Summary:
Summary Statement of Deficiencies D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on review of proficiency testing records, interview with the laboratory manager, and the technical consultant (TC), the laboratory failed to ensure that proficiency testing was performed for peripheral blood smear identification and urine sediment morphology. Findings: 1. The laboratory failed to enroll in the peripheral blood smear identification and urine sediment morphology. 2. The laboratory manager stated that they never received the pictures. 3. On the day of the survey the manager enrolled in PT to receive pictures for identification of blood cell and urine sediment morphology. 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 proficiency testing (PT) records and interview with the laboratory manager, the laboratory did not document the