Kids First Pediatrics Of Georgia Pc

Summary Statement of Deficiencies D0000 A recertification survey was performed on October 24, 2023. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) provider documents for 2021, 2022, and 2023, and staff interview, the laboratory failed to provide signed attestation statements for event 1 in 2022, and event 1 and 2 in 2023. Findings: 1. A review of the PT documents for 2022 event 1, revealed the laboratory did not provide documentation of a signed attestation statement confirming that PT samples were performed as routine patient samples. 2. A review of the PT documents for 2023 event 1 and 2 revealed the laboratory did not provide documentation of a signed attestation statement confirming that PT samples were performed as routine patient samples. 3. Interview with the Laboratory Director on 10 /24/2023, at approximately 1 pm, in the front office, confirmed that the attestation forms were not provided by MLE so they were not completed. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's 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 -- instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the Room Temperature (RT) log for years 2022- 2023, and staff interview, the laboratory failed to document

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on December 15, 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: 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: Document review and staff interview confirmed that the laboratory failed to provide 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 -- calibration documents for the Medonic Hematology Analyzer(Medonic) for years 2020 and 2021. Findings: 1) Review of the calibration documents for the Medonic revealed that the laboratory did not have documentation supporting 6 month calibrations for the year 2020 or 2021. 2) Interview with the Laboratory Director, on December 15, 2021, at approximately 3 pm, in the office manager's office, confirmed that the calibration documents were not available for years 2020 or 2021. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on April 30, 2018. 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 Mledcal Laboratory Evaluation (MLE) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events (3rd event of 2017 and 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 -- 1st event of 2018), resulting in the first unsuccessful occurrence for 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 Mledcal Laboratory Evaluation (MLE) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events (3rd event of 2017 and 1st event of 2018), resulting in the first unsuccessful occurrence for platelets (PLT) # 815. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #815 platelets on event 3 of 2017 with a score of 40% and event 1 of 2018 with a score of 40%. 2. Desk review of the laboratory's proficiency testing reports from MLE confirmed the laboratory failed platelets on event 3 2017 and event 1 of 2018 resulting in the first unsuccessful performance. -- 2 of 2 --