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 CAP (College of American Pathology) proficiency testing records and an interview with Technical Consultant (TC) #2, Testing Personnel (TP) #1 and the Nurse Practitioner, the surveyor determined the laboratory failed to ensure the testing personnel or the Laboratory Director (or qualified delegee) signed the attestation statements for Hematology, Event FH1 B 2018 and FH1 C 2019. This affected two of six testing events reviewed by the surveyor. The findings include: 1. A review of the proficiency testing records revealed the laboratory failed to ensure the testing personnel signed the attestation statement for Hematology Event FH1 B 2018, and failed to ensure the Laboratory Director (or qualified delegee) signed the attestation statement for Event FH1 C 2019. 2. The surveyor discussed the above noted findings with TC #2, TP #1 and the Nurse Practitioner, in an interview at approximately 1:00 PM on November 25, 2019. 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 a review of CAP (College of American Pathology) proficiency testing records, and an interview with Technical Consultant (TC) #2, Testing Personnel (TP) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- #1 and the Nurse Practitioner, the surveyor determined the laboratory failed to implement and document