Summary:
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 direct observation, review of laboratory environmental logs, and interview with the laboratory lead testing person, determined the laboratory failed to document refrigerator temperature for the Endocrinology analyzer Quality Control (QC) and reagents for 15 of 15 months (08/2021 through 11/2022). The findings include: 1. During a tour of the laboratory on 11.30.2022 at 10:15 A.M., the surveyor observed the "LG" refrigerator and the "Hisense" refrigerator in the laboratory. There was no thermometer in the "Hisense" refrigerator that contained Endocrinology analyzer Quality Control (QC) and reagents. 2. Review of laboratory environmental logs revealed laboratory failed to document refrigerator temperature for the "Hisense" refrigerator for 15 of 15 months (08/2021 through 11/2022). 3. Interview with testing person #1 listed on the Centers for Medicare and Medicaid Services Form 209 (CMS 209) at 10:45 am on 11.30.2022 in the laboratory confirmed the above findings. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require