Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (b)(7) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a lack of review of the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records and an interview with the Laboratory Director (LD) also qualified as the Technical Consultant (TC), the laboratory failed to ensure proficiency (PT) testing records were complete and retained for at least two years. This was noted for five of seven PT events reviewed in 2023 through 2024. The findings include: 1. A lack of review of the AAB-MLE PT records revealed no evidence of PT documentation, during the survey, of review and attestation pages from the Laboratory Director,or designee, and TP for the following surveys: a) 2023 Chemistry M3, b) 2024 Chemistry M1-M3, c) 2025 Chemistry M1. 2. During the laboratory tour at JCDH Central on 11/12/2025, at 9:15 AM, the Laboratory Director told the surveyor the PT documentation could not be located prior to the survey. D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on reviews of the American Association of Bioanalysts Medical Laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Evaluation (AAB-MLE) proficiency testing (PT) records and testing personnel semi annual and annual competencies, the Technical Consultant (TC) and the Laboratory Director who is also qualified as a TC failed to provide adequate technical and scientific oversight of the laboratory. The findings include: 1. A review of the laboratory records revealed the TC and LD failed to: a) Ensure proficiency (PT) testing records were complete and retained for at least two years (Refer to D2015). b) Ensure testing personnel had competency assessments that included all six minimal regulatory requirements (Refer to D6046). c) Failed to evaluate semi-annual competencies for testing personnel (TP) performing moderate complexity testing (Refer to D6053). d) Failed to evaluate annual competencies for testing personnel (TP) performing moderate complexity testing (Refer to D6054). D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (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. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the Laboratory Director (LD), the Technical Consultant (TC) who is also the LD, failed to ensure testing personnel had competency assessments that included all six minimal regulatory requirements. The surveyor noted the 6 elements were missing on 9 of 11 TP 2024 annual competencies and 1 of 11 TP 2024 semi-annual competency. The findings include: 1. A review of the personnel records revealed annual and semi- annual competency was assessed on RPR (Rapid Plasma Reagin) and Gram Stain testing by taking a quiz. The surveyor noted no documentation of the six minimal requirements for assessment of competency required by CLIA, as follows: 1. Monitoring the recording and reporting of test results. 2. Review of intermediate test results of worksheets, quality control records, proficiency testing results, and preventive maintenance results. 3. Direct observation of performance of instrument maintenance and function checks. 4. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. 5. Assessment of problem solving skills. 2. During an interview on 11 /21/2025, at 3:05 PM, the LD confirmed the above findings. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the Laboratory Director (LD), the Technical Consultant (TC) who is also qualified as the LD failed to evaluate semi-annual competencies for testing personnel (TP) performing moderate complexity testing. This was noted for one of two new TP listed on the CMS-209 (Laboratory Personnel Report) for 2024. The findings include: 1. A review of the -- 2 of 3 -- personnel records revealed no evidence of evaluation by either TC or the LD for the semi-annual competency of TP#8. 2. During an interview on 11/12/2025, at 3:12 PM, the surveyor gave the LD until 11/21/25 to email the missing documentation. The semi-annual competency on TP#8 was never received. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the Laboratory Director (LD), the Technical Consultant (TC) who is also qualified as the LD failed to evaluate annual competencies for testing personnel (TP) performing moderate complexity testing. This was noted for 9 of 9 previously qualified TP listed on the CMS-209 (Laboratory Personnel Report) for 2024 and 11 of 11 TP listed on the CMS- 209 for 2025. The findings include: 1. A review of the personnel records revealed no evidence of evaluation by either TC or the LD for the annual competencies of the following: a) 2024: TP#1-5,7,8,10,11 b) 2025: TP#1-11 2. During an interview on 11 /12/2025, at 3:12 PM, the surveyor gave the LD until 11/21/25 to email the missing documentation. The surveyor received the 2024 quizzes which did not include the proper criteria and the 2025 competencies were not performed. -- 3 of 3 --