SOURCES SOUGHT
Q -- NEW-AMA Lab CAP CVL
- Notice Date
- 7/5/2024 10:50:16 AM
- 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
- 36C25724Q0798
- Response Due
- 7/19/2024 8:00:00 AM
- Archive Date
- 08/18/2024
- 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 notice is for planning purposes only and shall not be considered an invitation for bid, request for quotation, request for proposal, or as an obligation of the government to acquire any products or services. Responses to this notice will be used for informational purposes only. No entitlement to payment of direct or indirect costs from the government will arise as a result from a response to this announcement. No contract will be awarded from this notice. The information requested in this notice will be used to determine if there are sufficient socioeconomic small business concerns that are capable of performing the work described for the requirement. The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office (NCO) 17 is seeking sources for the following procurement: 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. The vendor shall determine 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 vendor 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, Creatinine (eGFR) testing; including POCT testing for iSTAT analyzers. 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 The contract period of performance shall be a Base year (January 01, 2025, through December 31, 2025). 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 for the entire 12 months. 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). The government is not responsible for freight charges. Proficiency testing materials/supplies/specimens shall be delivered/shipped to: Amarillo Veterans Affairs Health Care System 6010 Amarillo Blvd., West. 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) 2305 Ave. F N.W., Suite 900 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. H. Licensing and Accreditation The Vendor shall have all licenses, permits, accreditation and certificates required by law and or regulatory compliance and is approved for PT via CLIA. 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 This contractor requires no access to AVAHCS or any VA information system. NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA. The C&A requirements do not apply. A Security Accreditation Package is not required. ATTACHMENT 1 Amarillo VA Health Care System Supply Needs for FY 2025 Deliver to: Amarillo Veterans Affairs Health Care System 6010 Amarillo Blvd., West Amarillo, TX 79106 Attention: Laboratory ITEM # DESCRIPTION QTY LN 2 Chem CVL (Beckman AU/DXI) 2 LN 3 Therapeutic Drug Monitoring CVL (Beckman AU/DXI) 2 LN 6 Urine Chemistry CVL (Beckman AU/DXI) 2 LN 7 Immunology CVL (Beckman AU/DXI) 2 LN 11 Serum Ethanol CVL (Beckman AU) 2 LN15 Hemoglobin A1c Accuracy Calibration Verification/Linearity (Tosoh G8) 2 LN 17 Whole Blood Glucose CVL (Accuchek Inform II) 1 LN 20 Urine Albumin CVL (Beckman AU) 2 LN 21 High Sensitivity CRP CVL (Beckman AU) 2 LN 24 Creatinine Accuracy CVL (Beckman AU) 2 LN 32 Ammonia CVL (Beckman AU) 2 LN 41 Procalcitonin CVL (Beckman DXI) 2 LN 49 Cystatin C CVL (Beckman AU) 2 CAP BIND Generic Survey Binders 6 ATTACHMENT 2 Lubbock CBOC Supply Needs for FY 2025 Deliver to: Lubbock VA Community Based Outpatient Clinic (CBOC) 3510 4th Ave Lubbock, TX 79415 Attention: VA Laboratory ITEM # DESCRIPTION QTY LN 2 Chem CVL Beck (Beckman AU) 2 LN 3 Therapeutic Drug Monitoring CVL (Beckman AU/DXI) 2 LN 6 Urine Chemistry CVL (Beckman AU) 2 LN 7 Immunology CVL (Beckman AU/DXI) 2 LN 11 Serum Ethanol CVL (Beckman AU) 2 LN15 Hemoglobin A1c Accuracy Calibration Verification/Linearity (Tosoh G*) 1 LN17 Whole Blood Glucose CVL (Accuchek Inform II) 2 LN 20 Urine Albumin CVL (Beckman AU) 2 LN 21 High Sensitivity CRP CVL (Beckman AU) 2 LN 24 Creatinine Accuracy CVL (Beckman AU) 2 LN 32 Ammonia CVL (Beckman AU) 2 LN 49 Cystatin C CVL (Beckman AU) 2 ATTACHMENT 3 Clovis CBOC Supply Needs for FY 2025 Deliver to: Clovis VA Community Based Outpatient Clinic (CBOC) 921 E. Llano Estacado Blvd. Clovis, NM 88101 Attention: VA Laboratory ITEM # DESCRIPTION QTY LN 17 WB GLUCOSE CVL 1 ATTACHMENT 4 Childress CBOC Supply Needs for FY 2025 Deliver to: Childress VA Community Based Outpatient Clinic (CBOC) 2305 Ave. F N.W., Suite 900 Childress, TX 79201-2322 Attention: VA Laboratory ITEM # DESCRIPTION QTY LN 17 WB GLUCOSE CVL 1 ATTACHMENT 5 Dalhart CBOC Supply Needs for FY 2025 Deliver to: Dalhart VA Community Based Outpatient Clinic (CBOC) 325 Denver Ave. Dalhart, TX 79022 Attention: VA Laboratory ITEM # DESCRIPTION QTY LN 17 WB GLUCOSE CVL 1 RESPONSE If interested, please provide the following information in a response: 1. Name of Company 2. Point of Contact; name, phone number and email address 3. DUNS number 4. Company socio-economic status (i.e., Small Business) 5. Capability Statement 6. Vendors expressing interest in participating in the requirement must complete and provide the attachment; Attachment A Line Items , with the response. a. In Column J, indicate alternate test name (if different than that already listed, as a separate line) b. In Column M/N for each test, provide the following information: i. Identify if the test is to be performed in-house or subcontracted. If subcontracted, provide Lab Name, (Column N.) ii. CLIA certificate number of the laboratory performing the test 7. Provide a copy of the CLIA certificate of accreditation for each laboratory listed in Column N of the attachment. The certificate must include the Lab Certification Code(s) and effective date for the laboratory specialties and subspecialties the laboratory is certified to perform. 8. In addition, for each laboratory listed in the attachment Column N, provide a declaration signed by the Laboratory Director listed on the CLIA Certificate of Accreditation that identifies which laboratory tests identified in the attachment are currently being performed at that laboratory. Failure to provide the requested information for any test listed in the attachment, or failure to provide the certificate of accreditation for any laboratory identified in the attachment will be considered by the VA to be a statement that the vendor responding to this notice is unable to provide that particular test. The information provided in a response to this notice may be used in developing an acquisition approach. Interested parties are responsible for adequately marking any proprietary or competitive sensitive information that is provided in a response. Interested firms must respond to the notice to be considered. For any questions regarding this notice email the Contracting Point of Contact (Ognian D. Ivanov, ognian.ivanov@va.gov) no later than Friday, July 19, 2025, 10:00 AM Central Time.
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