Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on July 25, 2025. 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: 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: A review of the laboratory facilities confirmed that was not adequate protection against all potential hazards. THE FINDINGS INCLUDE: 1. A tour of the laboratory testing area confirmed that there was not a designated clean sink to protect against potential cross contamination of specimens and testing personnel. 2. A tour of the facility revealed that an eyewash station was installed on the same sink used for discarding waste products and reagents. 3. An exit interview, with the laboratory staff, on July 25, 2025, at 1:00 pm, confirmed there was not adequate protection against all potential hazards in the testing laboratory. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. 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 -- This STANDARD is not met as evidenced by: A tour of the laboratory revealed that expired reagents were in use for patient testing and resulting. THE FINDINGS INCLUDE: 1. A tour of the testing laboratory revealed the following expired reagents were in use: a. MCKESSON NORMAL SALINE: Expired 02/13/2025 2. An exit interview, with the Laboratory Director and the Lab Team on July 25, 2025, at 1:00 pm confirmed that expired reagents were in use for patient testing and resulting. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A review of 2023 - 2025 Maintenance Records, confirmed that the annual preventitive maintenance, as required by the manufacturer, was not performed. THE FINDINGS INCLUDE: 1. A review of the Medonics Hematology Analyzer User Manual, Section 8.4 Instrument Maintenance confirmed that preventitive maintenance is required annually or every 20,000 samples. 2. A review of 2023 - 2025 Maintenance Records revealed that the required annual preventive maintenance for the Medonics Hematology Analyzer was not performed. 3. An exit interview, with the laboratory staff, on July 25, 2025, at 1:00 pm confirmed that the annual preventive maintenance for the Medonics Hematology Analyzer was not performed. D6011 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) (e)(2) provide a safe environment in which employees are protected from physical, chemical, and biological hazards; This STANDARD is not met as evidenced by: A review of the laboratory testing facility confirmed that the Laboratory Director failed to provide a safe environment for the laboratory testing personnel. Refer to D3011 D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) (e)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: A review of 2023 - 2025 Personnel Records, confirmed that the Laboratory Director failed to verify that testing personnel met required qualifications. THE FINDINGS INCLUDE: 1. A review of 2023 - 2025 Personnel Records confirmed that Testing Personnel #2 (TP2) ( Form 209: Laboratory Personnel Report) has unverified foreign credentials. 2. An interview with the Laboratory Director confirmed that a United -- 2 of 3 -- States Education Equivalency Evaluation was not performed. 3. An exit interview, with the Laboratory Director and Lab Personnel, on July 25, 2025, at 1:00 pm confirmed that the Laboratory Director failed to certify that all testing personnel met required education qualifications. -- 3 of 3 --