Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of laboratory procedures and interview with testing personnel # 8 and the general supervisor on February 8, 2018 at 11:00 AM confirmed the laboratory director failed to approve, sign and date nine of nine procedures before use. Findings: 1. Review of nine selected laboratory procedures revealed the laboratory director failed to approve the following procedures: a.) Sysmex XT Hematology analyzer operating procedure b.) Plasma components c.) Transfusion investigation d.) PTT reagent conversion protocol e.) General quality control procedures f.) Competency assessment procedures g.) Body fluid procedure h.) Individualized quality control plan (procedures) for blood gas analytes performed on I-stat. i) Laboratory Quality Assessment and Performance Improvement Plan 2. Interview with testing personnel # 8 and the general supervisor on February 8, 2018 at 11:00 AM confirmed the laboratory director failed to approve, sign and date laboratory procedures. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- This STANDARD is not met as evidenced by: Based on observation of environmental conditions, review of manufacturer's instructions, lack of documentation and interview with testing personnel # 8, the laboratory failed to define criteria consistent with manufacturers instructions and document humidity conditions for 2016, 2017 and to date 2018. Findings: 1. Observation of environmental conditions revealed a humidifier operating in the core laboratory area. 2. The manufacturer's instructions for the chemistry analyzer states, " Relative humidity must be maintained between equal to or greater than twenty percent and equal to or less than eighty percent." 3. No documentation was available to show the laboratory defined criteria consistent with the manufacturer's instructions for humidity conditions. No documentation was available to show the laboratory monitored and documented humidity conditions. 4. Interview with testing personnel # 8 on February 8, 2018 at 10:30 AM confirmed the laboratory failed to define criteria for humidity consistent with manufacturer's instructions and document those conditions. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review on instrument comparisons and interview with testing personnel #8 on February 8, 2018 at 10:00 AM confirmed, the laboratory failed to evaluate and define a relationship twice a year between analyzers performing troponin testing for 2016 and 2017. Findings: 1. Review of instrument comparisons revealed the laboratory did not have a system to define and evaluate a relationship between the Dimension EXL instrument and I-stat instrument performing troponin testing twice a year. 2. Interview with testing personnel # 8 on February 8, 2018 at 10:00 AM confirmed, the laboratory failed to define, evaluate and document instrument comparisons between the two instruments performing troponin testing. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the quality control (QC) program, quality assessment (QA) program, personnel records, procedure manual and interviews, the director failed to provide overall management and direction to the laboratory. The laboratory director failed to approve and ensure adequate validations (refer to #D6086); failed to ensure all proficiency testing reports received are reviewed by appropriate staff (refer to -- 2 of 10 -- #D6091); failed to approve and maintain the QC program (refer to #D6093); failed to approve and maintain the QA program (refer to #D6094); failed to ensure individuals serving as clinical consultants have appropriate education for providing consultation for laboratory services (refer to # D6101); failed to ensure all personnel have appropriate education for the type and complexity of services offered (refer to #D6102) and failed to ensure approved procedure manuals were available to all personnel responsible for testing (refer to #D6106). Based on these findings the laboratory failed to have an individual serving in the position of laboratory director. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of i-stat validation and interview with testing personnel #8 the laboratory director failed to ensure troponin vaildation on i-stat was adequate. Findings: 1. Review of i-stat troponin validation showed, no accuracy, reportable range verification and no laboratory director approval. 2. Interview with testing personnel #8 on February 8, 2018 at 3:30 PM confirmed the laboratory director failed to ensure troponin i-stat validation was adequate. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require