Citizens Imaging Center

Summary Statement of Deficiencies 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 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's Nova Biomedical StatSensor quality control records from 2024 and 2025, and staff interview, the laboratory failed to have documentation of monitoring quality control values over time for 24 of 24 months. The findings included: 1. A review of the laboratory's Nova Biomedical StatSensor quality control records from 2024 and 2025 determined the following lot numbers of control material were used: a) Quality Control 1 Lot: 5023130241 expiration date: 05 /18/2025 Lot: 5024057241 expiration date: 02/26/2026 b) Quality Control 3 Lot: 5023067242 expiration date: 03/08/2025 Lot: 5024059243 expiration date: 02/26 /2026 2. Further review of the records determined the laboratory failed to have documentation of monitoring quality control values over time for 24 of 24 months. 3. The laboratory director confirmed the findings in an interview conducted on 02/17 /2026 at 0947 hours in the conference room. He stated he evaluated the quantitative values as 'pass' or 'fail'. He agreed that this did not provide information to detect possible shifts and trends to evaluate instrument function. 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 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of patient test records, review of the laboratory's verification studies for the Nova Biomedical Statsensor, and staff interview, the laboratory failed to have documentation of verifying 2 of 2 patient normal ranges as part of the studies. The findings included: 1. A review of patient test records identified the laboratory utilized 2 patient normal ranges to assess whole blood creatinine results. They were: a) Male results 0.72 - 1.25 mg/dl b) Female results 0.57 - 1.11 mg/dl 2. A review of the laboratory's verification studies for the Nova Biomedical Statsensor determined verification of the normal ranges was not included in the studies. 3. The laboratory was asked to provide documentation of verifying the patient normal ranges. No documentation was provided. 4. The laboratory director confirmed the findings in an interview conducted on 03/1/2024 at 0930 hours in his office. D5817 TEST REPORT CFR(s): 493.1291(i) If a laboratory refers patient specimens for testing-- (i)(1) The referring laboratory must not revise results or information directly related to the interpretation of results provided by the testing laboratory; (i)(2) The referring laboratory may permit each 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 -- testing laboratory to send the test result directly to the authorized person who initially requested the test. The referring laboratory must retain or be able to produce an exact duplicate of each testing laboratory's report; and (i)(3) The authorized person who orders a test must be notified by the referring laboratory of the name and address of each laboratory location where the test was performed. This STANDARD is not met as evidenced by: Based on review of patient reports from 1/23/2024 to 2/14/2024, and staff interview, the laboratory failed to include the testing facility's name and address on 10 of 10 reports. The findings included: 1. A review of a random sampling of patient reports from 1/23/2024 to 2/14/2024 identified 10 of 10 patient reports which did not contain the testing facility's name and address. They were: Date Specimen ID 1/23 G00130R 1 /29 G00068R 1/30 G00062R 1/31 G00076R 1/31 G00080R 2/05 G00129R 2/07 G00075R 2/08 G00094R 2/09 G00158R 2/14 G00070R 2. The laboratory director confirmed the findings in an interview conducted 03/19/2024 at 0940 hours in his office. -- 2 of 2 --