Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on September 17, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on patient log review and staff interview, the laboratory failed to perform required quality control (QC) for all testing. Findings include: 1. Patient log rview revealed Potassium Hydroxide (KOH) QC was not performed for 2017(October through December), 2018, and 2019 thus far. 2. An interview with the office manager in a conference room on 9/17/2019 at approximately 1:00 p.m. confirmed the lack of QC for KOH testing for the aforementioned dates. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. 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 CONDITION is not met as evidenced by: Based on testing personnel (TP) document review and staff interview, the technical supervisor (TS) failed to perform annual competencies on TP as required. Findings include: For details refer to D6120 D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 testing personnel (TP) document review and staff interview, the technical supervisor (TS) failed to perform annual competencies on TP as required. Findings. 1. TP competency document review revealed the TS failed to perform annual competencies for the following TP in 2018 and 2019 thus far: (CMS 209) Staff #4, Staff #5, Staff #6, and Staff f#7. 2. An interview with the office manager in a conference room on 9/17/2019 at approximately 1:00 p.m. confirmed there were not annual competencies performed on TP in 2018 and 2019 thus far. This is a repeat deficiency -- 2 of 2 --