Orange County Urology Associates Pathology Lab

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of policies and procedures manuals and interview with the Laboratory Director (LD) on April 23, 2025, it was determined that the laboratory director failed to approve, sign, and date all policies and procedures. The findings include: 1. It was the practice of the laboratory to perform microbiology testing, histopathology grossing and urine cytology processing. 2. On April 23, 2025, at approximately 2:30 pm, the LD affirmed that the laboratory maintained no documentation indicating that written policies and procedures had been approved, signed, and dated by the current laboratory director. 3. The laboratory's testing declaration form, signed by the laboratory director on April 8, 2025, stated that the laboratory performed approximately 2900 tests annually. D5779

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review lack of the laboratory competency evaluation records, and interview with the laboratory personnel, it was determined that the laboratory failed to document the competency evaluation for the testing personnel. The findings included: a. The laboratory is a histopathology grossing and processing laboratory. b. The laboratory failed to make the competency evaluation records available at the time of survey (01/13/2022 @ 11:5 am) when requested. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation of the laboratory's Fisher brand thermometer, the temperature records, and interview with the testing personnel, it was determined that the laboratory failed to perform following the manufacturer's instructions and in a manner that provides test results/storage temperature monitoring within the laboratory's stated Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- performance specifications. The findings included: a. The laboratory is a histopathology grossing and urine cytology processing laboratory. b. A refrigerator is used to store urine specimens when received and before processed. c. A Fisher brand digital thermometer was used to monitor its storage temperature set between 0 to 7 degree Celsius. d. At the time of survey (01/13/2022 @ 11AM), the thermometer indicated its Min at -2 and Max at 25 degree Celsius which, in the past, were outside of the laboratory's setting of acceptable temperature range between 0 to 7 degree Celsius. e. The laboratory failed to notice and take