Metropolitan Laboratory Services, Inc

Summary Statement of Deficiencies D0000 An unannounced, off-cite CLIA proficiency testing (PT) desk review was conducted for Metropolitan Laboratory Services, Inc on January 10, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and includes the following: 493.803 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 an off-site desk review of the laboratory's 2022 College of American Pathologists proficiency testing (PT) records (2022 Events 1, 2 and 3), a total of three 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 -- (3) events, CASPER Report 155D and interview, the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for Digoxin in two consecutive Toxicology testing events resulting in an unsuccessful PT performance. See D2118. D2118 TOXICOLOGY CFR(s): 493.845(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: Based on the review the laboratory's College of American Pathologists (CAP) proficiency testing (PT) scores for the second and third events in 2022, the CASPER 0153D Unsuccessful (2 of 3) PT report and interview, the laboratory failed to achieve satisfactory performance of at least 80% for two consecutive events for the analyte Digoxin, resulting in unsuccessful PT performance. Findings include: 1. Review of the 2022 CAP General Chemistry/Therapeutic Drugs PT evaluations and CASPER 0153D Unsuccessful (2 of 3) PT report revealed the following scores: 2022 CAP 2nd event-Digoxin-20%, 2022 CAP 3rd event-Digoxin-0% with Exception Code [40] = Results for this kit were not received. 2. In an interview with the laboratory co-owner on January 10, 2023 at approximately 2:15 PM, the co-owner stated the laboratory has not tested specimens since September 2022 and confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced, Clinical Laboratory Improvement Amendments (CLIA) complaint investigation (Complaint #VA00052827) was conducted at Metropolitan Laboratory Services , Inc on September 13, 2021 to October 4, 2021 by a Medical Facilities Inspector from the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Based on a tour, review of documents and interviews, the inspector found the complainant's allegation of not reporting all positive and negative COVID-19 test results to the Virginian Department of Health was substantiated. Due to lack of evidence the allegations of inaccurate results and delay in result reporting were not substantiated. Specific deficiency cited is as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D3000 - 42 C.F. R. 493-1100 Condition: Reporting of SARS-CoV-2 Test Reports. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on a review of laboratory policies and procedures, patient test results, lack of documentation and interviews, the laboratory failed to report SARS-CoV-2 positive 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 -- and negative test results for thirty-five (35) of 35 testing dates from July 22, 2021 until September 13, 2021 while reporting four-hundred and fifty-two (452) patient results . Findings include: 1. An interview with the Laboratory Manager on September 13, 2021 at approximately 10:30 AM revealed the laboratory performed SARS CoV-2 testing utilizing the "BioGX Xfree COVID-19 Direct RT-PCR" test kit from November 2020 until September 13, 2021. 2. Review of the manufacturer's instructions for use (IFU) for "BioGX Xfree COVID-19 Direct RT-PCR", revealed a statement, "Conditions of Authorization for the Laboratory- ...c) Authorized laboratories that receive the BioGX Xfree COVID-19 Direct RT-PCR assay must notify the relevant health authorities of their intent to run the BioGX Xfree COVID- 19 Direct RT-PCR assay prior to initiating testing. d) Authorized laboratories using BioGX Xfree COVID-19 Direct RT-PCR assay must have a process in place for reporting test results to healthcare providers and relevant public health authorities." 3. Review of SARS CoV-2 patient test reports and test logs from July 22, 2021 until September 13, 2021 revealed 452 SARS CoV-2 patient results resulted and reported during the period of review (35 testing dates). The surveyor requested to review documentation of the reporting of the 452 SARS CoV-2 patient results to the Virginia Department of Health. The laboratory provided no documentation to review. 4. A phone interview with the Laboratory Manager on October 15, 2021 at approximately 12:30 PM, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at Metropolitan Laboratory Services (formerly Mira Scientific) on July 20-21, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on May 28, 2021 and virtual record review conducted on July 15, 2021. The laboratory was surveyed under 42 C.F.R. part 493 CLIA Regulations. The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D5400 - 42 C.F.R. 493.1250 Condition: Analytic Systems and D6076 - 42 C.F.R. 493.1441 Condition: High complexity laboratory director. Metropolitan Laboratory Services (formerly Mira Scientific) is performing SARS CoV-2 (COVID- 19) testing and is in compliance with the applicable COVID-19 reporting requirements. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: ***REPEAT DEFICIENCY**** Based on a review of the laboratory's proficiency testing (PT) records, the laboratory's 2019

Summary Statement of Deficiencies D0000 An unannounced, off-cite CLIA proficiency testing (PT) desk review was conducted for Mira Scientific on May 5, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and includes the following: 493.803 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: A. Based on an off-site desk review of the laboratory's 2019 and 2020 American Association of Bioanalysts (AAB) proficiency testing (PT) records (2019 2nd Event, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 2019 3rd Event and 2020 1st Event), a total of three (3) events, CASPER Report 155D and interview, the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for Anti-Streptolysin O (ASO), Infectious Mononucleosis (Mono) and Rheumatoid Factor (RF) in three (3) consecutive General Immunology testing events resulting in a repeat unsuccessful PT performance. See D2077. B. Based on an off-site desk review of the laboratory's 2019 and 2020 American Association of Bioanalysts (AAB) proficiency testing (PT) records (2019 2nd Event, 2019 3rd Event and 2020 1st Event), a total of three (3) events, CASPER Report 155D and interview, the laboratory failed to attain a score of one-hundred (100) percent of acceptable responses for ABO and Rh in three (3) consecutive events resulting in repeat unsuccessful PT performance. See D 2155. C. Based on an off-site desk review of the laboratory's 2019 American Association of Bioanalysts (AAB) proficiency testing (PT) records (2019 2nd Event, 2019 3rd Event and 2020 1st Event), a total of three (3) events, CASPER Report 155D and interview, the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for Rapid Plasma Reagin (RPR) in two (2) consecutive Syphilis Serology testing events resulting in unsuccessful PT performance. See 2067. D. Based on an off- site desk review of the laboratory's 2019 American Association of Bioanalysts (AAB) proficiency testing (PT) records (2019 2nd Event, 2019 3rd Event and 2020 1st Event), a total of three (3) events, CASPER Report 155D and interview, the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for Human Chorionic Gonadotropin (HCG) in two (2) consecutive Endocrinology testing events resulting in unsuccessful PT performance. See 2100. D2067 SYPHILIS SEROLOGY CFR(s): 493.835(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) records, CASPER Report 0155D and interview, the laboratory failed to submit PT results within the specified time frame for Syphilis Serology (Rapid Plasma Reagin-RPR) in two (2) consecutive Syphilis Serology testing events in 2019 and 2020. Findings include: 1. Review of the laboratory's AAB 2019 2nd, 2019 3rd Event and 2020 1st Event PT records, a total of three (3) events, revealed no results for RPR for 2019 3rd Event and 2020 1st Event resulting in an unsatisfactory PT performance. 2. Review of the laboratory's CASPER Report 0155D revealed the following 2019 and 2020 General Immunology events with results of less than 80% for RPR: 2019 3rd Event=0%; and 2020 1st Event=0%; resulting in unsatisfactory performance. 3. In a telephone interview with the interim laboratory manager (LM) on May 5, 2020 at 2:05 PM, the interim LM confirmed the findings and stated they were not performing RPR testing since the 1st Event of 2019. -- 2 of 5 -- D2077 GENERAL IMMUNOLOGY CFR(s): 493.837(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) records, CASPER Report 0155D and interview, the laboratory failed to submit PT results within the specified time frame for Anti-streptolysin O (ASO), Infectious Mononucleosis (IM), and Rheumatoid Factor (RF) in three (3) of three (3) General Immunology testing events in 2019 and 2020. Findings include: 1. Review of the laboratory's AAB 2019 2nd Event, 2019 3rd Event and 2020 1st Event PT records, a total of three (3) events, revealed no results for ASO, IM, and RF for 2019 2nd Event, 2019 3rd Event and 2020 1st Event resulting in a repeat unsatisfactory PT performance. 2. Review of the laboratory's CASPER Report 0155D revealed the following 2019 and 2020 General Immunology events with results of less than 80% for ASO, IM, and RF: 2019 2nd Event - ASO = 0%; IM = 0%; RF = 0%; 2019 3rd Event - ASO = 0%; IM = 0%; RF = 0%; 2020 1st Event- ASO=0%; IM=0%; RF=0%, resulting in unsatisfactory performance. 3. In a telephone interview with the interim laboratory manager (LM) on May 5, 2020 at 2:05 PM, the interim LM confirmed the findings and stated they were not performing ASO, IM, and RF testing since the 1st Event of 2019. D2100 ENDOCRINOLOGY CFR(s): 493.843(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) records, CASPER Report 0155D and interview, the laboratory failed to submit PT results within the specified time frame for Human Chorionic Gonadotropin (HCG) in two (2) consecutive Endocrinology testing events in 2019 and 2020. Findings include: 1. Review of the laboratory's AAB 2019 2nd Event, 2019 3rd Event and 2020 1st Event PT records, a total of three (3) -- 3 of 5 -- events, revealed no results for RPR for the 2019 3rd Event and 2020 1st Event resulting in an unsatisfactory PT performance. 2. Review of the laboratory's CASPER Report 0155D revealed the following 2019 and 2020 General Immunology events with results of less than 80% for HCG: 2019 3rd Event=0%; and 2020 1st Event=0%, resulting in unsatisfactory performance. 3. In a telephone interview with the interim laboratory manager (LM) on May 5, 2020 at 2:05 PM, the interim LM confirmed the findings and stated they were not performing HCG since the 1st Event of 2019. D2155 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) records, CASPER Report 0155D and interview, the laboratory failed to submit PT results within the specified time frame for ABO and Rh (Blood group typing) in three (3) of three (3) ABO/Rh testing events in 2019 and 2020. Findings include: 1. Review of the laboratory's AAB 2019 2nd Event, 2019 3rd Event and 2020 1st Event PT records, a total of three (3) events, revealed no results for ABO/Rh for 2019 2nd Event, 2019 3rd Event and 2020 1st Event resulting in a repeat unsatisfactory PT performance. 2. Review of the laboratory's CASPER Report 0155D revealed the following 2019 and 2020 ABO and Rh events with results of less than 100%: 2019 2nd Event - ABO = 0%; Rh = 0%; 2019 3rd Event - ABO = 0%; Rh = 0%; 2020 1st Event - ABO=0%; Rh=0%, resulting in unsatisfactory performance. 3. In a telephone interview with the interim laboratory manager (LM) on May 5, 2020 at 2:05 PM , the interim LM confirmed the findings and stated they were not performing ABO, and Rh testing since the 1st Event of 2019. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) records, CASPER Report 0155D and interview, the laboratory director failed to ensure PT results for Anti-Streptolysin O -- 4 of 5 -- (ASO), Infectious Mononucleosis (Mono), Rheumatoid Factor (RF) and ABO/Rh were submitted within the specified time frame for three (3) of three (3) events in 2019 and 2020 resulting in repeat unsuccessful PT performance. See D2077 and D2155. -- 5 of 5 --

Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing desk review of Mira Scientific was conducted on December 13 and 16, 2019 by a Medical Facilities Inspector of the Virginia Department of Health's Office of Licensure and Certification. The laboratory was inspected under 42 CFR Part 493 CLIA regulations. Specific deficiencies cited are as follows: 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: A. Based on an off-site desk review of the laboratory's 2019 proficiency testing (PT) records, a total of three (3) events, and interview, the laboratory failed to attain a score Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- of at least eighty (80) percent of acceptable responses for Anti-Streptolysin O (ASO), Infectious Mononucleosis (Mono) and Rheumatoid Factor (RF) in two (2) consecutive General Immunology testing events resulting in unsuccessful PT performance. See D2077. B. Based on an off-site desk review of the laboratory's 2019 proficiency testing (PT) records, a total of three (3) events, and interview, the laboratory failed to attain a score of at one-hundred (100) percent of acceptable responses for Blood group typing (ABO and Rh) in two (2) consecutive events resulting in unsuccessful PT performance. See D2155. D2077 GENERAL IMMUNOLOGY CFR(s): 493.837(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) records, CASPER Report 0153D and interview, the laboratory failed to submit PT results within the specified time frame for Anti-streptolysin O (ASO), Infectious Mononucleosis (IM), and Rheumatoid Factor (RF) in two (2) of three (3) General Immunology testing events in 2019. Findings include: 1. Review of the laboratory's AAB 2019 PT records, a total of three (3) events, revealed no results for ASO, IM, and RF for 2019 2nd Event and 2019 3rd Event resulting in an unsatisfactory PT performance. 2. Review of the laboratory's CASPER Report 0153D revealed the following 2019 General Immunology events with results of less than 80% for ASO, IM, and RF: 2019 2nd Event - ASO = 0%; IM = 0%; RF = 0%; 2019 3rd Event - ASO = 0%; IM = 0%; RF = 0%; resulting in unsatisfactory performance. 3. In a telephone interview with the interim laboratory manager (LM) on December 13, 2019 at 9:00 AM, the interim LM confirmed the findings and stated they were not performing ASO, IM, and RF testing since the 1st Event of 2019. The interim LM stated they did not use the "exception code " when submitting the results. D2155 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) records, CASPER Report 0153D and interview, the laboratory failed to submit PT results within the specified time frame for ABO and Rh (blood group typing) in two (2) of three (3) 2019 testing events in 2019. Findings include: 1. Review of the laboratory's AAB 2019 PT records, a total of three (3) events, revealed no results for ABO and Rh for 2019 2nd Event and 2019 3rd Event resulting in an unsatisfactory PT performance. 2. Review of the laboratory's CASPER Report 0153D revealed the following 2019 ABO and Rh events with results of less than 100%: 2019 2nd Event - ABO = 0%; Rh = 0%; 2019 3rd Event - ABO = 0%; Rh = 0%; resulting in unsatisfactory performance. 3. In a telephone interview with the interim laboratory manager (LM) on December 13, 2019 at 9:00 AM, the interim LM confirmed the findings and stated they were not performing ABO, and Rh testing since the 1st Event of 2019. The interim LM stated they did not use the "exception code " when submitting the results. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced, off-cite CLIA proficiency testing (PT) desk review was conducted for Tristar Medical Labs, Inc on August 2, 2019 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. Specific deficiencies cited are as follows: 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 an off-site desk review of the laboratory's to date 2019 proficiency testing (PT) records, a total of two (2) events, and interview with the Laboratory Manager, 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 -- the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for Lithium in two (2) consecutive Toxicology events resulting in unsuccessful PT performance. See 2118. D2118 TOXICOLOGY CFR(s): 493.845(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: Based on the off-site review of the CASPER 0153D Unsuccessful proficiency testing (PT) report, PT scores (the first and second events in 2019), and telephone interview with the Laboratory Manager (LM), the laboratory failed to achieved satisfactory performance of at least 80% for two (2) consecutive PT events for the analyte Lithium (Li), resulting in an unsuccessful performance. Findings include: 1. Review of the CASPER 0153D Unsuccessful PT report and the College of American Pathologists (CAP) PT scores for the first and second events in 2019 revealed the following Lithium scores: CAP-C-A Event 1 Li-0% CAP-C-B Event 2 Li-0% The laboratory has received 2 consecutive unsatisfactory CAP PT scores for the analyte listed above. 2. A telephone interview with the LM at approximately 10:00 AM confirmed that the laboratory received 2 consecutive unsatisfactory performance scores for the Li analyte. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Tristar Medical Labs, Inc on March 25-26 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing (PT) records and interview with the Technical Consultant (TC), the Laboratory Director (LD) and Testing Personnel (TP) failed to sign nine (9) of forty-eight (48) attestation statements reviewed from May 2017 until March 2019. Findings include: 1. Review of the laboratory's PT for twenty (20) events in 2017 and twenty-eight (28) events in 2018 revealed the LD and TP did not sign the following attestation statements: 2017 College of American Pathologists (CAP) B-B Bacteriology Event B; 2017 CAP C-C General Chemistry and Therapeutic Drug Survey Event C; 2017 CAP K-B Ligand Assay, General Event B; 2017 CAP CGL-A Coagulation, Limited Event A; 2018 CAP C-A General Chemistry and Therapeutic Drug Survey Event A; 2018 CAP C-C General Chemistry and Therapeutic Drug Survey Event C; 2018 CAP K-B Ligand Assay, General Event B; 2018 CAP FH-B Hematology Event B; and 2018 CAP CGL- B Coagulation, Limited Event B. A total of 9 events. 2. In an exit interview on 3/26 /19 at approximately 12:30 PM, the TC confirmed the findings. D3031 RETENTION REQUIREMENTS Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- 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 review of quality control (QC) records, and an interview with Testing Personnel (TP) C, the laboratory failed to retain the "Liquichek Immunoassay Plus Control Levels 1, 2, and 3" manufacturer's assay information inserts documenting Prostatic Specific Antigen (PSA), Lutenizing Hormone (LH), Vitamin B12, T-uptake, Free T3, Free T4, Total T3, Total T4, Thyroid Stimulating Hormone (TSH), Folate, Testosterone, Follicle Stimulating Hormone (FSH), and Human Chorionic Gonadotropin (HCG) QC acceptable ranges for one (1) of two (2) lot numbers utilized from April 19, 2018 up to the date of survey on March 25, 2019. Findings include: 1. Review of the laboratory's QC records from April 19, 2018 up to the date of survey on March 25, 2019 revealed the laboratory received and utilized 2 lot numbers of the "Liquichek Immunoassay Plus Control Levels 1, 2, and 3". One lot number QC, lot number 40920, had no documentation of acceptable ranges or manufacturer's package inserts retained. The surveyor requested the manufacturer's assay information insert for lot 40920. The laboratory provided no documentation to review. In an interview on 3/26/19 at approximately 10:30 AM, TP C stated she/he did not save the package insert. 2. In an exit interview on 3/26/19 at approximately 12:30 PM, the TC confirmed the findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: ***REPEAT DEFICIENCY*** Based on review of the laboratory's policy and procedure manual, manufacturer package inserts, quality control (QC) records, calibration records, patient records, quality assessment (QA) checklists, and interviews with the Laboratory Director (LD), Technical Consultant (TC), and Testing Personnel (TP), the laboratory failed to: 1. establish the "Mean of the PT Normal Range with each new lot" of "HemosIL RecombiPlasTin 2G" (Cross Reference D 5411); 2. ensure the Rapid Plasma Reagin (RPR) kit was within the manufacturer's stated expiration date (Cross Reference D 5417); 3. perform and document the Access 2 weekly maintenance (Cross Reference D 5429); 4. follow the established policy performing calibration for the GEN S and LH 750 Hematology analyzers every three months (Cross Reference D 5437-**REPEAT DEFICIENCY**); 5. establish QC ranges for the "Liquichek Immunoassay Plus Controls" and the "TOSOH Hemoglobin A1c Controls" (Cross Reference D 5469 A & B); 6. perform the twice annual -- 2 of 13 -- comparison of the Hematology and Chemistry instruments (Cross Reference D 5775); and 7. establish and follow a