Ocmulgee Medical Pathology Association, Inc

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of a random patient test report and interview with the Histology Technician 10/4/21, the laboratory failed to ensure the test reports included all required information. Findings: Review of a random patient dermatopathology test report(# SA21-000179-FS) revealed the frozen section location on the report was incorrect. The report stated the frozen sections were performed at a different address and CLIA number than the location where performed. At approximately 12:00 p.m., the histology technician confirmed the frozen section location on the test report was incorrect. She stated the transcription process changed in 2020 and could be the reason for the incorrect frozen section location. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of personnel records, the absence of documentation, and interview with the Histology Technician (testing personnel #2) 10/4/21, the Technical Supervisor (laboratory director) failed to evaluate the competency of 1 of 2 TP(testing personnel #2) in 2020. Findings: Review of personnel records revealed the Technical Supervisor had evaluated the competency for TP #2 on 12/12/19 and not again until 9/27/21, a period of 21 months. At approximately 12 p.m., the Histology technician confirmed the 2020 annual competency assessment was not done. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review, observation, and interview with TP (Testing Personnel) on 6 /10/19, the laboratory failed to discard reagents that had exceeded their expiration dates. Findings: Review of the "QC LOG FOR TECHNICAL EVALUATION OF TISSUE SLIDES" revealed the log included lot numbers and shipment dates for the Hematoxylin and Eosin stains, but did not include expiration dates. During interview at approximately 2:05 pm, TP #1 confirmed that stain expiration dates were not documented on the log. During tour of the laboratory at approximately 3:00 pm, the surveyor observed the following expired reagents that were available for use: 1. Surgipath Hematoxylin Gill II, (Lot number: 042517, expiration date: 10/25/2018); 2. Richard-Allan Scientific Eosin Y,(Lot number: 406207, expiration date: 3/2019). During interview at approximately 3:05pm, TP #1 confirmed the Hematoxylin and Eosin stains were expired. 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 --