Caswell Family Medical Center

Summary Statement of Deficiencies D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) 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; This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assessment plan, review of personnel records, and interview with TP (testing personnel) 2/16/23, the laboratory director failed to ensure that specific policies and procedures were established for evaluating the competency of all testing personnel as required. Findings: Review of the "Laboratory Quality Assurance and Quality Control Process" policy revealed "... Competency is reviewed at the time an employee is hired, at six months and annually thereafter. ..." The policy did not describe how the competency evaluations are conducted, including who is responsible, the criteria for acceptability, and the steps to take if competency requirements are not met. Review of personnel records revealed TP #1 had performed the competency evaluations for TP #2 and TP #3 during 2021 and 2022. TP #1's 2020 competency was performed by TP #2, and her 2021 competency was performed by a former TP. During interview at approximately 10:30 a.m., TP #1 confirmed that she had performed the competency evaluations for TP #2 and TP #3. She verified that her 2020 was performed by TP #2 and her 2021 competency was performed by a former TP. She stated the laboratory director had 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 -- reviewed and signed off on them, but they did not realize the competency evaluations had to be performed by the laboratory director or technical consultant. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with TP (testing personnel) 2/16 /23, the technical consultant (laboratory director) failed to perform and document a competency evaluation for 1 of 3 TP (TP #2) during 2020. Review of personnel records for TP #2 revealed competency evaluations performed in 2019, 2021, and 2022. There were no records available for a 2020 competency evaluation. During interview at approximately 10:20 a.m., TP #1 stated they were unable to locate TP #2's 2020 competency evaluation. TP #1 stated she was unsure whether TP #2 had a competency evaluation in 2020. -- 2 of 2 --

Summary Statement of Deficiencies D6098 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(8) The laboratory director must ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on review of laboratory test reports and interview with laboratory director (LD) 3/13/20, the LD failed to ensure patient test reports for urine microscopic and wet prep testing included pertinent information required for interpretation. Findings: Review of patient test report, date of birth (DOB) 9/10/1979, for the wet prep test revealed the reference range for Clue Cells was recorded as saline-saline. Review of patient test report, DOB 8/15/1958, for the urine microscopic test revealed no reference ranges for the following: White Blood Cell (WBC), Red Blood Cell (RBC), Epithelial Cells, Bacteria, Yeasts, Crystals or Casts. During exit interview at approximately 11:45 a.m. the LD confirmed the test reports failed to include pertinent information required for interpretation. She stated they did not realize the Clue Cells reference range showed up as saline-saline. She also stated the urine microscopic reference ranges were on previous reports, but they must have dropped off when a computer update took place. 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 --