Diagnostic Laboratory Services Kona 2

Summary Statement of Deficiencies 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, consultant competency. This STANDARD is not met as evidenced by: Based on a review of laboratory personnel records and an interview with the testing personnel on 06/15/2022 at 2:00 PM, it was determined that the laboratory failed to follow written policies and procedures to assess employee competency to ensure personnel maintain the required competency for accurate and reliable testing and reporting. The findings include: 1. The testing personnel was unable to retrieve the 2021 annual competency assessment for the individual who served as laboratory technical supervisor/general supervisor/testing personnel 2. The Field Operations Manager confirmed on 06/17/2022 at 11:28 AM that a 2021 annual competency assessment for the laboratory technical supervisor/general supervisor/testing personnel was not performed 2. The laboratory performed 3730 routine chemistry and urinalysis tests, and 44598 hematology tests in 2021 D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. 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 laboratory personnel records and an interview with the testing personnel on 06/15/2022 at 2:00 PM, and confirmation by the Field Operations Manager on 06/17/2022 at 11:28 AM, it was determined that the laboratory director failed to ensure that policies and procedures established for monitoring individuals who conduct preanalytical, analytical, and post analytical phases of testing were followed to ensure employee competency for accurate and reliable testing and reporting. See CFR 493.1235, D tag D5209. -- 2 of 2 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (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. (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 a review of laboratory preventative maintenance logs and an interview with the laboratory senior testing personnel on 06/07/2019, the lab failed to "perform and document function checks" for the monthly maintenance of the Horizon 755V centrifuge. The findings include: 1) The Centrifuge Preventative Maintenance Log for the year 2019 had no documentation to indicate the performance of the monthly centrifuge RPM maintenance for January 2019 to May 2019. 2) The laboratory senior testing personnel verified that the documentation was not done. 3) The monthly QA review failed to address the missing documentation. 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 --