Paul K Wein Md Pc Associates

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 Medical Laboratory Evaluation (MLE) 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 of three consecutive testing events in the Endocrinology subspecialty for the T3 Uptake test analyte in 2024, resulting in non-initial unsuccessful performance. Refer to D2107. 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 CMS PT CASPER 0155D and MLE PT summary reports from 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events in the Endocrinology subspecialty for the T3 Uptake test analyte. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: Endocrinology Subspecialty: 2024 First Event = 75% 2024 Second Event = 75% T3 Uptake Test Analyte: 2024 First Event = 0% 2024 Second Event = 0% 2. A review of the proficiency testing scores from MLE (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 MLE PT summary reports from 2024, the laboratory director (LD) failed to 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 MLE PT 2024-1 and 2024-2 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2107. -- 2 of 2 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the American Association Bioanalysts Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records for all three events in 2022, lack of documentation for all three events of 2023, and interview with the testing person (TP), the laboratory failed to retain documentation including signed attestation forms, AAB- MLE test result forms, AAB-MLE PT summary reports, as well as

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 testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the Medical Laboratory Evaluation (MLE) PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Red Blood Cell Count (RBC). The following scores were assigned: Red Blood Cell Count (RBC). 2022 first event = 0% 2022 second event = 20% 2022 third event = 0% This is considered repeatedly unsuccessful PT performance. Refer to D2130 D2122 HEMATOLOGY 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): 493.851(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 PT desk review of the CMS PT data reports and PT records from the MLE PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Hematology. The following scores were assigned: 2022 first event = 75% This is considered unsatisfactory PT performance. 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 a PT desk review of the CMS PT reports and PT records from the MLE PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte RBC. The following scores were assigned RBC 2022 first event = 0% 2022 second event = 20% 2022 third event = 0% This is considered repeatedly unsuccessful 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 MLE 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 speciality Hematology & test analyte's RBC. 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: -- 2 of 3 -- Based on PT desk review of the CMS PT data reports and MLE 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 speciality Hematology & test analyte's RBC. RBC 2022 first event = 0% 2022 second event = 20% 2022 third event = 0% This is considered repeatedly unsuccessful PT performance. Speciality Hematology. 2022 first event = 75% This is considered unsatisfactory PT performance. -- 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 testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the Medical Laboratory Evaluation (MLE) PT program, the laboratory failed to participate successfully in proficiency testing for speciality Hematology and the test analyte's Red Blood Cell Count (RBC), Thyroid Stimulating Hormone (TSH), Total Bilirubin, Creatinine and Sodium (NA) The following scores were assigned: Red Blood Cell Count (RBC). 2021 first event = 0% 2021 second event = 0% 2021 third event = 80% 2022 first event = 0% This is considered repeatedly unsuccessful PT performance. Speciality Hematology 2021 second event = 0% 2021 third event = 82% 2022 first Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- event = 75% Thyroid Stimulating Hormone (TSH) 2021 second event = 0% 2021 third event = 100% 2022 first event = 40% Total Bilirubin 2021 second event = 0% 2021 third event = 80% 2022 first event = 40% Creatinine 2021 second event = 0% 2021 third event = 60% Sodium (NA) 2021 second event = 0% 2021 third event = 40% This is considered unsuccessful PT performance. Refer to D2096, D2107, D2130 and D2131 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 a PT desk review of the CMS PT reports and PT records from the MLE PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte's Albumin, ALT, AST, Alk. Phos. Glucose, , T.Ca., T. Cholesterol, Cholesterol HDL, Triglycerides, K, CL, BUN, Uric Acid, T. Iron, T. Protein, BUN and Uric Acid. The following scores were assigned 2021 second event = 0% This is considered unsatisfactory PT performance D2088 ROUTINE CHEMISTRY CFR(s): 493.841(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 MLE PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the speciality Chemistry. The following scores were assigned 2021 second 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 proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the Medical Laboratory Evaluation (MLE) PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Total Bilirubin, Creatinine and Sodium (NA) The following scores were assigned: Total Bilirubin 2021 second event = 0% 2021 third event = 80% 2022 first event = 40% Creatinine 2021 second event = 0% 2021 third event = 60% Sodium (NA) 2021 second event = 0% 2021 third event = 40% This is considered unsuccessful PT performance. -- 2 of 5 -- D2098 ENDOCRINOLOGY CFR(s): 493.843(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 MLE PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the Free Thyroxine (FT4) and Triiodothyronnine (T3). The following scores were assigned 2021 second event = 0% This is considered unsatisfactory PT performance D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a PT desk review of the CMS PT reports and PT records from the MLE PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the speciality Endocrinology The following scores were assigned 2021 second event = 0% This is considered unsatisfactory 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 MLE PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte TSH. The following scores were assigned 2021 second event = 0% 2021 third event = 100% 2022 first event = 40% This is considered unsuccessful PT performance D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a PT desk review of the CMS PT reports and PT records from the MLE PT program, the laboratory failed to participate and perform successfully in a PT -- 3 of 5 -- program, approved by CMS, for the test analyte's Cell Identification (Cell I.D.), White Blood Cell Count (WBC), Hemoglobin (Hgb), Hematocrit (Hct) and Platelets. The following scores were assigned 2021 second event = 0% This is considered unsatisfactory PT performance 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 a PT desk review of the CMS PT reports and PT records from the MLE PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte RBC. The following scores were assigned RBC Speciality Hematology 2021 second event = 0% 2021 third event = 80% 2022 first event = 0% This is considered unsuccessful PT performance 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 a PT desk review of the CMS PT reports and PT records from the MLE PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the speciality Hematology. The following scores were assigned Speciality Hematology 2021 second event = 0% 2021 third event = 82% 2022 first event = 75% This is considered unsuccessful 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 MLE 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 speciality Hematology & test analyte's RBC, Hct, Platelet, Cell I.D., WBC, Hgb; speciality, Chemistry & test analyte's Albumin, ALT, AST, Alk. Phos, T. Bili., Glucose, , T.Ca., T. Cholesterol, Cholesterol HDL, Triglycerides, K, CL, NA, Creatinine, Mg, Uric Acid, T. Iron, T. Protein, BUN and Uric Acid; speciality Endocrinology & test analyte's TSH, FT4 and T3. Refer to D6016. -- 4 of 5 -- 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 MLE 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 speciality Hematology & test analyte's RBC, Hct, Platelet, Cell I.D., WBC, Hgb; speciality, Chemistry & test analyte's Albumin, ALT, AST, Alk. Phos, T. Bili., Glucose, , T.Ca., T. Cholesterol, Cholesterol HDL, Triglycerides, K, CL, NA, Creatinine, Mg, Uric Acid, T. Iron, T. Protein, BUN and Uric Acid; speciality Endocrinology & test analyte's TSH, FT4 and T3. The following scores were assigned: Red Blood Cell Count (RBC). 2021 first event = 0% 2021 second event = 0% 2021 third event = 80% 2022 first event = 0% This is considered repeatedly unsuccessful PT performance. Speciality Hematology 2021 second event = 0% 2021 third event = 82% 2022 first event = 75% Thyroid Stimulating Hormone (TSH) 2021 second event = 0% 2021 third event = 100% 2022 first event = 40% Total Bilirubin 2021 second event = 0% 2021 third event = 80% 2022 first event = 40% Creatinine 2021 second event = 0% 2021 third event = 60% Sodium (NA) 2021 second event = 0% 2021 third event = 40% This is considered unsuccessful PT performance. Speciality Chemistry and the 17 test analyte's 2021 second event = 0% Speciality Endocrinology and FT4 and T3 2021 second event = 0% Cell I.D, WBC,Hgb, Hct and Platelet 2021 second event = 0% This is considered unsatisfactory PT performance -- 5 of 5 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's procedure for the Laboratory Information System (LIS) software LABDAQ and an interview with the testing person, the laboratory failed to establish a complete LIS policy that specifies the frequency for which a laboratory should evaluate its record storage and retrieval system. FINDINGS The testing person confirmed on December 2, 2021 at approximately 10:15 AM, that the laboratory failed to establish a complete LIS policy that specifies the frequency for which a laboratory should evaluate its record storage and retrieval system. a. The LIS system was not backed up to include instrument charts, graphs, printouts, transcribed data, and manufacturers' assay information sheets for control and calibration materials. b. The laboratory failed to identify and take

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 testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the Medical Laboratory Evaluation (MLE) PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Hematology and the test analyte's Red Blood Cell Count (RBC), Hematocrit (Hct), Platelet, Magnesium (Mg). The following scores were assigned: Red Blood Cell Count (RBC), 2020 second event = 20% 2020 third event = 80% 2021 first event = 0% 2021 second event = 0% [ failure to participate] Refer to D2130 This is considered repeatedly unsuccessful PT performance. Speciality Hematology 2021 first event = 48% 2021 second event = 0% Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- [ failure to participate] Refer to D2131 Hematocrit (Hct), Platelet 2021 first event = 0% 2021 second event = 0% [ failure to participate] Refer to D2130 Magnesium (Mg) 2021 first event = 0% 2021 second event = 0% [ failure to participate] Refer to D2096 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 MLE PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Albumin, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (Alk. Phos), Glucose, Total Bilirubin (T. Bili), Total Calcium (T. Ca), Total Iron (T. Fe) ,Total Cholesterol (T. Chol.), Cholesterol HDL, Triglycerides, Potassium (K), Sodium (Na), Chloride (CL), Blood Urea Nitrogen (BUN), Uric Acid, Creatine and Total Protein (T. Protein) The following scores were assigned: 2021 second event = 0% [ failure to participate] This is considered unsatisfactory PT performance. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(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 PT desk review of the CMS PT data reports and PT records from the MLE PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Chemistry. The following scores were assigned: 2021 second event = 0% [ failure to participate] 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 MLE PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Magnesium (Mg). The following scores were assigned: 2021 first event = 0% 2021 second event = 0% [ failure to participate] This is considered unsuccessful PT performance. D2104 ENDOCRINOLOGY CFR(s): 493.843(d) -- 2 of 4 -- 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 MLE PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Thyroid Stimulating Hormone (TSH), Free Thyroxine (FT4) and Triiodothyronne (T3) The following scores were assigned: 2021 second event = 0% [ failure to participate] This is considered unsatisfactory PT performance. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT data reports and PT records from the MLE PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Cell Identification, (Cell I.D.), White Cell Blood Count (WBC) Hemoglobin (Hgb) The following scores were assigned: 2021 second event = 0% [ failure to participate] This is considered unsatisfactory PT performance. 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 PT desk review of the CMS PT data reports and PT records from the MLE PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Red Blood Cell Count (RBC) and Hematocrit (Hct) and Platelet. The following scores were assigned: 2020 second event = 20% 2020 third event = 80% 2021 first event = 0% 2021 second event = 0% [ failure to participate] This is considered repeatedly unsuccessful PT performance. Hematocrit (Hct) and Platelet 2021 first event = 0% 2021 second event = 0% [ failure to participate] This is considered unsuccessful PT performance 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: -- 3 of 4 -- Based on PT desk review of the CMS PT data reports and PT records from the MLE PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Hematology. The following scores were assigned: Speciality Hematology 2021 first event = 48% 2021 second event = 0% [ failure to participate] This is considered unsuccessful 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 MLE 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 speciality Hematology and the test analyte's RBC, Hct, Platelet, Cell I.D., WBC, Hgb, Mg, Albumin, ALT, AST, Alk. Phos. Glucose, T. Bili., T.Ca., T. Iron, T. Cholesterol, Cholesterol HDL, Triglycerides, K, Na, CL, BUN, Uric Acid, Creatine, T. Protein, TSH, FT4 and T3. 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 MLE 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 speciality Hematology and the test analyte's RBC, Hct, Platelet, Cell I.D., WBC, Hgb, Mg, Albumin, ALT, AST, Alk. Phos. Glucose, T. Bili., T.Ca., T. Iron, T. Cholesterol, Cholesterol HDL, Triglycerides, K, Na, CL, BUN, Uric Acid, Creatine, T. Protein, TSH, FT4 and T3. The following scores were assigned: Red Blood Cell Count (RBC), 2020 second event = 20% 2020 third event = 80% 2021 first event = 0% 2021 second event = 0% [ failure to participate] This is considered repeatedly unsuccessful PT performance. Speciality Hematology 2021 first event = 48% 2021 second event = 0% [ failure to participate] Hct and Platelet 2021 first event = 0% 2021 second event = 0% [ failure to participate] This is considered unsuccessful PT performance Magnesium (Mg) 2021 first event = 0% 2021 second event = 0% [ failure to participate] This is considered unsuccessful PT performance TSH, FT4 and T3 2021 second event = 0% [ failure to participate] The Speciality Chemistry and the 19 test analyte's 2021 second event = 0% [ failure to participate] This is considered unsatisfactory PT performance. -- 4 of 4 --

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 testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the Medical Laboratory Evaluation (MLE) PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Red Blood Cell Count (RBC). The following scores were assigned: 2020 second event = 20% 2020 third event = 80% 2021 first event = 0% This is considered unsuccessful PT performance. Refer to D2131. D2087 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(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 MLE PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Magnesium. The following scores were assigned: 2021 first event = 0% This is considered unsatisfactory PT performance. D2098 ENDOCRINOLOGY CFR(s): 493.843(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 MLE PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Free Thyroxine (FT4). The following scores were assigned: 2020 second event = 60% This is considered unsatisfactory PT performance. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT data reports and PT records from the MLE PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Hematocrit (Hct) and Platelet. The following scores were assigned: 2021 first event = 0% This is considered unsatisfactory PT performance. D2122 HEMATOLOGY CFR(s): 493.851(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 PT desk review of the CMS PT data reports and PT records from the MLE PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Hematology. The following scores were assigned: 2021 first event = 48% This is considered unsatisfactory PT performance. D2131 HEMATOLOGY CFR(s): 493.851(g) -- 2 of 3 -- 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 the MLE PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Red Blood Cell Count (RBC). The following scores were assigned: 2020 second event = 20% 2020 third event = 80% 2021 first event = 0% This is considered unsuccessful 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 and MLE 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 speciality Hematology and the test analyte's RBC, Hct, Platelet, FT4 and Magnesium 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 and MLE 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 speciality Hematology and the test analyte's RBC, Hct, Platelet, FT4 and Magnesium The following scores were assigned: RBC 2020 second event = 20% 2020 third event = 80% 2021 first event = 0% This is considered unsuccessful PT performance. Speciality Hematology and Hct and Platelet. 2021 first event = 0% Magnesium. 2021 first event = 0% Free Thyroxine. 2020 second event = 60% This is considered unsatisfactory PT performance. -- 3 of 3 --