Summary:
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 record review and an interview with the laboratory manager, the laboratory failed to establish and follow written procedures that meet the requirement to assess employees performing Bacteriology testing, affecting 2 out of 2 testing personnel (TP). Findings include: 1. The procedures manual, the Laboratory Personnel Report (CMS 209), and personnel records were reviewed. 2. The laboratory failed to have a written competency procedure that includes the following requirement: *The assessment of problem solving skills. 3. TP1 and TP4 were listed on the CMS 209 for performing Potassium Oxide (KOH) preparations and Scabies identifications. 4. The personnel documents for TP1 and TP4 did not include the assessment of problem solving skills during the years of 2019 and 2020. 5. On a Recertification survey conducted on 12/03/2020 at 12:15 PM, the office manager confirmed the above findings. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. 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 record review and an interview with the laboratory manager, the laboratory failed to document all control procedures performed, as specified in the specialty of Histopathology, affecting 91 out 325 patients. Findings Include: 1. The laboratory manual, Mohs surgery patients' logs from the dates of 06/10/2019 through 10/202020, and Hematoxylin and Eosin (H&E) tissue staining quality control (QC) worksheets were reviewed. 2. The laboratory's H&E-QC procedures required the TP to assess and document the stain quality of a selected slide each day Mohs surgery is performed. 3. The QC worksheets showed the H&E stain quality were not documented on the following Mohs surgery dates: 07/22/19; 07/29/19; 08/05/19; 08/12/19; 08/26/19; 09 /09/19; 10/28/19; 11/25/19; 12/02/19; 12/09/19; 12/16/19; 12/23/19; 12/30/19; 09/14 /20; and 09/21/20. 4. Review of Mohs patient logs revealed 91 patients were reported on the above dates. 5. The laboratory failed to follow written H&E-QC procedures to document H&E stain quality each day Mohs procedures were performed. 6. On a Recertification survey conducted on 12/03/2020 at 12:15 PM, the laboratory manager confirmed the above findings. -- 2 of 2 --