West Hills Pediatrics

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) policy, Wisconsin State Laboratory of Hygiene (WSLH) PT records, and interview with the Medical Assistant (MA), the laboratory failed to review and evaluate the PT results obtained for 1 of 3 WSLH Bacti_Viral events performed in 2025. Findings: 1. The laboratory's Proficiency Testing Policy stated, "The lab evaluates the accuracy of any analyte that is not scored by the lab's PT program." 2. On the day of survey, 8/13/2026 at 12:45 pm, review of the laboratory's WSLH PT results revealed the laboratory failed to review and evaluate the PT results not graded by the PT agency for the following 1 of 3 WSLH Bacti_Viral events performed in 2025: - WSLH PT 2025-Bacti_Viral Event #1: Module 5170, Group A Strep, ST-4 3. The MA confirmed the findings above on 8 /13/2026 at 12:45 pm. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's temperature logs, lack of documentation, and interview with the Medical Assistant (MA), the laboratory failed to monitor and document room humidity to ensure operating conditions were met for 1 of 1 Boekel scientific S/N# 041201515 Incubator used to incubate throat cultures from 02/12/2025 to 04/01/2026. Findings include: 1. The Boekel scientific manufacturer's operating environment specifications stated: "80% RH maximum." 2. On the date of the survey, 8/13/2026 at 12:30 pm, the laboratory failed to provide documentation for monitoring of room humidity to ensure operating conditions were met for the following incubator used to incubate throat culture plates from 02/12/2024 to 04/01/2026: - 1 of 1 Boekel scientific S/N# 041201515 3. The laboratory performed 170 Microbiology tests in 2025. (CMS-116 estimated annual volume, dated 6/25/2026). 4. The MA confirmed the findings above on 08/13/2026 at 12:30 am. -- 2 of 2 --

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 --