Erlanger Health

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the Department of Health and Human Services Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS- 209), College of American Pathologists (CAP) proficiency testing (PT) records, and staff interviews, the laboratory failed to ensure that one of the two total testing personnel (TP) who performed patient testing for KOH preps and scabies examinations also tested PT samples in 2023, 2024, and 2025. The findings include: 1. A review of Form CMS-209 revealed two TP who performed patient testing. 2. A review of the laboratory's CAP PT records for 2023, 2024, and 2025 revealed that five of five events reviewed were performed by TP1, resulting in one TP who did not participate in PT events: 2023: CM-A and CM-B 2024: CM-A and CM-B 2025: CM- A 3. The laboratory director confirmed the survey findings during an interview on 08 /12/2025 at 12:45 p.m. . 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual, lack of documentation, and staff interview, the laboratory failed to establish a written policy or procedure defining quality activities to monitor, assess, and correct problems in the laboratory's testing systems for 2023, 2024, and 2025. The findings include: 1. A review of the laboratory procedure manual revealed the following Quality Assurance statement that failed to define quality assessment activities to monitor, assess, and correct problems in the laboratory's testing systems on the day of the survey, 08/12/2025: "The lab director will monitor all aspects of the laboratory and make certain that all testing complies with the individual testing policy and procedure protocols." 2. There were no quality assessment records or documentation available. 3. The laboratory director confirmed that the laboratory did not have written quality assessment policies for monitoring and evaluating the pre-analytical, analytical, and post-analytical phases of the testing process in an interview on 08/12/2025 at 12:45 p.m. . D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the laboratory policy and procedure manual and staff interview, the laboratory failed to define criteria for essential laboratory conditions when it did not have an approved policy or procedure for temperature and humidity monitoring available on the day of the survey, 08/12/2025. The findings include: 1. A review of the laboratory's policy and procedure manuals revealed no policy defining the laboratory's temperature and humidity monitoring criteria. 2. The laboratory director confirmed the survey findings in an interview on 08/12/2025 at 12:45 p.m. . D5485 CONTROL PROCEDURES CFR(s): 493.1256(h) (h) If control materials are not available, the laboratory must have an alternative mechanism to detect immediate errors and monitor test system performance over time. The performance of alternative control procedures must be documented. (a) The laboratory must check the following for positive and negative reactivity using control organisms: This STANDARD is not met as evidenced by: Based on a review of laboratory policies and procedures, patient testing logs, lack of documentation, and staff interviews, the laboratory failed to define or document alternative control procedures for potassium hydroxide (KOH) testing and scabies examinations in 2023, 2024, and 2025, with 74 patients tested in 2023, 39 patients tested in 2024, and 23 patients tested in 2025. The findings include: 1. A review of the -- 2 of 3 -- laboratory's Provider Performed Microscopy (PPM) policies and procedures revealed a policy that contained no QC requirements for KOH testing or scabies examinations. 2. A review of patient testing logs revealed that the laboratory tested 74 patients in 2023, 39 patients in 2024, and 23 patients in 2025. 3. No QC documentation for KOH testing or scabies examinations was available for review on the day of the survey, 08 /12/2025. 4. The laboratory director confirmed the survey findings during an interview on 08/12/25 at 12:45 p.m. . D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) (e)(13) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on a review of laboratory policies and procedures and staff interviews, the laboratory director failed to have a personnel policy for competency assessment for testing personnel performing grossing procedures on patient tissue samples removed during Mohs surgical procedures in 2025. The findings include: 1. A review of the laboratory policies and procedures revealed that the laboratory did not have a personnel competency policy available on the day of the survey, 08/12/2025. 2. The laboratory director confirmed the survey findings during an interview on 08/12/25 at 12:45 p.m. -- 3 of 3 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the procedure manual, quality control (QC) temperature records, and an interview of the lead lab tech, the laboratory failed follow the cryostat temperature policy for 2019. Findings include: 1. Review of the procedure manual revealed a cryostat temperature range of -20 Celsius (C) to -30C. 2. Review of the cryostat temperature range on the temperature record of -15C to -25C. 3. Interview with the lead lab tech, August 21, 2019, at 9:30am, confirmed the cryostat temperature range in the procedure manual was not followed on the cryostat temperature record for 2019. 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 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 -- 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 four of four patient final test results, the Centers for Medicare and Medicaid Services (CMS)-116 form and interview with the lead histotech, the laboratory name and address were not correct on the final laboratory reports for 2019. The findings include: 1) Review of patients #1 (4.22.19 - EE19-0001), #2 (5.3.19 - EE19-0059), #3 (6.25.19 - EE19-0104), and #4 (8.6.19 - EE19-0172) final test results revealed the following name and no address: EMG Dermatology East Medical Office. 2) Review of the CMS -116 form revealed the laboratory name and address is UT Erlanger Dermatology, 1635 Gunbarrel Road, Suite 400, Chattanooga, TN 37421. 3) Interview on August 21, 2019 at 11:30am with the lead histotech confirmed the name was incorrect and address missing on the laboratory final reports. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of the Procedure Manual, review of the Centers for Medicare and Medicaid Services (CMS) 116 application, and an interview with the lead testing person determined the laboratory director failed to establish a procedure for the specialties of Mycology (Potassium Hydroxide - KOH for fungal) and Parasitiology (Wet Preps for parasites) in 2019. The findings include: 1) Review of the Procedure Manual did not reveal any KOH/Wet Prep procedures for 2019. 2) Review of the CMS 116 initial application revealed the laboratory specialties for Mycology and Parasitology. 3) Interview with the lead testing person at 10:30 AM on August 21, 2019, confirmed there were no KOH/Wet Prep procedures in the laboratory procedure manual for 2019. D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on observation of the histopathology work area, lack of safety procedure and -- 2 of 3 -- interview with the lead histotech the laboratory director failed to provide a safety procedure to ensure a xylene exposure monitoring plan for xylene in use for the year 2019. Findings include: 1. On August 21, 2019 at approximately 8:15 am the histopathology work area was observed and xylene was present and a reagent alcohol gallon container was stored by the staining hood instead of the flammables cabinet. 2. There was no safety procedure manual available for review that described steps for the following: To ensure protection from physical, chemical, biochemical and electrical hazards, and biohazardous materials such as xylene, a potential carcinogenic chemical. 3. In an interview, on August 21, 2019, at approximately 9:00 am, the lead histotech confirmed that the laboratory was using reagent alcohol without storing in the flammables cabinet and also using xylene, but did not have a xylene exposure monitoring plan for the safety of personnel in 2019. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on a review of the procedure manual and an interview of the lead lab tech, the laboratory director failed to approve the laboratory procedure manual for 2019. Findings include: 1. Review of the procedure manual form for "Review by Laboratory Director" revealed a date of 5/23/19, but no signature/approval by the laboratory director. 2. Interview with the lead lab tech, August 21, 2019, at 9:30am, confirmed the procedure manual was not signed/approved by the laboratory director for 2019. -- 3 of 3 --