Summary:
Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the surveyor's observations during the laboratory tour, and interviews with the office manager (OM); the laboratory failed to follow safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials. The findings include: 1. The laboratory failed to follow their safety policy and procedure to provide protection from physical, chemical, biochemical, and biohazardous materials as needed based on the laboratory's risk assessment. 2. Surveyor observed during the laboratory tour that no eye wash station or eye wash portable bottle kit was found in the testing area. 3. the laboratory had a biological spill kit, however; no chemical spill kit was available. 4. The OM by interview on September 4, 2025, at approximately 4:00 p.m. affirmed that the laboratory lacked an eye washing station and a chemical spill kit 5. The safety of laboratory testing personnel could not be assured at this time. 6. The annual testing declaration form submitted at the time of the survey stated 550 samples were processed and reported for Dermatopathology during the time when safety concern for all testing personnel could not be assured. D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) (a)(7) Slide, block, and tissue retention-- (a)(7)(i) Slides. (a)(7)(i)(A) Retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). (a)(7)(i)(B) Retain histopathology slides for at least 10 years from the date of examination. (a)(7)(ii) Blocks. Retain pathology specimen Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- blocks for at least 2 years from the date of examination. (a)(7)(iii) Tissue. 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 updated policies and procedures reflecting the current practice, review of randomly selected patient test records, and interview with the office manager (OM); the laboratory failed to provide an approved and signed policy and procedure for retention of documents and storage requirements. Findings include: 1. In reference to the retention requirements in 42 CFR Part 493.1105 (Standard Retention Requirements), the laboratory is herein cited for the deficient practice of lacking an approved and signed retention and storage requirements policy and procedure. 2. The OM stated during an interview on 9/4/2025 at approximately 3:00 p. m., that the laboratory does not have a policy and procedure for record retention and storage for: test results, test procedures, quality system assessment record, and Histopathology slides. 3. Based on the laboratory's testing declaration submitted at the time of the survey, the laboratory performed an estimated 550 patient samples during the time that no retention and storage policy and procedure was implemented. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of patient testing records, patient final testing reports, and interviews with the office manager (OM) on September 4, 2025, at approximately 3:00p.m.; it was determined that for one (1) out of five (5) randomly selected patient Mohs testing records reviewed, the laboratory failed to follow written policies and procedures for specimen analytical phase testing, through completion of testing and reporting results. The findings included: 1. Review of Mohs documentation and patient's final test report found the following discrepancy: Patient 1: Date of Mohs 7/20/2023, location stated in the Mohs log as Right Inferior Helix. Location stated in the final report; Right Lateral Forehead. 2. The OM affirmed that records were discrepant for one (1) out of five (5) Mohs patients' records reviewed as stated in #1 above. 3. No