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, 3/10/2026 at 09:30 am, 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 3 /10/2026 at 11:00 am. 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 Quincy Lab, Inc. Model 10-180 Incubator used to incubate throat cultures from 07/16/2024 to date of survey. Findings include: 1. The manufacturer's operating environment specifications stated: "80% RH maximum." 2. On the date of the survey, 3/10/2026 at 10:00 am, 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 07/16/2024 to 3/10/2026: - 1 of 1 Quincy Lab, Inc. Incubator, Model 10-180 3. The laboratory performed 34 Microbiology tests in 2025. (CMS-116 estimated annual volume, dated 2/19/2026). 4. The MA confirmed the findings above on 3/10/2026 at 10:45 am. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (1) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. This STANDARD is not met as evidenced by: Based on lack of Quality Control documentation and interview with the Medical assistant (MA), the laboratory failed to document a positive and negative reactivity for 1 of 2 lots/shipments of Bacitracin (A) Discs used for throat culture testing from 06/25 /2025 to the date of survey. Findings include: 1. On the day of survey, 03/10/2026 at 10:45am, the laboratory could not provide the records for the positive and negative reactivity checks performed for 1 of 2 lots/shipments of Bacitracin (A) Discs (lot# 4123262) used for throat culture testing from 06/25/2025 to 03/10/2026. 2. Review of the laboratory's test logs revealed the laboratory performed throat cultures for 71 patients from 06/25/2025 to 03/10/2026. 3. The MA confirmed the findings above on 03/10/2026 at 11:00 am. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based upon a review of proficiency testing records and interview with the Laboratory Supervisor on the date of the survey (06/17/2020), the laboratory failed to ensure that 1 of 2 Wisconsin State Laboratory of Hygiene (WSLH), 2020 attestation statements was signed by the Director and analyst. Findings: 1. At the time of the survey, (09:30 06/17/2020), 1 of 2 WSLH 2020 testing event attestation statements reviewed did not have the analyst and Laboratory Director's signature. 2. During the survey (10:30 06 /17 2020), Laboratory Supervisor confirmed the above findings. 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. 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 a review of proficiency testing records and interview with the Laboratory Supervisor on the date of the survey (06/17/2020), the Laboratory failed to ensure review and evaluation of the results obtained on proficiency testing for 1 of 3 American Academy of Family Physicians (AAFP) 2019 events. . Findings: 1. The Director's review signature for proficiency test score reports was not found for 1 of 3 AAFP microbiology proficiency events in 2019. 2. The laboratory could not provide documentation of evaluation & review performed on the 2019 AAFP microbiology event 1, with a score of 80%. 3. During the survey (10:30 06/17/2020), the Laboratory Supervisor confirmed the above findings. -- 2 of 2 --