Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation and interview with the practice manager (PM), the laboratory failed to ensure the bi-annual accuracy evaluations of mycology analyte Potassium Hydroxide (KOH) preparations for three of three testing years 2022, 2023, and 2024, affecting 97 KOH patient tests. Findings include: 1. Review of the "Dermatology Associates of LaGrange Chapter 2: Quality Assurance 2.04 Quality Management and Competency Testing Evaluators" policy revealed the following information. "Principle: ...An integral part of these responsibilities is a clear and comprehensive assessment of the competence required to deliver quality services as mandated by CLIA 88 ... General supervisor responsibilities: ...The director or technical supervisor may delegate to the general supervisor the responsibilities for ...D. 2. Proficiency testing ... c. Accurate running and reporting of survey specimens. d. Accurate resulting of samples split for peer performance." 2. Review of laboratory records and lack of documentation revealed the laboratory failed to ensure the bi-annual accuracy evaluations of KOH for three of three testing years 2022, 2023, and 2024. 3. On 12/05/2024, at 12:07 p.m., the PM stated no bi-annual accuracy evaluations of KOH were performed in 2022, 2023, and 2024. 4. Review of laboratory records found 97 KOH patient tests were performed in 2022 through the date of survey, 12/05/2024. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation and interview with the practice manager (PM), the laboratory failed to ensure accuracy evaluations of the parasitology analyte scabies preparations for three of three testing years 2022, 2023, and 2024, affecting 5 scabies patient tests. Findings include: 1. Review of the "Dermatology Associates of LaGrange Chapter 2: Quality Assurance 2.04 Quality Management and Competency Testing Evaluators" policy revealed the following information. "Principle: ...An integral part of these responsibilities is a clear and comprehensive assessment of the competence required to deliver quality services as mandated by CLIA 88 ... General supervisor responsibilities: ...The director or technical supervisor may delegate to the general supervisor the responsibilities for ... D. 2. Proficiency testing ... c. Accurate running and reporting of survey specimens. d. Accurate resulting of samples split for peer performance." 2. Review of laboratory records and lack of documentation revealed the laboratory failed to ensure accuracy evaluations of the parasitology analyte scabies for three of three testing years 2022, 2023, and 2024. 3. On 12/05/2024, at 12:07 p.m., the PM stated no accuracy evaluations of scabies preparations were performed in 2022, 2023, and 2024. 4. Review of laboratory records found five scabies patient tests were performed in 2022 through the date of survey, 12/05/2024. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)