Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 2, 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to test the PT samples with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory. Findings include: 1. American Academy of Family Physicians (AAFP) document review revealed the laboratory failed to rotate testing personnel (TP) in the examination of PT samples for the following Bacteriology PT events: 2017: Events 2 and 3; 2018 - All 3 events. 2. An interview with the laboratory director in the clinic lobby on 4/2/2019 at approximately 1:00 p.m. confirmed TP was not rotated for the aforementioned Bacteriology PT events. 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 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 -- 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 proficiency test (PT) document review and staff interview, the laboratory failed to maintain a copy of all records for a minimum of 2 years as required. Findings include: 1. American Academy of Family Physicians (AAFP) PT document review revealed there were no PT attestation statements or bacteriology PT log sheets available at the time of survey for the following Bacteriology PT events: 2017 - Events 1 and 2: 2018 - All 3 events. 2..An interview with the laboratory director in the clinic lobby on 4/2/2019 at approximately 1:00 p.m. confirmed there were no attestation statements or bacteriology sheets available at the time of survey for the aforementioned PT events. 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 review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory failed to establish and follow written policies and procedures to assess testing personnel (TP) competency as required. Findings include: 1. SOP review revealed the laboratory did not establish and follow a TP competency policy and procedure. 2. An interview with the laboratory director in the clinic lobby on 4/2 /2019 at approximately 1:00 p.m. confirmed there was not a TP competency policy and procedure in the SOP. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to ensure all PT verification activities were documented as required. Findings include: 1. American Academy of Family Physicians PT document review revealed