii. Oblige the contractor to provide the proficiency testing laboratory s POC, the respective Regional Medical Technologist, and the laboratory s accrediting organization: a) Documentation of proficiency testing formal evaluations b) Written notification when proficiency testing results are not received by contractor c) Written notification when analyte performance is scored as unacceptable d) Written notification when analyte overall performance is assessed as unsatisfactory ix. Provide a plan for replacement of defective or damaged deliverable (proficiency testing material/supplies) x. Provide a glossary of terms if technical terminology is used. Otherwise, information must be phrased in audience appropriate language xi. Have an electronic method (ie., website, fax, email) for receipt of VA furnished correspondence (i.e., proficiency testing results, VA facility demographics) that is required for the proficiency testing program. Contract prices should include any costs associated with electronic data transmission. Task 2: Deliverables: Mailed, Written Correspondence, Microsoft Access based files 1. All Mailed deliverables, which includes proficiency testing material/supplies shall be shipped Freight On Board (FOB) Destination (paid by contractor). i. Proficiency Testing specimens/materials shall be delivered to the individual VHA laboratory determined by patient testing performed at each individual laboratory. The package should be shipped according to shipping table provided by contractor. 2. Written correspondence may be shipped FOB Destination (paid by contractor) or delivered electronically (PDF, Word, Excel, or other mutual agreement between COR and Contractor) to respective VHA clinical laboratory POC and/or VA Regional Technologist (as provided by individual laboratories post award). Electronic format must mirror contents of paper format. i. Proficiency Testing updates shall be provided to all VHA clinical laboratory POCs, VA Regional Technologists, and the COR within 10 working days of change. ii. Proficiency Testing Manuals, Proficiency Testing Catalogs, and Proficiency Testing event calendars and/or shipping tables shall be made available to all VHA clinical laboratory POCs, VA Regional Technologists and the COR within 10 working days of award for base and each option year. iii. Formal evaluation reports and other proficiency testing notifications shall be made available to the respective VHA clinical laboratory POC, the respective VA Regional Technologist, and the laboratory s accrediting organization within 30 calendar days of evaluation. 3. Microsoft Access database compatible format files (i.e., XML, Excel, HTML) shall be submitted to the COR electronically. i. Proficiency testing ordering, shipping, pricing information (to include updates/changes), and cut-off dates shall be provided to COR or NEO Liason within 10 working days of availability ii. Summary/Confirmation of all order changes and a running balance report shall be provided weekly, in weekly increments (or 30 calendar days for initial annual order). iii. Consolidated or summarized data report for overall proficiency testing performance shall be provided weekly, in weekly increments a) The contractor shall provide PT survey performance data in both a paper report format as well as Extensible Mark-up Language (XML) format available through a secured FTP server connection for import into the National Enforcement Office Database. 4. The contractor shall submit documentation (formal evaluations and other proficiency testing notifications) to the laboratory s accrediting organization using any compatible format/method routinely accepted by the accrediting organization. F. Authorized Ordering Offices Task orders, for the individual facility, will be awarded by the Contracting Officer and managed by the National Enforcement Office. Changes to orders can be made on a weekly basis during the course of the contract. Actual (running) balance will be reconciled between the contractor and the COR or National Enforcement Office liaison weekly. G. Government Furnished Items Contract prices should include any costs associated with electronic data transmission. 1. Each VHA clinical laboratory will provide proficiency testing results to the contractor via electronic method(s) determined by contractor 2. Each VHA clinical laboratory will provide its respective POC and other demographics using forms provided by contractor 3. National Enforcement Office or COR will provide regional Medical Technologist information to contractor post award. 4. National Enforcement Office or COR will provide initial (annual) proficiency testing order (manually and/or electronically), by due date determined by contractor, using forms provided by contractor. 5. National Enforcement Office or COR will provide all order changes to contractor on a weekly basis, electronically. H. Changes to the Statement of Work: Any changes to this SOW shall be authorized and approved only through written correspondence from the Contracting Officer. I. Travel Travel is not anticipated for this effort. J. Contractor Experience Requirements The contractor must be on CMS list of CLIA-approved proficiency testing providers for the following specialty/subspecialties: Microbiology, Bacteriology, Mycobacteriology, Mycology, Parasitology, Virology, Diagnostic Immunology, Syphilis, General Immunology, Immunoglobulins, Chemistry (routine), Blood Gases, Endocrinology, Toxicology, Hematology, Immunohematology, Histocompatibility and Cytology.