Valencia Branch Laboratory Inspection Documents

• Issue Brief - Valencia Branch Laboratory (VBL) - November 2021
• Complaint inspection closure letter – November 10, 2021 – LFS closure letter to the laboratory. The laboratory is in compliance. (PDF) 
• Routine inspection closure letter – November 10, 2021 – LFS closure letter to the laboratory.  The laboratory is in compliance, withdrawal of sanctions. (PDF)

Complaint Inspection Documents

• Routine initial state inspection report issued February 19, 2021 – LFS report (PDF) and Cover letter (PDF) 
• Routine inspection – March 1, 2021 lab response to LFS – 1st submission (PDF) 
• Routine inspection – March 8, 2021 lab response to LFS – 2nd submission (PDF)
• Attachment 1 – Sample Look Back and Look Forward (Excel)
  
• Attachment 2 – CA-QM-FM-018 Audit Schedule Plan (PDF)
  
• Attachment 3 – AUDIT PLAN – End-to-End 10 specimen January 2021 (PDF)
• Attachment 4 – Audit Report – 21Audit004 – End to End Tracer – Verified3 (PDF)
• Routine inspection – March 11, 2021 lab response to LFS – 3rd submission (PDF)
• LFS Cover letter – 03-11-21 (PDF)
  
• Routine inspection – March 30, 2021 lab response to LFS – 4th submission (PDF)
• CDPH VBL 2567 Section Updates (PDF)
  
• Routine inspection – May 17, 2021 – LFS review of the laboratory's cumulative submissions (PDF)
• Routine inspection – May 24, 2021 lab response to LFS – 5th submission (PDF)
  
• RE_ Routine inspection – LFS review of the laboratory's cumulative submissions (PDF)
  
• Attachment D3027_1 – 21Audit008 – End-To-End Tracer – Final Report with Requisitions (PDF)
• Attachment D5301_1 – CA_PER_FM_031 (PDF)
  
• Attachment D5301_2 – Training Record – COLOR Dashboard Records – Quality – March 4, 2021 (PDF)
• Attachment D5400_1 – Dr. Kimsey Letter (PDF)
• Attachment D5400_2 – LFS Letter May 2021 (PDF)
  
• Attachment D5400_3 – Perkin Elmer New Coronavirus Nucleic Acid Detection Kit v7 (PDF)
• Attachment D5400_4 – COVID High Ct NGS Data Report 03-2021 v7 (PDF)
  
• Attachment D5400_5 – LDT Validation Summary (PDF)
• Attachment D5400_6 – Analytical Study (PDF)
  
• Attachment D5400_7 – 8 Performance Evaluation report v03 (PDF)
• Attachment D5400_8 – CA-VALRPT-LAB-003 (PDF)
• Attachment D5400_9 – Right to Reference Letter CA Lab (PDF)
  
• Routine inspection – June 8, 2021 LFS review of lab's May 24, 2021 submission (PDF)
• Routine inspection – June 18, 2021 lab response to LFS – validation plan – 6th submission (PDF)
  
• CA-VALPLN-LAB-000 Validation Plan SARS-CoV2 June LFS – Final (PDF)
  
• Routine inspection – July 3, 2021 lab response to LFS – request for extension; additional details of validation plan – 7th submission (PDF)
• Routine inspection – July 21, 2021 LFS letter to laboratory regarding its requests for additional extensions (PDF)
• Routine inspection – August 20, 2021 lab response to LFS – 8th submission – email (PDF)
• Routine inspection – October 21, 2021 LFS sent Notice of Intent to Impose Sanctions (PDF)
  
• Directed plan of correction
  
• State onsite monitoring
  
• Routine inspection – October 27, 2021 lab response to LFS – 9th submission (PDF)
• Response to LFS Letter dated 10-21-2021 – State Routine Inspection – Notice of Intent to Impose Sanctions upon CDPH Branch Laboratory CPH889339 – email (PDF)
  
• Routine inspection – October 28, 2021 LFS email to lab director – provide documents lab submitted to CMS on September 10, 2021 – email (PDF)
  
• Routine inspection – November 2, 2021 lab response to LFS – 10th submission
  
• CA-CLSRV-GUIDE-002 Nasal Swab Self Collection Instructions (PDF)
  
• CA-RPT-POL-002 Policy for Changes to Test Interpretation (PDF)
  
• CA-VALRPT-LAB-021 Validation Report for SARS-CoV-2 Dry Swab Supplemental (PDF)
  
• EMAIL – November 02, 2021 – CMS submission sent 9-10-21 – email (PDF)
  
• Letter of Explanation to Ordering Physician (PDF)
  
• Review of NGS Data to Verify Cut Off (PDF)
  

If you are having difficulty accessing any of these documents, please contact CDPH at cdphpress@cdph.ca.gov to request this information in an alternate format. ​