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 manufacturer's instructions, general immunology quality control records review (in years 2021-2022) and laboratory general supervisor interview at 10:30 AM on August 16, 2022, it was determined that the laboratory failed to perform Mycoplasma test as required by manufacturer's instructions by Meridian Immunocard method. The findings include: 1. The manufacturers establishes that the Mycoplasma test must be performed at room temperature between 22 C to 25 C reviewed at 10:30 AM 2. Review of general immunology records from December 31, 2021 to August 12, 2022, the records showed that the laboratory processed and reported one hundred twenty (120) Mycoplasma patient's samples tests that was performed at temperatures below of range in the following thirty three(33) days reviewed at 10:45 AM: Date Temp.C # samples 12/31/21 20.0 3 1/3/22 20.0 11 1/4/22 20.0 2 1/5/22 20.0 7 1/7/22 21.0 6 1/8/22 20.0 1 1/10/22 20.0 8 1/11/22 20.0 5 1/12/22 20.0 4 1/14/22 20.0 9 1/18 /22 01.0 2 1/19/22 20.0 1 1/20/22 20.0 2 1/24/22 20.0 1 2/18/22 20.0 2 3/5/22 20.0 1 3 /15/22 21.0 1 3/16/22 20.0 4 3/17/22 21.0 4 3/22/22 20.0 4 3/24/22 20.0 2 3/25/22 20.0 2 3/28/22 21.0 3 3/29/22 20.0 1 3/30/22 20.0 2 3/31/22 20.0 4 4/1/22 20.0 5 4/2 /22 20.0 2 4/6/22 21.0 4 4/28/22 21.0 16 5/27/22 21.0 1 6/6/22 21.0 4 8/12/22 21.0 5 3. The laboratory processed and reported one hundred twenty (120)) Mycoplasma patient's samples tests those days reviewed at 10:45 AM. 4. The laboratory general 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 -- supervisor confirmed on August 16, 2022 at 10:50 AM that the laboratory performed Mycoplasma patient's samples tests below the range established by the manufacturer's those days. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on Immuno Card Mycoplasma manufacturer's instructions, general immunology (Mycoplasma) quality control records reviewed from December 2021 to August 15, 2022 and laboratory general supervisor interview on August 16, 2022 at 10:30 AM, it was determined that the laboratory director failed to ensure that the laboratory follow the manufacturer's instructionsw for monitor and documented the room temperature when tested for Mycoplasma by Immuno Card Meridian Method. The finding includes: 1. The laboratory did not follow the manufacturer's instructions for monitor and documented the room temperature from December 31, 2021 to August 12, 2022 when the patient's specimens were tested for Mycoplasma by Immuno Card Meridian Method. Refer to D5413. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on Immuno Card Mycoplasma manufacturer's instructions, general immunology (Mycoplasma) quality control records reviewed from December 2021 to August 15, 2022 and laboratory general supervisor interview on August 16, 2022 at 10:30 AM, it was determined that the laboratory testing personnel failed to follow the manufacturer's instructionsw for monitor and documented the room temperature when tested for Mycoplasma by Immuno Card Meridian Method. The finding includes: 1. The laboratory did not follow the manufacturer's instructions for monitor and documented the room temperature from December 31, 2021 to August 12, 2022 when the patient's specimens were tested for Mycoplasma by Immuno Card Meridian Method. Refer to D5413. -- 2 of 2 --