Cynthia Chambless Md

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on September17, 2024. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 CASPER 155 report and review of the American Association of Bioanalysts (AAB) reports, the laboratory failed to maintain satisfactory 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 -- proficiency testing (PT) participation for White Blood Cell count (WBC) in 2024 events 1 & event 2, resulting in an initial unsuccessful participation for WBC. Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of AAB reports, the laboratory failed to maintain satisfactory participation in two consecutive testing events ( 2024 events 1 & 2), resulting in an initial unsuccessful participation for WBC. Findings: 1. A review of Casper Report 155 revealed the laboratory failed WBC on the following: 2024 Event 1 WBC Score 0% 2024 Event 2 WBC Score 0% 2. A review of the laboratory's API Reports confirmed the laboratory failed WBC with the aforementioned 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 review of the CMS CASPER 155 report and review of AAB reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the CMS CASPER Report 155 and the AAB 2024 events 1 & 2 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in WBC in two consecutive testing events, resulting in the initial unsuccessful participation for WBC. Refer to D 2130 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on September 14, 2023. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of the American Association of Bioanalysts (AAB) reports, the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory failed to successfully participate in proficiency testing (PT) in 3 consecutive events for white blood cell differential (WBC Diff) resulting in the non- initial unsuccessful participation for WBC Diff. Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CMS CASPER 155 report and review of AAB PT reports, the laboratory failed to demonstrate satisfactory performance in three consecutive testing events for WBC Diff, resulting in the non- initial unsuccessful participation for WBC Diff. Findings: 1. A review of Casper Report 155 disclosed the laboratory failed WBC Diff on the following: 2022 Event 3 Score 0% 2023 Event 1 Score 0% 2023 Event 2 Score 28% 2. A review of the laboratory's AAB Reports confirmed the laboratory failed WBC Diff with the aforementioned 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 review of the CMS CASPER 155 report and review of the AAB reports, the laboratory director failed to provide overall management and direction for successful participation in PT. The laboratory director failed to ensure PT samples were tested as required. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the CMS CASPER Report 155 and the AAB 2022 event 3 and 2023 events 1 and 2 PT evaluation reports, the laboratory director failed to ensure successful PT participation in three consecutive testing events. Refer to D 2130 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on May 17, 2023. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 CASPER 155 report and review of the American Association of Bioanalysts (AAB) reports, the laboratory failed to maintain satisfactory 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 -- proficiency testing (PT) participation for white blood cell differential (WBCD), Hematocrit (HCT), and white blood cell count (WBC) in 2022 event 3 and 2023 event 1, resulting in an initial unsuccessful participation for WBCD, HCT, & WBC. Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of American Association of Bioanalysts (AAB) reports, the laboratory failed to maintain satisfactory proficiency testing (PT) participation for white blood cell differential (WBCD), Hematocrit (HCT), and white blood cell count (WBC) in 2022 event 3 and 2023 event 1, resulting in an initial unsuccessful participation for WBCD, HCT, & WBC. Findings: 1. A review of Casper Report 155 revealed the laboratory failed WBCD on the following: 2022 Event 3 Score 0% 2023 Event 1 Score 0% 2. A review of Casper Report 155 revealed the laboratory failed HCT on the following: 2022 Event 3 Score 0% 2023 Event 1 Score 60% 3. A review of Casper Report 155 revealed the laboratory failed WBC on the following: 2022 Event 3 Score 0% 2023 Event 1 Score 20% A review of the laboratory's AAB Reports confirmed the laboratory failed WBCD, HCT, & WBC with the aforementioned 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 review of the CMS CASPER 155 report and review of American Association of Bioanalysts (AAB) reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the CMS CASPER Report 155 and the American Association of Bioanaysts (AAB) 2022 event 3 and 2023 event 1 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in two consecutive testing events (2022 event 3 and 2023 event 1), resulting in the non-initial unsuccessful participation for white blood cell differential (WBCD), Hematocrit (HCT), and white blood cell count (WBC). Findings: 1. A review of Casper Report 155 revealed the laboratory failed WBCD on the following: 2022 Event 3 Score 0% 2023 Event 1 Score 0% 2. A review of Casper Report 155 revealed the laboratory failed HCT on the following: 2022 Event 3 Score 0% 2023 Event 1 Score 60% 3. A review of Casper Report 155 revealed the laboratory failed WBC on the following: 2022 Event 3 Score 0% 2023 Event 1 Score 20% A review of the laboratory's AAB Reports confirmed the laboratory failed WBCD, HCT, & WBC with the aforementioned scores. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on May 26, 2021. Condition and Standard level Citations were found. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) Proficiency Testing (PT) provider, for the year 2020, tha laboratory failed to enroll in a PT program for Subspecialist of Hematology (CBC). The laboratory was still testing patient samples. Reference: D6015 D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(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 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 -- director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) Proficiency Testing (PT) provider, for the year 2020, the Laboratory Director (LD) failed to confirm that the laboratory was enrolled in a PT program for Specialty of Hematology (CBC), for the year 2020 The laboratory was still testing patient samples. Findings: 1. Based on review of the AAB PT documets, the laboratory failed to participate for all three events in 2020 for the Specialty of Hematology. 2. Staff interview with the LD and staff #3(CMS form 209) on May 26th, 2021,at approximately 5pm in the back hall, and with Staff #3 on the phone on May 26th, 2021 at approximately 4:45pm, confirmed that the AAB PT for the year 2020 was not ordered, by the deadline. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 27, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the calibration records of the Sysmex XP-300 Hematology Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- analyzer from 2017 and 2018, and staff interview the laboratory was not calibrating the Hematology Analyzer every 6 months as required. Findings: 1. Review of the Sysmex XP-300 hematology analyzer calibration records from 2017 and 2018, showed that the laboratory had not calibrated the analyzer every 6 months as required. The records show that there was a calibration performed: 11-2016 3-2017 - 4 months 3-2018 - 12 months 10-2018 - 7 months 2. Interview with staff #2 (CMS-209 form) on 02/27/2019 at approximately 12:45 pm in the back office, confirmed that the calibration was performed as stated above. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Quality Control (QC) documents for the Sysmex XP-300 (CBC analyzer) and staff interview the laboratory was not reviewing the Levey Jennings(LJ) Charts for the QC to detect immediate errors. Findings: 1. Based on review of the QC documents for the CBC analyzer, the laboratory was not documenting review of the LJ charts to detect shifts and trends of the QC results 2. Interview with staff #2, on 02/27/2019 at approximately 12:45 pm in the back office confirmed that the laboratory was not printing or reviewing the LJ charts for the QC on the CBC analyzer. -- 2 of 2 --