Summary:
Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation , laboratory technical supervisor and laboratory general supervisor interview on June 29, 2023 at 11:40 AM; it was determined that the laboratory failed to ensure that the laboratory space were arranged and cleaned available for handling, examination and testing of patient samples. The findings include: 1. The laboratory area was not arranged properly. Strongly crowded with material (instruments, computers, binder and documents). The laboratory have binders, folders, keyboard, worksheet records and laboratory material above the chemistry and hematology analyzer. 2. The laboratory technical supervisor confirmed on June 29, 2023 at 11:40 A.M., that the testing area was very crowded and letting few space to perform the patient samples and documentation. 3. The laboratory processed and reported approximately 5,180 patient samples from March 20, 2023 to June 28, 2023. D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: 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 -- Based on laboratory direct observation and interview with the laboratory technical supervisor and laboratory general supervisor; on June 29, 2023 at 11:40 AM; it was determined that the laboratory director failed to ensure that the laboratory space were arranged and cleaned available for handling, examination, testing of patient samples and documentation. Refer to D3001. -- 2 of 2 --