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 review of records, lack of documentation and interview with the technical consultant (TC) #2, the laboratory failed to monitor room temperatures where the arterial blood gas (ABG) test reagents were stored from 09/15/2019 to the day of survey. Findings Include: 1. The Area Hospital - ABG laboratory manual procedure, B. Storage and Stability states, "1. ABL 90 solution packs: store at room temperature (2-25 degrees celsius)". "3. Qualicheck 5+ external QC levels 1, 2, 3 and calibration verification kit: store at room temperature (2-25 degrees celsius)". 2. On the day of survey, 09/15/2021, review of records revealed, the laboratory did not monitor room temperatures where the Radiometer ABL90 Flex ABG reagents were stored from 09 /15/2019 to 09/15/2021. 3. The TC #2 confirmed the findings about on 09/15/2021 around 10:00 am. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the 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 -- manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 review of the laboratory records, lack of documentation and interview with technical consultant (TC) #2, the laboratory failed to establish a complete procedure, demonstrate and document verification of performance specifications for precision, reportable range of test results and verify that the manufacturer's reference intervals are appropriate for the laboratory's patient population performed on the Radiometer ABL90 Flex, before reporting patient results in 2019. Findings Include: 1. On the days of survey, 09/15/2021, the laboratory provided a copy of an EP evaluator alternative method comparison performed for the Radiometer ABL90 Flex analyzer, that was not signed by the current laboratory director. 2. The laboratory could not provide verification of performance specifications for precision, reportable range of test results and verification that the manufacturer's reference intervals are appropriate for the laboratory's patient population performed on the Radiometer ABL90 Flex before reporting patient results in 2019. 3. TC# 2 confirmed the findings above on 09/15 /2021 around 10:20 am. 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 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