Laboratory Medicine Consultants Inc

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) 493.823(a) 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 the surveyor's review of the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) evaluation and interviews with the technical supervisor (TS) and technical consultant (TC); it was determined that the laboratory failed to obtain an overall testing event score of at least 80 percent (%) in Bacteriology. The findings include: 1. The laboratory was enrolled in AAB-MLE PT program and received an overall unsatisfactory score of 76% for Bacteriology in the first event of 2025 (Q1-2025). 2. The TS and TC affirmed by interviews on February 6, 2026 at approximately 9:30 a.m. that the laboratory obtained the unsatisfactory score as mentioned in statement #1. The quality and accuracy of patient testing results cannot be assured. 4. According to the testing declaration form submitted at the time of survey, the laboratory performed and reported approximately 7,680 patient samples for Bacteriology including the time the laboratory obtained the unsatisfactory scores for proficiency testing. . D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (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 the surveyor's review of the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records and interviews with the technical supervisor (TS) and technical consultant (TC), it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for the Total Iron Binding Capacity (TIBC) analyte in the first event of 2025 (Q1-2025). The findings include: 1. The surveyor reviewed the PT records wherein AAB-MLE reported an unsatisfactory score of 60% for the TIBC analyte in Routine Chemistry for the Q1-2025 event. The report is as followed: Sample Reported Expected 1 *154 194 - 292 2 162 137 - 205 3 *92 184 - 277 4 588 479 - 719 5 506 404 - 607 Legend: * = unsatisfactory score 2. The TS and TC affirmed by interviews on February 6, 2026, at approximately 9:35 a.m. that the laboratory obtained the unsatisfactory PT score for the TIBC analyte as mentioned in statement #1. 3. The accuracy and reliability of patient test reported cannot be determined. 4. According to the laboratory's testing declaration form (Lab-144) submitted on the day of the survey, the laboratory performed approximately 5,000 patient test samples annually for the TIBC analyte including the time when the laboratory received the unsatisfactory proficiency testing score. . D2121 HEMATOLOGY CFR(s): 493.851(a) (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 the surveyor's review of the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE)proficiency testing (PT) records, and interviews with the technical supervisor (TS) and technical consultant (TC), it was determined that the laboratory failed to attain at least 80 percent of the acceptable response resulting to an unsatisfactory performance for the Coagulation subspecialty in the third event in 2024 (Q3-2024) and third event of 2025 (Q3-2025) for the Activated Partial Thromboplastin Time (APTT), Prothrombin Time (PT) and International Normalized Ratio (INR) analytes. The findings include: 1. The laboratory was enrolled in the AAB-MLE PT program and received an unsatisfactory scores of the following: a. APTT, 0%, Q3-2024 Specimen Reported Grading Range 11 *12.9 24.9 - 33.6 12 *20.4 25.2 - 34.0 13 *19.3 37.0 - 50.1 14 *16.0 33.4 - 45.1 15 *12.9 26.3 - 35.6 b. PT, 0%, Q3-2024 Specimen Reported Grading Range 11 *29.7 12.9 - 17.4 12 *36.2 12.6 - 17.0 13 *36.7 12.0 - 16.3 14 *32.5 19.6 - 26.5 15 *26.9 12.0 - 16.3 c. INR, 40%, Q3-2024 Specimen Reported Grading Range 11 *1.30 0.91 - 1.23 12 *2.91 1.05 - 1.43 13 2.64 2.39 - 3.23 14 1.89 1.68 - 2.27 15 *1.30 0.85 - 1.14 d. APTT, 60%, Q3-2025 Specimen Reported Grading Range 11 *39.3 24.5 - 33.1 12 34.5 32.6 - 44.1 13 28.0 25.1 - 33.9 14 38.2 35.9 - 48.5 15 *30.8 22.4 - 30.3 e. PT, 40%, Q3-2025 Specimen Reported Grading Range 11 *19.6 12.2 - 16.5 12 *16.6 17.0 - 23.0 13 12.0 10.4 - 14.1 14 *21.4 22.7 - 30.8 15 13.7 11.0 - 14.9 f. INR, 60%, Q3-2025 Specimen Reported Grading Range 11 *2.69 1.11 - 1.5 12 2.01 1.78 - 2.41 13 1.14 0.85 - 1.15 14 3.13 2.63 - 3.56 15 *1.44 0.93 - 1.26 2. The TS and TC affirmed by interviews on February 6, 2026, at approximately 9:30 a.m. that the laboratory obtained the PT unsatisfactory scores as mentioned in statement #1. 3. According to the laboratory testing declaration submitted on the day of the survey, the laboratory performed approximately 6,600 pstient samples annually for Coagulation that included the APTT, PT and INR analytes. Thus, the reliability and quality of patient results -- 2 of 3 -- reported could not be assured at the time when the laboratory obtained unsatisfactory scores. . D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 surveyor's review of the laboratory's proficiency testing (PT) records and interviews with the technical supervisor and technical consultant on February 6, 2026; it was determined that the laboratory director failed to ensure that the proficiency testing was performed as required under subpart H of this part. The findings include: 1. The laboratory received an overall 76% unsatisfactory score for Bacteriology. See D2020 2. The laboratory received an unsatisfactory score of 60% for the TIBC analyte in Routine Chemistry. See D2087 3. The laboratory received unsatisfactory scores for Coagulation subspecialty in the third event of 2024 and 2025. See D2121 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on 07/15/2025, 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 AAB-Medical Laboratory Evaluation 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 PSA resulting in unsuccessful performances. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 for two of three consecutive events (2025-1 and 2025-2) for the analyte Prostate Specific Antigen (PSA): The finding include: PSA 20% - 2025 first testing event; PSA 20% - 2025 second testing event. A review of the 2025 scores from AAB- Medical Laboratory Evaluation 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 AAB- Medicial Laboratory Evaluation 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 AAB- Medical Laboratory Evaluation records for 2025-1 and 2025-2 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 04/23/2025, 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]; 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 AAB - Medical Laboratory Evaluation (AAB) report (for proficiency testing events: 2024-2 and 2025-1), the laboratory failed to successfully 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 -- 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 for the analyte - Triiodothyronine (T3), resulting in an unsuccessful performance. Refer to 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 desk review of Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB - Medical Laboratory Evaluation (AAB) report (for proficiency testing events 2024-2 and 2025- 1), the laboratory failed to achieve satisfactory performance for two of three consecutive proficiency events in 2024 and 2025, for the analyte - Triiodothyronine (T3). The finding include: 2024 AAB second event, T3 - 0%, 2025 AAB first event, T3 - 40%. A review of the 2023 and 2024 proficiency testing scores from AAB 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 Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D report and AAB records for 2024-2 and 2025-1 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 Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D report AAB records for 2024-2 and 2025-1 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2107. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 5/15/2024, 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 AAB-Medical Laboratory Evulation records (2023-3 and 2024-1), 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 Bacteriology resulting in unsuccessful performance. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation reports, the laboratory failed to achieve satisfactory performance for two consecutive proficiency events (2023-3 and 2024-1) for analyte Bacteriology.. The finding include 1. The laboratory received the following scores: 70% on the 2023 Bacteriology third event 44% on the 2024 Bacteriology first event 2. A review of the 2023 and 2024 proficiency Testing scores from AAB-Medical Laboratory Evaluation 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 0155 report and AAB- Medical Laboratory Evaluation records for 2023-3 and 2024-1 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to 6016. 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 0155 report and AAB- Medical Laboratory Evaluation records for 2023-3 and 2024-1 events, the laboratory director failed to ensure successful participation in an HHS approved proficeincy test program. Refer to D2028. -- 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 Endocrinology constituting unsuccessful PT performance. (See D2107) 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 -- D2107 ENDOCRINOLOGY CFR(s): 493.843(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, HCG as follows: 2020 Q1 2020 Q3 HCG 60% 40% 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, HCG. 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, HCG, 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 D2107) -- 2 of 2 --