Summary:
Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of Centers for Medicare & Medicaid Services (CMS) Form 209, review of 2023 testing personnel (TP) competency records, interview with TP #6 and review of TP #3 and TP #6 education qualifications 12/20/23, the technical consultant (laboratory director) failed to assess the competency of 19 of 19 TP in 2023. Findings: Review of CMS Form 209 submitted at time of survey revealed the laboratory director serves as the technical consultant for the laboratory. Review of 2023 competency assessments for TP #1, TP #2, TP #3, TP#4, TP #5, TP #6, TP #7, TP #8, TP # 10, TP #12, TP # 13, TP #14, TP #15, TP # 16, TP #17, TP #18, TP #19, TP # 20 and TP #21 revealed the competency assessments were signed by a "Laboratory Manager', "Southern Pines Nursing Supervisor", "Seven Lakes Nursing Supervisor", "Raeford Nursing Supervisor"and "Laboratory Director". During interview with TP #6 at approximately 12:00 p.m., TP #6 stated the competency assessments were performed by her and TP #3, and then signed off by the laboratory manager, nursing supervisor of each facility and the laboratory director to show the competency assessments were completed. Review of education qualifications for TP #3 and TP #6 revealed high school diplomas. TP #3 and TP #6 do not qualify as technical consultants and therefore cannot perform TP competency assessments. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not 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 -- limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of College of American Pathologists (CAP) proficiency testing (PT) attestation statements and review of 2023 TP competency assessment records 12/20/23, the technical consultant (laboratory director) failed to ensure TP competency evaluations included the assessment of test performance for the specialities of Hematology, Neonatal Bilirubin and Urine Colony Count by either testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples for all testing personnel. Review of laboratory policy "Laboratory Personnel Competency" revealed "...* Assessment of test performance through testing previously analyzed specimens, internal blind samples or external PT samples...". 1. The technical consultant (TC) failed to ensure 12 of 18 TP 2023 competency evaluations included the assessment of test performance for the speciality of Hematology. Findings: Review of 2023 CAP PT attestation statements for the 3 events in the speciality of Hematology revealed 6 of 18 TP participated in PT for 2023; TP #2, TP #5, TP # 7, TP #11, TP #12 and TP # 15. Review of 2023 TP competency records revealed all 18 TP reviewed had a check mark for "Cell-Dyn Emerald/CBC- Proficiency Test Performance & Participation". Review of 2023 TP competency records for the 12 TP who had not participated in PT for the speciality of Hematology; TP #1, TP #3, TP #4, TP #6, TP #8, TP #13, TP #16, TP #17, TP #18, TP #19, TP #20 and TP #21, revealed no documentation of an assessment using either previously analyzed specimens or internal blind testing samples for the speciality of Hematology. 2. The technical consultant failed to ensure 13 of 18 TP 2023 competency evaluations included the assessment of test performance for the speciality of Urine Colony Count. Findings: Review of 2023 CAP PT attestation statements for the 3 events in the speciality of Neonatal Bilirubin revealed 5 of 18 TP participated in PT for 2023; TP #2, TP #5, TP #11, TP #12 and TP # 16. Review of 2023 TP competency records revealed all 18 TP reviewed had a check mark for "Reichert Bilirubin - Proficiency Test Performance & Participation". Review of 2023 TP competency records for the 13 TP who had not participated in PT for the speciality of Neonatal Bilirubin; TP #1, TP #3, TP #4, TP #6, TP #7, TP #8, TP #13, TP #15, TP #17, TP #18, TP #19, TP #20 and TP #21, revealed no documentation of an assessment using either previously analyzed specimens or internal blind testing samples for the speciality of Neonatal Bilirubin. 3. The technical consultant failed to ensure 12 of 18 TP 2023 competency evaluations included the assessment of test performance for the speciality of Neonatal Bilirubin. Findings: Review of 2023 CAP PT attestation statements for the 3 events in the speciality of Urine Colony Count revealed 6 of 18 TP participated in PT for 2023; TP #2, TP #5, TP #7, TP #11, TP #15 and TP # 16. Review of 2023 TP competency records revealed all 18 TP reviewed had a check mark for "Uricult Collection Reading/Documentation - Proficiency Test Performance & Participation". Review of 2023 TP competency records for the 12 TP who had not participated in PT for the speciality of Urine Colony Count; TP #1, TP #3, TP #4, TP #6, TP #8, TP #12, TP #13, TP #17, TP #18, TP #19, TP #20 and TP #21, revealed no documentation of an assessment using either previously analyzed specimens or internal blind testing samples for the speciality of Urine Colony Count. -- 2 of 2 --