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 a review of annual competency evaluations and interview with the technical consultant (TC), the laboratory did not evaluate the TC for duties performed as the TC. Findings: 1. A review of competency testing records from 2019 to 2021 showed that there was no competency assessment performed on the TC in 2019 and 2020. 2. During an interview on 05/19/2022 at 3:00 PM, the TC confirmed that competency reviews were not performed and documented on the TC for their role as TC. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on procedure manual, laboratory reagent package insert, and patient log record review and interview with the technical consultant (TC), the laboratory did not follow the manufacturer's instructions for performing bacteriology testing. Findings: 1. The laboratory is performing presumptive identification of group A streptococcus on 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 -- throat cultures, using "HardyDisk Bacitracin Differentiation Disks" which are impregnated with low levels of Bacitracin. 2. During an interview at 10:15 AM on the day of the survey, the TC stated that the laboratory evaluates the culture plates at 24 and 48 hours after inoculation. 3. A review of the laboratory's "Throat Culture Log" from 05/02/2022 to 05/10/2022 showed that 3 of 16 patients' throat culture plates were innoculated on 05/06/2022 and interpreted after 3 days' incubation on 05/09/2022; and 4. 13 of 16 patients' throat culture plates were interpreted 2 days after innoculation. 5. The laboratory's "Strep Group A Screen" procedure instructs testing personnel to "Incubate the plates in ambient air at 35-37C for 48 hours." 6. Review of the package insert for the "HardyDisk Bacitracin Differentiation Disks" showed that culture plates must be incubated "for 18-24 hours at 35C" before being read or interpreted. 7. During an interview on 05/19/2022 at 3:00 PM the TC confirmed that the laboratory did not follow the manufacturer's instructions for performing throat cultures. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: A. Based on review of the standard operating procedure (SOP) manual, quality assessment (QA) plan,