SOURCES SOUGHT
Q -- NEW - Lab Accreditation (CAP) for CVL surveys
- Notice Date
- 10/24/2022 12:03:05 PM
- Notice Type
- Sources Sought
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- 257-NETWORK CONTRACT OFFICE 17 (36C257) ARLINGTON TX 76006 USA
- ZIP Code
- 76006
- Solicitation Number
- 36C25723Q0079
- Response Due
- 10/31/2022 8:00:00 AM
- Archive Date
- 11/30/2022
- Point of Contact
- Ognian Ivanov, Contract Specialist, Phone: 210-694-6302
- E-Mail Address
-
ognian.ivanov@va.gov
(ognian.ivanov@va.gov)
- Awardee
- null
- Description
- Sources Sought Notice This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government. This notice is intended strictly for Market Research. This is a Request for Information ONLY. This is NOT a solicitation for proposals, bids, proposal abstracts, or quotations. The Government is conducting a market survey to help determine the availability and technical capability of qualified service-disabled veteran-owned small businesses, veteran-owned small businesses, small businesses, HUBZone small businesses and/or other large businesses capable of serving the needs identified below. This notice of intent is for open market as well as Federal Supply Schedule items. Procurement and Delivery of Linearity Survey Supplies and Service Amarillo VAHCS A. Background The Amarillo Veterans Affairs Health Care System (AVAHCS) Department of Pathology & Laboratory Service (P&LMS) and all Community Based Outpatient Clinics (CBOC) that perform testing on patients (human specimens) must subscribe to an external proficiency testing program as an enhancement to the internal quality control program that meets Clinical Laboratory Improvement Act (CLIA) 1988 and amendments to: Ensure reliability of patient testing in the laboratory. Meet accreditation requirements. Must subscribe to external proficiency test (PT) programs for all analytes for which PT is available, including waived testing, provider performed microscopy, and unregulated analytes. VHA Handbook 1106.01, Page 24-25, Paragraph 8, section b (1), January 29,2016 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169 8. PROFICIENCY TESTING b. PT Requirements. The laboratory must perform, and report PT from a CMS ram approved by the VA National Enforcement Officer for every instrument/method (including backups) utilized for patient testing and for every site where patient testing is performed. All of these tests systems must be formally evaluated by the provider for satisfactory performance. (1) A separate PT kit must be ordered for each instrument, method, or site utilized for patient testing. All the challenges provided in one kit for a specific analyte must be run on the same instrument, method, or site to allow the tracking of the instrument, method, or site performance throughout the year. Clinical Lab Tool- CL.265.05 Is proficiency testing performed and reported on every instrument utilized for patient testing and for every site where patient testing is performed? PT must be performed and reported on each instrument in each of the following circumstances: When the lab has multiple instruments used interchangeably to perform patient testing. For any instrument or method that the lab would use as a backup to perform the patient test runs if the primary instrument is down. At each ancillary testing site. On each instrument at each ancillary testing site. AVAHCS P&LMS performs clinical diagnostic tests on patients (human specimens) and in the event should any or all departments within the P&LMS should 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 particular diagnostic testing. CAP has determined the analyte specific evaluation criteria and target values used to grade PT results for 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 submitted by the manufacturer, 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 AVAHCS P&LMS and ancillary testing sites that perform patient testing are in compliance with the VHA Handbook 1106.01 proficiency testing requirements for a term of 12 months (1 year). AVAHCS P&LMS and ancillary testing sites perform patient testing in the following CLIA specialties/subspecialties: Arterial Blood Gases, General Immunology, Hematology, Routine Chemistry (serum and urine), and Urine Toxicology; as well as serum Alcohol, Ammonia, CRP, and Creatinine (eGFR) testing. PT shall be performed in each department of the P&LMS and all ancillary testing sites that perform patient testing in accordance with calendar of events or shipping table provided by the vendor. Each department/site must perform PT testing on every analyzer (including backup analyzers) for the primary test method for each test/assay performed on-site. The PT program must be CLIA approved for all aforementioned CLIA specialties/subspecialties. All pertinent proficiency testing information shall be internally managed via Microsoft database. C. Period of Performance This is an Indefinite Deliver Indefinite Quantity (IDIQ) five year contract with a period of performance 01/01/2023 12/31/2027 (five ordering period contract.) Place of performance see F. Delivery Methods and Locations 2a through 2e. D. Type of Contract The AVAHCS intends to award a Firm Fixed Price, Indefinite Deliver Indefinite Quantity (IDIQ) contract. E. Vendor Responsibilities The Vendor shall provide, at minimum, specimens for all CLIA specialties/subspecialties for which patient testing is performed in the AVAHCS and CBOC s. The Vendor shall provide a mechanism to notify AVAHCS and CBOC s if proficiency testing updates become available and promptly notify the Ordering Contact in writing (mailed or electronic) of such updates. The Vendor shall establish an event calendar and/or shipping table that identifies the date each proficiency testing deliverable is scheduled to be shipped to AVAHHCS and CBOC s. The Vendor shall have a method that allows AVAHCS and its CBOC s to transmit proficiency testing results electronically (i.e., secured website, secure direct interface capability, facsimile, etc.) The Vendor shall meet evaluation criteria (allowable limits and target values) determined by CLIA for each regulated analyte. For other than regulated analytes, the grading criteria may be determined by AVAHCS and its CBOC s, The Vendor shall include formal evaluation of results for each test. Formal evaluation reports must include: 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). A summary of the individual laboratory s historic performance over the past three (3) proficiency testing events for each regulated analyte. Overall performance summary report for each regulated analyte that indicates whether current performance is satisfactory, at risk pending future performances, or unsatisfactory. A summary of peer participant results. As applicable for each analyte: analyte tested, test methodology, reported results, graded score, peer statistics (such as mean and standard deviation) and AVAHCS and CBOC determined intended result. The reason any proficiency testing result was not scored/graded. The Vendor shall oblige AVAHCS Ordering Contact and the respective Regional Medical Technologist: Documentation of proficiency testing formal evaluations. Written notification when proficiency testing results are not received by vendor. Written notification when analyte performance is scored as unacceptable. Written notification when analyte overall performance is assessed as unsatisfactory. The Vendor shall provide a plan for replacement of defective or damaged deliverable (proficiency testing material/supplies). The Vendor shall provide a glossary of terms if technical terminology is used. Otherwise, information must be phrased in audience appropriate language. The Vendor shall have an electronic method (i.e., website, facsimile, e-mail) 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. The Vendor shall provide the facility with the most current Food and Drug Administration (FDA) approved reagents, controls, calibration materials, and any consumables necessary for analyzing/testing on both primary and back-up analyzers. All requirements and provisions defined in the specification of this solicitation will apply to any vendor, i.e., branch, division, sub-Vendor, etc. supplying parts or reagents on behalf of the Vendor. For reagents with hazardous constituents, vendor shall provide a mechanism for the Laboratory to meet local discharge requirements. The vendor shall supply information regarding any hazardous chemicals. F. Delivery Methods and Locations All mailed deliverables, which includes proficiency testing material/supplies, shall be shipped Freight On Board (FOB) Destination (paid by Vendor). Proficiency testing materials/supplies/specimens shall be delivered/shipped to : Amarillo Veterans Affairs Health Care System 6010 Amarillo Blvd., West Amarillo, TX 79106 Lubbock VA Community Based Outpatient Clinic (CBOC) 3510 4th Ave Lubbock, TX 79415 Clovis VA Community Based Outpatient Clinic (CBOC) 921 E. Llano Estacado Blvd. Clovis, NM 88101 Childress VA Community Based Outpatient Clinic (CBOC) 903 US Highway 83 N Childress, TX 79201-2322 Dalhart VA Community Based Outpatient Clinic (CBOC) 325 Denver Ave. Dalhart, TX 79022 The package should be shipped according to shipping table provided by the Vendor. G. Billing Vendor shall bill monthly in arrears upon receipt/acceptance of the supplies. Each location shall be billed separately with the understanding that all payments shall be invoiced to and will be the responsibility of the Amarillo location. Vendor shall use the Tungsten e-Invoice system for all billings. www.tungsten-network.com Period of Performance shall be indicated on all invoices. A Government customer termination agreement prior to the contract term of one year ( 12 months) the contract pricing awarded will be adjusted. Pricing published shall be based on a 60 month term. However, upon early termination, alternate pricing, which is part of this contract, shall apply. A CCR number shall be maintained in addition to a current DUNS number for all Contractor information. H. Licensing and Accreditation The Vendor shall have all licenses, permits, accreditation and certificates required by law and or regulatory compliance. Personnel assigned by the Vendor to perform these services covered under this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. I. Security ""The C&A requirements do not apply, and that a Security, Accreditation Package is not required. ATTACHMENT 1 Amarillo VA Health Care System Supply Needs Deliver to: Amarillo Veterans Affairs Health Care System 6010 Amarillo Blvd., West Amarillo, TX 79106 Attention: Laboratory ITEM # DESCRIPTION QTY LN 2 BV Chem CVL Beck (Except AU) 2 LN 3 Therapeutic Drug Monitoring CVL 2 LN 6 Urine Chemistry CVL 2 LN 7 Immunology CVL 2 LN15 Hemoglobin A1c Accuracy Calibration Verification/Linearity 2 LN 11 Serum Ethanol CVL 2 LN 17 Whole Blood Glucose CVL 1 LN 19 Reticulocyte CVL 2 LN 20 Urine Albumin CVL 2 LN 21 High Sensitivity CRP CVL 2 LN 24 Creatinine Accuracy CVL 2 LN 32 Ammonia CVL 2 LN 41 Procalcitonin CVL 1 VBP Virtual Biopsy Program-online 1 VBP1 Virtual Biopsy Program, Addl. On-line 1 CAP BIND CAP Generic Survey Binders 20 Fuel Surcharge ATTACHMENT 2 Lubbock CBOC Supply Needs Deliver to: Lubbock VA Community Based Outpatient Clinic (CBOC) 3510 4th Ave Lubbock, TX 79415 Attention: VA Laboratory ITEM # DESCRIPTION QTY LN 2 BV Chem CVL Beck (Except AU) 2 LN 3 Therapeutic Drug Monitoring CVL 2 LN 6 Urine Chemistry CVL 2 LN 7 Immunology CVL 2 LN 11 Serum Ethanol CVL 2 LN15 Hemoglobin A1c Accuracy Calibration Verification/Linearity 1 LN17 Whole Blood Glucose CVL 2 LN 20 Urine Albumin CVL 2 LN 21 High Sensitivity CRP CVL 2 LN 24 Creatinine Accuracy CVL 2 LN 32 Ammonia CVL 2 Fuel Surcharge ATTACHMENT 3 Clovis CBOC Supply Needs Deliver to: Clovis VA Community Based Outpatient Clinic (CBOC) 921 E. Llano Estacado Blvd. Clovis, NM 88101 Attention: VA Laboratory ITEM 3 DESCRIPTION QTY LN 17 WB GLUCOSE CVL 1 Fuel Surcharge ATTACHMENT 4 Childress CBOC Supply Needs Deliver to: Childress VA Community Based Outpatient Clinic (CBOC) 903 US Highway 83 N Childress, TX 79201-2322 Attention: VA Laboratory ITEM 3 DESCRIPTION QTY LN 17 WB GLUCOSE CVL 1 Fuel Surcharge ATTACHMENT 5 Dalhart CBOC Supply Needs Deliver to: Dalhart VA Community Based Outpatient Clinic (CBOC) 325 Denver Ave. Dalhart, TX 79022 Attention: VA Laboratory ITEM 3 DESCRIPTION QTY LN 17 WB GLUCOSE CVL 1 Fuel Surcharge The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, women-owned small business, HUB Zone, 8(a), small business or large business, relative to NAICS 621511. Responses to this notice will be used by the Government to make appropriate acquisition decisions. A solicitation is not currently available. If a solicitation is issued, it will be announced on Commercial Business Opportunities website http://www.beta.sam.gov or GSA E-Buy at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. Please advise if you can provide the service/supplies for this requirement. Please submit all information to Ognian Ivanov mailto:ognian.ivanov@va.gov no later than Monday ,October 31, 2022, 11:00 AM ET (10:00 AM CT).
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/b0d89326ac794f8987481f44916f504f/view)
- Place of Performance
- Address: Department of Veterans Affairs Amarillo VA Health Care System 6010 Amarillo Blvd. West, Amarillo, TX 79106-1991, USA
- Zip Code: 79106-1991
- Country: USA
- Zip Code: 79106-1991
- Record
- SN06501400-F 20221026/221024230059 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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