Hematology Oncology Solutions Of Tallahassee

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Hematology Oncology Solutions of Tallahassee on 12/11/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D2000-Enrollment of Testing Samples-493.801 D5400-Analytic Systems-493.1250 D6000-Moderate Complexity Lab Director-493.1403 D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing records, attestation statements, and interview with the Laboratory Director, the laboratory failed to test proficiency samples in the same manner as patients' specimens for two of two years (2023-2024) reviewed. Findings included: 1. The laboratory failed to report proficiency testing samples in the same manner as it reports patient specimens for three (1st and 2nd event of 2023 and 3rd event of 2024 ) of six (1st, 2nd, and 3rd events of 2023 and 2024 hematology samples. Refer to D2006. 2. The laboratory failed to test proficiency samples the same number of times that it routinely tests patient samples for two (1st event of 2023 and 3rd event of 2024) of six (1st, 2nd, and 3rd events of 2023 an 2024) for 2023-2024. Refer to D2010. 3. The laboratory failed to maintain a copy of the attestation statement provided by the proficiency (PT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- program), signed by the Testing Person and the Laboratory Director for a minimum of two years in two (1st and 2nd event 2024) of six (1st, 2nd, and 3rd events for 2023 & 2024) PT events. Refer to D2015. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) records and interview, the laboratory failed to report proficiency testing samples for hematology in the same manner as it reports patient specimens tests for three (1st and 2nd event of 2023 and 3rd event of 2024 ) of six events (1st, 2nd, and 3rd events of 2023 and 2024). The findings included: 1. Review of the 1st event of 2023 sample #HSY-1 the laboratory reported 560 for platelet (PLT) count to the proficiency program-the printouts from the hematology instrument documented PLT count of 555 and 564. Sample #HSY-2 the laboratory reported 230 for PLT count to the proficiency program-the printouts from the hematology instrument documented PLT count of 218 and 245. The laboratory reported 6.5 for White Cell Count (WBC)- the printouts from the hematology instrument documented WBC 6.4 and 6.6: and for Red Cell Count (RBC) the laboratory reported 4.36-the printouts documented RBC of 4.32 and 4.40. Sample #HSY-3 the laboratory reported 11.3 for WBC- the printouts from the hematology instrument documented WBC 11.1 and 11.5: and for RBC the laboratory reported 5.34-the printouts documented RBC of 5.30 and 5.37. Sample #HSY-4 the laboratory reported 100 for PLT count to the proficiency program-the printouts from the hematology instrument documented PLT count of 99 and 103. Sample #HSY-5 the laboratory reported 468 for PLT count to the proficiency program-the printouts from the hematology instrument documented PLT count of 477 and 459. 2. Review of the 2nd event of 2023 sample #HSY-06 the laboratory reported 11.4 for WBC- the printouts from the hematology instrument documented WBC 11.3. Sample #HSY-07 the laboratory reported 90 for PLT- the printouts from the hematology instrument documented PLT 93. 3. Review of the 3rd event of 2024 sample #HSY-12 the laboratory reported 6.8 for WBC- the printouts from the hematology instrument documented WBC 6.9 and 6.6, and for RBC the laboratory reported 4.69-the printouts documented RBC of 4.70 and 4.68, and the laboratory reported 221 for PLT count to the proficiency program-the printouts from the hematology instrument documented PLT count of 227 and 215. Sample #HSY-13 for RBC the laboratory reported 3.68- the printouts documented RBC of 4.04 and 3.93, and the laboratory reported 346 for PLT count to the proficiency program-the printouts from the hematology instrument documented PLT count of 348 and 345. Sample #HSY-14 the laboratory reported 104 for PLT count to the proficiency program-the printouts from the hematology instrument documented PLT count of 100 and 107. Sample #HSY-15 the laboratory reported 15.3 for WBC- the printouts from the hematology instrument documented WBC 15.7 and 14.9, and for RBC) the laboratory reported 5.45-the printouts -- 2 of 6 -- documented RBC of 5.50 and 5.39. 4. Interview on 12/06/24 at 1:30 PM the Laboratory Director confirmed the hematology proficiency results reported and the results from the instrument printouts did not match but could not explain the discrepancies. The Laboratory Director stated patient results would be reported as documented from one run of hematology testing not in the manner as the proficiency results for the 1st, 2nd event of 2023 and 3rd event of 2024. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) records and interview, the laboratory failed to test proficiency samples the same number of times that it routinely tests patient samples for two (1st event of 2023 and 3rd event of 2024) of six (1st, 2nd, and 3rd events of 2023 an 2024) proficiency events reviewed. This is a repeat deficiency from the recertification survey dated 11/14/2022. Finding included: 1. API proficiency records for 2023-2024 revealed hematology API samples were tested multiple times. 2. Hematology 1st event of 2023 samples were run on 3/08/2023 as follows: #HSY1-4:43 PM and 4:55 PM #HSY2-4:44 PM and 4:57 PM #HSY3- 4:46 PM and 5:01 PM #HSY4-4:47 PM and 5:02 PM #HSY5-4:41 PM and 4:49 PM 3. Hematology 3rd event of 2024 samples were run on 11/08/2024 as follows: #HSY11- 9:34 AM and 9:35 AM #HSY13- 4:46 PM and 5:01 PM #HSY14-4:47 PM and 5:02 PM #HSY15-4:41 PM and 4:49 PM 4. Review of the

Summary Statement of Deficiencies D0000 A recertification survey was conducted on November 4, 2022 continuing to November 14, 2022 to gather additional documentation and information. Hematology Oncology Solutions of Tallahassee, clinical laboratory was not in compliance with 42 CFR 493, Requirements for Laboratories. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to test proficiency test samples the same number of times it tests patient samples for 4 of 4 testing events reviewed for 2021 and 2022. Findings include: Review of the laboratory's proficiency testing records with American Proficiency Institute on November 4, 2022 at 10:00 a. m., revealed hematology proficiency samples were tested multiple times. For the Hematology Testing Event #1 2021, samples were run on March 25, 2021 as follows: #HSY 1 - 8:22 a.m. and 3:38 p.m. #HSY 2 - 8:24 a.m. and 3:40 p.m. #HSY 3 - 8:25 a. m. and 3:42 p.m. #HSY 4 - 8:27 a.m. and 3:44 p.m. #HSY 5 - 8:30 a.m. and 3:46 p.m. For the Hematology Testing Event #3 2021, samples were run on November 18, 2021 as follows: #HSY 11 - 10:11 a.m. and 10:12 a.m. and on November 23, 2021 at 8:56 a. m. #HSY 12 - 10:05 a.m. and 10:06 a.m. #HSY 13 - 10:14 a.m. and 10:15 a.m. #HSY 14 - 10:16 a.m. and 10:17 a.m. #HSY 15 - 10:02 a.m. and 10:04 a.m. For the Hematology Testing Event #1 2022, samples were run on March 9, 2022 as follows: #HSY 1 - 1:24 p.m. and 1:42 p.m. #HSY 2 - 1:43 p.m. and 1:49 p.m. #HSY 3 - 1:27 p. m. and 1:44 p.m. #HSY 4 - 1:28 p.m. and 1:46 p.m. #HSY 5 - 1:29 p.m. and 1:47 p.m. For the Hematology Testing Event #2 2022, samples were run on July 13, 2022 as follows: #HSY 6 - 12:51 p.m. and 1:06 p.m. #HSY 7 - 12:53 p.m. and 1:08 p.m. #HSY 8 - 12:54 p.m. and 1:10 p.m. #HSY 9 - 12:55 p.m. and 1:11 p.m. #HSY 10 - 1: 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 -- 05 p.m. and 1:12 p.m. The tests performed were White Blood Cell Count, Red Blood Cell Count, Hemoglobin, Hematocrit, Platelet Count, Mean Corpuscular Volume, Mean Corpuscular Hemoglobin, Mean Corpuscular Hemoglobin Concentration, Red Cell Distribution Width, Mean Platelet Volume, Neutrophils/Granulocytes, Lymphocytes, and Monocytes/Mixed. An interview on November 4, 2022, at 11:20 a. m., the Laboratory Director confirmed proficiency samples were tested multiple times and they only rerun abnormal patient samples. 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 record review and interview, the laboratory failed to have the laboratory director and testing personnel sign and date the attestation sheet for 3 of 4 proficiency testing events in 2021 and 2022. Findings include: Review of American Proficiency Institute proficiency testing records November 4, 2022 at 10:00 a.m., revealed the laboratory director and testing personnel had not signed and dated the attestation sheet for the 2nd hematology testing event of 2021, the 1st testing event of 2022, and the testing personnel had not signed and dated the attestation sheet for the 3rd testing event of 2021. Interview with the Laboratory Director November 4, 2022 at 11:20 a. m., confirmed the attestation sheets had not been signed and dated. 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. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to establish and follow a written quality assessment policy. Findings include: Record review on November 4, 2022 at 9:30 a.m., revealed no documentation of a written quality assessment policy for the laboratory. Interview with the Laboratory Director on November 4, 2022 at 9: 30 a.m., confirmed the laboratory did not have a written quality assessment policy. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) -- 2 of 3 -- 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 record review and staff interview, the laboratory failed to have a procedure manual. Findings include: At the time of survey on November 4, 2022, at 11:15 a.m., the laboratory was unable to show documentation of a procedure manual reviewed and signed by the Laboratory Director. Interview with the Laboratory Director on November 4, 2022, at 11:20 a.m., confirmed no procedure manual had been written. 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 record review and staff interview, the laboratory failed to document acceptable reference ranges for laboratory room and refrigerator temperature and "Chemo Room" and refrigerator temperatures where quality control and patient specimens are stored. Findings include: Review of temperature logs on November 4, 2022 at 10:15 a.m., revealed acceptable temperature ranges missing from laboratory room and refrigerator log for October 2022, and "Chemo Room" and refrigerator for July 2022. Interview with the office manager on November 4, 2022 at 10:30 a.m., confirmed the acceptable temperature ranges were missing from log sheets for October and July of 2022. -- 3 of 3 --