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 review of the laboratory's policies and procedures, lack of a laboratory safety procedure, and interview with office manager (OM); the laboratory failed to establish safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials. The findings include: 1. Based on the survey on April 9, 2025, at approximately 1:30 p.m. the laboratory failed to provide a written policy and procedure for laboratory safety. 2. The OM confirmed by interviews April 9, 2025, at approximately 1:35p.m., that the laboratory lacked written safety policy and procedures based on the laboratory's risk assessment. 3. Based on the laboratory's annual testing volume declaration signed by the laboratory director on 4/9/2025, the laboratory processed and reported approximately 544 patients' test samples. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on review of patient testing records, patient final testing reports, and interviews with the laboratory director (LD) and the office manager (OM) on April 9, 2025, at approximately 12:30 p.m. it was determined that for four (4) 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 discrepancies: Patient 1: Date of Mohs 03/08/2024, No QC slide prepared or found at the time of the survey Patient 2: Date of Mohs 06/14/2024, Mapping for Mohs missing Patient 3: Date of Mohs 08/23/2024, location; hand, reported as Stage I, two (2) slides prepared labelled as Stage III Patient 4: Date of Mohs 02/07/2025, Mapping for Mohs missing 2. The OM affirmed that records were discrepant and /or incomplete for four (4) out of five (5) Mohs patients records reviewed as stated in #1 above 3. Based on the laboratory's annual test volume declaration signed by the LD on 04/09/2025 the laboratory performed and reported 544 Mohs procedures for which its accuracy cannot be confirmed. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on the lack of a Quality Assurance plan (QA), review of the laboratory's policies and procedures, and interview with the laboratory director (LD) the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor and assess records identified in the general laboratory systems. The findings include: 1. Based on the day survey on April 9, 2025, at approximately 12:30 p.m., no documentation could be retrieved by the laboratory to show that a QA plan was in place for the years 2024 and 2025. 2. The LD confirmed by interview on April 9, 2025, at approximately 1:00 p.m., that the laboratory did not establish a QA plan to follow written policies and procedures reflecting the current practice for an ongoing mechanism to monitor and assess records identified in the general laboratory systems. 3. According to the testing declaration submitted on April 9, 2025, signed and dated by the laboratory director, the laboratory performed annually 544 dermatopathology, 5 KOH wet mounts, and 5 Sarcoptes scabiei slide preparations, analysis, and diagnosis without an established QA plan. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of