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 observation during the laboratory tour, review of the laboratory's policy and procedure, and interviews with practice manager (PM) and medical assistant (MA), 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 3:30 p.m. the laboratory failed to provide a written policy and procedure for laboratory safety. 2. The PM and MA confirmed by interviews April 9, 2025, at approximately 3:40p.m., that the laboratory lacked a written safety procedures based on the laboratory's risk assessment. 3. Based on the laboratory's annual testing volume declaration signed by the laboratory director on 4/8/2025, the laboratory processed and reported approximately 1,200 Dermatopathology patients' test samples. 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: 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 -- Based on the lack of a Quality Assurance plan (QA), review of the laboratory's policies and procedures, and interview with the office practice manager (PM), 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 3:00 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 PM confirmed by interview on April 9, 2025, at approximately 3:00 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 on April 8, 2025, the laboratory performed annually 1,200 Dermatopathology 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