Summary:
Summary Statement of Deficiencies D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the CMS-209 (Laboratory Personnel Report) Form, laboratory policies and procedures, laboratory records, lack of documentation, and interview with testing personnel (TP) #5; the laboratory failed to establish and follow written policies and procedures to assess seven of seven TP competencies (see D5209), failed to document the check of positive and negative reactivity of immunohistochemical stains each time of use for three of three histopathology patients reviewed (see D5601a) and to document a control slide of known reactivity of special stains with each patient slide or group of patient slides for three of three histopathology patients reviewed (see D5601b), and failed to perform