Fmccp North Hills Health Center

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor review of verification records for the CHEM8+ and CG4+ cartridges for the i-STAT analyzer and interview with a technical consultant (Staff A), the laboratory did not evaluate precision for two of the two cartridge types before using the cartridges for patient testing starting on December 6, 2024. Findings include: 1. Review of the document, "North Hills iSTAT (365246) 12-2013 Validation Summary", for the i-STAT analyzer, serial number SN365246, showed no evidence of evaluation of precision of the analyzer for either the CHEM8+ or CG4+ cartridges. The Laboratory Director approved the summary and the use of the CHEM8+ and CG4+ cartridges for patient testing on November 22, 2024. 2. Interview with Staff A on August 8, 2025, at 11:30 AM confirmed the verification studies for the i-STAT analyzer did not include evaluation of precision for the CHEM8+ or the CG4+ cartridges and confirmed the laboratory did not evaluate precision prior to the start of patient testing with the two cartridge types on December 6, 2024. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) 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 -- (e)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and This STANDARD is not met as evidenced by: Based on surveyor review of documented humidity readings in the laboratory and interview with the General Supervisor (Staff B), the Laboratory Director did not ensure the humidity in the laboratory was appropriate for the testing performed in December 2024 and January 2025, two of two winter months reviewed. Findings include: 1. Review of documented humidity readings in the laboratory from December 2024 and January 2025 showed the acceptable relative humidity range was 18 - 80% and showed personnel documented humidity readings less than 18% on 60 of the 62 days in the two months. The records showed personnel documented

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 surveyor review of temperature logs, observation of freezer storage and interview with the general supervisor, the laboratory has not defined storage conditions that are consistent with the manufacturer's instructions for pediatric bilirubin controls. Findings include: 1. Review of temperature logs showed the laboratory's acceptable freezer temperature range is less than or equal to negative 15 degrees Celsius (C). 2. Observation of the freezer on September 3, 2019 at 1:00 PM revealed Bio-Rad Pediatric Controls stored in the freezer. The manufacturer's packaging showed the acceptable storage range was negative 20 to negative 70 degrees C. 3. Interview with the general supervisor on September 3, 2019 at 1:15 PM confirmed the laboratory defined acceptable storage temperature range is not consistent with the manufacturer's instructions. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least 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 -- annually, after the first year. This STANDARD is not met as evidenced by: Based on review of competency evaluation records and interview with the general supervisor, the technical consultant did not document the required annual competency evaluation for chemistry and microscopic testing in 2018 for one of two testing personnel. Findings include: 1. Review of competency evaluation records for staff A showed no evidence of evaluation of competency for the Piccolo chemistry analyzer or microscopic testing in 2018. 2. Interview with the general supervisor on September 3, 2019 at 10:50 AM confirmed the competency records for staff A were not complete for 2018. -- 2 of 2 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and interview with the general supervisor, the laboratory did not retain records from the serum pregnancy 2017 second PT event. Findings include: 1. Review of PT records showed no evidence of testing records, signed attestation statements, PT results and scores from the PT provider, or documentation of review for the serum pregnancy event two of 2017. 2. Interview with the general supervisor, staff A, at 10:45 AM on January 23, 2018 confirmed laboratory testing records and documented review of results could not be located for this PT event. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)