Summary:
Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based of review of the diatron "P500-1 - Pictus 500 Clinical chemistry analyser installation and user's manual," review of 2024 and 2025 laboratory records, and interview with the Office Manager on 05/12/2025, the laboratory failed to define an appropriate humidity range consistent with the manufacturer's instructions and monitor the humidity to ensure reliable test system operation. Findings: Review of the diatron "P500-1 - Pictus 500 Clinical chemistry analyser installation and user's manual" revealed in Chapter 11 Technical Specifications, page 137, "...Relative humidity: 35 - 80% non-condensing..." Review of laboratory records revealed no documentation of humidity readings for 2024 and 2025. During interview at approximately 12:05 p.m. the office manager confirmed humidity has not been monitored or recorded in the laboratory. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic 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 -- phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel records for 2024 and 2025, and interview with the office manager 05/12/2025, the Laboratory Director (LD) failed to specify in writing the duties and responsibilities for the Clinical Consultant (CC) and Technical Consultant (TC) involved in the daily operation of the laboratory. Findings: Review of personnel records revealed the absence of a job description for the following positions: 1. CC 2. TC During interview at approximately 10:30 a.m. the office manager confirmed no positions descriptions available for the positions. -- 2 of 2 --