Summary:
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 ImmunoCard Mycoplasma pneumoniae (Meridian) manufacturer's instructions, Mycoplasma pneumoniae testing records review (years 2023-2024) and general supervisor interview on March 7, 2024 at 12:00 P.M, it was determined that the laboratory failed to follow the manufacturer's instruction regarding to the established temperature range for Mycoplasma pneumoniae when 78 out of 78 days from July 2023 to December 2023 performed mycoplasma specimens below the established temperature range. The findings include: 1. The laboratory uses ImmunoCard Mycoplasma (Meridian) to perform Mycoplasma patient's samples tests. (Reviewed on March 7, 2024 at 12:00 P.M) 2. The ImmunoCard Mycoplasma (Meridian) manufacturer's instructions establish that the Mycoplasma test must be performed at room temperature between 22 C to 25 C. (Reviewed on March 7, 2024 at 12:05 P.M) 3. From July 1., 2023 to December 30, 2023, the records of the Mycoplasma pneumoniae testing showed that the laboratory processed and reported 357 out of 357 patient's specimens with a temperature range below 22.0 C. (Reviewed on March 7, 2024 at 12:10 P.M) 4.The general supervisor confirmed during an interview, on March 7, 2024 at 12:10 P.M, that the laboratory processed patient's samples outside the established temperature range. 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 -- D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing records (years 2023-2024) and laboratory general supervisor interview on March 7, 2024 at 12:30 P.M, it was determined that the laboratory director did not assure that the manufacturer's instructions regarding to the established temperature range for Mycoplasma pneumoniae test, when the laboratory processed and reported 357 out of 357 patient's specimens for Mycoplasma pneumoniae. Refer to D5413. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing records (years 2023-2024) and laboratory general supervisor interview on March 7, 2024 at 12:30 P.M, it was determined that the general supervisor did not assure that the manufacturer's instructions were followed by the testing personnel regarding to temperature range for Mycoplasma pneumoniae test. Refer to D5413. -- 2 of 2 --