E-Lab Of Las Vegas

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on October 4, 2022. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a random patient audit of eight patients tested between the dates of April 19, 2021 and January 15, 2022, and an interview with the general supervisor, the laboratory failed to retain the quality control records for the SARS-CoV-2 molecular tests performed. Findings include: 1. A random audit of eight patients tested between the dates of April 19, 2021 and January 15, 2022 for the Quidel Lyra SARS-CoV-2 molecular tests performed on the Thermofisher QuantStudio 7 revealed that the laboratory failed to have the quality control records available for review at the time of the survey. 2. The general supervisor stated during an interview conducted on October 4, 2022 at approximately 12:00 PM that the quality control results were stored in the Thermofisher QuantStudio 7 analyzer but failed to recall how to retrieve them from the instrument. The laboratory performs approximately 1000 virology tests annually. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on a lack of the laboratory quality assessment records, a review of the director approved quality assessment policy, and an interview with the general supervisor and the laboratory owner, the laboratory failed to retain quality assessment records for a minimum of two years. Findings include: 1. The laboratory failed to retain records of quality assessment to have available for review at the time of the survey. 2. A review of the director approved quality assessment policy includes a schedule of elements under review each month on page 5. The policy and procedure states, "Review the element(s) assigned for each month. Document the review and attach all supporting data and information." 3. An interview with the general supervisor and the owner on October 4, 2022 at approximately 11:00 AM revealed that the laboratory failed to retain the quality assessment records for review, and failed to confirm whether the quality assessment was performed. The laboratory performs approximately 1000 virology tests annually. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the 2021 American Association of Bioanalysts (AAB) Nonchemistry Quarter 1 Proficiency Testing (PT) report, the December 2021 in-house alternative proficiency testing report, the 2022 College of American Pathologists (CAP) SARS-CoV-2 Molecular event A PT report, and an interview with the General Supervisor, the laboratory failed to verify the accuracy of the SARS-CoV-2 molecular testing at least twice annually. Findings include: 1. A review of the 2021 AAB Nonchemistry Quarter 1 PT report for SARS-CoV-2 testing revealed that the laboratory failed to achieve a passing score of at least 80%. The laboratory obtained a score of 67%. 2. A review of the December 14, 2021 in-house alternative proficiency testing for the SARS-CoV-2 test revealed that the laboratory achieved a score of 100% for the event. 3. A review of the 2022 CAP SARS-CoV-2 Molecular PT results revealed that it was reported to CAP that the laboratory was unable to analyze the specimens. 4. During an interview conducted on October 4, 2022 at approximately 10: 30 AM, the general supervisor stated that the laboratory was unable to obtain reagents to perform the SARS-CoV-2 molecular testing. It was also confirmed that the laboratory failed to participate in either an approved proficiency testing program, or an in-house alternative testing program during 2022. The laboratory performs approximately 1000 virology tests annually. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a random patient audit of eight patients tested for SARS-CoV-2 molecular testing between the dates of April 19, 2021 and January 14, 2022, a review of the laboratory maintenance logs for the Thermofisher Quantstudio 7, a review of the user guide for the Thermofisher Quantstudio 7, and an interview with the general supervisor, the laboratory failed to ensure that the monthly maintenance established by the manufacturer for the Thermofisher Quantstudio 7 was performed and documented each day of patient testing. Findings include: 1. A random patient audit of eight patients tested for SARS-CoV-2 molecular testing between the dates of April 19, 2021 and January 14, 2022 revealed that the laboratory failed to document the monthly background calibration maintenance for the Thermofisher Quantstudio 7 analyzer as required by the manufacturer on four of eight dates of patient testing. The monthly background calibration was not documented for the months of May, 2021, June, 2021, July, 2021, and August, 2021. 2. The general supervisor confirmed the findings during an interview conducted on October 4, 2022 at approximately 12:00 PM. The laboratory performs approximately 1000 virology tests annually. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a random patient audit of eight patients tested for SARS-CoV-2 molecular testing between the dates of April 19, 2021 and January 14, 2022, a review of the laboratory maintenance logs for the Thermofisher Quantstudio 7, a review of the user guide for the Thermofisher Quantstudio 7, and an interview with the general supervisor, the laboratory failed to ensure that the laboratory established daily and monthly maintenance for the Thermofisher Quantstudio 7 was performed and documented each day of patient testing. Findings include: 1. A random patient audit of eight patients tested for SARS-CoV-2 molecular testing between the dates of April 19, 2021 and January 14, 2022 revealed that the laboratory failed to document the daily or monthly maintenance for the Thermofisher Quantstudio 7 analyzer for seven of eight dates patient testing. 2. The laboratory failed to retain the maintenance logs for review of documentation of the Quantstudio 7 daily maintenance consisting of performing the Start-Up Sequence and Wiping Down the Sample Block, and the monthly Decontamination of the Sample Block for the months of May, 2021, June, 2021, July, 2021, and August, 2021. 3. A random patient audit of eight patients tested for SARS-CoV-2 molecular testing between the dates of April 19, 2021 and January 14, 2022 revealed that the laboratory failed to document daily maintenance consisting of performing the Start-Up sequence and wiping down the sample block on the following days of use: April 19, 2021, September 4, 2021, October 29, 2021, December 27, 2021, and January 15, 2022.. 4. A random patient audit of eight patients tested for SARS-CoV-2 molecular testing between the dates of April 19, 2021 and -- 3 of 4 -- January 14, 2022 revealed that the laboratory failed to document monthly maintenance consisting of decontamination of the sample block on the months of: September, 2021, October, 2021, December, 2021, and January, 2022. 5. The general supervisor confirmed the findings during an interview conducted on October 4, 2022 at approximately 12:00 PM. The laboratory performs approximately 1000 virology tests annually. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of the director approved laboratory quality assessment policy, the lack of laboratory quality assessment records, a random patient audit of eight patients tested for SARS-CoV-2 molecular testing between the dates of April 19, 2021 and January 14, 2022, and an interview with the general supervisor, the laboratory director failed to ensure that the established quality assessment program was maintained to assure the quality of the laboratory services proved, and to identify failures in quality when they occur. Findings include: 1. The director failed to ensure that the laboratory retained records of quality assessment for a minimum of two years. There were no records of quality assessment available since the previous survey on March 31, 2021. It could not be confirmed whether quality assessment activities were performed in accordance with the director approved procedure. 2. The of the director approved quality assessment policy stated on Page 5, "Review the element(s) assigned for each month. Document the review and attach all supporting data and information." 3. The director failed to ensure that the laboratory retained the Thermofisher Quantstudio 7 maintenance logs for the months of May, 2021, June, 2021, July, 2021, and August, 2021. 4. The director failed to ensure that the labortory performed and documented daily and monthly maintenance in accordance with the manufacturer's instructions for the Thermofisher QuantStudio 7 analyzer or the laboratory established maintenance schedule. 5. The director failed to ensure that the laboratory verified the accuracy of the SARS-CoV molecular testing between the January, 2022 and October 4, 2022. 6. The findings were confirmed during an interview with the laboratory general supervisor conducted on October 4, 2022 at approximately 1:00 PM. The laboratory performs approximately 1000 virology tests annually. -- 4 of 4 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA initial survey conducted at your facility on March 31, 2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a random audit of patient records, a review of the Quantstudio 7 Pro Maintenence Log, and an interview with the laboratory director, and with testing personnel #1 on the Centers for Medicare and Medicaid Services (CMS) 209 form, the laboratory failed to document the daily maintenance on all days of patient testing. Findings include: 1. A random audit of six patient test reports between the dates of January 4, 2021 and March 19, 2021 revealed that the daily maintenance was not documented for one of six days of patient testing. There was no documentation of the daily maintenance for the date of January 22, 2021. 2. A random audit of six patient test reports between the dates of January 4, 2021 and March 19, 2021 revealed that the daily maintenance was not documented accurately for the actual dates of patient testing due to the mislabeling of each day of the month for the maintenance log. The maintenance of the analyzer was not documented on February 15, 2021 and March 19, 2021. 3. A review of the daily maintenance log revealed that the log did not allocate spaces to document maintenance that corresponded to the dates between the 15th day of each month and the 21st day of each month. This was confirmed during an Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- interview conducted on 3/31/21 at approximately 10:15 am with the laboratory director and testing personnel #1 listed on the CMS 209 form. The laboratory performs approximately 1000 Virology tests annually. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of the director approved quality assessment policy, monthly quality assessment documentation for the months of January, February and March 2021, and an interview with the laboratory director, the director failed to ensure that the established quality assessment program was maintained to ensure the quality of laboratory services and to identify failures in quality when they occur. Findings include: 1. The laboratory director failed to follow the director approved policy and procedure for quality assessment evaluation and documentation when evaluating the laboratory services provided by the laboratory for testing months January, February, and March 2021. 2. The laboratory director documented "N/A" for QA Plan, and Personnel Training covered in January, 2021, for Test Tracking and Communication covered in February 2021, and for Specimen Handling and Proficiency Testing covered in March 2021on the Quality Assurance Review Summary. This was confirmed during an interview conducted with the laboratory director on March 31, 2021 at approximately 10:30 am. The laboratory performs approximately 1000 Virology tests annually. -- 2 of 2 --