East Cobb Pediatrics

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 02, 2025. 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: D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on June 18, 2021. 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 deficiencies were cited: 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 desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (2nd event of 2020 and 1st event of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815. Findings include: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to maintain satisfactory performance in two consecutive events (2nd event of 2020 and 1st event od 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815.. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815 on event 2 of 2020 with a score of 0% and event 1 of 2020 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from API confirms the laboratory failed Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815. on event 2 of 2020 and event 1 of 2021 resulting in the first unsuccessful 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (2nd event of 2020 and 1st event of 2021), resulting in the first unsuccessful occurrence for Findings include: Refer to D 6016 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 -- 2 of 3 -- 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (2nd event of 2020 and 1st event of 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed event 2 of 2020 and event 1 of 2021 Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815 with scores of 0% 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (AP) confirmed the laboratory failed Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815 with scores of 0% for events 2 of 2020 and 1 of 2021, resulting in the 1st unsucessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 23, 2021. 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: D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to participate in CLIA required PT. Findings include: 1. American Proficiency Institute (API) PT document review revealed the laboratory failed to participate in the following Hematology PT events: 2019 -- Event Two; 2020 -- Event Two. 2. An interview with the Clinic Coordinator in Exam Room #2 on 3/23/2021 at approximately 4:00 p.m. confirmed the aforementioned failure to participate in PT events. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to perform and document equipment maintenance with required frequency. Findings include: 1. Observation during the laboratory tour on 3/23/2021 at approximately 4:15 p.m. revealed the Path Group centrifuge was last calibrated on 9/27/2019. 2. An interview with the Clinic Coordinator in the laboratory on 3/23/2021 at approximately 4:15 p.m. confirmed the lack of required annual centrifuge calibration. 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 calibration document review and staff interview, the laboratory failed to perform instrument calibration every six months as required. Findings include: 1. Beckman Coulter AcT Diff calibration document review revealed a gap in the required six-month calibration intervals for the following time periods: 4/9/2019 to 11 /27/2019 (seven months); 11/27/2019 to 7/22/2020 (8 months). 2. An interview with the Clinic Coordinator in Exam Room #2 on 3/23/2021 at approximately 3 p.m. confirmed the aforementioned gaps in calibration intervals. 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 -- 2 of 3 -- 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 quality control (QC) document review and staff interview, the laboratory failed to monitor over time the accuracy and precision of test performance as required. Findings include: 1. Beckman Coulter AcT Diff QC review revealed the lack of Levey-Jennings charts available at the time of survey for the following time periods: 2018 (November and December), 2019, 2020, and 2021 thus far. 2. An interview with the Clinic Coordinator on 3/23/2021 in Exam Room #2 at approximately 3:15 p.m. confirmed the lack of Levey-Jennings charts for the aforementioned time periods. -- 3 of 3 --