Summary:
Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on record review, observation, and interview, the laboratory failed to retain one (PT#1) out of seven histopathology patient slides reviewed for 10 years. Findings included: 1. Review of the policy and procedure manual revised on 10/2022 revealed there was no policy on slide retention. 2. Review of patient records revealed PT#1 was diagnosed with Squamous Cell Carcinoma, Fragments on 3/6/2012 with two slides created labeled 12-052510 A and 12-02540 B. 3. Observation of slides cases on 12/20 /202 at 1:51 pm, revealed the slides for PT#1 (12-02540 A and 12-02540B) were not retained. 4. During interview on 12/20/2022 at 1:51 pm, SP-1 (Pathology Coordinator) indicated that the laboratory only stored slides for seven years. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --