Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the 2017 and 2018 proficiency testing (PT) records and interview with testing personnel number one, the laboratory failed to document the PT results of the urine colony count culture onto the urine culture worksheet and the PT results of the throat culture onto the throat culture worksheet, in 2017 and 2018. The findings include: 1) Review of the 2017 events one, two, three, 2018 events one, and two PT records revealed the urine culture worksheets and the throat culture worksheets did not include the PT sample results; a separate sheet of paper contained the results of the PT samples with no date and no testing personnel initials. 2) Interview on November 9, 2018 at 11:30 a.m. with testing personnel number one confirmed the urine culture worksheets and the throat culture worksheets do not include the PT sample results. The 2017 and 2018 PT throat culture results and the urine colony count culture results were written on a separate sheet of paper for the providers to review. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 review of the personnel records, the laboratory procedure manual and interview with the laboratory director, the laboratory failed to have a personnel competency assessment procedure to include the six competency assessment criteria. The findings include: 1) Review of the laboratory procedure manual revealed the personnel competency procedure and worksheet did not include the following six criteria for ensuring competency: direct observation of test performance; monitoring the recording and reporting of test results; review of intermediate test results; direct observation of instrument mainteance; assessment of test performance; and, assessment of problem solving skills. 2) Review of the 2017 and 2018 testing personnel competency records revealed no documentation for these six criteria included in the competency documentation for bacteriology and hematology specialties. 3) Interview on November 9, 2018 at 3:45 p.m. with the laboratory director confirmed the laboratory procedure for competency assessment did not include all six assessment criteria and was not in use during the 2017 and 2018 testing personnel competency performance. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: The laboratory failed to: follow the manufacturer instructions for inoculation of the sterile urine specimen (Refer to D5411 citation number one); failed to follow the manufacturer instructions for incubation of uninoculated quality control culture plates for 72 hours (Refer to D5411 citation number two); failed to follow the manufacturer instructions for reporting patient results (Refer to D5411 citation number three); failed to ensure the complete blood count (CBC) quality control (QC) was not in use after the expiration date (Refer to D5415); failed to document the urine culture quality control results with each new lot number (Refer to D5481); failed to identify and perform