Orlando Health Medical Group Inc

Summary Statement of Deficiencies D0000 Recertification survey was conducted on January 31, 2024. Orlando Health Medical Group Inc clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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. This CONDITION is not met as evidenced by: Based on review of the Laboratory Personnel Report, Individual Quality Control Plan (IQCP) and Initial Training/Observation documentation; and interview, the laboratory failed to monitor and evaluate the overall quality of the general laboratory system and correct identified problems as evidenced by the lack of six month competency documentation for two (C, D) of four (A, B, C, D) testing personnel in 2023. (See D5209) 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. 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 review of the Laboratory Personnel Report, Individual Quality Control Plan (IQCP) and Initial Training/Observation documentation; and interview, the laboratory failed to document the six month competency assessments on two (C,D) of four (A, B, C, D) testing personnel in 2023. This is a repeat deficiency from the recertification survey on 10/28/2021. Findings: Review of "The Laboratory Personnel Report" signed and dated by the Laboratory Director on 01/31/2024, showed there were four testing personnel. Review of the Individual Quality Control Plan (IQCP) for Activated Clotting Time (ACT) testing noted "Competency will be performed at 6 month, 1 year and annually per policy." Review of the Initial Training/Observation for Testing Personnel C listed her hire date as 03/26/2023 and her training date of 02/28/2023. Review of the Initial Training/Observation for Testing Personnel D listed her hire date as 06/12/2023 and her training date of 06/13/2023. No other competency evaluations were available for review for Testing Personnel C and D. On 01/31/2024 at 10:15 AM, Technical Consultant B stated the six month competency evaluations for Testing Personnel C and D were not completed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on October 28, 2021. Florida Heart and Vascular Multispecialty Group PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical 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 staff interview, the laboratory failed to have all testing personnel rotate through performance of proficiency testing (PT) samples for five of five events (2020 2nd, 3rd, 2021 1st, 2nd) for the specialty of hematology. Findings: Review of the American Proficiency Institute (API) PT for the blood gas hemoglobin showed Testing Personnel A and Testing Personnel E, each performed a portion of the PT for the 2020 2nd and 3rd event, and 2021 1st, 2nd, and 3rd events. Review of the Laboratory Personnel Report, signed and dated by the Laboratory Director on 10/27 /2021, listed six Testing Personnel. Review of a copy of the Laboratory Personnel Report from their other laboratory with the same testing personnel with hire dates added showed Testing Personnel A was hired 11/2018, Testing Personnel B was hired 03/08/2021, Testing Personnel C was hired 04/2020, Testing Personnel D was hired 04 /2021, Testing Personnel E was hired 03/2020, and Testing Personnel F was hired 01 /27/2020. On 10/28/2021 at 10:20 AM, Testing Personnel A stated they were the only ones who performed PT. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 -- 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) records documenting the Avoximeter 1000E blood gas instrument for four (March - June) of 10 months (March - December) the instrument was used in 2020. Findings: Review of the laboratory's QC records showed the log titled, "Avoximeter 1000E Daily QC Log" for recording the liquid controls was not available for review from March through June of 2020. Review of the laboratory's QC records titled, "Avoximeter 1000E Maintenance Log" showed maintenance was performed on the instrument from March through December 2020. On 10/28/2021 at 11:35 AM, Testing Personnel A stated she did not know were the logs were located. 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 staff interview, the laboratory failed to fully document training and competency assessments on six of six (A, B, C, D, E, F) testing personnel in 2020 and 2021. Findings: Review of "The Laboratory Personnel Report" signed and dated by the Laboratory Director on 10/27/2021 showed there were six testing personnel. The laboratory's policy titled "Personnel Training and Competency" noted, "Training and Competency documentation will be done after the 90 day orientation period, at 6 months and a reevaluation of competency will be performed and documented every year thereafter." Review of a copy of the Laboratory Personnel Report including hire dates showed Testing Personnel A was hired 11/2018, Testing Personnel B was hired 03/08/2021, Testing Personnel C was hired 04/2020, Testing Personnel D was hired 04/2021, Testing Personnel E was hired 03/2020, and Testing Personnel F was hired 01/27/2020. Review of the competency evaluation documentation for Testing Personnel A showed there was no annual competency performed in 2020. Review of the competency evaluation documentation for Testing Personnel B showed there was no documentation of training and competency after the 90 days orientation period in 2021. Review of the competency evaluation documentation for Testing Personnel C showed there was no documentation of training and competency after the 90 days orientation period or at six months in 2020. Review of the competency evaluation documentation for Testing Personnel D showed there was no documentation of training and competency after the 90 days orientation period in 2021. Review of the competency evaluation documentation for Testing Personnel E showed there was no documentation of training and competency after the 90 days orientation period or at six months in 2020.. Review of the competency evaluation documentation for Testing Personnel F showed there was no documentation of competency at six months in 2020. On 10/28/21 at 1:05 PM, Testing Personnel A stated there were missing competencies. D5403 PROCEDURE MANUAL -- 2 of 4 -- CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on December 21, 2020 for Florida Heart & Vascular Center Multispecialty Group PA. Florida Heart & Vascular Center Multispecialty Group, PA is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2020, the laboratory did not have successful performance in proficiency testing for the specialty of hematology. Refer to D2130. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers 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 -- for Medicare & Medicaid Services (CMS) 153 and 155 reports, on December 21, 2020 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, hemoglobin, for two consecutive proficiency testing events in 2020. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the specialty of hematology. Findings include: On December 21, 2020 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, hemoglobin, as shown below. Event #2, 2020 hemoglobin-60% Event #3, 2020 hemoglobin-20% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology. Findings include: On December 21, 2020, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two consecutive proficiency testing events for the analyte, hemoglobin, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for the analyte, hemoglobin, in the specialty of hematology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on December 21, 2020 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #2, 2020 Hemglobin-60% Event #3, 2020 Hemglobin-20% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification survey was conducted on April 7, 2020. Florida Heart and Vascular Multispecialty Group PA clinical laboratory was found not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 instrument printouts of the patient test results from the Avoximeter 1000E blood gases analyzer from 3/11/2020 to 4/07/2020. Findings: Review of the Avoximeter 1000E blood gases analyzer performance verification showed the instrument was validated on 3/11/2020. Review of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification form (CMS-116) states the laboratory performs 500 tests annually. No instrument printouts with patient results were available for review. During an interview on 4/07/2020 at 12:48 PM, the Catheter Lab Manager stated that the nurse are throwing away the instrument printouts with the patient test results on it. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests 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 2 -- This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to have verification of the educational qualifications (degrees) of 2 (D, G) out of 13 Testing Personnel for the volume and complexity of tests prefromed (A-K). Findings: Cross Reference D6065. Based on record review and interview, the laboratory failed to have verification of the educational qualifications (degrees) of 2 (D, G) out of 13 Testing Personnel (A-K). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have verification of the educational qualifications (degrees) of 2 (D, G) out of 13 (A - K) Testing Personnel. Findings: Review of the CMS 209 Laboratory Personnel Report, signed by the Laboratory Director on 4/07/2020, revealed that there are 13 employees listed as moderate complexity testing personnel. Review of personnel documentation revealed no documentation of the educational qualifications (degrees) for Testing Personnel D and G. During an interview on 4/07/2020 at 1:59 PM, the Executive Manager stated she did not have a copy of the degrees for all of the testing personnel. -- 2 of 2 --