Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of troponin proficiency testing for 2017, 2018 and 2019 and interview with testing personnel #7 the laboratory failed to perform samples by personnel who routinely perform the testing in the laboratory. Findings: 1. Review of proficiency testing for 2017, 2018 and 2019 testing personnel # 9 performed all proficiency testing samples. 2. Interview with testing personnel #7 on February 4, 2019 at 11:45 AM confirmed testing personnel #9 performed all proficiency testing for 2017, 2018 and to date 2019. 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 temperature logs, troponin package and interview with testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- personnel #7 the laboratory failed to document and monitor room temperature in one of two pharmacies that contain troponin tests. findings: 1. Review of temperature logs showed r & d pharmacy that contains troponin tests did not document or monitor room temperature. 2. Review of troponin package states store at "2 degrees Celsius to 30 degrees Celsius". 3. Interview with testing personnel #7 on February 4, 2019 at 12: 30 PM confirmed the laboratory failed to document and monitor room temperature in r & d pharmacy that contains troponin tests. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records from 2017, 2018 and to date 2019 and interview with testing personnel # 7 the laboratory director failed to ensure PT samples are tested by all of the individuals who test patient samples. Findings: 1. Review of 2017, 2018 and to date 2019 PT revealed that only one of twenty eight testing personnel performs all of the PT sample testing. 2. Interview with testing personnel #7 on February 4, 2019 at 12:15 PM confirmed all of the PT samples from 2017, 2018 and to date 2019 were tested by the same person. 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