Murray Hill Urology, Pc

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observations, review of Quality Control (QC) and calibration data, as well as interview with the Laboratory Director (LD), Pathologist, and Testing Personnel (TP), the laboratory failed to remove from inventory expired reagents in the patient specimen processing laboratory. FINDINGS: 1. The surveyor's observations in the patient specimen processing laboratory confirmed on November 19, 2024, at approximately 11:30 A.M. that two boxes of HS CRP (high sensitivity C-reactive protein) lot: 36, expiration: October 31, 2024, were not removed from inventory. 2. The current, approved SOPs did not include instructions for removal of expired reagents and calibration materials from inventory. 3. The LD, Pathologist, and TP confirmed the findings on November 19, 2024, at approximately 11:30 A.M. It was noted that the LD, Pathologist, and TP confirmed the respective expired calibration and control materials were not utilized for patient specimen processing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on August 19, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and College of American Pathologists (CAP) PT summary reports, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- the laboratory failed to successfully participate in the CMS approved PT program for three consecutive testing events in the Endocrinology subspecialty for the Cortisol, Free TY (Thyroxine), T3 Uptake, Triiodothyronine, TSH (Thyroid Stimulating Hormone), and TY test analytes in 2023 and 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 CAP PT summary reports from 2023 and 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for three consecutive testing events in the Endocrinology subspecialty for the Cortisol, Free TY, T3 Uptake, Triiodothyronine, TSH, and TY test analytes. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: Endocrinology Subspecialty: 2023 Second Event = 14% 2023 Third Event = 14% 2024 First Event = 11% Cortisol Test Analyte: 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 0% Free TY Test Analyte: 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 0% T3 Uptake Test Analyte: 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 0% Triiodothyronine Test Analyte: 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 0% TSH Test Analyte: 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 0% TY Test Analyte: 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 0% 2. A review of the proficiency testing scores from CAP (2023 and 2024) confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of CMS PT CASPER 0155D and CAP PT summary reports from 2023 and 2024, the laboratory director (LD) failed to 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of CMS PT CASPER 0155D and CAP PT 2023-2, 2023-3, and 2024- 1 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2107. -- 3 of 3 --

Summary Statement of Deficiencies D2004 ENROLLMENT CFR(s): 493.801(a)(3) For each specialty, subspecialty and analyte or test, participate in one approved proficiency testing program or programs, for one year before designating a different program and must notify CMS before any change in designation; This STANDARD 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) and College of American Pathologist (CAP) PT programs, the laboratory failed to participate in one approved proficiency testing program for one year before designating a different program. FINDINGS: The laboratory is enrolled in both API and CAP PT programs for General Immunology, Chemistry, Endocrinology testing for the same test analyte's and reporting both results to CMS for 2023 1st & 2nd test events. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 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 Chloride. The following scores were assigned: 20222 second event = 20% 2022 third event = 0% 2023 first event = 100% 2023 second event = 40% This is considered unsuccessful PT performance. Refer to D2096 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 analyte Total Calcium. The following scores were assigned: 2023 second event = 0% This is considered a 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 test analyte Chloride. The following scores were assigned: 2022 second event = 20% 2022 third event = 0% 2023 first event = 100% 2023 second 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. -- 2 of 3 -- 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's Chloride and Total Calcium Refer 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's Chloride and Total Calcium. The following scores were assigned: Chloride 2022 second event = 20% 2022 third event = 0% 2023 first event = 100% 2023 second event = 40% This is considered unsuccessful PT performance. Total Calcium 2023 second event = 0% This is considered a unsatisfactory 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 observation of a vial of urine test strips BTNX Rapid Response Lot# URS 0040167 expiration date 07/2022 on March 15, 2022 at 10:00 AM, the laboratory failed to retain a copy of the BTNX manufacturer's packet insert. FINDINGS: The laboratory failed to retain a copy of the BTNX manufacturer's packet insert for the urine Rapid Response test strips. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) Proficiency Testing (PT) Chemistry & Endocrinology records for 2019, 2020 and 2021 and an interview with the laboratory director and testing person, the laboratory director and testing person failed to sign the attestation forms attesting that the PT samples were tested in the same manner as patient specimens. D2015 TESTING OF PROFICIENCY TESTING SAMPLES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the CAP PT 2019, 2020 and 2021 records and an interview with the laboratory director, the laboratory failed to retain copies of the attestation forms by the laboratory director and the testing person for the 2019, 2020 and 2021 test events. FINDINGS: The laboratory director and the testing person confirmed on March 15, 2022 at 10:15 AM, they failed to retain the CAP PT attestation forms for all three events in 2019, 2020 and 2021. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on direct observation of the work area in the main laboratory on March 15, 2022 at 9:45 AM, review of the

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 analytes Chloride (CL), Sodium (Na) and Thyroxine. The following scores were assigned: Chloride 2020 second event = 60% 2020 third event = 60% 2021 first event = 60% 2021 second event =100% 2021 third event = 20% This is considered repeatedly unsuccessful PT performance Sodium 2020 second event = 60% 2020 third event = 100% 2021 first event = 60% This is considered unsuccessful PT performance. Refer to D2096 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 -- D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a PT desk review of the CMS PT reports and PT records from the API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Alpha Fetal Protein (AFP Tumor Marker). The following scores were assigned: 2020 second event = 60% This is considered unsatisfactory PT performance D2076 GENERAL IMMUNOLOGY CFR(s): 493.837(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on 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 General Immunology. The following scores was assigned: 2020 second event = 60% This is considered unsatisfactory 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 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's Albumin, Alanine Transaminase (ALT) ,Total Bilirubin, Total Cholesterol, Calcium (Ca), Creatinine, Glucose,Total Iron (T. Fe), Lactate dehydrogenase (LDH), Potassium (K), Total Protein, Urea Nitrogen (BUN) and Uric Acid. The following scores were assigned 2020 second event = 60% 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 -- 2 of 4 -- program, approved by CMS, for the speciality Chemistry The following scores were assigned 2020 second event = 68% 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 API PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Chloride (CL) and Sodium. The following scores were assigned: Chloride 2020 second event = 60% 2020 third event = 60% 2021 first event = 60% 2021 second event =100% 2021 third event = 60% This is considered repeatedly unsuccessful PT performance. Sodium 2020 second event = 60% 2020 third event = 100% 2021 first event = 60% This is considered unsuccessful 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 lack of PT records from the API PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Cortisol and Thyroxine. The following score was assigned: 2021 third event = 60% This is considered unsatisfactory PT performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on PT desk review of the CMS PT 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 specialities General Immunology, Chemistry and the test analyte's AFP, Chloride, Albumin, ALT ,Total Bilirubin, Total Cholesterol, T. Ca, Creatinine, Glucose, T. Fe, LDH, K, Na, Total Protein, BUN, Uric Acid, Cortisol. and Thyroxine Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 3 of 4 -- 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 speciality General Immunology and the test analyte's AFP, Chloride, Albumin, ALT ,Total Bilirubin, Total Cholesterol, Ca, Creatinine, Glucose, T. Fe, LDH, K, Na, Total Protein, BUN, Uric Acid Cortisol and Thyroxine The following scores were assigned: Chloride 2020 second event = 60% 2020 third event = 60% 2021 first event = 60% 2021 second event =100% 2021 third event = 20% This is considered repeatedly unsuccessful PT performance. Sodium 2020 second event = 60% 2020 third event = 100% 2021 first event = 60% This is considered unsuccessful PT performance. Speciality General Immunology/AFP 2020 second event = 60% Speciality Chemistry 2020 second event = 68% Albumin, ALT , Total Bilirubin, Total Cholesterol, Ca, Creatinine, Glucose, T. Fe, LDH, K, Total Protein, BUN and Uric Acid. 2020 second event = 60% Cortisol and Thyroxine 2021 third event = 60% This is considered unsatisfactory 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 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 Chloride (CL). The following scores were assigned: 2020 first event = 60% 2020 second event = 60% 2020 third event = 60% This is considered repeatedly unsuccessful PT performance. Refer to D2096. D2096 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 2 -- 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 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 Chloride (CL). The following scores were assigned: 2020 first event = 60% 2020 second event = 60% 2020 third event = 60% 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 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 Chloride. 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 Chloride. The following scores were assigned: 2020 first event = 60% 2020 second event = 60% 2020 third event = 60% This is considered repeatedly unsuccessful PT performance. -- 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 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 analytes Chloride (CL) and Thyroxine (T4). The following scores were assigned: Chloride (CL) 2020 first event = 60% 2020 second event = 60% Thyroxine (T4) 2019 third event = 60% 2020 first event = 100% 2020 second event = 60% This is considered an 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 -- 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 Albumin, Alanine transaminase (ALT) ,Total Bilirubin, Total Cholesterol, Calcium (Ca), Creatinine, Glucose,Total Iron (T. Fe), Lactate dehydrogenase (LDH), Potassium (K), Sodium (Na), Total Protein, Urea Nitrogen (BUN) and Uric Acid. The following scores were assigned 2020 second event = 60% 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 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 Chloride (CL). The following scores were assigned: Chloride (CL) 2020 first event = 60% 2020 second event = 60% This is considered a unsuccessful PT performance. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a PT desk review of the CMS PT reports and PT records from the API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Thyroxine (T4). The following scores were assigned: Thyroxine (T4) 2019 third event = 60% 2020 first event = 100% 2020 second event = 60% This is considered an 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on PT desk review of the PT CMS 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, for the test analytes CL, T4, Albumin, ALT ,Total Bilirubin, Total Cholesterol, Ca, Creatinine, Glucose, Total Fe, LDH, K, Na, Total Protein, BUN and Uric Acid. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on PT desk review of the PT CMS data reports and 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, for the test analytes CL, T4, Albumin, ALT ,Total Bilirubin, Total Cholesterol, Ca, Creatine, Glucose, Total Fe, LDH, K, Na, Total Protein, BUN and Uric Acid The following scores were assigned: Chloride (CL) 2020 first event = 60% 2020 second event = 60% Thyroxine (T4) 2019 third event = 60% 2020 first event = 100% 2020 second event = 60% This is considered an unsuccessful PT performance. Albumin, ALT , Total Bilirubin, Total Cholesterol, Ca, Creatine, Glucose, Total Fe, LDH, K, Na, Ttotal Protein, BUN and Uric Acid.. 2020 second event = 60% 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 American Proficency Institute (API) PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Sodium (Na). The following scores were assigned: 2019 first event = 20% 2019 second event = 40% This is considered unsuccessful PT performance. Refer to 2096. 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 3 -- 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 API PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Sodium (Na). The following scores were assigned: 2019 first event = 20% 2019 second event = 40% This is considered unsuccessful 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 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 Cortisol. The following scores were assigned: 2019 second event = 60% This is considered unsatisfactory PT performance D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on PT desk review of the PT CMS data reports and 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, for the test analytes Sodium and Cortisol. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on PT desk review of the PT CMS data reports and API PT program records, -- 2 of 3 -- 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 analytes Sodium and Cortisol. The following scores were assigned: Sodium 2019 first event = 20% 2019 second event = 40% This is considered unsuccessful PT performance. Cortisol. 2019 second event = 60% This is considered unsatisfactory PT performance. -- 3 of 3 --

Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on surveyor's direct observation of the work area in the laboratory and confirmed in an interview with the laboratory director and technical consultant/testing person, the laboratory failed to have adequate workbench space and floor space. FINDINGS: The laboratory director, technical consultant/testing person confirmed on March 12, 2019 at approximately 1:30 PM, that the laboratory itself was not maintained to ensure the space was adequate for conducting all phases of testing. a. the laboratory failed to have clean workbenches; papers, manuals, testing material boxes, etc. were stacked on all open spaces b. the DPC Immunlite 2000 and Horiba Pentra 400 analyzers were covered with stacked paper and test materials c. the reagents for the Horiba Pentra 400 were on the floor and in front of refrigerator next to the analyzer d. manuals, binders and boxes stacked on top of both refrigerators not within the 23 inch space required for fire safety 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 manual, Bio-rad Unity Peer 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 -- Review reports for 2017 & 2018 in the Laboratory Information System (LIS), QC file for the Siemens DPC Immunlite 2000 and ABX Horiba Pentra 400 and an interview with the technical consultant/testing person, the laboratory failed to retain chemistry, endocrinology and general immunology quality control (QC) records and QC & calibration control Bio-rad assay sheets from January 2, 2017 through March 12, 2019. FINDINGS: 1. The current technical consultant/testing person confirmed on March 12, 2019 at approximately 1:30 PM the surveyor's findings that the laboratory failed to retain chemistry, endocrinology and general immunology QC records and QC & calibration control Bio-rad assay sheets from January 2, 2017 through March 12, 2019. The following number of patient samples were tested and results reported for these specialties during the above time-period: a. approximately 2000 patient samples for both chemistry and endocrinology b. approximately 1000 patient samples for general immunology 2. The current technical consultant/testing person stated, "that he only keeps a current lot of QC raw data in the LIS LABDAQ software system and deletes the QC data after he enters the results to Bio-rad Unity QC Peer Review program" 3. Surveyor could not determine if the QC raw data entered into the Bio-rad system was accurate due to the lack of documentation. a. surveyor was unable to confirm that the manufacturer's established QC package insert ranges matched the current lot numbers of QC material. 4. The laboratory's LIS using LABDAQ software was down during this survey and the records were not available for review of the current lot of controls for the Immunlite 2000 and Horiba Pentra 400. 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: **AMENDED DEFICIENCY STATEMENT** Based on surveyor review the American Proficiency Institute (API) Proficiency Testing (PT) records on-line in the LABDAQ system, observed College of Pathologist (CAP) PT report and interview with the technical consultant/testing person, the laboratory failed to retain API & CAP PT records and documentation to include signed attestation forms, instrument printouts and a signed PT summary reports for the 3rd event of 2017, all three events in 2018 and 1st event of 2019. FINDINGS: The technical consultant/testing person confirmed on March 12, 2019 at approximately 1:30 PM the surveyor's findings that the laboratory failed to retain API & CAP PT records and documentation to include signed attestation forms, test results & instrument printouts and a signed PT summary reports for the 3rd event of 2017, all three events in 2018 and 1st event of 2019. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on the surveyor's review of API PT summary reports on-line and an interview with the technical consultant/testing person, the laboratory failed to evaluate 3rd event of 2017, all three events in 2018 and 1st event of 2019 PT summary reports; perform and document remedial action for the PT scores of less than 100%. -- 2 of 4 -- D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor's review of API PT records, laboratory test requisition records and confirmed in an interview with the technical consultant/testing person, the laboratory failed to verify twice annually the accuracy of test results for Androstenedione, Calcitonin, Thyroid Binding Globulin tests for 2018. Approximately 100 patients samples were tested and reported for the above tests in 2018. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on the surveyor's review of API PT summary reports on-line and an interview with the technical consultant/testing person, the laboratory failed to evaluate the 2nd & 3rd events of 2017, all three events in 2018 and 1st event of 2019 PT summary reports; perform and document remedial action for the PT scores of less than 100% and for the following analytes: 2017 second event: Chloride = 80% Total Iron = 80% Total LDH = 80% Chemistry 97% Thyroid Stimulating hormone (TSH) = 80% Thyroxine = 80% Endocrinology = 94% 2017 third event: Chloride = 40% Total cholesterol = 80% Creatinine = 80% BUN = 80% Chemistry = 94% Thyroxine = 40% Endocrinology = 91% 2018 first event: Endocrinology = 93% Alpha Feto-Protein (AFP) =80% General Immunology = 80% Albumin = 80% Total Iron = 80% Uric Acid = 0% Chemistry =93% Thyroxine = 80% Endocrinology = 97% 2018 third event: Chemistry = 99% Sodium = 80% 2019 first event: General Immunology = 80% AFP = 80% Chemistry = 96% Sodium = 20% Endocrinology = 97% Cortisol = 80% D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's Quality Assessment (QA) policies and procedures and confirmed in an interview with the technical consultant/testing person, at the time of this survey, the laboratory failed to follow their established QA policy and perform a QA review for the 2017 and 2018 calendar years. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 -- 3 of 4 -- The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor's review of laboratory records and findings and an interview with the pathologist/laboratory director, the laboratory director failed to fulfill his responsibilities and provide overall management of the laboratory. Refer to D6091and D6094. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require