Lonestar Gastroenterology, Pa

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. 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 review of the laboratory's policies and procedures, observation, formaldehyde badge test, interview, and pre-survey paperwork, the laboratory failed to monitor the formaldehyde exposure monitoring test for two of two years reviewed in 2023 and 2024. Findings follow. A. Review of the laboratory's policy and procedure titled Laboratory Standard (Occupational Exposure to Hazardous Chemicals in Laboratories Standard) under Procedure stated, "Permissible Exposure Limits 1.1 The laboratory shall assure the employees' exposures to OSHA regulated substances do not exceed the Permissible Exposure Limit (PEL). 2. Initial monitoring 2.1 The laboratory shall initially measure the employee's exposure to any substance regulated by an OSHA standard (i.e. formaldehyde) which requires monitoring if there is reason to believe that exposure levels for that substance ever exceeds the Short-Term Exposure Limit (STEL), action level, or in the absence of an action level, the PEL. 3. Periodic Monitoring 3.1 If the levels of these substances fall below the action level and STEL the substance shall continue to be monitored on an annual schedule. If the action level or STEL is exceeded

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, grossing report, test report, and interview, the laboratory failed to identify and correct an error in reporting gastrointestinal biopsy grossing specimens for one of ten cases reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Quality Assurance Program, effective 11/01/2022, at Procedure under 3. Post-analytical stated, "3.1 QC slides (SOP Daily Routine in Histology) 3.2 Place slides in proper location in for distribution (SOP: Daily Routine in Histology) 3.3 File blocks and slides (SOP: Histology Daily Routine) 3.4 Block count analysis (SOP: Histology Daily Routine) 3.5 Pathologist Daily Review". B. Review of the Grossing Sheet for case LP23-0275 for specimen B from the colon, transverse, showed the specimen was received in 3 portions that were light-brown mucosal tissue measuring 5 mm to 2 mm, submitted in one cassette. C. Review of the Gastrointestinal Pathology Report for case LP23-0275 showed specimen B from the colon, transverse, stated, "It contains three portions of white brown mucosal tissue ranging from 0.5 cm to 0.2 cm in greatest dimension. The specimen is entirely submitted in one cassette." D. Interview with the histotechnologist on August 7, 2023 at 1540 hours confirmed the test report color description was incorrect. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --