Lutherville Hematology And Oncology Services

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to ensure that the attestation worksheets were signed by all the testing personnel (TP) who performed PT. Findings: 1. The hematology PT records for 2023 were reviewed for a total of three events. 2. The attestation worksheet for the first event of 2023, F1-A, was reviewed. Four different TP had performed the testing but there were only three signatures on the attestation worksheet. 3. The attestation worksheet for the second event of 2023, F1-B, was reviewed. Two different TP had performed the testing but there was only one signature on the attestation worksheet. 4. During the survey on 04/12/2024 at 11: 45 AM, the TC confirmed that the attestation worksheets failed to include the required signatures of all the appropriate TP. 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 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on standard operating procedure manual (SOPM) and hematology quality control (QC) record review and interview with the technical consultant (TC), the laboratory did not follow written procedures for validating new lot numbers of hematology QC. Findings: 1. The procedure "Sysmex XP-300 Automated Hematology Analyzer CLSI Procedure," "Starting a New Lot of Controls" in the SOPM states, "Parallel test new controls by analyzing the three levels of control a minimum of twice a day for 5 days prior to expiration of the previous lot. After a minimum of 10 data points are accumulated and values are running within assay ranges, the lot may be placed into production." 2. During an interview at 12:00 PM, the TC stated that each new lot number of hematology QC is run for 3 days in parallel with the old lot number before being put into use. 3. A review of hematology QC from May through July 2022 showed that the "old" lot number of QC (lot #: 2109, expiration date: 07/27/2022) was run in parallel with the "new" lot number of QC (lot #: 2193, expiration date: 10/19/2022) for 3 days on 07/25/2022, 07/26/2022, and 07/27 /2022. 4. During an interview on 08/23/2022 at 12:30 PM, the TC confirmed that the written SOPM did not accurately reflect the actual practice of the laboratory. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) 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 -- 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 observation, temperature log record review, and interview with the technical consultant (TC), the laboratory failed to define, monitor, and document laboratory reagent refrigerator temperature to ensure proper reagent storage and reliable test system operation. Findings: 1. During a tour of the laboratory at 10:45 AM on the day of the survey it was observed that the in-use "Eightcheck-3UP X-TRA" hematology quality control (QC) vials were stored in a small refrigerator in the laboratory. The remaining stock of QC was stored in another refrigerator in a storeroom. 2. A review of temperature logs from January through August 2022 showed that there were temperature logs for one refrigerator labeled "P2." 3. During an interview on 08/23 /2022 at 11:00 AM the TC stated that "P2" was the refrigerator in the storeroom. The TC confirmed that temperatures were not being monitored and recorded for the refrigerator in the laboratory where the in-use hematology QC was stored. -- 2 of 2 --