Joseph Slomowits Md

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on December 11, 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), American Proficiency Institute (API), College of American 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 -- Pathologists (CAP), and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) PT summary reports, the laboratory failed to successfully participate in the CMS approved PT program for two of three consecutive testing events in the Hematology specialty for the RBC (Red Blood Cell) and Hematocrit (HCT) -Non-Waived test analytes, resulting in unsuccessful performance. Refer to D2130. 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 CMS PT CASPER 0155D and API PT summary reports from 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for two out of three consecutive testing events in the Hematology specialty for the RBC and HCT (Non-Waived) test analytes. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: Hematology Specialty: 2024 Second Event = 0% 2024 Third Event = 66% RBC Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% 2024 Third Event = 20% HCT (Non-Waived) Test Analyte: 2024 Second Event = 40% 2024 Third Event = 0% 2. A review of the proficiency testing scores from API, CAP, and AAB-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 API, CAP, and AAB-MLE PT summary reports from 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 API, CAP, and AAB-MLE PT 2024-2 and 2024-3 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on September 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 American Proficiency Institute (API) PT summary reports, the 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 -- laboratory failed to successfully participate in the CMS approved PT program for two of three consecutive testing events in the Hematology subspecialty for the Platelets test analyte in 2023 and 2024, resulting in non-initial unsuccessful performance. Refer to D2130. 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 CMS PT CASPER 0155D and API PT summary reports from 2023 and 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events in the Hematology subspecialty for the Platelets test analyte. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: Platelets Test Analyte: 2023 Third Event = 60% 2024 Second Event = 0% 2. A review of the proficiency testing scores from API (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 API 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. 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 API PT 2023-3 and 2024-2 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on July 10, 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 Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and American Proficiency Institute (API) PT summary reports, the laboratory failed to 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 -- successfully participate in the CMS approved PT program for the Routine Chemistry specialty, ALT (SGPT) (Alanine Aminotransferase), Alk Phos (Alkaline Phosphatase), AST (SGOT) (Aspartate Aminotransferase), Bili Total (Bilirubin Total), CL (Chloride), LDH Total (Lactate Dehydrogenase), Na (Sodium), Uric Acid, Endocrinology specialty, and TY (Thyroxine T4) test analytes. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: Routine Chemistry Specialty: 2023 Third Event = 0% 2024 Second Event = 76% ALT (SGPT) Test Analyte: 2023 First Event = 20% 2023 Third Event = 0% 2024 Second Event = 40% Alk Phos Test Analyte: 2023 Third Event = 0% 2024 Second Event = 40% AST (SGOT) Test Analyte: 2023 Third Event = 0% 2024 Second Event = 40% Bili Total Test Analyte: 2023 Third Event = 0% 2024 Second Event = 40% CL Test Analyte: 2023 Third Event = 0% 2024 Second Event = 60% LDH Total Test Analyte: 2023 Third Event = 0% 2024 Second Event = 20% Na Test Analyte: 2023 Second Event = 40% 2023 Third Event = 0% 2024 Second Event = 40% Uric Acid Test Analyte: 2023 Third Event = 0% 2024 Second Event = 60% Endocrinology Specialty: 2021 Third Event = 35% 2022 First Event = 70% 2023 Second Event = 70% 2023 Third Event = 0% 2024 First Event = 75% 2024 Second Event = 70% TY Test Analyte: 2021 Third Event = 0% 2022 First Event = 60% 2. A review of the proficiency testing scores from API (2021, 2022, 2023, and 2024) confirmed the above findings. 3. Initial Offsite PT desk reviews were conducted August 2021, November 2021, March 2022, April 2022, July 2022, July 2023, December 2023, and April 2024. a. Subsequent plans of correction (POC) were respectively sent March 11, 2022, May 5, 2022, July 12, 2022, July 17, 2023, and December 18, 2023. b. Satisfactory POCs were accepted March 25, 2022, July 24, 2022, August 15, 2022, October 25, 2023, and January 31, 2024, respectively. This is considered non-initial unsuccessful PT. 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 CMS PT CASPER 0155D and API PT summary reports, the laboratory failed to attain a score of at least 80 percent of acceptable responses for the ALT (SGPT), Alk Phos, AST (SGOT), Bili Total, CL, LDH Total, Na, and Uric Acid test analytes in each testing event. Refer to D2016. 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 CMS PT CASPER 0155D and API PT summary reports, the laboratory failed to successfully participate in CMS approved proficiency testing program for the endocrinology specialty. Refer to D2016. D2107 ENDOCRINOLOGY -- 2 of 4 -- 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 API PT summary reports, the laboratory failed to achieve satisfactory performance for the TY test analyte in two out of three consecutive testing events. Refer to D2016. 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 CMS PT CASPER 0155D and API PT summary reports, the laboratory failed to achieve an overall satisfactory testing performance event score for the endocrinology specialty in two consecutive testing events and two out of three consecutive testing events. Refer to D2016. 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 CMS PT CASPER 0155D and API PT summary reports, the laboratory director (LD) failed to fulfill LD responsibilities and ensure that the laboratory achieved a satisfactory performance for the routine chemistry and endocrinology specialties; the ALT (SGPT), Alk Phos, AST (SGOT), Bili Total, CL, LDH Total, Na, and Uric Acid, and TY test analytes; as well as successfully participate in the CMS approved PT program. 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; -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on CMS PT CASPER 0155D and API PT summary reports, the LD failed to test the routine chemistry and endocrinology specialties; the ALT (SGPT), Alk Phos, AST (SGOT), Bili Total, CL, LDH Total, Na, and Uric Acid, and TY test analytes as required; as well as achieve a satisfactory performance in the CMS approved PT program. Refer to D2016. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on May 22, 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 Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and American Proficiency Institute (API) PT summary reports, the laboratory failed to 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 -- successfully participate in the CMS approved PT program for the ALT (SGPT) (Alanine Aminotransferase), Na (Sodium), BUN (Blood Urea Nitrogen), endocrinology specialty, triiodothyronine, TSH (Thyroid Stimulating Hormone), and Cell ID or WBC Diff (Cell Identification or White Blood Cell Differential) test analytes. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: ALT (SGPT) Test Analyte: 2023 First Event = 20% 2023 Third Event = 0% Na Test Analyte: 2023 Second Event = 40% 2023 Third Event = 0% BUN Test Analyte: 2021 Third Event = 0% 2022 Second Event = 60% Endocrinology Specialty: 2021 Third Event = 35% 2022 First Event = 70% 2023 Second Event = 70% 2023 Third Event = 0% Triiodothyronine Test Analyte: 2021 Third Event = 0% 2022 First Event = 60% TSH Test Analyte: 2021 Third Event = 40% 2022 First Event = 20% 2022 Second Event = 40% 2023 Second Event = 0% 2023 Third Event = 0% Cell ID or WBC Diff Test Analyte: 2022 First Event = 53% 2022 Second Event = 60% 2022 Third Event = 67% 2. A review of the proficiency testing scores from API (2021, 2022, 2023, and 2024) confirmed the above findings. 3. Initial Offsite PT desk reviews were conducted August 2021, November 2021, March 2022, April 2022, July 2022, July 2023, December 2023, and April 2024. a. Subsequent plans of correction (POC) were respectively sent March 11, 2022, May 5, 2022, July 12, 2022, July 17, 2023, and December 18, 2023. b. Satisfactory POCs were accepted March 25, 2022, July 24, 2022, August 15, 2022, October 25, 2023, and January 31, 2024, respectively. This is considered non-initial unsuccessful PT. 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 CMS PT CASPER 0155D and API PT summary reports, the laboratory failed to attain a score of at least 80 percent of acceptable responses for the ALT (SGPT), Na, and BUN test analytes in each testing event. Refer to D2016. 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 CMS PT CASPER 0155D and API PT summary reports, the laboratory failed to successfully participate in CMS approved proficiency testing program for the endocrinology specialty. Refer to D2016. 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. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on CMS PT CASPER 0155D and API PT summary reports, the laboratory failed to achieve satisfactory performance for the triiodothyronine and TSH test analytes in two consecutive testing events. Refer to D2016. 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 CMS PT CASPER 0155D and API PT summary reports, the laboratory failed to achieve an overall satisfactory testing performance event score for the endocrinology specialty in two consecutive testing events and two out of three consecutive testing events. Refer to D2016. 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 CMS PT CASPER 0155D and API PT summary reports, the laboratory failed to achieve satisfactory performance for the Cell ID or WBC Diff test analyte in two consecutive events and two out of three consecutive testing events. Refer to D2016. 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 CMS PT CASPER 0155D and API PT summary reports, the laboratory director (LD) failed to fulfill LD responsibilities and ensure that the laboratory achieved a satisfactory performance for the endocrinology specialty; the ALT (SGPT), Na, BUN, triiodothyronine, TSH, and Cell ID or WBC Diff test analytes; as well as successfully participate in the CMS approved PT program. 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 -- 3 of 4 -- 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 CMS PT CASPER 0155D and API PT summary reports, the LD failed to test the endocrinology specialty; the ALT (SGPT), Na, BUN, triiodothyronine, TSH, and Cell ID or WBC Diff test analytes as required; as well as achieve a satisfactory performance in the CMS approved PT program. Refer to D2016. -- 4 of 4 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of waived testing records and interview with the testing person (TP), the laboratory failed to follow the Osom Rapid Strep A, Alere Afinion Glycated hemoglobin (HgbA1c), and Urinalysis Dipstick manufacturer's quality control (QC) testing instructions from July 2021 through the survey date. FINDINGS: 1. The TP confirmed on January 5, 2024, at approximately 1:00 P.M. that the laboratory failed to perform the required Osom Rapid Strep A, Alere Afinion Glycated hemoglobin (HgbA1c), and Urinalysis Dipstick QC testing from July 2021 through the survey date. This is contrary to the manufacturer's QC performance testing instructions. 2. OSOM Rapid Strep test manufacturer's instructions required QC testing to be performed with each new lot as well as new, untrained operator. a. No documentation of QC performance testing was available from July 2021 through the survey date. b. Approximately two hundred twenty patients were tested each year through the survey date. 3. Alere Afinion Glycated hemoglobin (HgbA1c) manufacturer's instructions required external controls to be tested with each new lot, shipment, and at least every thirty days. a. It was noted that QC performance testing records were available for each new lot received. b. The most recent QC performance testing record available for the external control lot in use was May 2022; No minimum thirty day QC performance testing records were available. c. Approximately one thousand one hundred thirty-one patients were tested each year through the survey date. 4. The urinalysis dipstick manufacturer's instructions required QC testing to be performed for every new lot, shipment, opened bottle, and for strips stored in excess of thirty days. a. No documentation of QC performance testing was available from July 2021 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 -- through the survey date. b. Approximately six hundred eighty-four patients were tested each year through the survey date. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on Proficiency Test (PT) desk review of the Center for Medicaid & Medicare Services (CMS) PT data reports and PT summary reports from American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the speciality Endocrinology, and the test analytes Thyroid Stimulating Hormone (TSH), Alanine Transaminase (ALT), Total Bilirubin (T.Bili) and Sodium (Na). The following scores were assigned: Speciality Endocrinology 2023 second event = 70% 2023 third event = 0% TSH 2023 second event = 0% 2023 third event = 0% ALT 2023 first event = 20% 2023 third event = 0% T. Bilirubin 2023 second event = 60% 2023 third event = 0% This is considered 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 -- unsuccessful PT performance. Na 2023 first event = 20% 2023 second event = 40% 2023 third event = 0% This is considered repeatedly unsuccessful PT performance. Refer to D2096, D2107 and D2108 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 API PT program, the laboratory failed to participate successfully in proficiency testing program for the (15) test analyte's Albumin (Alb), Total Calcium (T. Ca), Total Protein, Creatine Kinase (CK), Creatinine, Blood Urea Nitrogen (BUN), Aspartate Transferase (AST), Triglycerides, Potassium (K), Chloride (CL), Magnesium (Mg), Uric Acid, High Density Lipoprotein (HDL) Cholesterol (Chol.) and Glucose The following scores were assigned: 2023 third 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 API 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 2023 third 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 summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the ALT, T..Bili. and Na. The following scores were assigned: ALT 2023 first event = 20% 2023 third event = 0% T. Bilirubin 2023 second event = 60% 2023 third event = 0% This is considered unsuccessful PT performance. Na 2023 first event = 20% 2023 second event = 40% 2023 third event = 0% This is considered repeatedly unsuccessful PT performance. Refer to D2096, D2107 and D2108 D2098 ENDOCRINOLOGY -- 2 of 4 -- 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 API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analytes Triiodothyroxine, Thyroxine, T3 Uptake). The following scores were assigned: 2023 third event = 0% This is considered a 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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte TSH. The following scores were assigned: TSH 2023 second event = 0% 2023 third event = 0% This 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 summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the speciality Endocrinology. The following scores were assigned: 2023 second event =70% 2023 third 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 API program records, the laboratory -- 3 of 4 -- 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 Endocrinology, and the test analytes TSH, ALT, Total Bilirubin, Na, speciality Chemistry and 15 chemistry analytes. 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 API 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 Endocrinology, and the test analytes TSH, ALT, Total Bilirubin, Na, speciality Chemistry and 15 chemistry analytes. The following scores were assigned: Speciality Endocrinology 2023 second event = 70% 2023 third event = 0% TSH 2023 second event = 0% 2023 third event = 0% ALT 2023 first event = 20% 2023 third event = 0% T. Bilirubin 2023 second event = 60% 2023 third event = 0% This is considered unsuccessful PT performance. Na 2023 first event = 20% 2023 second event = 40% 2023 third event = 0% This is considered repeatedly unsuccessful PT performance Speciality Chemistry and 15 chemistry analytes 2023 third event = 0% 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 Test (PT) desk review of the Center for Medicaid & Medicare Services (CMS) PT data reports and PT summary reports from American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte's Thyroid Stimulating Hormone (TSH) and Urea Nitrogen. The following scores were assigned: Thyroid Stimulating Hormone (TSH) 2021 second event = 0% (non-participation) 2021 third event = 40% 2022 first event = 20% 2022 second event = 40% This is considered 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 -- repeatedly unsuccessful PT performance. Urea Nitrogen 2021 third event= 0% 2022 second event = 60% This is considered unsuccessful PT performance. Refer to D2107 and D2097 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 API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analytes Total Cholesterol, Alanine Aminotransferease (ALT), Magnessium and Lactate Dehydrogenase (LDH) The following scores were assigned: Total Cholesterol 2021 third event = 20% ALT 2022 first event = 60% Magnessium 2022 second event= 60% LDH 2022 second event = 0% This is considered a 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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte Urea Nitrogen. The following scores were assigned: Urea Nitrogen 2021 third event= 0% 2022 second event = 60% 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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte TSH. The following scores were assigned: TSH 2021 second event = 0% (non-participation) 2021 third event = 40% 2022 first event = 20% 2022 second event = 40% This is considered repeatedly unsuccessful PT performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 3 -- 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 the API PT summary reports, the laboratory director failed to fulfill the laboratory director's responsibilities to ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the test analyte's TSH, Urea Nitrogen, Total Cholesterol, ALT, Magnessium and LDH. 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 the API PT summary reports, the laboratory director failed to fulfill the laboratory director's responsibilities to ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the test analyte's TSH, Urea Nitrogen, Total Cholesterol, ALT, Magnessium and LDH. Thyroid Stimulating Hormone (TSH) 2021 second event = 0% (non-participation) 2021 third event = 40% 2022 first event = 20% 2022 second event = 40% This is considered repeatedly unsuccessful PT performance. Urea Nitrogen 2021 third event= 0% 2022 second event = 60% This is considered unsuccessful PT performance. Total Cholesterol 2021 third event = 20% ALT 2022 first event = 60% Magnessium 2022 second event= 60% LDH 2022 second event = 0% This is considered a 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 Test (PT) desk review of the Center for Medicaid & Medicare Services (CMS) PT data reports and PT summary reports from American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the sub-speciality Endocrinology and the test analyte's Thyroid Stimulating Hormone (TSH) and Triiodothyronine (T3). The following scores were assigned: Sub-Speciality Endocrinology 2021 third event = 35% 2022 first event = 70% Thyroid Stimulating Hormone (TSH) 2021 second event = 0% (non-participation) 2021 third event = 40% 2022 first event = 20% Triiodothyronine (T3). 2021 second event = 0% (non-participation) 2021 third event = 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 -- 0% 2022 first event = 60% This is considered repeatedly unsuccessful PT performance. Refer to D2107 and D2108. 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 API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte Aspartate Aminotransferase (AST). The following scores were assigned: 2021 second event = 0% 2021 third event = 100% 2022 first event = 60% 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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, the test analyte's TSH and T3. The following scores were assigned: TSH 2021 second event = 0% (non-participation) 2021 third event = 40% 2022 first event = 20% T3 2021 second event = 0% (non-participation) 2021 third event = 0% 2022 first event = 60% This is considered repeatedly 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 summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the sub-speciality Endocrinology. The following scores were assigned: Sub specialty Endocrinology 2021 second event = 0% (non- participation) 2021 third event = 35% 2022 first event = 70% This is considered repeatedly unsuccessful PT performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 3 -- 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 the API PT summary reports, the laboratory director failed to fulfill the laboratory director's responsibilities to ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the sub-speciality Endocrinology and the test analyte's TSH, T3and AST. 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 API 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 sub- speciality Endocrinology and the test analyte's TSH and T3 and AST. The following scores were assigned: Sub- Speciality Endocrinology 2021 third event = 35% 2022 first event = 70% Thyroid Stimulating Hormone (TSH) 2021 second event = 0% (non-participation) 2021 third event = 40% 2022 first event = 20% Triiodothyronine (T3). 2021 second event = 0% (non-participation) 2021 third event = 0% 2022 first event = 60% This is considered repeatedly unsuccessful PT performance. AST 2021 second event = 0% 2021 third event = 100% 2022 first event = 60% This is considered unsuccessful 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 Test (PT) desk review of the Center for Medicaid & Medicare Services (CMS) PT data reports and PT summary reports from American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the Chemistry test analyte's Total Cholesterol, Blood Urea Nitrogen (BUN) and the sub-speciality Endocrinology and the test analyte's Thyroid Stimulating Hormone (TSH), Thyroxine (T4) and Triiodothyronine (T3). The following scores were assigned: Total Cholesterol 2021 second event = 0% (non-participation) 2021 third event = 20% BUN 2021 second event = 0% (non- participation) 2021 third event = 0% Sub specialty Endocrinology 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 -- 2021 second event = 0% (non-participation) 2021 third event = 35% Thyroid Stimulating Hormone (TSH) 2021 second event = 0% (non-participation) 2021 third event = 40% Thyroxine (T4) and Triiodothyronine (T3). 2021 second event = 0% (non-participation) 2021 third event =0% This is considered unsuccessful PT performance. Refer to D2096, D2107 and D2108. 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 API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the Chemistry test analyte's Total Cholesterol, Blood Urea Nitrogen (BUN). The following scores were assigned: Total Cholesterol 2021 second event = 0% (non-participation) 2021 third event = 20% BUN 2021 second event = 0% (non- participation) 2021 third event = 0% 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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, the test analyte's Thyroid Stimulating Hormone (TSH), Thyroxine (T4) and Triiodothyronine (T3). The following scores were assigned: TSH 2021 second event = 0% (non-participation) 2021 third event = 40% T4 and T3 2021 second event = 0% (non-participation) 2021 third 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 summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the sub-speciality Endocrinology. The following scores were assigned: Sub specialty Endocrinology 2021 second event = 0% (non- -- 2 of 3 -- participation) 2021 third event = 35% 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 the API PT summary reports, the laboratory director failed to fulfill the laboratory director's responsibilities to ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the Chemistry test analyte's Total Cholesterol, Blood Urea Nitrogen (BUN) and the sub-speciality Endocrinology and the test analyte's Thyroid Stimulating Hormone (TSH), Thyroxine (T4) and Triiodothyronine. 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 the API PT summary reports, the laboratory director failed to fulfill the laboratory director's responsibilities laboratory director's responsibilities to ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the Chemistry test analyte's Total Cholesterol, Blood Urea Nitrogen (BUN) and the sub-speciality Endocrinology and the test analyte's Thyroid Stimulating Hormone (TSH), Thyroxine (T4) and Triiodothyronine (T3). The following scores were assigned: Total Cholesterol 2021 second event = 0% (non-participation) 2021 third event = 20% BUN 2021 second event = 0% (non- participation) 2021 third event = 0% Sub specialty Endocrinology 2021 second event = 0% (non-participation) 2021 third event = 35% Thyroid Stimulating Hormone (TSH) 2021 second event = 0% (non-participation) 2021 third event = 40% Thyroxine (T4) and Triiodothyronine (T3). 2021 second event = 0% (non-participation) 2021 third event =0% This is considered unsuccessful 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 Test (PT) desk review of the Center for Medicaid & Medicare S services (CMS) PT data reports and PT records from American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Thyroxine (T4) and Total Calcium (T. Ca). The following scores were assigned: Thyroxine (T4) 2020 third event = 40% 2021 first event = 100% 2021 second event = 0% [failure to participate] Total Calcium (T. Ca) 2020 third event = 60% 2021 first event = 100% 2021 second event = 0% [failure to participate] This is considered unsuccessful PT performance. Refer to D2096 and D2107 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D2093 ROUTINE CHEMISTRY 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 API 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/Amylase/AST/Total Bilirubin/Chloride/Total Cholesterol/ HDL Cholesterol/Creatine/Glucose/Total LDH/Magnesium/Potassium/Sodium/Total Protein /Triglycerides/BUN/Uric Acid The following scores were assigned: 2021 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 records from API PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte' Total Calcium (T. Ca). The following scores were assigned: 2020 third event = 60% 2021 first event = 100% 2021 second event = 0% [failure to participate] This is considered unsuccessful PT performance. D2104 ENDOCRINOLOGY CFR(s): 493.843(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 API PT program, the laboratory failed to participate successfully in proficiency testing for the specialty Endocrinology and the test analyte's Thyroid Stimulating Hormone (TSH), Triiodothyronne (T3), T-Uptake. The following scores were assigned: 2021 second event = 0% [non-participation] 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 -- 2 of 3 -- 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 API PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Thyroxine (T4) The following scores were assigned: Thyroxine (T4) 2020 third event = 40% 2021 first event = 100% 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 API 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 specialties Chemistry/20 analyte's and Endocrinology/3 analyte's and the test analyte's T4 and T.Ca. 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 API 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 specialties Chemistry/20 analyte's and Endocrinology/3 analyte's and the test analyte's T4 and T.Ca. Thyroxine (T4) 2020 third event = 40% 2021 first event = 100% 2021 second event = 0% [failure to participate] Total Calcium (T. Ca) 2020 third event = 60% 2021 first event = 100% 2021 second event = 0% [failure to participate] This is considered unsuccessful PT performance Specialty Chemistry and the 20 test analyte's 2021 second event = 0% [non-participation] Specialty Endocrinology and the 3 test analyte's 2021 second event = 0% [non-participation] This is considered un satisfactory PT performance. -- 3 of 3 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's waived testing records and interview with the laboratory testing person, the laboratory failed to follow the manufacturer's instructions for performing the required quality control testing when testing Quidel Quick View in-line Rapid Strep A, Alere Afinion Glycated hemoglobin (HgbA1c) and Contour Next EZ Glucose from September November 2018 through survey date. FINDINGS: 1. The laboratory testing person confirmed on June 15, 2021 at approximately 10:00 AM that the laboratory failed to follow the manufacturer's instructions for performing the required quality control testing when testing Quidel Quick View in-line Rapid Strep A, Alere Afinion Glycated hemoglobin (HgbA1c) and Contour Next EZ Glucose from January 1, 2020 through survey date. 2. Quidel Quick View in-line Rapid Strep A requires the external control to be tested with each new lot and/or shipment of test kits. a. The testing did not record the lot numbers and expiration dates for the kits used for patient testing, therefore, the surveyor could not determine the number of test kits were used for patient testing. b. Approximately 327 patients were tested and reported from January 1, 2020 through survey date. 3. Alere Afinion Glycated hemoglobin (HgbA1c) requires the external control to be tested with each new lot and/or shipment of test cassettes. a. The testing did not record the lot numbers and expiration dates for the kits used for patient testing, therefore, the surveyor could not determine the number of test cassettes were used for patient testing. b. Approximately 436 patients were tested and reported from January 1, 2020 through survey date. 3. Contour Next EZ Glucose meter (S/N E251646) requires the external controls to be tested with each new lot of test strips a. The laboratory did not 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 -- perform external controls for the current lot for test strips DUOFPEC53A expiration date 6/30/22 b. The testing did not record the lot numbers and expiration dates for the test strips used for patient testing, therefore, the surveyor could not determine the number of test strips were used for patient testing. c. Approximately 50 patients were tested and reported from January 1, 2020 through survey date D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on surveyor's review of the Beckman Access 2 control records for Covid 19- Immunoglobin antibody (IgG) records and an interview with the laboratory testing person, the laboratory failed to maintain their Covid-19 reporting to the NYC Communicable Disease program for reporting both positive and negative Covid 19 test results from March 20, 2020 through survey date. FINDINGS: 1. On September 18, 2020, Executive Order 202.61 was issued requiring the following. All clinical labs and POLs or healthcare providers conducting Covid-19 testing must report Covid 19 test results immediately (within 24 hours of receiving results) through New York State Electronic Clinical Laboratory Reporting System (ECLRS). a. Following up on the recent New York State Executive Order No. 202.61, on September 18, 2020, the New York City Department of Health and Mental Hygiene issued an alert advising providers that perform all point-of-care (POC) Covid 19 testing must report Covid 19 test results electronically via the New York State Electronic Clinical Laboratory Reporting System (ECLRS). 2. The laboratory implemented the Covid testing performed on the Beckman Access 2 analyzer using Covid -19 AB IgG test kit March 20, 2020. 3. The laboratory tested 294 patients from March 20, 2020 through survey date. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent -- 2 of 4 -- calibration verification. This STANDARD is not met as evidenced by: Based on surveyor's review of the calibration verification records and an interview with the laboratory testing person, the laboratory failed to perform calibration verification at least once every six months for T3-uptake performed on the Beckman Access 2 from November 2018 through survey date. FINDINGS: 1. The laboratory testing person confirmed on June 15, 2021 at approximately 11:30 AM , the laboratory failed to perform calibration verification at least once every six months for T3-uptake performed on the Beckman Access 2 from November 2018 through survey date. a. Approximately 439 patients were tested and reported during this time period. 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's policies and procedures and an interview with the office manager, the laboratory failed to establish a Risk Assessment (RA) plan as part of the Individualized Quality Control Plan (IQCP) for testing Group A Strep and for performing throat culture testing using Select Strep Agar and 0.04 Bacitracin disk. FINDINGS: The laboratory testing person confirmed on June 15, 2021 at approximately 11:00 AM, that the laboratory failed to a establish a Risk Assessment (RA) plan as part of the Individualized Quality Control Plan (IQCP) for testing Group A Strep and for performing throat culture testing using Select Strep Agar and 0.04 Bacitracin disk. a. Risk Assessment plan to identify and evaluate potential failures and sources of error for testing Group A Strep with Bacitracin disk, to include the five Risk Assessment Components: Specimen, Test System, Reagent, Environment, and Testing Personnel. 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 surveyor's findings and interview with the laboratory testing person, the laboratory director failed to provide overall management of the laboratory. The laboratory director failed to ensure that the laboratory: The QC program was maintained, refer to D6020. -- 3 of 4 -- D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a surveyor's review of bacteriology and endocrinology QC records and confirmed in an interview with the laboratory testing person at the time of this survey, the laboratory director failed to ensure that the QC program for bacteriology and endocrinology was maintained to assure the quality of laboratory services. Refer to: D5439 and D5445. -- 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 American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Platelet Count. The following scores were assigned: 2020 first event = 0% [non-participation] 2020 second event = 60% This is considered unsuccessful PT performance. Refer to D2130. D2123 HEMATOLOGY CFR(s): 493.851(c) 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 -- Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT data reports and PT records from the API PT program, the laboratory failed to participate successfully in proficiency testing for the specialty Hematology and the test analytes White Blood Cell (WBC), Red Blood Cell (RBC), Hematocrit (Hct), Hemoglobin (Hgb) and Cell Identification/WBC Differential. The following score was assigned: 2020 first event = 0% [non- participation] This is considered an 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 API PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Platelet Count. The following scores were assigned: 2020 first event = 0% [non-participation] 2020 second event = 60% 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 PT CMS data reports and APT PT reports, 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 test analyte Platelet Count and the specialty Hematology and the test analytes WBC,RBC,Hct,Hgb and WBC Diff. 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 -- 2 of 3 -- 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 APT PT reports, 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 test analyte Platelet Count and the specialty Hematology and the test analytes WBC, RBC, Hct, Hgb and WBC Diff. The following scores were assigned: Platlet Count 2020 first event = 0% [non-participation] 2020 second event = 60% This is considered unsuccessful PT performance. Specialty Hematology and the five analytes: 2020 first event = 0% [non-participation] This is considered an 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 a proficiency testing ( PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT reports and PT records from the American Proficiency Institute (API) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Creatinine. The following scores were assigned: 2017 third event = 60% 2018 first event = 40% This is considered unsuccessful PT performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Creatinine. The following scores were assigned: 2017 third event = 60% 2018 first event = 40% 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 API 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 Creatinine. 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 API 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 Creatinine. The following scores were assigned: 2017 third event = 60% 2018 first event = 40% This is considered unsuccessful PT performance. -- 2 of 2 --