Jackson Clinic Pa Of Humboldt,The

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 the laboratory procedure manual and staff interview, the laboratory director failed to approve, sign and date the procedure titled "REPORTING ATYPICAL LYMPHS ON MANUAL DIFFERENTIAL" that had a procedure effective date of 05/17/24. The findings include: 1. Review of the laboratory procedure titled "REPORTING ATYPICAL LYMPHS ON MANUAL DIFFERENTIAL" revealed the procedure had not been approved, signed and dated by the laboratory director. The effective date of the procedure was 05/17/24. 2. The technical consultant confirmed the survey findings during interview on 06/10/24 at 3 p. m. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 observation of the laboratory, document request, patient final test reports and staff interview, the laboratory failed to perform twice a year comparison of results between automated and manual white blood cell (WBC) differential 2021, 2022, and 2023. The findings include: 1. Observation of the laboratory on 03/15/23 at 8:15 a.m. revealed a Sysmex XP 300 (serial #B3616) in use for performing automated WBC differential and a microscope in use for performing manual WBC differential. 2. Request made to the technical consultant 03/15/23 at 11 a.m. for documentation of comparisons between the two WBC differential methods revealed no documentation was present. The technical consultant stated they do not perform formal comparisons between the two methods. 3. Review of randomly selected patient reports revealed the laboratory performed both automated WBC differential and manual WBC differential (MRNs 9176538, 4926556, 99700577, 100436510, 1040302) in 2021, 2022, and 2023. 4. Interview with the lead testing person and technical consultant on 03/15/23 at 12:30 p.m. confirmed the laboratory performs both automated and manual WBC differential and did not perform comparisons between the two methods twice a year in 2021, 2022, and 2023. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) 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 observation of the laboratory, review of the 1-11-18 complete blood count (CBC) installation records and interview with technical consultant number one, the laboratory director failed to ensure the verification of performance specification include the precision and accuracy. The findings include: 1) Observation of the laboratory on May 30, 2018 at 9:30 a.m. revealed the CBC instrument Sysmex XP- 300, serial number B3616, in use for patient testing. 2) Review of the 01-11-18 installation records revealed precision and accuracy records were not available for review. 3) Interview on May 30, 2018 at 11:30 am with technical consultant number one confirmed the Sysmex XP-300 instrument was installed 1-11-18, accuracy and precision records were not available for review and that patient testing began 1-26-18 with this instrument. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --