Executive Physical Program

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on August 20, 2026, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) records (2025-1, 2025- 3, and 2026-1), the laboratory failed to successfully participate in a proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the hs-CRP and Vitamin B12 analytes resulting in unsuccessful performances. See D2084 and D2107 respectively. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for two out of three consecutive events (2025-3 and 2026-1) for the high sensitivity C- Reactive Protein (hs-CRP) analyte (specialty Diagnostic Immunology): The findings include: 1. hs-CRP 0% - 2025 third testing event; hs-CRP 0% - 2026 first testing event. A review of the 2025 & 2026 scores from American Proficiency Institute (API) confirmed the above findings. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for two out of three consecutive events (2025-1 and 2025-3) for the analyte Vitamin B12 (specialty Chemistry): The findings include: 1. Vitamin B12 20% - 2025 first testing event; Vitamin B12 60% - 2025 third testing event. A review of the 2025 scores from American Proficiency Institute (API) confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and American Proficiency Institute (API) records for the 2025-1, 2025-3, and 2026-1 -- 2 of 3 -- events, the laboratory director failed to provide overall management and direction of the laboratory services to ensure successful participation of the proficiency testing. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and American Proficiency Institute (API) records for 2025-1, 2025-3, and 2026-1 events, the laboratory director failed to ensure successful proficiency testing participation as required in this subpart. Refer to D2084 and D2107. -- 3 of 3 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) documentation, CASPER 0155D Individual Laboratory Profile report, and interviews with the technical consultant (TC) and administrator on August 14, 2026, the laboratory failed to attain at least 80 percent acceptable responses for multiple analytes in different testing events from 2023 to 2025. The findings include: 1. The surveyor reviewed the API PT documentation and found that the laboratory obtained unsatisfactory scores of the following: a. 60% Sodium analyte during the second event of 2023; b. 60% Albumin analyte during the third event of 2024; b. 0% Aspartate aminotransferase (AST) and Total Protein analytes during the third event of 2024; c. 0% Amylase analyte during the first event of 2025; d. 60% for Calcium, Glucose and Iron analytes during the first event of 2025; e. 20% Cholesterol analyte during the first event of 2025; f. 40% Gamma-Glutamyl Transferase (GGT) analyte during the first event of 2025; g. 0% Lactate Dehydrogenase analyte during the second event of 2025; h. 60% Phosphorus analyte during the second event of 2025; i. 0% Alkaline Phosphatase and Carbon Dioxide analytes during the third event of 2025; The scores were verified using the CASPER 0155D Individual Laboratory profile report. 2. During an interview on August 14, 2026, at approximately 9:13 a.m., the TC and administrator confirmed that the laboratory obtained the unsatisfactory scores for multiple analytes in different testing events from 2023 to 2025. 3. According to the laboratory's testing declaration form (Lab-144) submitted at the time of survey, the laboratory performed and reported approximately 865 patient samples annually in Routine Chemistry including the time when the laboratory obtained Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- unsatisfactory scores for multiple analytes in different testing events from 2023 to 2025. . D2098 ENDOCRINOLOGY CFR(s): 493.843(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) records and an interview with the technical consultant and administrator on August 14, 2026, the laboratory failed to attain at least 80 percent of the acceptable score in Endocrinology for the Folate analyte for the first event of 2025 (Q1-2025) and Follicle-Stimulating Hormone (FSH) analyte during the third event of 2025 (Q3-2025). The findings include: 1. The surveyor reviewed the API PT performance evaluation documentation and found that the laboratory obtained an unsatisfactory score of 20% for the Folate analyte in Q1-2025 event and 40% FSH analyte during the Q3-2025. The report is as follows: a. 20% Folate analyte score for the Q1-2025 event: Sample Result Expected IA-01 *12.0 4.5 - 8.5 IA-02 *15.5 6.5 - 12.3 IA-03 0.5 0.0 - 1.0 IA-04 *3.3 0.5 - 2.6 IA-05 *7.0 2.6 - 5.0 b. 40% FSH analyte score for the Q3-2025 event: Sample Result Expected IA-11 0.0 0.0 - 1.0 IA-12 *14.4 14.8 - 21.0 IA-13 *24.7 25.2 - 36.3 IA-14 46.6 44.6 - 64.3 IA-15 *34.2 34.7 - 50.0 Legend: * = unsatisfactory score 2. The technical consultant and administrator confirmed by an interview on August 14, 2026, at approximately 9:13 a.m. that the laboratory obtained unsatisfactory PT scores for the Folate analyte during the Q1- 2025 event and FSH analyte during the Q3-2025 event. 3. According to the laboratory ' s testing declaration, the facility performed and reported approximately 698 Endocrinology patient test samples-including Folate and FSH analytes annually, including the period when the laboratory received unsatisfactory proficiency testing scores. . D2121 HEMATOLOGY CFR(s): 493.851(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) records, the CASPER 0155D report, and an interview with the technical consultant and administrator on August 14, 2026, it was determined that the laboratory failed to achieve at least 80 percent acceptable responses for multiple analytes in Hematology specialty during the first event of 2024 (Q1-2024). The findings include: 1. Review of the laboratory's API PT records showed that the laboratory received unsatisfactory scores for the following analytes during the Q1- 2024 event: a. 67% Cell ID test; b. 40% Red Blood Cell (RBC) and Hematocrit analytes; c. 60% Hemoglobin analyte; d. 60% Platelet analyte. These results were further verified through the CASPER 0155D report. 2. During an interview on August -- 2 of 5 -- 14, 2026, at approximately 9:13 a.m., the technical consultant and administrator confirmed that the laboratory received the unsatisfactory scores for the Cell ID test, RBC, Hematocrit, Hemoglobin, and Platelet analytes during the Q1-2024 event. 3. According to the testing declaration form (Lab-144) submitted on the day of the survey, the laboratory tested and reported approximately 763 patient sample results annually for Hematology specialty that included the Cell ID test, RBC, Hematocrit, Hemoglobin, and Platelet analytes. . 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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on the review of the laboratory's policy for record retention, ten patient test records from September 11, 2024 to May 26, 2026, lack of preventive maintenance (PM), quality control, and patient test records and interviews with the technical consultant and administrator on August 14, 2026, the laboratory failed to retain analytic system records for at least 2 years. The findings include: 1. The laboratory's policy for record retention was not followed as evidence by: a. Six of the ten requested patient test records were not retrievable at the time of the survey. b. Seven of the ten requested patient records lacked retrievable preventive maintenance documentation. c. Six of the ten requested patient records lacked retrievable quality control documentation. 2. During an interview on August 14, 2026, at approximately 2:00 p.m., the technical consultant and administrator confirmed that the laboratory failed to follow their retention policy and was unable to retrieve the analytic system records for the following dates: a. Patient #1, September 11, 2024; b. Patient #2, February 27, 2025; c. Patient #3, May 20, 2025; d. Patient #4, September 10, 2025; e. Patient #6, February 27, 2025; f. Patient #7, October 27, 2025 g. Patient #8, December 8, 2025, all records were available except for the PM documentation. 3. According to the testing declaration submitted at the time of the survey, the laboratory performed and reported approximately 2,965 patient samples annually during periods when analytic system records-including patient test records, preventive maintenance documentation, and quality control records-were not retained for at least two years. . D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's competency assessment policy and procedure, ten patient records from September 11, 2024 to May 26, 2026, lack of personnel competency documentation, and an interview with the technical consultant and administrator on August 14, 2026, it was determined that the laboratory did not follow its written competency assessment policies and procedures as required under -- 3 of 5 -- CLIA Subpart M. The findings include: 1. The laboratory's policy and procedure for testing personnel competency assessment aligned with CLIA requirements but was not followed. 2. Record review showed that no competency assessment documentation was available for the testing personnel prior to performing patient testing in 2024, 2025, and 2026. Four patient records were retrieved out of the ten requested, as shown below: Accession # | Date of Testing 225467 - 03/20/2026 222774 - 12/08/2025 224326 - 02/03/2026 226563 - 05/26/2026 The remaining six requested patient records were not retrievable at the time of the survey. 3. During an interview on August 14, 2026, at approximately 2:00 p.m., the technical consultant and administrator confirmed that the laboratory failed to conduct and document the competency assessment for the testing personnel prior to testing patient samples for the years 2024, 2025, and 2026. 4. No

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on 07/17/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful American Proficiency Institute participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) records (2025-1 and 2025-2), the laboratory failed to successfully participate in a proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the analyte Sodium resulting in unsuccessful performance. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API - American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for two out of three events (2025-1 and 2025-2) for the analyte Sodium (specialty Routine Chemistry). The finding include: Sodium 60% - 2025 first testing event; Sodium 60% - 2025 second testing event; A review of the 2025 scores from American Proficiency Institute (API) confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and American Proficiency Institute records for 2025-1 and 2025-2 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and AAB records for 2024-3 and 2025-2 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 4/3/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCES D2016 - 42 C.F.R. 493.803 Condition: Successful Participation [proficiency testing]; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) records (for proficiency testing events: 2024-3 and 2025-1), the laboratory failed to successfully participate in 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 -- a proficiency testing program approved by HHS for each specialty, subspecialty and analytes or test in which the laboratory is certificaed under CLIA, the laboratory failed to successfully participate in the analyte Creatinine, resulting in an initial unsuccessful performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and American Proficiency Institute (API) records, the laboratory failed to achieve satisfactory performance for Creatinine: Laboratory scored 60% for the 2024 Creatinine third testing event; Laboratory scored 40% for the 2025 Creatinine first testing event. A review of the 2024-2025 API proficiency testing records confirmed the above scores. 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 the proficiency testing desk review of the laboratory's CASPER 0155D report and American Proficiency Institute (API) records, the laboratory director failed to ensure successful participation in the HHS proficiency testing program. Refer to D2096. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on proficiency testing desk review of the laboratory's CASPER 0155D report and American Proficiency Institute (API) records, the laboratory director failed to ensure that proficiency samples were tested as required under Subpart H. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies 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 Surveyor review of laboratory's proficiency testing (PT) records, and interview with the laboratory technical consultant on August 17, 2023, at 12:35 pm, the laboratory testing person and director failed to attest to the routine integration of the PT samples into the patient workload using the laboratory's routine methods in one PT event out of 6 events reviewed. The findings include: 1. The laboratory participated in the API PT program for the year 2021, 2022 and 2023. However, the laboratory did not have any documentation showing that its testing person and director had attested to the routine integration of the CBC PT samples into the patient workload for the 2nd event in 2023. Therefore, it cannot be assured that the laboratory did not handle the PT samples differently than the patients' samples and the correct PT results might not reflect the laboratory's patients result accuracy. 2. The laboratory technical consultant on August 17, 2023, at 12:35 pm, affirmed that the laboratory did not have the attest documentation for the CBC PT 2nd event in 2023. 3. The laboratory's testing declaration form, signed by the laboratory director on 8/162023 stated that the laboratory performs approximately 23,000 CBC tests, annually. 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. 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 -- This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) records, and interview with the laboratory technical consultant on August 17, 2023, at 1:00 pm, the laboratory failed to attain a score of at least 80 percent of acceptable responses for calcium, CO2, glucose and total protein at the 1st event in 2023 and is unsatisfactory analyte performance for the testing event. The findings include: 1. The laboratory participated in the API PT program for the year 2023. The laboratory scored 60% for calcium, 40% for CO2, 60% for glucose and 40% for total protein at the 1st event which resulted in an unsatisfactory analyte performance. Therefore, the accuracy of the patient test results reported by the laboratory during the proficiency testing event cannot be assured and might have harmed patients. 2. The laboratory technical consultant on August 17, 2023, at 1:00 pm, affirmed that the laboratory scored 60% for calcium, 40% for CO2, 60% for glucose and 40% for total protein at the 1st event in 2023. 3. The laboratory's testing declaration form, signed by the laboratory director on 8/16/2023 stated that the laboratory performs approximately 67,600 tests in routine chemistry, annually. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) records, and interview with the laboratory technical consultant on August 17, 2023, at 1:10 pm, the laboratory failed to take remedial action after receiving the unsatisfactory analyte performance at the 1st event in 2023. The findings include: 1. The laboratory participated in the API PT program for the year 2023. The laboratory scored 60% for calcium, 40% for CO2, 60% for glucose and 40% for total protein at the 1st event which resulted in an unsatisfactory analyte performance. However, the laboratory did not take any remedial action for the failure except re-running the PT sample. The remedial action must address the underlying cause, future prevention and impact on the patients results. Therefore, the accuracy of the patient test results reported by the laboratory during the proficiency testing event cannot be assured and might have harmed patients. 2. The laboratory technical consultant on August 17, 2023, at 1:10 pm, affirmed that the laboratory did not take any remedial or

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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Endocrinology constituting unsuccessful PT performance. (See 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 2 -- 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Thyroid Stimulating Hormone (TSH), as follows: 2021 Q3 2022 Q2 TSH 40% 40% Q2 = Second testing event Q3 = Third testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT resulted in an initial unsuccessful performance for the analyte, TSH . 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, TSH, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (see D2016 and D2107) -- 2 of 2 --

Summary Statement of Deficiencies 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 the surveyor's review of the laboratory's records for evaluation of proficiency testing performance from CMS, laboratory proficiency reporting from API, and an interview with laboratory personnel (LP) and the technical consultant (TC) on 11/18/2020 between 11:00 a.m. and 12:30 p.m., it was determined that there were several unacceptable (below 80 %) proficiency testing (PT) results for Iron, Alkaline Phosphatase (ALP) and ALT/SGPT for Cycle 1 (2019). Findings include: 1. On 11/18/2020, an inspection was conducted between 11 a.m. and 12:30 p.m. 2. During a review of the laboratory documentation from API (agency providing the proficiency specimens), it was noted at approximately 11:45 a.m. that there were several unacceptable PT results for cycle Q1 on the 2019 report. The laboratory utilizes the Horiba Med. Pentra 400 instrument for general chemistry testing The LP and TC recognized these atypical results. 3. The findings and acceptable ranges were as follows: Analyte: Iron (5/5 Unacceptable) Sample Actual Result Expected Result (range) 1 237 133-201 2 243 153-231 3 166 104-158 4 49 24-37 5 102 64-97 Analyte: ALP (5/5 Unacceptable) Sample Actual Result Expected Result (range) 1 170 75-141 2 505 213-397 3 342 142-265 4 54 25-48 5 200 86-160 Analyte: ALT/SGPT (4/5 Unacceptable) Sample Actual Result Expected Result (range) 1 31 19-29 2 333 218- 328 3 212 139-209 5 119 78-118 4. The LP and TC affirmed the unacceptable results listed above. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- The laboratory 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 and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of the proficiency laboratory documentation records and interviews with the LP and TC, it was determined that the laboratory director failed to ensure the verification and accuracy of test results of regulated analytes and to identify failures as they occurred for the previously mentioned Cycle 1 2019 proficiency testing. The findings include: See D-2087 D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on a review of the proficiency laboratory documentation records and interviews with the LP and TC, it was determined that the technical consultant failed to ensure the the verification and accuracy of test results of regulated analytes and to identify failures as they occurred for the previously mentioned Cycle 1 2019 proficiency testing. The findings include: See D-2087 -- 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting unsuccessful PT performances. (See 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 2 -- 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Chloride (CL), resulting in an "non-initial" (subsequent) unsuccessful performance. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, CL, as follows: 2016 Q1 20% 2016 Q2 20% 2017 Q2 40% 2018 Q1 60% 2019 Q1 60% 2019 Q2 20% Q1 = First Testing Event Q2 = Second Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an subsequent unsuccessful performance for the analyte, CL. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, CL, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2096) -- 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the subspecialty of Routine Chemistry constituting unsuccessful PT performance. (See 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 2 -- 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Chloride (CL), resulting in an non-initial (subsequent) unsuccessful performance. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, CL, as follows: 2016 Q1 20% 2016 Q2 20% 2017 Q2 40% 2018 Q1 60% Q1 = First Testing Event Q2 = Second Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an subsequent unsuccessful performance for the analyte, CL. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, CL, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performances. (See D2016 and D2096) -- 2 of 2 --