Laboratorio Clinico Levittown

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 manufacturer's instructions, Mycoplasma pneumoniae testing records, and interview with the laboratory general supervisor on November 3, 2023, at 1:15 PM; it was determined that the laboratory failed to follow manufacturer's instructions regarding to the established temperature range for Mycoplasma pneumoniae test. The findings include: 1.The manufacturer's instructions establish to perform the test procedures between 22 to 25C. (Reviewed on November 3,2023 at 1:15 P.M.) 2. On November 3,2023 at 1:20PM, the Mycoplasma pneumoniae testing records showed that from December 26, 2022 to November 2, 2023, the laboratory processed and reported 85 out of 841 patient's specimens with a temperature of 21.6C. 3. The laboratory general supervisor confirmed during interview on November 03,2023 at 1:26 PM, that the laboratory processed patient's samples outside the established temperature range. 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 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 -- and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing records and general supervisor interview on November 3,2023, at 2:00PM, it was determined that the testing personnel did not follow the manufacturer's instructions regarding to the established temperature range for Mycoplasma pneumoniae test, when she processed 85 patient's specimens for Mycoplasma pneumoniae. Refer to D5413. 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 and general supervisor interview on November 3,2023, at 2:00PM it was determined that the 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 85 out of 841 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 and general supervisor interview on November 3,2023, at 2:00PM, 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 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on General Immunology ( Mycoplasma Pneumoniae test ) quality control records review ( 2020-2021 ) and interview with the laboratory supervisor on January 31, 2022 at 3:15 PM , it was determined that the laboratory failed to include a negative and positive external control material when performed Mycoplasma Pneumoniae test by Immuno Card method. The findings include : a. The laboratory performed Mycoplasma Pneumoniae test by Immuno Card method. b. Mycoplasma quality control logs were reviewed from 8/2021 to 11/2021. c. The records showed that the laboratory did not include a negative and positive external control material from August, 2021 to November, 2021. d. The laboratory performed and reported 11 patient samples from August 16, 2021 to November 4, 2021. e. The laboratory supervisor confirmed on January 31, 2022 at 3:15 P.M., that the laboratory failed to include a negative and positive external control material each day of testing when performed Mycoplasma Pneumoniae test by Immuno Card method. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, 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 -- and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Immuno Card Mycoplasma testing records and laboratory supervisor interview on January 31, 2022 at 3:15 PM, it was determined that the laboratory director did not fulfill her responsibilities to ensure that the laboratory did not run an external negative and positive control material each day of patient testing from August 16, 2021 to November 4, 2021. Refer D5449 -- 2 of 2 --