Vanguard Medical, Pa

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 the lack of Temperature Logs (TL), review of the Operators Manual (OM) for the Olympus CX22 microscope and interview with the Office Supervisor (OS), the laboratory failed to monitor and document room temperature and humidity range where the Professional component (PC) for Histopathology tests are performed from 1 /19/22 to the date of the survey. The finding include: 1. The OM defined the operating environment ambient temperature for the aforementioned equipment 5 to 40C (41 to 104 F). 2. The OM defined the operating environment maximum relative humidity for the aforementioned equipment 80% for temperatures up to 31C (88F). 3. There was no TL in the office where PC was being performed. 4. The OS confirmed on 8/1/23 at 1:35 pm the laboratory failed to monitor and document room temperature and humidity. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with the Laboratory Director (LD), the laboratory failed to document the reaction of the Hematoxylin and Eosin stain used for Histopathology tests from 6/6/19 to the date of the survey. The LD confirmed on 1/19/22 at 11:30 am that the laboratory did not document reaction of stains. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --