Khoury Medical Care Pc

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on October 16, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. 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 Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and College of American Pathologists (CAP) PT summary reports, 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 successfully participate in the CMS approved PT program for two consecutive testing events in the Routine Chemistry subspecialty for the Prostate Specific Antigen, Total test analyte in 2025 resulting in unsuccessful performance. Refer to 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 CMS PT CASPER 0155D and CAP PT summary reports from 2025, the laboratory failed to achieve satisfactory performance (80% or greater) for two consecutive testing events for the analyte Prostate Specific Antigen, Total. FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. Prostate Specific Antigen, Total Analyte: 2025 First Event = 0% 2025 Second Event = 0% b. A review of the PT scores from CAP (2025) 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 review of CMS PT CASPER 0155D and CAP PT summary reports from 2025, the Laboratory Director (LD) 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 review of CMS PT CASPER 0155D and CAP PT summary reports, the LD failed to ensure successful participation in an HHS approved PT program. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on January 6, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. 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 Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and College of American Pathologists (CAP) PT summary reports, 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 -- the laboratory failed to successfully participate in the CMS approved PT program for consecutive testing events in the General Immunology specialty for the Immunoglobulin E (IgE) test analyte in 2022, 2023, and 2024; Routine Chemistry specialty for the Amylase, Chloride (CL), Cholesterol, High Density Lipoprotein (HDL), and Uric Acid test analytes in 2022, 2023, and 2024; and the Endocrinology subspecialty for the T3 Uptake, Triiodothyronine, and Thyroid (TY) test analytes in 2022 and 2024 resulting in unsuccessful performance. Refer to D2084, D2096, and 2107. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 CMS PT CASPER 0155D and CAP PT summary reports from 2022, 2023, and 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for consecutive testing events in the General Immunology specialty for the IgE test analyte. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: General Immunology Specialty: 2023 Second Event = 56% 2024 First Event = 50% 2024 Third Event = 76% IgE Test Analyte: 2022 First Event = 0% 2022 Second Event = 0% 2022 Third Event = 0% 2023 Second Event = 0% 2024 First Event = 0% 2024 Second Event = 0% 2024 Third Event = 0% 2. A review of the proficiency testing scores from CAP (2022, 2023 and 2024) confirmed the above findings. 3. During the on-site survey conducted January 31, 2024, it was noted that the facility claimed to discontinue IgE testing. 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 CMS PT CASPER 0155D and CAP PT summary reports from 2022, 2023, and 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for consecutive testing events in the Routine Chemistry specialty for the Amylase, CL, Cholesterol, HDL, and Uric Acid test analytes. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: Amylase Test Analyte: 2022 First Event = 0% 2022 Second Event = 0% 2022 Third Event = 0% 2024 First Event = 0% 2024 Second Event = 0% 2024 Third Event = 0% CL Test Analyte: 2022 Third Event = 0% 2023 First Event = 60% 2023 Second Event = 40% Cholesterol, HDL Test Analyte: 2022 Third Event = 0% 2023 First Event = 20% Uric Acid Test Analyte: 2022 Third Event = 0% 2023 Second Event = 60% 2023 Third Event = 0% 2. A review of the proficiency testing scores from CAP (2022, 2023, and 2024) confirmed the above findings. 3. During the on-site survey conducted January 31, 2024, it was noted that the facility claimed to discontinue amylase testing. -- 2 of 3 -- 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 CMS PT CASPER 0155D and CAP PT summary reports from 2022 and 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for consecutive testing events in the Endocrinology subspecialty for the T3 Uptake, Triiodothyronine, and TY test analytes. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: Endocrinology Subspecialty: 2022 First Event = 51% 2022 Second Event = 54% 2022 Third Event = 48% 2024 First Event = 57% 2024 Second Event = 51% 2024 Third Event = 57% T3 Uptake Test Analyte: 2022 First Event = 0% 2022 Second Event = 0% 2022 Third Event = 0% 2024 First Event = 0% 2024 Second Event = 0% 2024 Third Event = 0% Triiodothyronine Test Analyte: 2022 First Event = 0% 2022 Second Event = 0% 2022 Third Event = 0% 2024 First Event = 0% 2024 Second Event = 0% 2024 Third Event = 0% TY Test Analyte: 2022 First Event = 0% 2022 Second Event = 0% 2022 Third Event = 0% 2024 First Event = 0% 2024 Second Event = 0% 2024 Third Event = 0% 2. A review of the proficiency testing scores from CAP (2022 and 2024) 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 review of CMS PT CASPER 0155D and CAP PT summary reports from 2022, 2023, and 2024, the laboratory director (LD) 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 review of CMS PT CASPER 0155D and CAP PT 2022-1, 2022-2, 2022-3, 2023-1, 2023-2, 2023-3, 2024-1, 2024-2, and 2024-3 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2084, D2096, and 2107. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on December 12, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. 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 Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and College of American Pathologists (CAP) PT summary reports, 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 successfully participate in the CMS approved PT program for six of nine testing events in the Routine Chemistry specialty for the CA (Calcium), Total test analyte in 2022, 2023, and 2024, resulting in 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 CMS PT CASPER 0155D and CAP PT summary reports from 2022, 2023, and 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for six of nine testing events in the Routine Chemistry specialty in the analyte CA, Total. FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. CA, Total Test Analyte: 2022 First Event = 60% 2022 Third Event = 0% 2023 Third Event = 0% 2024 First Event = 20% 2024 Second Event = 0% 2024 Third Event = 0% b. A review of the proficiency testing scores from CAP (2022, 2023, and 2024) 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 review of CMS PT CASPER 0155D and CAP PT summary reports from 2022, 2023 and 2024, the Laboratory Director (LD) 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 review of CMS PT CASPER 0155D and CAP PT 2022-1, 2022-3, 2023-3, 2024-1, 2024-2, and 2024-3 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on October 31, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. 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 Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and College of American Pathologists (CAP) PT summary reports, 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 successfully participate in the CMS approved PT program for three consecutive testing events in the Routine Chemistry subspecialty for the CA (Calcium), Total test analyte in 2023 and 2024 resulting in 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 CMS PT CASPER 0155D and CAP PT summary reports from 2023 and 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for three consecutive testing events in the Routine Chemistry subspecialty for the CA, Total test analyte. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: CA, Total Test Analyte: 2023 Third Event = 0% 2024 First Event = 20% 2024 Second Event = 0% 2. A review of the proficiency testing scores from CAP (2023 and 2024) 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 review of CMS PT CASPER 0155D and CAP PT summary reports from 2023 and 2024, the laboratory director (LD) failed to provide overall management and direction of the laboratory services. Refer to D2016. 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 CMS PT CASPER 0155D and CAP PT 2023-3, 2024-1, and 2024- 2 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on August 21, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. 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 Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and College of American Pathologists (CAP) PT summary reports, 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 -- the laboratory failed to successfully participate in the CMS approved PT program for three consecutive testing events in the Routine Chemistry for the CA (Calcium), Total test analyte in 2023 and 2024 as well as two of three consecutive testing events in the Toxicology subspecialty for the Lithium test analyte in 2024, resulting in unsuccessful performance. Refer to D2096 and D2118. 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 CMS PT CASPER 0155D and CAP PT summary reports from 2023 and 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for three consecutive testing events in the Routine Chemistry subspecialty for the CA, Total test analyte. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: CA, Total Test Analyte: 2023 Third Event = 0% 2024 First Event = 20% 2024 Second Event = 0% 2. A review of the proficiency testing scores from CAP (2023 and 2024) confirmed the above findings. 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 CMS PT CASPER 0155D and CAP PT summary reports from 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events in the Toxicology subspecialty for the Lithium test analyte. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: Toxicology Subspecialty: 2024 First Event = 0% 2024 Second Event = 0% Lithium Test Analyte: 2024 First Event = 0% 2024 Second Event = 0% 2. A review of the proficiency testing scores from CAP (2024) 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 review of CMS PT CASPER 0155D and CAP PT summary reports from 2023 and 2024, the laboratory director (LD) failed to failed to provide overall management and direction of the laboratory services. Refer to D2016. -- 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 review of CMS PT CASPER 0155D and CAP PT 2023-3, 2024-1, and 2024- 2 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096 and 2118. -- 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 Proficiency Test (PT) desk review of the Center for Medicaid & Medicare Services (CMS) PT data reports and PT summary reports from College of American Proficiency (CAP) PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte's Chloride and Total Cholesterol. The following scores were assigned: Chloride 2022 third event = 0% 2023 first event = 60% Total Cholesterol 2022 third event = 0% 2023 first event = 20% This is considered unsuccessful PT performance. Refer to D2096 D2093 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT data reports and PT records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Chemistry and the test analyte's ALT/SGPT/Albumin/Alkaline Phosphates/AST/Total Bilirubin/Chloride/Total Cholesterol/ HDL Cholesterol /Creatine/Glucose/Total LDH/Total Calcium/ Magnesium/Potassium/Sodium/Total Protein/Triglycerides/BUN/Uric Acid/Total Iron The following scores were assigned: 2022 second event = 0% [non-participation] This is considered unsatisfactory PT performance. 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 PT desk review of the CMS PT data reports and PT summary reports from CAP PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte Chloride and HDL Cholesterol. The following scores were assigned: Chloride 2022 third event = 0% 2023 first event = 60% Total Cholesterol 2022 third event = 0% 2023 first event = 20% This is considered unsuccessful PT performance.Chloride 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 PT desk review of the CMS PT and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the test analyte's Chloride and Total Cholesterol and the speciality Chemistry and twentey analytes. 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 -- 2 of 3 -- 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 PT desk review of the CMS PT and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the test analyte's Chloride and Total Cholesterol and the speciality Chemistry and twentey analytes The following scores were assigned: 2022 second event = 0% [non-participation] This is considered unsatisfactory PT performance. Chloride 2022 third event = 0% 2023 first event = 60% Total Cholesterol 2022 third event = 0% 2023 first event = 20% This is considered unsuccessful PT performance. -- 3 of 3 --

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on a proficiency testing ( PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT records and verified by the College of American Pathologists (CAP) PT program, the laboratory failed to have the PT test results released to New York State Department of Health (NYSDOH), Physician's Office Evaluation Program (POLEP) in the calendar year 2020, 2021 and 2022. THIS IS A REPEATED DEFICIENCY FROM THE PROFICIENCY TESTING DESK REVIEW CONDUCTED ON MAY 2, 2019. 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 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 -- assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing ( PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT reports and PT records from the College of American Pathologists (CAP) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialities Endocrinology and Toxicology and the test analyte's Immunoglobin E Antibody (IgE), Amylase, Chloride (CL), Thyroid Function Test T3 Uptake, Triiodothyronine (T3), Thyroxine (T4) and Lithium The following scores were assigned: IgE, Amylase, T3 Uptake, T3, T4, Lithium and the speciality Toxicology 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) Speciality Endocrinology 2021 third event = 57% 2022 first event = 51% Chloride 2021 third event = 60% 2022 first event = 40% This is considered unsuccessful PT performance. Refer to D2085, D2097, D2107, D2108, D2118 and D2119 D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(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 a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Alpha Fetoprotein (AFP) The following scores were assigned: 2021 third event = 0% This is considered unsatisfactory PT performance D2076 GENERAL IMMUNOLOGY CFR(s): 493.837(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 a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the speciality General Immunology. The following scores were assigned: 2021 third event = 56% This is considered unsatisfactory PT performance D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(g) -- 2 of 6 -- 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 a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte IgE. The following scores were assigned: 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) This is considered unsuccessful PT performance. 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 PT desk review of the CMS PT data reports and PT records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Total Calcium (T. Ca) and Sodium (Na) The following scores were assigned: 2022 first event = 60% This is considered unsatisfactory PT performance. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(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 a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte's Amylase and CL The following scores were assigned: Amylase 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) Chloride 2021 third event = 60% 2022 first event = 40% This is considered unsuccessful PT performance. 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 a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte's T3 Uptake, T3, T4. The following -- 3 of 6 -- scores were assigned: 2021 third event = 0% 2022 first event = 0% This is considered unsuccessful PT performance. D2108 ENDOCRINOLOGY CFR(s): 493.843(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 PT desk review of the CMS PT data reports and PT records from CAP PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Endocrinology. The following scores were assigned: 2021 third event = 57% 2022 first event = 51% This is considered unsuccessful PT performance. 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 PT desk review of the CMS PT data reports and PT records from CAP PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Lithium. The following scores were assigned: 2021 third event = 0% [failure to participate] 2022 first event = 0% [failure to participate] This is considered unsuccessful PT performance. D2119 TOXICOLOGY CFR(s): 493.845(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 PT desk review of the CMS PT data reports and PT records from CAP PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Toxicology The following scores were assigned: 2021 third event = 0% [failure to participate] 2022 first event = 0% [failure to participate] This is considered unsuccessful PT performance. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a -- 4 of 6 -- proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT data reports and PT summary reports from CAP PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the speciality Hematology and the test analyte's White Blood Cell Count (WBC), Red Blood Cell Count (RBC), Cell Identification (Cell I.D.), Hemoglobin (Hgb), Hematocrit (Hct) and Platelet Count. The following scores were assigned: 2021 third event = 0% (failure to participate) This is considered unsatisfactory PT performance. 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 PT desk review of the CMS PT data reports and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the specialities Endocrinology, General Immunology and Toxicology and the test analyte's IgE, Amylase, CL, T3 Uptake, T3, T4, Lithium, AFP, T. Ca, Na, WBC, RBC, Cell I.D., Hgb, Hct and Platelet Count. 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 PT desk review of the CMS PT data reports and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the specialities Endocrinology, General Immunology and Toxicology and the test analyte's IgE, Amylase, CL, T3 Uptake, T3, T4, Lithium, AFP, T. Ca, Na, WBC, RBC, Cell I.D., Hgb, Hct and Platelet Count. The following scores were assigned: IgE, Amylase, T3 Uptake, T3, T4, Lithium and the speciality Toxicology 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) Speciality Endocrinology -- 5 of 6 -- 2021 third event = 57% 2022 first event = 51% Chloride 2021 third event = 60% 2022 first event = 40% This is considered unsuccessful PT performance. Speciality General Immunology. 2021 third event = 56% AFP,WBC,RBC, Cell I.D., Hgb, Hct and Platelet Count. 2021 third event = 0% (failure to participate) T. Ca and Na 2022 third event = 60% This is considered unsatisfactory PT performance -- 6 of 6 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory Quality Control Plan (IQCP), QC records for the Affirm VIII test system and an interview with the technical consultant, the laboratory failed to established a Quality Control Plan (QCP) section of the IQCP for the Affirm VIII and perform and investigation to identify the testing system failure under Risk Assessment section of the IQCP. FINDINGS: 1. The technical consultant confirmed on November 30, 2021 at approximately 1:30 PM the surveyor's findings that the laboratory failed to establish a QCP to include the number of controls, the type of controls and the frequency controls are performed, as part of a complete IQCP. a. The QCP section of the laboratory's established IQCP states, "Monitor QC and precision of test performance and must include number of QC, type of QC, frequency of QC." The QCP failed to define the number of controls, frequency of controls and type of controls. 2. The BD Affirm VPIII Microbial Identification Test includes two internal controls on each PAC: a Positive Control bead and a Negative Control bead. These control beads are tested simultaneously with each patient specimen, ensuring the proper performance of PAC, Reagent Cassette (RC) and Processor. Each new lot and/or shipment of PAC test cassettes must be tested with a commercially prepared Trivalent swab of Candida albicans, Trichomonas and Gardnerella species to assure 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 -- adequate sample lysis. a. Surveyor reviewed the following QC records (internal & external) for 2021: Date performed/Kit lot # & expiration date/Control lot # & expiration date/internal & external results 2/15/21 #7036104 expires 5/21/21-Negative #20346781 expires 6/19/22 results- negative 2/15/21 #7036104 expires 5/21/21- Positive #20346781 expires 6/19/22 results- positive 6/23/21 #7739247 expires 3/5/22- Negative #2004568 expires 7/3/22 results - negative 6/23/21 #7739247 expires 3/5/22- Positive #2004568 expires 7/3/22 results - positive 10/9/21 #7781482 expires 5/3/22- Negative #20375484 expires 9/1/22 results -negative 5/23/21 #7739247 expires 3/5 /22-Postive #2004568 expires 7/3/22 results -positive 3. The laboratory director failed to establish a Risk Assessment (RA) plan to include all phases of bacteriology, mycology and parasitology testing using the Affirm VIII microbial identification system, to include potential sources of error for the five Risk Assessment Components: Specimen, Test System, Reagent, Environment, and Testing Personnel. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's temperature logs and an interview with the technical consultant, the laboratory failed to monitor the room and refrigerator /freezer temperatures for the calendar year 2018 through survey date. FINDINGS: 1. The technical consultant confirmed on July 30, 2019 at approximately 2:30 PM, that the laboratory testing person did not record the exact temperatures from the thermometers but used a check mark instead for the calendar years 2018 through survey date. 2. The manufacturers for the following analyzers: Horiba Pentra 400, Abbott Cell-Dyn 1700, Beckman Access 2, BD Viper LT, Bio-rad PR4100 and Alere Affirm VPN require the temperatures as follows: room 15-30C or 68-77 F; refrigerator 2-8C or 35-45F and freezer at -20C. a. The laboratory stores test kits, reagents at room temperature, control and calibration material, patient specimens, Proficiency testing samples in the refrigerator and/or freezer. 3. The surveyor could not determine if the temperatures were within the required ranges for the calendar year 2018 through survey date. a. The laboratory's temperature logs did have the above ranges recorded on the top of the log sheets b. The testing person did not record the exact temperatures from the thermometers but used a check mark instead. 4. Approximately 250 patient samples were stored in the refrigerator and tested during the above time-period. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on a proficiency testing ( PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT records and the verified with the College of American Pathologists (CAP) PT program, the laboratory failed to have the PT test results released to New York State Department of Health (NYSDOH), Physician's Office Evaluation Program (POLEP) in the calendar year 2018 and 2019. 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 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 -- 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 proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the College of American Pathologists (CAP) PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Glucose. The following scores were assigned: 2018 third event = 60% 2019 first event = 20% This is considered unsuccessful PT performance. Refer to 2096. 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 PT desk review of the CMS PT data reports and PT records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Amylase. The following scores were assigned: 2019 first event = 0% This is considered unsatisfactory PT performance. 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 PT desk review of the CMS PT data reports and PT records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Glucose. The following scores were assigned: 2018 third event = 60% 2019 first event = 20% This is considered unsuccessful PT performance. D2109 TOXICOLOGY CFR(s): 493.845(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 a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Lithium. The following scores were assigned: 2019 first event = 0% This is considered unsatisfactory PT performance. -- 2 of 3 -- D2110 TOXICOLOGY CFR(s): 493.845(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 a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the subspecialty Toxicology. The following scores were assigned: 2019 first event = 0% This is considered unsatisfactory PT performance. 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 PT desk review of the PT CMS data reports and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the subspecialty Toxicology and the test analytes Glucose, Amylase and Lithium. 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 PT desk review of the PT CMS data reports and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the subspecialty Toxicology and the test analytes Glucose, Amylase and Lithium. The following scores were assigned: Glucose 2018 third event = 60% 2019 first event = 20% This is considered unsuccessful PT performance. Amylase, Toxicology and Lithium 2019 first event = 0% This is considered unsatisfactory PT performance. -- 3 of 3 --