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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 01, 2018 FBO #6064
DOCUMENT

Q -- LAB ACCREDITATION ROBLEY REX VAMC and CBOCs, Louisville, KY - Attachment

Notice Date

6/29/2018
 

Notice Type

Attachment
 

NAICS

541380 — Testing Laboratories
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 9;1639 Medical Center Parkway;Suite 400;Murfreesboro TN 37129
 

ZIP Code

37129
 

Solicitation Number

36C24918Q9496
 

Response Due

7/5/2018
 

Archive Date

8/4/2018
 

Point of Contact

Tina Briones Smith
 

E-Mail Address

Contracting Officer
(Christina.smith7@va.gov)
 

Small Business Set-Aside

N/A
 

Description

Page 1 of 3 This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. Purpose and Objectives: Your responses to the information requested will assist the Government in determining the appropriate acquisition method. NAICS code: 541380 and sized standard is $15M. NOTE: Respondent claiming SDVOSB and VOSB status must be registered and CVE verified in VetBiz Registry www.vetbiz.gov. Project requirements: This is a requirement for non-personal service to provide Accreditation of Laboratory Services for all CLIA (Clinical Laboratories Improvement Amendment) certified, and FDA defined complexity levels (high, moderate, waived) testing sites identified for Louisville VAMC. All testing sites that perform laboratory tests for patient care within the VHA must be in compliance with CFR Part 493 and must maintain accreditation by a nationally recognized, a VA designated laboratory accrediting agency/program with deemed status from the Center for Medicare and Medicaid Services (CMS). The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, and other items and non-personal necessary to perform Accreditation of Laboratory Services as defined in this Work Statement. The Contractor shall be identified by Centers for Medicare and Medicaid Services (CMS) as an accrediting agency under the Clinical Laboratories Improvement Amendment (CLIA) and identified by The Joint Commission (TJC) as having a comparative agreement pursuant to the Cooperative Accreditation Initiative. Department of Veterans Affairs (VA) Laboratories have been accredited for over 35 years. The laboratory accreditation process is a complex system of related and dependent activities. It includes pre-inspection/review activities (e.g., on-site inspection/reviews, inspection/review notification to Laboratory Director/Chief and VA National Enforcement Office (NEO) Representative, inspection/review validation/notification process); post-inspection/review report(s) in a exportable format (access compatible); data measurement, complaint management program and reporting requirements and data submissions. Maintaining laboratory accreditation is directed by: Veterans Health Administration (VHA) Handbook 1100.16 which establishes policy and responsibilities in obtaining and retaining The Join Commission (TJC) accreditation VHA Handbook 1106.01 which establishes policy and responsibilities for Pathology and Laboratory Medicine Service (P&LMS) This requirement includes inspection, quality assessment and laboratory accreditation services for all FDA defined complexity levels (high, moderate, waived), at specified Louisville VHA laboratories and CBOCs, where patient testing is performed. Specialties/subspecialties (in language/terms reference on CMS, Clinical and Laboratory Standards Institute (CLSI), and Good Laboratory Practices (GLP) public websites) that fall under this requirement include: Specialties Chemistry, Hematology, Immunohematology (Blood Bank), Microbiology, Anatomic Pathology, Point-of-Care Testing, Subspecialties Transfusion Medicine, Toxicology, Coagulation, Immunology, Urinalysis, Histology, Cytopathology, Molecular Pathology, Bacteriology, Blood Gas, Cytology, Histopathology, General Immunology, Immunochemistry, Molecular Microbiology, Mycobacteriology, Mycology, Point-of-Care Testing, Routine Chemistry, Syphilis Serology Quality Oversight Lab General, Team Leader Assessment of Director & Quality, All Common, Safety, Specimen Collection, Laboratory Computer Services, Environment, Communications, Laboratory Director Responsibilities; Quality Improvement, Complaint Review, and Autopsy Currently, there are eight Louisville VA patient testing sites (One major hospital clinical laboratory - VISN pays for accreditation - and seven CBOCs) that utilize inspection, quality assessment, and laboratory accreditation services under this requirement. One is high complexity (Robley Rex VAMC), and seven are waived as categorized by the FDA. Complexity testing is determined by the needs of each site and can change. During this contract s period of performance, the total number of inspections, quality assessments, and laboratory accreditation sites is not expected to change more than 10%, as long as the facilities needs comply with the testing complexity defined by the FDA. NAME OF LABORATORY ADDRESS (Bldg, floor, room where facility located; street address; city, state, zip code) COMPLEXITY LEVEL (High, Moderate, Provider Performed Microscopy or Waived CLIA IDENTIFICATION NUMBER Louisville VAMC (C306) 800 Zorn Ave Louisville, KY 40206 Highly Complex 18D0987425 VA Healthcare Center, Shively 3934 North Dixie Highway, Ste 210 Louisville, KY 40216 Minimally Complex 18D1070930 VA Healthcare Center, New Albany 4347 Security Pkwy New Albany, IN 47150 Minimally Complex 15D1070934 VA Healthcare Center, Dupont 4010 Dupont Circle Louisville, KY 40207 Minimally Complex 18D1070941 VA Healthcare Center, Carroll 1911 US Hwy 227 Carrollton, KY 41008-8037 Minimally Complex 18D2001281 VA Healthcare Center, Grayson 619 W. Main Street Clarkson, KY 42726-7044 Minimally Complex 18D2001279 VA Healthcare Center, Scott 1467 N. Scott Valley Drive Scottsburg, IN 47170-7795 Minimally Complex 15D2001284 Anticipated period of performance: 01 August 2018 through 31 July 2019. Information sought: Response to this announcement shall not exceed 10 pages and should include the following information: (1) A tailored capability statement indicating the firm s ability to provide a product and related services; (2) The respondents DUNS number, organization name, address, point of contact, and size and type of business (e.g., SDVOSB/VOSB, etc,) pursuant to the applicable NAICS code; (3) Information should be provided electronically in a Microsoft Word or Adobe PDF format. Please e-mail your response with the above information to Christina.smith7@va.gov with the subject line "Sources Sought Notice # 36C24918Q9496 by Noon on 05 July 2018. Any questions should be emailed to Christina.smith7@va.gov. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/NaVAMC/VAMCCO80220/36C24918Q9496/listing.html)
 

Document(s)

Attachment
 

File Name: 36C24918Q9496 36C24918Q9496.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4450538&FileName=36C24918Q9496-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4450538&FileName=36C24918Q9496-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Robley Rex VA Medical Center;800 Zorn Ave.;Louisville, KY

Zip Code: 40206
 

Record

SN04974206-W 20180701/180629230818-ea4e09f7ba5e57e49c3869edb8f64423 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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