Oncology Care Partners Of Florida, Llc

Summary Statement of Deficiencies D0000 A recertification survey conducted on 05/02/2024 found the ONCOLOGY CARE PARTNERS OF FLORIDA LLC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 record review and interview, the laboratory failed to have all testing personnel (TP) rotate through the testing of Proficiency Testing (PT) for the Hematology specialty in three out of six events reviewed. Findings included: Review of FORM CMS-209 signed and dated by the Laboratory Director (LD) on 05/02/2024 revealed the laboratory had three TP listed (TP#A, TP# B and TP#C). -Review of personnel records revealed that TP#A, TP#B and TP#C had annual competencies during 2023. -Review of American Proficiency Institute (API) PT records for 2022 (second and third event), 2023 (first, second and third event) and 2024 (first event), revealed that TP#A had no PT participation during 2023. During an interview on 05/02 /2024 at 11:30 AM, the laboratory Consultant confirmed that the laboratory failed to rotate the PT between all TP for the period of reference. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. 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 record review and staff interview, the laboratory received an unsatisfactory score for 1 (1st event 2024) out of 6 (2nd event 2022 to 1st event 2024) events reviewed for Hematology specialty. Findings included: Review of American Proficiency Institute (API) proficiency testing (PT) records revealed a score of 0 % for White Blood Cells Differential and 60% for White Blood Cells Count (WBC) tests resulting in an overall score of 76 % in the 1st event of 2024. Review of Quality Control (QC) records for the day that the laboratory tested the PT samples revealed that the laboratory failed to run at least two levels of QC on the day they ran the PT samples. During an interview on 05/02/2024 at 11:00 AM, the laboratory Consultant confirmed the proficiency testing failure and that the laboratory failed to run QC on the day they tested the PT samples. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain daily maintenance records for 1 out of 24 months for the Sysmex Complete Blood Counter (CBC) XN-430 analyzer in the last 2 years. Findings included: Review of Daily Maintenance log for Sysmex CBC XN-430 from May 2022 to April 2024, revealed that the laboratory failed to have the Daily Maintenance tasks log for May 2022. During an interview on 05/02/2024 at 11:30 AM, the Laboratory Consultant explained that the laboratory was purchased on October 2023 and the records they have were what they received from previous owner, so she confirmed that the laboratory failed to have the daily maintenance log for May 2022. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on March 16, 2022. GenesisCare USA of Florida LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. The following Condition was not met: D6000 - Moderate Complexity Laboratory Director D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 record review and interview, the Laboratory Director and Testing Personnel failed to have documentation of the signing of the attestation form for proficiency testing (PT) for two (2021 2nd, 3rd event) of six (2020 1st, 2nd, 3rd & 2021 1st, 2nd, 3rd events) for the specialty of hematology. Findings: Review of the American Proficiency Institute (API) Attestation Statement noted "Signatures Required - Testing personnel and laboratory director must physically sign an attestation statement for PT results, and retain the signed statement (or a copy) for a minimum of 2 years." Review of the API PT records showed that the signing of the attestation statement for the 2nd and 3rd events in 2021 were missing. On 03/16/2021 at 1:53 PM, Laboratory Consultant acknowledge the attestations signatures were missing 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 maintain copies of the testing results (instrument printouts) from the proficiency testing (PT) for two (2021 2nd, 3rd) of six (2020 1st, 2nd, 3rd & 2021 1st, 2nd, 3rd) events for the specialty of hematology. Findings: Review of the American Proficiency Institute (API) PT records showed the instrument printouts from the Beckman Coulter AcT 5diff hematology analyzer for the 2nd and 3rd events in 2021 were missing. On 03/16 /2021 at 1:53 PM, Laboratory Consultant stated she did not know where the instrument printouts were located. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain Quality Control (QC) documents from 01/28/2020 to 12/22/2020. This is a repeat deficiency for the recertification survey performed on 01/28/2020. Findings: 1. Review of QC for the daily controls (low, normal, high) run on the Beckman Coulter AcT 5diff hematology analyzer revealed there were no records available for review before 12/22/20. Review of the QC for the daily controls from 11/05/2021 to 01/04/2022 revealed the laboratory only had documentation of the low level (lot #361121) and normal level (lot #371121) controls. Documentation of the high level control was not available for review. On 03/16/2022 at 2:41 PM the Laboratory Consultant stated she did not know where the QC records were. 2. Review of the hematology analyzer's background counts revealed there were no records before 12/01/2020. On 03/16/2022 at 2:41 PM the Laboratory Consultant stated she did not know where the QC records were. 3. According to the Coulter AcT 5diff Control Plus hematology daily controls must be store at a temperature of 2 - 8 degrees Celsius. Review of the laboratory's refrigerator temperature records revealed there were no logs available for review from 01/29/2020 to 01/05/22. On 03/16/2022 at 4:10 PM the Laboratory Consultant stated she did not know where the refrigerator temperature log were. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory Director failed to document the review and evaluation of proficiency testing (PT) for two (2020 2nd, 2021 1st) of six (2020 1st, 2nd, 3rd & 2021 1st, 2nd, 3rd) events for the specialty of hematology. Findings: Review of the American Proficiency Institute (API) PT showed the Laboratory Director failed to sign the "Proficiency Testing Performance Evaluation" forms for the 2nd event in 2020, and the Performance Review and the

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Calvin S. Rosenfeld MD PA DBA Oncology Associates on 01/28/2020. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D5200-General Laboratory Systems- 493.1230 D5400-Analytic Systems- 493.1250 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Manager the laboratory failed to retain QC (Quality Control) records for at least 2 years. Findings Included: Review of QC results revealed no records prior to 12/27/2018. Interview 01/28/2020 at 4:11 PM the Laboratory Manager confirmed that there were no QC records prior to 12/27/2018. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This CONDITION is not met as evidenced by: Based on record review and interview with the Laboratory Manager the laboratory failed to have competency evaluations on 2 (#A and #B) out of 2 Testing Personnel (See D5209) and the laboratory failed to have any QA (Quality Assurance) records (D5293). D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Manager the laboratory failed to have competency evaluations on 2 (#A and #B) out of 2 Testing Personnel. This is a repeat deficiency from the 06/18/2018 recertification survey. Findings Included: Review of the CMS 209 (signed by the Laboratory Director 01/27/2020) revealed that there were 2 Testing Personnel. Review of the employee files revealed no competency evaluations for Testing Personnel #A or #B. Interview on 01/28/2020 at 2:49 PM the Laboratory Manager confirmed that there were no competency evaluations for Testing Personnel #A and #B. Review of the

Summary Statement of Deficiencies D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing records and interview with officer manager (OM), the laboratory failed to have a passing score for the first testing event of 2018 for the specialty of hematology. The findings include Review of API proficiency records revealed that there was 0 % for the White Blood Cell Differential (WBC) and 60 % for Red Blood Cell (RBC) with an overall result of 73 % for the specialty of hematology for the 1st event of 2018. During an interview on 6/18/2018 at 12:30 PM, the OM confirmed that the laboratory failed the event of reference. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on API testing evaluation review and staff interview, it was determined that 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 4 -- laboratory had scored 60 % for Red Blood Cell (RBC) and 0 % for White Blood Cell (WBC) Identification (ID) for the first event of 2018 and had no documentation that the laboratory had taken remedial action. The findings include: Review of API testing evaluation for 1st event 2018 revealed a failing score of 73% for the Hematology Specialty O % score for WBC and 60 % for RBC. The PT performance review form showed no signature of the laboratory director and no documentation of the