Hematology - Oncology Of Alabama

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records and an interview with the Technical Consultant (TC), the Testing Personnel (TP) failed to sign the PT attestation statements for the specialty in Hematology. This was noted in four of the six events reviewed from 2024-2025. The findings include: 1. A review of the AAB- MLE PT records revealed no signature of the TP on PT attestation statements for the following surveys: a) Hematology 2024 M1 Event, b) Hematology 2024 M2 Event, c) Hematology 2025 M2 Event, d) Hematology 2025 M3 Event. 2. During the exit conference on 12-11-2025 at 12:30 PM, the TC confirmed the above findings. 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. 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 -- This STANDARD is not met as evidenced by: Based on reviews of the environmental logs, the Sysmex XN-L Instrument General Information Guide, the Quality Control (QC) package insert, the patient testing electronic records and an interview the Technical Consultant (TC), the laboratory failed to document the temperatures and humidity on days when patient testing was performed. The surveyor noted no documentation for three of the 60 days reviewed in 2025. The findings include: 1. A review of the environmental logs revealed missing documentations of the room and humidity and refrigerator temperatures for the following days; a) June 13, 2025 b) July 11, 2025 c) October 3, 2025 2. A review of the Sysmex XN-L Analyzer Manual revealed on page 41 the following manufacturer instrument specifications for temperature and humidity. A) Operating environment Ambient temperature: 15 to 35C B) Relative humidity: 20 to 85% 3. A review of the XN-L Check Control Materials package insert revealed the follwoing instructions for storage and shelf life before and after opening. A) Storage and shelf life of unopened product. XN-L CHECK is to be stored in a dark place at 2-8 C. B) Storage and shelf life after first opening. Open vials and vials which have been sampled by cap piercing will retain stability for 15 days if stored in a dark place at 2-8 C after being re-capped. 4) A review of the electronic records revealed 44 patients were tested when the room temperature and humidity and the refrigerator temperature were not documented. 4. The TC confirmed the above findings during the exit conference on 12-11-2025 at 12: 30 PM. -- 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 a review of the Sysmex XP-300 Hematology Quality Control (QC) records and an interview with Testing Personnel #1, the laboratory failed to use acceptable in- date QC material. This was noted for two days of patient testing and affected 151 patient Complete Blood Count (CBC) tests. The findings include: 1. A review of the Hematology QC records revealed lot #31640710 expired on 9/20/2023. 2. A review of Hematology QC records revealed the laboratory continued to use lot #31640710 after expiration on two days of patient testing, as follows: a) 9/21/2023; 61 patient CBC tests were performed. b) 9/22/2023; 90 patient CBC tests were performed. 3. During an interview on 2/6/2024 at 11:04 AM, Testing Personnel #1 confirmed the above findings. -------------------------------------------------------------------------------------- Based on a review of the Sysmex XP-300 Hematology Quality Control (QC) records and an interview with Testing Personnel #1, the laboratory failed to use acceptable in date QC material. This was noted for two days of patient testing and 151 patient Complete Blood Count (CBC) tests were affected. The findings include: 1. A review of the Hematology QC records revealed lot #31640710 expired on 9/20/2023. 2. A review of Hematology QC records also revealed lot #31640710 was ran on the following days: a) 9/21/2023; 61 patient CBC tests were performed. b) 9/22/2023; 90 patient CBC tests were performed. 3. During an interview on 2/6/2024 at 11:04 AM, Testing Personnel #1 confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES 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 -- CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: PLEASE EDIT--NEEDS CLARIFICATION Based on a review of the personnel records and an interview with Testing Personnel #1, the Technical Consultant failed to evaluate annual competency documentation for Testing Personnel performing moderate complex patient testing. This was noted for three of three testing personnel in 2023. The findings include: 1. A review of the personnel records revealed no evidence of Technical Consultant's evaluation on the 2023 annual competency documentation for Testing Personnel #1, 2, and 3. [WHAT DOES THIS MEAN? THERE WERE NO 2023 COMPETENCY ASSESSMENTS?OR COMPETENCY ASSESSMENTS WERE PERFORMED, WITHOUT DOC. THE TC DID THE EVALUATION ( NO SIGNATURE)? WAS A COMPETENCY PERFORMED BY AN UNQUALIFIED PERSON, OR JUST NOT SIGNED AT ALL?] 2. During an interview on 2/6/2024 at 9:32 AM, Testing Personnel #1 confirmed the above findings. -- 2 of 2 --