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 the lack of written policies and procedures manual for retention and storage applicable to dermatopathology, review of five (5) randomly chosen patient test records, and interviews with the office manager (OM) and medical assistant (MA); the laboratory failed to have written policies for documentation and slide retention and storage for dermatopathology. The findings included: 1. Based on the survey conducted on June 25, 2024, at approximately 2:30 p.m., no written policies for retention and storage of documents and slides were found at the time of survey. 2. The OM and MA affirmed by interview on June 25, 2024, at approximately 2:30 p.m. that the laboratory had no retention and storage policies for documents and slides. 3. Based on the laboratory declaration form submitted on June 25, 2024 and review of 5 randomly chosen dermatopathology test records out of 327 tests performed annually for dermatopathology, the laboratory had no retention and storage policies. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. 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 -- This STANDARD is not met as evidenced by: Based on interview with the office manager and medical assistant on June 25, 2024, at approximately 2:30 p.m., the laboratory director is herein cited for the deficient practice for failure to ensure that an established, approved, signed, and dated procedure manual reflecting the current practice is available to all personnel responsible for any aspect of the testing process. Findings include: See D3043. -- 2 of 2 --