Chattanooga Childrens Clinic

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 a review of the laboratory's proficiency testing (PT) records and staff interviews, the laboratory director failed to sign four PT attestation statements (four of five) reviewed from 2024 and 2025. The findings include: 1. A review of the laboratory's American Proficiency Institute (API) PT records revealed the laboratory director did not sign the attestation statements for the following events: - 2024 Hematology/Coagulation Event 3 - 2025 Hematology/Coagulation Events 1, 2 and 3 2. The technical consultant and clinic manager confirmed the survey findings during an interview on 02/11/2026 at 1:45 p.m. . D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer's control package insert and assay sheet, and staff interviews, the laboratory failed to label six of six 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 -- control vials used for performing quality control on the Complete Blood Count (CBC) hematology analyzer with an open date and a corrected expiration date on the date of the survey, 02/11/2026. The findings include: 1. Observation of the laboratory on 02 /11/2026 at 12:45 p.m. revealed the Horiba ABX Micros 60 CBC Analyzer (serial number 404CS94023) used for patient testing, and three levels (six vials) of ABX Minotrol 16 Hematology controls that were not labeled with an open date and a corrected expiration date. Current lot - Low Abnormal: Lot 53211601, Expiration date 02/14/2026 - Normal: Lot 53211602, Expiration date 02/14/2026 - High Abnormal: Lot 53211603, Expiration date 02/14/2026 New lot - Low Abnormal: Lot 60121601, Expiration date 04/11/2026 - Normal: Lot 60121602, Expiration date 04/11/2026 - High Abnormal: Lot 60121603, Expiration date 04/11/2026 2. A review of the manufacturer's control package insert revealed the following: "After opening, ABX Minotrol 16 is stable throughout the open-vial dating, as indicated on the assay sheet, when stored at 2 C - 8 C (35 F to 46 F). A review of the ABX Minotrol 16 assay sheet revealed an open-vial stability requirement of 30 days. 3. The technical consultant and clinic manager confirmed the survey findings during an interview on 02/11/2026 at 1: 45 p.m. Word Key: C = degrees Celsius F = degrees Fahrenheit . D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: ___________________________________ Based on observation around 10:00 a.m. February 22, 2018 (during lab tour) of Glucola stored in reagent refrigerator and interview with the office manager, determined the laboratory failed to establish safety procedures to ensure that biohazardous materials and Glucola for human consumption were not stored in the same refrigerator. The findings include: 1. Observed around 10: 00 a.m. February 22, 2018, many bottles of Glucola used for human consumption stored in reagent refrigerator with materials considered biohazardous materials. 2. An interview at approximately 12:00 p.m. February 22, 2018 with the office manager confirmed there was no procedure to ensure that biohazardous materials and Glucola were not stored in the same refrigerator. ____________________________________ D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: ____________________________________ Based on CMS form-209 "Laboratory Personnel Report", Technical Consultant job responsibilities, competencies for testing 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 -- persons 5 of 5, lack of competencies for Technical Consultant and interview with the office manager and primary laboratory testing person, determined there were no competencies for technical consultant and technical consultant failed to perform competencies on testing personnel as stated in job responsibilities for 2016 and 2017. The findings include: 1. CMS form-209 shows one Technical Consultant and 5 testing persons. 2. Technical Consultant (TC) job responsibilities state: "TC evaluates and documents performance of individuals responsible for testing at 6 months and 12 months in the first year of employment and yearly after". 3. Competencies for 5 of 5 testing persons were performed by primary laboratory testing person who does not qualify as a technical consultant for 2016 and 2017. 4. There were no competencies documentated for technical consultant for 2016 or 2017. 5. Interview at approximately 12:00 p.m. February 22, 2018 with the office manager and primary testing person confirmed there were no competencies documented for technical consultant and competencies for testing persons 5 of 5 were not performed by the technical consultant for the two year period. _____________________________________ 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 of in use Complete Blood Count (CBC) control materials (lacking open date) around 10:00 a.m. February 22, 2018 during lab tour and interview with the primary laboratory testing person and office manager, determined the laboratory failed to document open date and open vial expiration date for CBC control materials in use 2/22/18. The findings include: 1. Observed during lab tour 2/22/18 around 10:00 a.m. in use CBC control materials lacking open date/open vial expiration date. 2. Interview at approximately 12:00 p.m. February 22, 2018 with primary laboratory teseting person and office manager, confirmed there was no open date on in use CBC control materials. ___________________________________ D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: ___________________________________ Based on review of unacceptable CBC quality control (QC) material for level 3 in April 2017, procedure review, lack of