Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) during calendar year 2018 and 2019 from the PT provider American Proficiency Institute (API) and interview, the laboratory failed to attest on two of four reveiwed events that proficiency testing samples were handled in the same manner as patient samples. Findings: 1. A review of proficiency testing events during 2018, Microbiology 3rd Event and 2019 Microbiology 1st Event revealed that attestation statement did not contain the signature of the laboratory director (LD) or designee, and the signature of the testing personnel, attesting that the laboratory handled proficiency testing samples in the same manner as patients. 2. Interview with the Laboratory Director on December 19, 2019 at 10:45 a.m. confirmed, the laboratory failed to attest on two of four reveiwed events that proficiency testing samples were handled in the same manner as patient samples. 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 review of the laboratory's 2018 and 2019 API PT documentation, and interview, the laboratory failed to document all proficiency testing evaluation and 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 -- verification activities for the specialty of microbiology for the 3rd Event of 2018 and all (3) Events of 2019. Findings Include: 1. Review of the laboratory's 2018 and 2019 APT PT documentation for microbiology had no documentation for evaluation and verification activities (4 of 4 events) occuring after the date of last survey August 23, 2018. 2. The LD stated the laboratory does perform an evaluation but did not document the review. 3. The LD in interview on December 19, 2019 at 11:00 a.m. confirmed, the laboratory failed to document all proficiency testing evaluation and verification activities for the specialty of microbiology for the 3rd Event of 2018 and all (3) Events of 2019. 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