Shelbyville Pediatrics

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 11/12/2025. The facility was found to not be in compliance with the laboratory requirements of 42 CFR Part 493 with standard deficiencies cited. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 direct observation, policy review, calibration records, and confirmed in interview, the laboratory failed to perform 6 month calibration verification for 2 out of 3 events observed. The findings included: During a tour of the laboratory on 11/12 /2025 at 10:50 AM, a Medonic M Hematology Analyzer, Serial Number 26442, was observed. Review of the policy procedure in the section labeled Medonic M, (revised 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 -- date not documented) stated: "Calibration must be performed upon setup of the instrument and then at a minimum of every 6 months." Review of the calibration records revealed the following: May 2024 - calibration performed November 2024 - no documentation May 2025 - no documentation During an interview on 11/12/2025 at 11:40 a.m. in the office area next to the laboratory, the Technical Consultant (TC) was asked to provide documentation for 6 month calibration. Documentation was not provided. This confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on 09/18/2023. The facility was found to not be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, document review, and confirmed in staff interviews; the laboratory failed to label one (1) of one (1) set of complete blood count (CBC) quality controls with an opened date. The findings include: During the laboratory tour, on 09 /18/2023 at 2:50 PM, current vials of CBC quality controls in use were requested. Testing Personnel (TP) #1 presented a cup that contained three (3) vials of "Boule Con-Diff" (hematology quality controls used to monitor the performance of hematology analyzer systems), lot number 22305, with a printed expiration date of 10 /11/2023. Observation of the quality controls revealed the vials were opened, but not labeled with an opened date, and therefore, there was no way to determine how long the quality controls had been in use. Review of the laboratory procedure manual, signed by the Laboratory Director on 03/25/2021, revealed a document labeled "Hematology Medonic M [a cell analyzer system]," which stated, Boule Con-Diff Controls, tri-level, store at two (2) to ten (10) degrees Celsius (C). Per review, unopened vials were stable until the expiration date on the package, ninety (90) days, and opened vials were stable for fourteen (14) days. Review of the undated instructions for the "Boule Con-Diff Tri-Level" quality controls, revealed "Open vial 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 -- stability 14 days after opening when returned to refrigerator after each use." Review of the undated package insert for the "Boule Con-Diff" quality controls, revealed, "Open vial stability 14 days." During an interview, on 09/18/2023 at 2:55 PM, TP #1 stated she did not know when the quality controls were opened. During an interview, on 09/18/2023 at 3:00 PM, the Technical Consultant (TC) acknowledged the opened vials (of quality controls) should have been labeled with the open date as required. -- 2 of 2 --

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 the desk review of hematology proficiency testing results from the American Proficiency Institute on 03/18/2021, the laboratory failed to successfully participate in two (2) consecutive hematology testing events. See D2122 and D2131 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. 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 -- This STANDARD is not met as evidenced by: Based on the desk review of proficiency testing results from the American Proficiency Institute, the laboratory failed to attain an overall satisfactory score of at least eighty percent (80 %) in two (2) Hematology testing events. Findings include: The facility scored Zero percent (0 %) in the second (2nd) testing event of 2020 and scored Zero percent (0 %) in the third (3rd) testing event in 2020. D2131 HEMATOLOGY CFR(s): 493.851(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 the desk review of proficiency testing results from the American Proficiency Institute on 03/18/2021, the laboratory failed to achieve satisfactory overall Hematology testing event scores in two (2) consecutive testing events. Findings include: The laboratory failed to achieve satisfactory performance in the second (2nd) testing event of 2020 with a score of zero percent (o %) and failed to achieve satisfactory performance in the third (3rd) event of 2020 with a score of zero percent (o %). -- 2 of 2 --

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 staff interview, and review of the Procedure Manual for the Cell Dyn Emerald Hematology analyzer on April 18, 2019 at 2:35 PM, the laboratory failed to perform and document calibration procedures in accordance with manufacturer's instructions. Findings include: 1. Review of the Procedure Manual for the Cell Dyn Emerald Hematology analyzer revealed calibration should be performed at least every six (6) months. 2. Record review revealed there was no documented evidence the laboratory performed calibration verification between April 18, 2017 through April 17, 2019. 3. Testing personnel acknowledged in an interview on 04/18/2019 at 2:35 PM , the laboratory failed to have a system in place to ensure calibration of the Cell Dyn Emerald analyzer be performed and documented in accordance with manufacturer's requirements. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --