Summary:
Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, College of American Pathologist (CAP) proficiency testing (PT) records, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to ensure accuracy of four of twelve samples not evaluated by the PT provider for two of two PT events in the specialty of hematology since the beginning of testing in August of 2024. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled "Quality Control", which stated, under "Quality Control to be Performed Semi- Annually:", "The Supervisor or designee will evaluate the results provided by the agency [CAP} and take