L&G Laboratory Inc

Summary Statement of Deficiencies 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: Based on the review of the AAB-Medical Laboratory Evaluation (AAB) proficiency testing (PT), the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, five (5) randomly selected patient test records, and interviews with the laboratory's technical Consultant (TC) and testing personnel (TP); the laboratory failed to attain a score of at least 80 percent of acceptable responses for the chemical analyte Prostate Specific Antigen (PSA) Total, for the third event in 2025 (Q3-2025). The findings included: 1. Review of PT records for Q3-2025, AAB reported an unsatisfactory score for PSA Total. chemical analyte of 20%. 2. TC and TP confirmed by interview on March 24, 2026, at approximately 11:30 a.m. that the laboratory obtained the PT score mentioned in statements #1. 3. According to the laboratory's testing declaration submitted on the day of the survey and signed by the laboratory director on 03/24/2026, the laboratory performed and reported approximately 54,000 routine chemistry analytes annually which include PSA Total, on patient laboratory test samples during the time the laboratory received unsatisfactory proficiency testing results. Thus, the reliability and quality of PSA Total patient results reported could not be assured. D2098 ENDOCRINOLOGY CFR(s): 493.843(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 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 -- event. This STANDARD is not met as evidenced by: Based on the review of the AAB-Medical Laboratory Evaluation (AAB) proficiency testing (PT), the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, five (5) randomly selected patient test records, and interviews with the laboratory's technical Consultant (TC) and testing personnel (TP); the laboratory failed to attain a score of at least 80 percent of acceptable responses for the following analytes: luteinizing hormone (LH) for the third event of 2025 (Q3-2025), Triiodothyronine ((T3) for the second event of 2025 (Q2-2025), and TSH for the second event of 2025 (Q2-2025). The findings included: 1. AAB reported the following unsatisfactory results for: Event Analyte Score % Q3- 2025 LH 20 Q2-2025 T3 0 Q2-2025 TSH 0 2. TC and TP confirmed by interview on March 24, 2026, at approximately 11:40 a.m. that the laboratory obtained the PT score obtained for the analytes mentioned in statements #1. 3. According to the laboratory's testing declaration submitted on the day of the survey and signed by the laboratory director on 03/24/2026, the laboratory performed and reported approximately 6,000 endocrinology analytes annually which included LH, T3, and TSH on patient laboratory test samples during the time the laboratory received unsatisfactory proficiency testing results. Thus, the reliability and quality of LH, T3, and TSH patient results reported could not be assured. 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 AAB-Medical Laboratory Evaluation (AAB) proficiency testing (PT), the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, five (5) randomly selected patient test records, and interviews with the laboratory's technical Consultant (TC) and testing personnel (TP); the laboratory failed to attain at least 80 percent of the acceptable response resulting to an unsatisfactory performance for the Hematology third event for 2025 (Q3-2025) for RBC, Hematocrit (HT), and Hemoglobin (HGB) analytes. The findings include: 1. The laboratory was enrolled in the AAB PT program and received an unsatisfactory score of 0% for Q3-2025 for RBC, HT, and HGB for Q3-2025. 2. TC and TP affirmed by interviews on March 24, 2026, at approximately 11:50 a.m. that the laboratory obtained Hematology 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 30,000 samples annually for Hematology that included RBC, HCT, and HGB analytes. Thus, the reliability and quality of Hematology patient results reported could not be assured at the time when the laboratory obtained unsatisfactory scores. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency -- 2 of 3 -- specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the surveyor's direct observation during the laboratory tour, review of the laboratory's policies and procedures, preventive maintenance (PM) documentation, five (5) patient records, and interviews with the laboratory's technical consultant (TC) and testing personnel (TP); the laboratory failed to establish and follow a policy and procedure in place for small equipment as defined by the manufacturer, with at least the frequency recommended for the laboratory's equipment prior to patient testing. The findings included: 1.The laboratory failed to provide PM documentation for the years 2024 and 2025 for small equipment (vortex, centrifuge, etc.) used in the laboratory for patient samples testing according to manufacturer's requirements, to be performed annually. 2. No

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on 07/17/2025, 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 (AAB) 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 AAB-Medical Laboratory Evaluation report, the laboratory failed to achieve satisfactory performance for 2025-1 and 2025-2, for the analyte Free Thyroxine. The finding include: Free Thyroxine 40% - 2025 first testing event, Free Thyroxine 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- Medical 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 D2107. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 12/19/2024, 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 Certificate and Survey Provider Enhanced Reporting (CASPER) - 0155D and AAB-Medical Laboratory Evaluation records (2024-1 and 2024-3), 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 3 -- 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 specialty of Hematology and analyte Hematocrit, resulting in unsuccessful performances. Refer to D2130 and D2131. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 AAB-Medical Laboratory Evaluation report, the laboratory failed to achieve satisfactory performance for two consecutive events (2024 first & third testing events) for the HCT: The findings include: 1. HCT - 0% 2024 first testing event, HCT - 20% 2024 third testing event. 2. HGB - 0% 2024 first testing event, HGB - 20% 2024 third testing event. 3. WBC Count - 0% 2024 first testing event, WBC Count - 60% 2024 third testing event. AAB-Medical Laboratory Evaluation confirmed the above findings. D2131 HEMATOLOGY CFR(s): 493.851(g) 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 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation report, the laboratory failed to achieve an overall event scores of satisfactory performance for two consecutive events or two out of three consecutive events for the specialty of Hematology: The findings include: 1. Hematology- 38% 2024 first testing event, Hematology - 53% 2024 third testing event. 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- Medical Laboratory Evaluation records for 2024-1 and 2024-3 proficiency events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. -- 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 a proficiency testing desk review of the CASPER 0155D report and AAB- Medical Laboratory Evaluation records for 2024-1 and 2024-3 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2130 and D2131. -- 3 of 3 --