Anniston Pediatrics Inc

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the laboratory's proficiency testing provider, AAB-Medical Laboratory Evaluation (AAB-MLE). The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] 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 off-site proficiency testing (PT) desk reviews of the CASPER 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 -- 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the AAB-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing in the Specialty of Hematology, Red Blood Cell (RBC), Hematocrit and Hemoglobin. The laboratory failed two consecutive PT events in 2024 and 2025, resulting in initial unsuccessful proficiency testing performance. Refer to D2130 and D2131. . D2130 HEMATOLOGY CFR(s): 493.851(f) (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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the AAB-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Red Blood Cell (RBC), Hematocrit, and Hemoglobin, resulting in initial unsuccessful performance. The findings included: 1. Based on review of the CASPER Reports 153D and 155D, Individual Laboratory Profile reports, the laboratory received the following failing scores, resulting in unsatisfactory performances for two consecutive events, as follows: A. 2024-Event M3: RBC, Hematocrit and Hemoglobin- Each 0% due to "Failure to Participate" B. 2025-Event M1: RBC, Hematocrit and Hemoglobin- Each 40% 2. A review of the laboratory's proficiency testing results from AAB-MLE confirmed the above findings. . D2131 HEMATOLOGY CFR(s): 493.851(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from AAB-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing in the Specialty of Hematology, resulting in initial unsuccessful performance. The findings included: 1. Based on review of the CASPER Reports 153D and 155D, Individual Laboratory Profile reports, the laboratory received the following failing scores, resulting in unsatisfactory performances for the Specialty of Hematology for two consecutive events, as follows: A. 2024-Event M3: 0% C. 2025-Event M1: 68% 2. A review of the laboratory's proficiency testing results from AAB-MLE confirmed the above findings. . D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 3 -- The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from AAB- Medical Laboratory Evaluation (AAB-MLE), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. 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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from AAB-Medical Laboratory Evaluation (AAB-MLE), the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program in the Specialty of Hematology, Red Blood Cell (RBC), Hematocrit and Hemoglobin in two consecutive 2024-2025 AAB-MLE PT events, resulting in initial unsuccessful participation. Refer to D2130 and D2031. -- 3 of 3 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Hematology calibration records and an interview with the Practice Manager (PM), the laboratory failed to perform calibration on the Medonic M-Series Hematology analyzer at least every six months as per manufacturer's specifications. This was noted for one of the four calibrations from 2023 through 2024. The findings include: 1. A review of the Hematology calibration records revealed the Medonic M-Series analyzer was calibrated 10-20-2023 and the next calibration was performed eight months later on 06-26-2024. 2. A further review of Medonic M-Series service reports revealed a preventive maintenance was performed on 05-10-2024 without calibration documentation. 2. In an email the PM sent to the surveyor on 12-03-2024 at 1:28 PM, she confirmed the calibration was not performed during the annual preventive maintenance. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) 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) 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 a review of Complete Blood Count (CBC) Quality Control (QC) records for the Medonic M-Series Hematology analyzer, and an interview with the Practice Manager (PM), the surveyor determined the laboratory failed to implement mechanisms to track for shifts and trends over time from the previous survey date of 11-30-2022 through the current survey date of 11-26-2024. The findings include: 1. A review of the CBC QC records for the Medonic M-Series Hematology analyzer revealed the laboratory had no mechanism to track for shifts and trends over time in their QC testing. The laboratory had retained records of the daily QC testing. 2. PM confirmed the above findings during the exit conference on 11-26-2024 at 2:00 PM. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the Practice Manager (PM), the technical consultant failed to ensure five of the five testing personnel performing moderate complexity testing had competency assessments that included the six minimal regulatory requirements from 2022 through 2024. The surveyor noted five of the six requirements were missing on annual and semi-annual competencies. The findings include: 1. A review of the personnel records revealed annual and semi-annual Hematology competency assessments were completed without the documentation of the five minimal requirements for assessment of competency. Missing requirements are as follows; 1. Monitoring the recording and reporting of test results. 2. Review of intermediate test results of worksheets, quality control records, proficiency testing results, and preventive maintenance results. 3. Direct observation of performance of instrument maintenance and function checks. 4. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. 5. Assessment of problem solving skills. 2. PM confirmed the above findings during the exit conference on 11-26-2024 at 2:00 PM. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of the Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to document

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 review of CMS Casper reports (#153/#155) and a telephone interview with laboratory staff on 8/10/2020 at 1:07 PM, the surveyor determined the laboratory failed to successfully participate in proficiency testing for Hematocrit (HCT) for two of three consecutive events, Event #3, 2019 and Event #2, 2020. These failures resulted in an initial unsuccessful proficiency testing participation for the laboratory. The findings include: 1. A review of the Casper reports revealed the laboratory failed HCT testing for two of three testing events, as follows: a) The laboratory scored sixty percent (60 %) for Hct on Hematology testing Event #3, 2019. b) The laboratory scored zero percent (0 %) for Hct for Event #2, 2020. 2. In a telephone interview on 8 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 -- /10/2020 at 1:07 PM, the laboratory staff stated the proficiency testing was overlooked for Event #2, 2020, due to the current pandemic activities and remodeling at the facility. The staff further stated the proficiency testing has been done, and the laboratory is currently awaiting a report from CLIA. The laboratory continued patient testing during the time of the missed proficiency testing. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of CMS Casper reports (#153/#155) and a telephone interview with laboratory staff on 8/10/2020 at 1:07 PM, the surveyor determined the laboratory failed to perform satisfactorily in proficiency testing for Hematocrit (HCT) for two of three consecutive events, Event #3, 2019 and Event #2, 2020. These failures resulted in an initial unsuccessful proficiency testing participation for the laboratory (D2016). The findings include: Refer to D2016. -- 2 of 2 --