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 testing personnel (TP); 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 1:00p.m. the laboratory failed to provide a written policy and procedure for laboratory safety. 2. The TP confirmed by interviews April 15, 2025, at approximately 1:30p.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 /15/2025, the laboratory processed and reported approximately 222,072 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 laboratory's staff; the laboratory failed to establish 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 15, 2025, at approximately 12:30 p.m., no documentation could be retrieved by the laboratory to show that a written QA plan was in place for the years 2023, 2024, and 2025. 2. Laboratory staff reviewed and documented monthly patient tracers. The laboratory staff randomly selected 3 patients and reviewed the requisition, final report, test results, QC, and preventive maintenance. However, no written QA plan was found at the time of the survey. 3. The laboratory staff confirmed by interview on April 15, 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 15, 2025, signed and dated by the laboratory director, the laboratory performed annually 222,072 bacteriology molecular tests and diagnosis without an established written QA plan. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)