West Hills Pediatrics

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the medical assistant (MA), the laboratory failed to include pertinent reference intervals/normal values on 1 of 1 patient test report when microbiology test results were reported from 03/10/2023 to the day of survey. Findings include: 1. On the day of survey 02/12/2025 at 10:30 am, review of 1 of 1 patient test report revealed the laboratory failed to include pertinent reference intervals/normal values for the following microbiology test results reported from 03/10/2023 to 02/12/2025: - Bacteria culture screen (throat culture) 2. The laboratory reported 170 bacteria cultures were performed annually. (CMS 116) 3. The MA confirmed the findings above on 02/12/2025 at 11:40 am. 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 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 review of laboratory throat culture quality control (QC) log, QC result, and interview with the laboratory director (LD), the laboratory testing personnel (TP) failed to record QC results in June 2018. Findings include: 1. The June 2018 Taxo Disks and Media QC log reads as follows: Date S. pyogenes Result S. aureus Result Lot Number Lot Number 06/20 1806700 Blank 1723629 Blank 2. The TP streaked all (2 of 2) QC strains on 06/20/2018. 3. The TP documented no (2 of 2) QC results on QC log sheet. 4. The TP accepted the 06/20/2018 QC run. 5. The LD confirmed above findings on 07/19/2018 at 11:30 AM. 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 --