Mega Lab-Health Care Svc, Llc

Summary Statement of Deficiencies D0000 An off-site CLIA proficiency testing desk review of Mega-Lab Health Care Svc, LLC was completed on September 9, 2024 by a Medical Facilities Inspector of the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The laboratory was found not in compliance with the following Condition under 42 CFR part 493 CLIA Regulations: D2016 - 42 C.F.R. 493.803 (a)(b)(c) Condition- Successful Participation. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report and College of 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 -- American Pathologists (CAP) proficiency testing scores for 1. 2023 (Event three) and 2024 (Event one), the laboratory failed to successfully participate in a proficiency testing program approved by Health and Human Services (HHS) for the analyte Total Bilirubin (TBil). Refer to D2096 A. 2. 2024 (Events one, and two), the laboratory failed to successfully participate in a proficiency testing program approved by Health and Human Services (HHS) for the analytes Amylase (Amy), Total Cholesterol (Chol), High Density Lipoprotein Cholesterol (HDL), Creatine Kinase (CK), Iron (Fe), Triglyceride (Trig). Refer to D2096 B. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: A. Based on a proficiency testing (PT) desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report, and College of American Pathologists (CAP) evaluation reports for 2023 (Events two and three) and 2024 (Events one and two), the laboratory failed to achieve satisfactory performance (80%) for the Chemistry analyte Total Bilirubin (TBil) for two (2) of four (4) events reviewed. The laboratory had unsatisfactory scores for TBil for two consecutive PT events (2023 Event 3, and 2024 Event 1) resulting in initial unsuccessful participation. The findings include: 1. Review of the CASPER-0155 report revealed the following unsatisfactory scores: 2023 Event 3: TBil = 40%, 2024 Event 1: TBil = 40%, 2. A review of the laboratory's 2023 events 2 and 3 and 2024 event 1 and 2 CAP PT scores for the analyte TBil confirmed the above findings resulting in initial unsuccessful participation for the analyte TBil. B. Based on a proficiency testing (PT) desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER) -0155 report, and College of American Pathologists (CAP) evaluation reports for 2023 (Events two and three) and 2024 (Events one and two), the laboratory failed to achieve satisfactory performance (80%) for the Chemistry analytes Amylase (Amy), Total Cholesterol (Chol), High Density Lipoprotein Cholesterol (HDL), Creatine Kinase (CK), Iron (Fe), Triglyceride (Trig) for two (2) of four (4) events reviewed. The laboratory had unsatisfactory scores for Amylase (Amy), Total Cholesterol (Chol), High Density Lipoprotein Cholesterol (HDL), Creatine Kinase (CK), Iron (Fe), and Triglyceride (Trig) for two consecutive PT events (2024 Events 1 and 2) resulting in initial unsuccessful participation. The findings include: 1. Review of the CASPER-0155 report revealed the following unsatisfactory scores: 2024 Event 1: Amylase (Amy), Total Cholesterol (Chol), High Density Lipoprotein Cholesterol (HDL), Creatine Kinase (CK), Iron (Fe), and Triglyceride (Trig) = 0%, 2024 Event 2: Amylase (Amy), Total Cholesterol (Chol), High Density Lipoprotein Cholesterol (HDL), Creatine Kinase (CK), Iron (Fe), and Triglyceride (Trig) = 0%, 2. A review of the laboratory's 2023 events 2 and 3 and 2024 event 1 and 2 CAP PT scores for the Chemistry analytes above confirmed the findings resulting in initial unsuccessful participation for the analytes Amylase (Amy), Total Cholesterol (Chol), High Density Lipoprotein Cholesterol (HDL), Creatine Kinase (CK), Iron (Fe), and Triglyceride (Trig). -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced on-site CLIA initial survey was conducted at Mega Lab-Health Care Svc, LLC on January 25, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on December 21, 2021 and virtual record review conducted on January 18, 2022. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The inspector noted that the laboratory performs SARS-CoV-2 (COVID-19) testing and is in compliance with the applicable COVID-19 reporting requirements. The specific deficiency cited is as follows: D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a tour, review of the manufacturer's package insert, test result logs, and interviews, the facility failed to follow the manufacturer's instructions for the sample type while performing three (3) COVID-19 (SARS-CoV-2) tests for two (2) testing days between July 21, 2021 and January 21, 2022. Findings include: 1. During a tour of the laboratory on January 25, 2022 at approximately 11:30 AM, the inspector inquired of Testing Personnel A (TP A) regarding the laboratory protocol for "Inconclusive" COVID-19 patient results received when performing SARS CoV-2 (COVID-19) testing using the TaqPath COVID-19 Combo Kit on the QuantStudio 5. TP A stated that they repeat the test on the Accula SARS CoV-2 test system using the patient's viral transport media (VTM) solution. They take the swab provided with the Accula SARS CoV-2 kit and "swirl" it in the patient's VTM and proceed with the test according to the Accula kit manufacturer's instructions. 2. Review of the Accula SARS CoV-2 Test system's manufacturer's instructions for use (IFU) revealed the 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 -- following statements, "LIMITATIONS-Collection of patient samples into media other than the supplied Accula SARS-CoV-2 Buffer (such as UTM, VTM, or saline), or dilution of previously collected samples out of UTM, VTM, or saline into the Accula SARS-CoV-2 Buffer is off-label use and has be shown to adversely impact test performance." 3. Review of the QuantStudio 5's COVID-19 patient test results from July 21, 2021 until January 21, 2022 revealed the following patient COVID-19 results analyzed as "Inconclusive": 07/21/2021-Accession number 0011-ML000265; 09/01 /2021-Accession number 0011-ML000998; 01/21/2021-Accession number 0011- ML001821; 01/21/2021-Accession number 0011-ML005333. The surveyor requested to review the method used for the repeat testing of the above listed "Inconclusive" results. The laboratory provided the following documentation: 07/21/2021-Accession number 0011-ML000265-specimen repeated using the TaqPath Combo Kit with a positive result reported; 09/01/2021-Accession number 0011-ML000998-specimen repeated using the Accula kit with a positive result reported; 01/21/2021-Accession number 0011-ML001821-specimen repeated using the Accula kit with a negative result reported; and 01/21/2021-Accession number 0011-ML005333-specimen repeated using the Accula kit with a negative result reported. 4. In an exit interview with the Technical Supervisor and TP A on January 25, 2022 at approximately 12:00 PM, the above findings were confirmed. -- 2 of 2 --