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 Practice Administrator (PA), the laboratory failed to follow their written policies and procedures to assess the competency of Testing Personnel (TP) performing moderately complex throat culture procedures. This deficient practice had the potential to affect 2459 patients tested in the subspecialty of bacteriology. Findings Include: 1. Review of the laboratory's Form CMS-209, approved, signed, and dated by the Laboratory Director on 02/26/2019, revealed fifteen individuals listed as TP. 2. The surveyor requested all TP competency assessment records for 2017-2019 from the PA. The PA was unable to provide competency assessment records for all TP as requested. 3. Review of the laboratory's "Muddy Creek Pediatrics Throat Culture Quality Assessment Procedure", approved via signature and date by the Laboratory Director in 12/16/2013 and provided on the date of the inspection, found the following statement: "To test our throat culture quality we will: ... Maintain competency records for staff" 4. The PA confirmed the laboratory did not follow their own policy and procedure, and did not maintain competency records as stated in the procedure. The interview occurred on 02/26/2019 at 2:00 PM. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on document review, and an interview with the Practice Administrator (PA), the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems. This deficient practice had the potential to affect 2459 patients tested in the subspecialty of bacteriology. Findings include: 1. Review of the "MCP Policy and Procedure Clinical Department - Documenting In-House Test Results Policy no: CD-SO010", found the following statement under Quality Control: "1. The Clinical Nurse Manager and/or designee will audit this process through observation of MA technique at least once annually and will also audit a minim of 5 charts of patients who have had a test listed above to be sure the process was completed in accordance with the established procedure." 2. No quality assessment documentation was found for 2018 or 2019. 3. An interview with the PA on 02/26/19 at 3:00 PM, confirmed quality assessment was not performed at the intervals stated in their policy and procedure. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of