Summary:
Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing records and an interview with Testing Personnel #1, the laboratory failed to document reviews of proficiency testing results. This was noted for eight of 17 events performed in 2020 to 2022. The findings include: 1. A review of the API proficiency testing records revealed the laboratory had no documentation of review of results for the following surveys: a. 2020 Hematology 3rd Event. b. 2020 Microbiology 3rd Event. c. 2021 Microbiology 1st Event. d. 2021 Hematology 2nd Event. e. 2021 Microbiology 3rd Event. f. 2022 Hematology 1st Event. g. 2022 Microbiology 2nd Event. h. 2022 Hematology 2nd Event. 2. During an interview on August 30, 2022, at 12:11 PM, Testing Personnel #1 confirmed the above findings. . D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory patient test reports and an interview with Testing Personnel #1, the laboratory failed to implement a mechanism to produce urine and throat culture reports, and ensure patient test reports included all required parameters. This was noted on four of four test reports for the specialties of hematology and microbiology. The findings include: 1. During a review of the post-analytical processes, the surveyor reviewed patient test reports and noted the following: a) Complete Blood Count performed on the Sysmex XP 300 Hematology analyzer; the laboratory was unable to provide reference ranges for each patient population. b) Respiratory panel performed on the Biofire Film Array Touch analyzer; test report does not include two patient identifiers. c) Throat and Urine Culture reports; the laboratory was unable to generate patient reports. 2. During an interview on August 30, 2022, at 3:35 PM, Testing Personnel #1 confirmed the above findings. . D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic 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 a review of the personnel records and an interview with Testing Personnel #1, the Laboratory Director (LD) failed to specify, in writing, the responsibilities and duties for the Technical Consultant (TC). This was noted for one of four laboratory personnel on the CMS-209 (Laboratory Personnel Report). The findings include: 1. A review of the Personnel records revealed the Technical Consultant did not have a job description of assigned duties and responsibilities. 2. During an interview on August 30, 2022, at 3:35 PM, Testing Personnel #1 confirmed the above findings. -- 2 of 2 --