Summary:
Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) records, interviews with the laboratory supervisor (LS) and testing personnel (TP), it was determined that the laboratory failed to attain at least 80 percent of the acceptable response resulting to an unsatisfactory performance for the Hematology second event in 2022 (Q2-2022) for the White Blood Cell (WBC) differential test. The findings include: 1. Based on the surveyor's review of the laboratory's PT records, API reported a 67% score for the WBC automated differential test for Q2-2022. Further review of the quality assessment documentation showed that this score was negatively impacted by the 0% score for Monocytes. 2. The LS and TP affirmed on March 12, 2025 at approximately 9:50 a.m. that the laboratory obtained the PT scores mentioned in statement #1. 3. According to the laboratory testing declaration submitted on the day of the survey, the laboratory performed approximately 16,412 samples annually for Hematology that included the WBC automated differential test in the Cell Blood Count panel. Thus, the reliability and quality of Hematology patient results reported could not be assured at the time when the laboratory failed to attain an unacceptable score of at least 80 percent. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on the review of the laboratory's quality assessment policies and procedures, personnel competency documentation, seven (7) patient records, and an interview with the laboratory supervisor (LS) on March 12, 2025, at approximately 9:20 a. m., as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to perform competency assessment for several laboratory personnel for the years 2022, 2023, and 2024. Findings include: 1. Based on the review of the laboratory's quality assessment policies and procedures, competency evaluation records, and 7 patient records, the laboratory is herein cited for the deficient practice for failure to perform competency assessment for several testing personnel (TP) for the years 2022, 2023, and 2024. a. KC was missing competency for 2021. b. OR was missing competencies for 2022, 2023, and 2024. c. HW was missing competency for 2024. 2. The LS affirmed by interview on March 12, 2025, at approximately 9:20 a. m. that the laboratory had no records of any competency assessment specified in statement #1 for the years 2022, 2023, and 2024 for the Folsom, CA location. 3. According to the laboratory's annual testing declaration submitted at the time of the survey, the laboratory reported and performed approximately 16,412 tests for Hematology for which competency assessments of several testing personnel were not performed. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's preventive maintenance (PM) documentation, observations during the tour, and an interview with the laboratory supervisor (LS), it was determined that the laboratory failed to ensure performed tests and function checks were documented properly prior to patient testing. The findings include: 1. Based on the review of the laboratory's PM documentation, no annual calibration records were found for the thermometer for the years 2022 and 2023. 2. The LS affirmed by interview at approximately 10:40 a.m. on March 12, 2025, that the laboratory missed to perform an annual calibration for the thermometer as mentioned in statement #1. 3. Based on the annual testing declaration form submitted at the time of the survey, the laboratory performed and reported approximately 16,412 patient tests for Hematology, including the time the missing annual PM for the thermometer occurred. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory -- 2 of 4 -- services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on the deficiencies cited, the Laboratory Director is herein cited for deficient practice in ensuring that systems for the preanalytic, analytic, and postanalytic phases of the laboratory were monitored and followed. Findings include: 1. The laboratory received unsatisfactory performance results for Hematology. See D2121. 2. Competency assessments were missed to be performed. See D5209. 3. Missing maintenance and function check documentation. See D5435. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require