Donald R Schneider Md & Zachary R Schneider Md

Summary Statement of Deficiencies 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 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 manufacturer's user's manual, review of the temperature charts, and interview with the laboratory director (LD), the laboratory failed to monitor humidity in the space where the hematology analyzer was located. Findings: 1. The laboratory performed hematology testing using a Medonic M-Series analyzer. 2. The Medonic user's manual listed acceptable operating conditions for humidity as "Up to 80%." 3. The laboratory's temperature logs did not include humidity. 4. During the survey on 09/18/2024 at 12:30 PM, the LD confirmed that the laboratory was not monitoring humidity in the space where the hematology analyzer was located. D5783

Summary Statement of Deficiencies 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: Note: This is a repeat deficiency. The laboratory was cited during the re-certification survey on 9/25/2018 for not ensuring that proficiency testing attestation statements were signed by the laboratory director. The

Summary Statement of Deficiencies 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: Note: This is a repeat deficiency. The laboratory was cited during the re-certification survey on 9/28/2016 for not signing attestation statements. The