Legacy Md Medical Group Inc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on 07/18/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) records (2025-1 and 2025-2), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the analyte Free Thyroxine resulting in unsuccessful performance. See D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API - American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance events (2025-1 and 2025-2), the analyte Free Thyroxine. The finding include: Free Thyroxine 20% - 2025 first testing event; Free Thyroxine 20% - 2025 second testing event. A review of the 2025 scores from American Proficiency Institute (API) confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and American Proficiency Institute records for 2025-1 and 2025-2 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and American Proficiency Institute records for 2025-1 and 2025-2 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2107. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 8/13/2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) records (2023-3 and 2024-2), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the subspecialty of Routine Chemistry for the analyte Sodium (Na) resulting in a unsuccessful performance. Refer to D2096. 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: Based on desk review of Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API evaluation reports, the laboratory failed to achieve satisfactory performance for two of three proficiency events in 2023 and 2024 for analyte Na. The finding include 1. The laboratory received the following scores: 60% on the 2023 Na third event 0% on the 2024 Na second event 2. A review of the 2023 and 2024 proficiency Testing scores from American Proficiency Institute Confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 155 report API records for 2023-3 and 2024-2 events, the laboratory director failed to provide overall management and a direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CASPER 155 report API records for 2023-3 and 2024-2 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the America Proficiency Institute (API) and the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D for the years 2023 and 2024 the laboratory obtained unsuccessfully score for testosterone analyte for three consecutive events, see D2099 for endocrinology subspecialty and routine chemistry (sodium analyte) in which the laboratory is certified under CLIA. SeeD2087 and D2096. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the America Proficiency Institute (API) proficiency testing (PT) records, six (6)) randomly selected patient results, and interview with the technical consultant (TC); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Routine Chemistry various analytes. The finding included: 1. Based on review of PT records from API the following unsatisfactory results were obtained for: a) Amylase, first event in 2024 (Q1-2024) = 40% b) Chloride, Second event 2024 (Q2-2004) = 40% c) Folate, Second event 2024 (Q2-2004) = 0% d) Sodium, Third event 2023 (Q3-2023) = 60% d) Sodium. Second event 2024 (Q2-2004) = 0% 2. Based on the laboratory testing declaration submitted at the time of the survey on July 23, 2024, the laboratory analyzed and reported approximately 70,000 Routine Chemistry tests including the analytes in #1 above during the time the laboratory had unsatisfactory proficiency testing results. 3. The TC affirmed on 7/23/2024 at approximately 11:45 a.m. that the laboratory received the above unsatisfactory proficiency testing score from API. 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: Based on review of the American Proficiency Institute (API) and the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API evaluation reports, the laboratory failed to achieve satisfactory performances in 2023 and 2024 in two out of three consecutive testing events for sodium analyte. The finding included: 1. Third Event 2023 (Q3-2023) Sodium 60% 2. Second Event 2024 (Q1-2024) 0% D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the America Proficiency Institute (API) proficiency testing (PT) records and the Certification and Survey Provider Enchanced Reporting (CASPER) Report 0155D Individual Laboratory Profile , six (6) randomly selected patient results, and interview with the technical consultant (TC); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Endocrinogy testosterone analyte. The finding included: 1. Based on review of PT records from API the following unsatisfactory results were obtained for testosterone analyte: a) Third event of 2023 (Q3-2023) 0% b) First event of 2023 (Q1-2024) 0% c) -- 2 of 6 -- Second event of 2024 (Q2-2024) 50% for testosterone analyte. 2. Based on the laboratory testing declaration submitted at the time of the survey on July 23, 2024, the laboratory analyzed and reported approximately 5,000 Endocrinology tests including testosterone analyte during the time the laboratory had unsatisfactory proficiency testing results. 3. The TC affirmed on 7/23/2024 at approximately 11:45 a.m. that the laboratory received the above unsatisfactory proficiency testing score from API. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the lack of laboratory written policies and procedures for all tests performed in the laboratory (Virology, General Immunology, Routine Chemistry, Endocrinology and Hematology) and interviews with the technical consultant (TC) laboratory testing personnel (TP); it was determined that the laboratory failed to have available and follow written procedures for all test performed in the laboratory. The findings included: 1. On the day of the survey on July 23, 2024, at approximately 12:15 p.m. the laboratory failed to provide written policies and procedures for all test performed in the laboratory. 2. The TC and TP confirmed on 7/23/2024 at approximately 12:30 p. m. that the laboratory did not have written policies and procedures available for all tests performed in the laboratory. 3. Based on the laboratory's annual testing volume declaration signed by the laboratory director on 7/23/2024, the laboratory processed and reported 112,000 patients' sample without having a procedure each diagnostic test performed. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on the surveyors' observation during the laboratory's tour of reagent materials used in the laboratory and interviews with the technical consultant (TC) and testing personnel (TP); it was determined that the laboratory failed to label various reagents used for test performance to indicate the reagent's received date, opening, preparation, and expiration dates when such reagents are used in the laboratory. The findings included: 1. Based on the surveyor's observation during the laboratory tour on July 23, 2024, at approximately 1:30 pm.; no received date, opening, preparation, or expiration date labels were used or documented for all test reagents used throughout the laboratory. 2. The laboratory's TC and TP affirmed in an interview conducted on July 23, 2024, at approximately 2:00 p.m. that all the reagents used in the laboratory were not labeled with the received date, opening, preparation, and expiration dates or -- 3 of 6 -- documented in a reagent preparation log. 3. Based on the laboratory's annual testing declaration submitted at the time of the survey, the laboratory analyzed approximately 112,000 for which testing reagents were not labelled. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual, lack of a policy and a list of critical values for all tests performed in the laboratory including hematology and chemistry and its reporting procedure, review of six (6) randomly selected patient sampling test results and interview with the technical consultant (TC) and testing personnel (TP); it was determined that the laboratory failed to have and follow a policy for reporting of critical values. The findings included: 1. The laboratory's policy and procedure manual did not have a critical results notification policy, neither was a list of established critical values for all tests performed in the laboratory. 2. For two (2) out of six (6) patients results reviewed there was no documentation notes on how critical values were handled and reported by the TP. 3. The TC and TP affirmed on July 23, 2024, at approximately 1;45 p.m. that the laboratory did not have a written policy and procedure on critical values documentation for reporting. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the proficiency testing reported results review of the American Proficiency Institute and the CASPER 155 report American Proficiency Institute records for 2023 third event and 2024 first and second event, the laboratory director failed to provide overall management and a direction of the laboratory services. Refer to D 2087 and D6016. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) -- 4 of 6 -- 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)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records, six (6) randomly selected patients tests records, lack of laboratory test procedures, and interview with the technical consultant and testing personnel (TP); it was determined that the laboratory director is cited herein due to failure to ensure that several aspects of the preanalytic and analytic phases of the laboratory testing were monitored. See D5401, D5415, D5417, D5813. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the proficiency testing report review of the American Proficiency Institute and the CASPER 155 report records for 2023 and 2024 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2087, D2096, and D2099. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on direct observation and interview with the technical consultant and testing personnel; it was determined that the laboratory director failed to ensure that a signed and dated approved written procedure manual is always available to all personnel responsible for any aspect of the testing process. See D5401. -- 5 of 6 -- D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on the lack of laboratory's policies and procedures, reagents labels, expired reagents stored in the laboratory, lack of critical values list, failed proficiency testing for various analytes, and interview with the laboratory testing personnel it was determined that the technical consultant failed to identify the training needs and assure that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed. The findings included: D2099, D5415, D5417, and D5813. -- 6 of 6 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on April 10, 2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - C.F.R. 493.803 Conditions: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; Laboratory Director. 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: This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155D and American Proficiency Institute (API) records (2023-1, 2023-2, and 2023-3), the laboratory failed 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 -- to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the subspecialty of Virology resulting in subsequent unsuccessful performance. Refer to D2064. D2064 VIROLOGY CFR(s): 493.831(e) Failure to achieve an overall testing event score of satisfactory performance for 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155D Individual laboratory Profile and American Proficiency Institute evaluation report, the laboratory failed to achieve satisfactory performance for three of three events in 2023 for the subspecialty of Virology: The finding include: 1. The laboratory received the following scores: 67% on the 2023 first event 67% on the 2023 second event 67% on the 2023 third event A review of the 2023 proficiency testing scores from American Proficiency Institute confirmed the above findings. Refer to D2016. 2. A review of the 2023 proficiency testing scores from American Proficiency Institute confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 155 report and API records for 2023-1, 2023-2, and 2023-3 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CASPER 155 report API records for 2023-1, 2023-2, and 2023-3 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2064. -- 2 of 2 --

Summary Statement of Deficiencies 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Virology constituting unsuccessful PT performance. (See D2064) 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 -- D2064 VIROLOGY CFR(s): 493.831(e) Failure to achieve an overall testing event score of satisfactory performance for 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Virology, as follows: 2023 Q1 2023 Q2 Virology 67% 67% Q1 = First testing event Q2 = Second testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT events resulted in an initial unsuccessful performance for Virology.. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: For Virology, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance (see D2016 and D2064). -- 2 of 2 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on interviews with the staff on April 29, 2021, review of CMS 155 report (Individual Laboratory Profile) and review of American Proficiency Institute (customer number 73669) proficiency testing records from the 1st testing event of 2019 through the 1st testing event of 2021, for one out of seven proficiency testing events reviewed, the laboratory failed to attain a score of at least 80 percent in total cholesterol testing. The findings included: a. The laboratory performs total cholesterol testing on the Horiba ABX Pentra 400 analyzer. b. Laboratory proficiency testing records as well as the CMS 155 Report showed the laboratory attained a score of 20% for total cholesterol testing during the 3rd proficiency testing event of 2019. c. A testing person affirmed on April 29, 2021 at approximately 11:00 am, the unsatisfactory score of 20% obtained by the laboratory for total cholesterol testing during the 3rd proficiency testing event of 2019. d. Based on the annual test volume reported, the laboratory performed and reported approximately 100,000 tests under the specialty of chemistry. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: 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 -- Based on interviews with the staff on April 29, 2021, review of CMS 155 report (Individual Laboratory Profile) and review of American Proficiency Institute (customer number 73669) proficiency testing records from the 1st testing event of 2019 through the 1st testing event of 2021, the laboratory failed to attain a score of at least 80 percent in white blood cell (WBC) differential (lymphocyte, granulocyte, and monocyte identification) testing. The findings included: a. The laboratory performs complete blood count (CBC) testing on the Horiba ABX Micros 60 analyzer (serial number: S12C595452). b. Laboratory proficiency testing records as well as the CMS 155 Report showed the laboratory attained the following scores for each individual analyte. 1. Proficiency testing results in white blood cell (WBC) differential (lymphocyte, granulocyte, and monocyte identification) failed to attain an overall testing score of 80 percent for the 1st event of 2019. a) Granulocyte count proficiency test results indicated that four out of five American Proficiency Institute proficiency samples tested were not within acceptable range. Sample Reported Expected Performance HEM-01 62.9 64.4 - 70.1 Unacceptable HEM-02 36.1 35.8 - 43.1 Acceptable HEM-03 77.0 77.5 - 83.1 Unacceptable HEM-04 61.9 62.6 - 67.9 Unacceptable HEM-05 69.2 72.8 - 82.6 Unacceptable A testing person affirmed on April 29, 2021 at approximately 11:00 am, the unsatisfactory score of 20% obtained by the laboratory for granulocyte count testing during the 1st proficiency testing event of 2019. b) Lymphocyte count proficiency test results indicated that two out of five American Proficiency Institute proficiency samples tested were not within acceptable range. Sample Reported Expected Performance HEM-01 30.2 24.6 - 29.9 Unacceptable HEM-02 59.8 46.5 - 59.3 Unacceptable HEM-03 16.4 13.8 - 17.3 Acceptable HEM-04 32.4 26.0 - 32.6 Acceptable HEM-05 17.7 4.0 - 18.0 Acceptable A testing person affirmed on April 29, 2021 at approximately 11:00 am, the unsatisfactory score of 60% obtained by the laboratory for lymphocyte count testing during the 1st proficiency testing event of 2019. c) Monocyte count proficiency test results indicated that two out of five American Proficiency Institute proficiency samples tested were not within acceptable range. Sample Reported Expected Performance HEM-01 6.9 3.4 - 7.7 Acceptable HEM-02 4.1 2.7 - 12.6 Acceptable HEM-03 6.6 2.3 - 6.1 Unacceptable HEM-04 5.7 3.1 - 7.7 Acceptable HEM-05 13.1 2.9 - 9.4 Unacceptable A testing person affirmed on April 29, 2021 at approximately 11:00 am, the unsatisfactory score of 60% obtained by the laboratory for monocyte count testing during the 1st proficiency testing event of 2019. 2. Proficiency testing results in white blood cell (WBC) differential (lymphocyte, granulocyte, and monocyte identification) failed to attain an overall testing score of 80 percent for the 1st event of 2020. a) Granulocyte count proficiency test results indicated that four out of five American Proficiency Institute proficiency samples tested were not within acceptable range. Sample Reported Expected Performance HEM-01 36.3 32.9 - 39.6 Acceptable HEM-02 77.4 78.0 - 82.6 Unacceptable HEM-03 63.2 63.4 - 68.0 Unacceptable HEM-04 62.1 62.2 - 67.0 Unacceptable HEM-05 73.2 75.2 - 83.7 Unacceptable A testing person affirmed on April 29, 2021 at approximately 11:00 am, the unsatisfactory score of 20% obtained by the laboratory for granulocyte count testing during the 1st proficiency testing event of 2020. b) Lymphocyte count proficiency test results indicated that two out of five American Proficiency Institute proficiency samples tested were not within acceptable range. Sample Reported Expected Performance HEM-01 56.5 42.1 - 59.4 Acceptable HEM-02 17.1 12.7 - 17.0 Unacceptable HEM-03 31.5 23.4 - 31.3 Unacceptable HEM-04 32.2 23.4 - 32.2 Acceptable HEM-05 16.1 13.4 - 17.1 Acceptable A testing person affirmed on April 29, 2021 at approximately 11:00 am, the unsatisfactory score of 60% obtained by the laboratory for lymphocyte count testing during the 1st proficiency testing event of 2020. c. Based on the annual test volume reported, the laboratory performed and reported approximately 45,000 tests for the specialty of hematology. -- 2 of 3 -- D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on interview with staff and review of quality control records, the laboratory director failed to ensure the proficiency samples are tested as required under Subpart H of this part. The findings included: a. The laboratory failed to attain satisfactory analyte performance for proficiency testing in the specialties of chemistry (refer to D2087) and hematology (refer to D2121). -- 3 of 3 --

Summary Statement of Deficiencies 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting unsuccessful PT performance. (See D2096) 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 -- 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: Based on desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Chloride (Cl) , as follows: 2019 Q1 2019 Q3 Cl 60% 0% Q1 = First testing event Q3 = Third testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT resulted in an initial unsuccessful performance for the analyte, Cl. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, Cl, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2096) -- 2 of 2 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing (PT) result reports, and interview with the technical consultant, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory used Horiba Petra 400 to perform routine chemistry including but are not limited to the followings: Uric Acid, Cholesterol. b. The laboratory enrolled its PT with API (America Proficiency Institute) PT program to evaluate its proficiency testing performance for Petra 400 testing systems. c. The laboratory attained a score of 60 % for Uric Acid in the 2nd 2018 routine chemistry PT event, which was unsatisfactory analyte performance for the testing event. d. The laboratory performed Uric Acid in approximately 85 patient samples monthly. e. The laboratory affirmed (11/20/18 @ 11:30 am) that the laboratory attained a score of 60 % for Uric Acid in the 2nd 2018 routine chemistry PT event, which was unsatisfactory analyte performance for the testing event. 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: 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 -- Based on review of the laboratory records, and interview with the technical consultant, it was determined that the laboratory failed to, at least twice annually, verify the accuracy of any test or procedure it performs that is not included in subpart I of 42 CFR part 493. The findings included: a. The laboratory performed urine drug screen by using Horiba Petra 400 with Thermo Fisher Scientific reagents, b. The laboratory failed to perform and document the evaluation of the testing performance at least twice annually. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory records, and interview with the technical consultant, it was determined that the laboratory director failed to review, approve, sign, and date the procedures or validation documents before use. The findings included: a. At the time of the survey (11/20/18 @ 11:55 AM), the laboratory director did not sign and date the validation documents for urine drug screen by Horiba Petra 400 analyzer. b. The technical consultant affirmed (11/20/18 @ 11:55 AM) that the validation documents for urine drug screen testing by Horiba Petra 400 analyzer were not approved, signed, and dated by the current laboratory director. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing (PT) result reports, and interview with the technical consultant, it was determined that the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of 42 CFR part 493. The findings included: See D-2087 D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the laboratory records, and interview with the technical consultant, it was determined that the laboratory director failed to ensure that the quality control program was established and maintained to assure the quality of laboratory services provided. The findings included: See D-5407, and D-5217 -- 3 of 3 --