Summary:
Summary Statement of Deficiencies 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 a record review and an interview with the laboratory lead, the laboratory failed to test the American Proficiency Institute (API) proficiency testing (PT) samples for complete blood count (CBC) analysis by personnel who perform patient testing since the last survey on September 28, 2016. Findings: 1. A review of PT records from API revealed the laboratory failed to rotate the testing of CBC samples from API by personnel who routinely perform testing in the laboratory since the last survey. 2. An interview on September 17, 2018 at 11:15 AM, with the laboratory lead, confirmed the laboratory failed to test the CBC proficiency samples by personnel who routinely perform patient CBC analysis since the last survey. 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 testing (PT) record review and an interview with the laboratory manager, the laboratory failed to document the review and