A O P Pa Dba Central Georgia Cancer Care

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on August 5, 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: 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 American Proficiency Institute (API) Proficiency Testing (PT) documents the laboratory failed to received successful evaluation scores the the Specialty, Hematology, Sub-specialty White Blood Cell Differental (WBC DIFF), for event two and three in 2020. REFERENCE: D2123, D6019 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 -- 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 review of the American Proficiency Institute (API), Proficiency Testing (PT), evaluation reports and staff interview, the laboratory failed to receive successful scores for 2020 event 2 and 3 for the Specialty Hematology, sub-speciality White Blood Cell Differential. Findings: 1. Review of the API PT documents for 2020, 2nd event for Hematology, the laboratory failed to achieve an acceptable score for the subspecialty of White Blood Cell Differential. The facility scored 20% for the overall White Blood Cell Differential (WBC DIFF), It was noted on the review that the specimens were not tested as instructed in the API directions for testing the hematology samples. The instructions state that the samples were to be tested in the Quality Control mode for the Sysmex 430 Hematology analyzer. 2. Review of the API PT documents for 2020, 3rd event for Hematology, the laboratory failed to participate in the 3rd event by failing to submit results. There was no evaluation report for the 3rd event. It was noted on the evaluation report review that the laboratory manager was out on medical leave and the results were not submitted to API for evaluation. There was no self evaluation documents available at the time of the survey. 3. Review of the API PT documents for 2020, event 2 and 3 for Hematology, the laboratory failed to score successfully, 2 out of 3 events for the WBC DIFF. The laboratory received an overall score of 20% for the WBC DIFF for the 2nd , and 0% for the 3rd event. 4. Review of the API PT documents for 2020, event 1 and 3 for Specialty Hematology, sub-specialty ProTime (PT) the laboratory recieved a score of 60% on event 1 for PT, and received a score of 0% on event 3 for PT for failure to submit the results for evaluation. There was no self-evaluation documentation available at the time of the survey. 4. Interview with the Laboratory Manager, on August 5, 2021, at approximately 12:30pm, in the Manager's office, confirmed the above aforementioned statements. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 16, 2019. 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: Based on review of the Calibration documentation, and Operator's Manual for 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 -- Horiba Pentra 60+, hematology analyzer, and staff interview, the laboratory failed to perform calibration every 6 months. Findings: 1. Review of the calibration documents showed that the Horiba Pentra 60+ was calibrated, 12/2016, and 10/2018. There was no documentation of a calibration being performed in 2017. 2. Interview with the laboratory supervisor, April 16, 2019 at approximately 4pm, in a staff office, confirmed that there was no documentation of calibrations being performed in 2017. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (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 ACE Axcel Chemistry analyzer, and staff interview, the laboratory failed to establish or verify the criteria for acceptability of the QC material. Findings: 1. Review of the QC documents for the Chemistry analyzer, showed that the laboratory was using the stated value of the commercially assayed material as stated on the package insert from the manufacturer. There was no documentation that the laboratory had verified the ranges as stated. Review of the Levy Jennings(LJ) charts showed that the values obtained were below the package insert value and there was no way to determine if the QC was acceptable or not. 2. Interview with the Laboratory Supervisor, on April 16, 2019, at approximately 3:15pm, in a staff office, confirmed that they were using the manufacturer established ranges and had not verified the acceptability of the ranges. -- 2 of 2 --