Genesiscare Usa Of Florida, Llc

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Genesiscare USA of Florida, Llc was found to not be in compliance with the CLIA laboratory requirements of 42 CFR 493. . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to ensure weekly maintenance was performed on the Cell Dyn Emerald analyzer for 3 of 3 months reviewed (November 22, December 22, January 23). The findings include: The Cell Dyn Emerald Instructions for Use booklet states "Bleach Cleaning the system with a bleach solution is performed weekly and as needed if instrument use conditions cause frequent rejection of measured or quality control material out of range issues". The laboratory was unable to show documented weekly maintenance of the instrument. The interview with Testing Person A on 1/18/23 at 11:00am confirmed weekly maintenance was not documented. 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 D0000 A desk review survey of the laboratory's proficiency test results was performed on February 15, 2022 for GenesisCare USA of FL, LLC. The GenesisCare USA of FL, LLC laboratory 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 2021, the laboratory did not have successful performance in proficiency testing in the specialty of hematology. Refer to D 2130. 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 February 15, 2022 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, white blood cell differential for two consecutive testing events in 2021. 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 February 15, 2022, 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, white blood cell differential, as shown below. Event #2, 2021 white blood cell differential-73% Event #3, 2021 white blood cell differential-53% 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 February 15, 2022, 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 testing events for the analyte, white blood cell differential, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D 2130. 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 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 February15, 2022 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two consecutive testing events as shown below. Event #2, 2021 white blood cell differential-73% Event #3, 2021 white blood cell differential-53% -- 3 of 3 --

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Genesiscare USA of Florida, Llc was found to not be in compliance with the CLIA laboratory requirements of 42 CFR 493. . 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 review of proficiency testing records and interview with staff, the Laboratory Director or designee failed to sign proficiency test attestation statements for 4 of 5 testing events reviewed. The findings include: Review of American Proficiency Institute (API) Hematology test records showed the Laboratory Director or designee failed to sign API's attestation statements attesting to the routine integration of the proficiency samples into the patient workload using the laboratory's routine methods for the following testing events: a. 2020 - Event 1, Event 2, and Event 3 b. 2021 - Event 1 During interview on 5/12/21 at 11:00 AM, the testing person confirmed the attestation statements listed above were not signed by the Laboratory Director or designee. . 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. 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 -- This STANDARD is not met as evidenced by: Based on review of proficiency test records and interview with staff, the laboratory failed to test proficiency samples the same number of times that patient samples are tested for 1 of 5 testing events reviewed. The findings include: A review of 2020's 3rd event American Proficiency Institute (API) proficiency documentation showed testing of the five proficiency samples was performed twice on 11/19/2020. The tests performed were: White Cell Count, Red Cell Count, Hemoglobin, Hematocrit, Platelet Count, Mean corpuscular volume (MCV), Red cell distribution width (RDW), Lymphocytes, Granulocytes, Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), and Mean platelet volume (MPV). HEM 11 - Tested on 11/19/20 at 2:43 PM and 3:10 PM HEM 12 - Tested on 11/19/20 at 2:46 PM and 3:12 PM HEM 13 - Tested on 11/19/20 at 2:47 PM and 3:19 PM HEM 14 - Tested on 11/19/20 at 2:49 PM and 3:22 PM HEM 15 - Tested on 11/19/21 at 2:50 PM and 3:24 PM Interview with the testing person on 5/12/21 at 11:00 AM confirmed hematology proficiency testing had been performed in duplicate to make sure the answers were correct. It was further confirmed that patients are not tested in duplicate. . 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 staff interview, the laboratory failed to retain the Cell- Dyn 1800 instrument reports for their proficiency testing results for 3 of 5 events reviewed in 2019 and 2020. The findings include: A record review of the American Proficiency Institute (API) proficiency test events showed that no records from the instrument (Cell-Dyn 1800) used to perform the Complete Blood Count (CBC) was maintained for the following events: a. 2019 Event 3 b. 2020 Event 1 and Event 2 An interview with the testing person on 5/12/21 at 11:30am confirmed that the records from the Cell-Dyn 1800 were not kept. . D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed proficiency testing for the analytes of Leukocyte Count and White Blood Cell Differential in the specialty of -- 2 of 5 -- Hematology for the second event of 2020. The findings include: The 5/12/21 record review of the API proficiency scores for Event 2 of 2020 showed the facility scored a 60% for Leukocyte count, an overall score of 47% for the White Blood Cell Differential, which includes a score of 20% for Granulocytes and 20% Lymphocytes. The interview with the testing person on 5/12/21 at 11:00 AM confirmed the proficiency testing failure. . D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on record review and staff interview, the facility failed to ensure that Hematology proficiency testing was evaluated and

Summary Statement of Deficiencies D0000 At the time of the announced, onsite initial survey, 21st Century Oncology Llc was found to not be in compliance with the CLIA laboratory requirements of 42 CFR 493 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 record review and interview with laboratory personnel, the laboratory was not enrolled in proficiency testing (PT) for the specialty of Hematology for 2019. Findings include: At the time of survey, the laboratory was unable to provide documentation to show enrollment in proficiency testing. The interview with the Office Manager at 10:50 a.m. on September 23, 2019 confirmed that the laboratory did not have documentation to indicate PT enrollment or testing. Testing performed under this specialty includes Complete Blood Count. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. 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 -- This STANDARD is not met as evidenced by: Based on lack of records and staff interview, the laboratory did not have a written quality assessment (QA) policy for preanalytic systems. Findings include: At the time of survey, the laboratory was unable to provide documentation of a QA policy. The interview with the Office Manager at 10:30am on 9/23/19 revealed there was no quality assessment policy to monitor, assess, and correct problems identified in preanalytic systems. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's lack of records and staff interviews, the laboratory failed to have a procedure manual signed by the laboratory director (refer to D5401); failed to establish a quality control procedure (refer to D5441); and failed to have a quality assessment procedure in place for analytic systems (refer to D5791). The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results. . 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 record review and staff interview, the laboratory failed to have a procedure manual. Findings include: At the time of survey, the laboratory was unable to show documentation of a procedure manual reviewed and signed by the Laboratory Director. The interview with the Office Manager on 9/23/19 at 10:45am confirmed no procedure manual had been written. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) -- 2 of 6 -- Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to establish a quality control (QC) procedure for how it verified the accuracy and precision of the Complete Blood Count testing performed on patient samples. Findings include: At the time of survey, the laboratory was unable to provide a QC procedure. The interview with the Office Manager on 9/23/19 at 10:30am confirmed no QC procedure was in place. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on lack of records and staff interview, the laboratory did not have a written quality assessment (QA) policy for analytic systems. Findings include: At the time of survey, the laboratory was unable to provide documentation of a QA policy. The interview with the Office Manager at 10:30am on 9/23/19 revealed there was no quality assessment policy to monitor, assess, and correct problems identified in analytic systems. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on lack of records and staff interview, the laboratory did not have a written quality assessment (QA) policy for post-analytic systems. At the time of survey, the laboratory was unable to provide documentation of a QA policy. The interview with the Office Manager at 10:30am on 9/23/19 revealed there was no quality assessment policy to monitor, assess, and correct problems identified in post-analytic systems. 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. -- 3 of 6 -- This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory director failed to provide sufficient over sight of the laboratory's testing process. The findings include: 1. The Laboratory Director failed to ensure that the laboratory was enrolled in proficiency testing . Refer to D6015. 2. The Laboratory Director failed to establish a quality control (QC) program. Refer to D6020. 3. The Laboratory Director failed to establish and follow a quality assurance program. Refer to D6021. 4. The Laboratory Director failed to ensure the laboratory had a process in place to evaluate personnel competency of the staff performing moderate complexity testing. Refer to D6030. 5. The Laboratory Director failed to ensure a procedure manual was in place and available to all testing personnel. Refer to D6031. . D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure that the laboratory was enrolled in proficiency testing with an approved proficiency testing program in 2019. Findings include: An attempt to review the laboratory's proficiency testing revealed that no documentation of proficiency testing was available for inspection. The laboratory performs testing on the following analytes: Erythrocytes Count (RBC), Hematocrit, Hemoglobin, Leukocyte Count (WBC), and Platelet Count. During an interview on 9/23/19 at 10:50 AM, the Office Manager stated they were not enrolled in proficiency testing with an approved proficiency testing company. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the Laboratory Director failed to identify that the laboratory failed to establish a quality control (QC) program. Findings include: At the time of survey, the laboratory was unable to provide a QC procedure. The interview with the Office Manager on 9/23/19 at 10: 30am confirmed no QC procedure was in place. D6021 LABORATORY DIRECTOR RESPONSIBILITIES -- 4 of 6 -- CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory Director failed to establish and follow a quality assurance program. Findings included: At the time of survey, the laboratory was unable to provide documentation of a Quality Assurance program. The interview with the Office Manager on 9/23/19 at 10:45am revealed that there was no quality assessment policy to monitor, assess, and correct problems identified in pre- analytic, analytic, and post-analytic systems. . D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory director failed to ensure a personnel competency program was in place to evaluate staff competency. Findings include: The facility was unable to provide documentation of a competency program approved by the Laboratory Director and performed by a Technical Consultant for personnel performing laboratory testing for Complete Blood Count. The interview with the Office Manager on 9/23/19 at 10:15am confirmed that no competency program with Technical Consultant over sight was in place for laboratory personnel. . D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; -- 5 of 6 -- This STANDARD is not met as evidenced by: Based on the lack of a procedure manual and staff interview, the Laboratory Director failed to ensure a procedure manual was in place and available to all testing personnel. Findings include: At the time of survey, the laboratory was unable to show documentation of a procedure manual reviewed and signed by the Laboratory Director. The interview with the Office Manager on 9/23/19 at 10:45am confirmed no procedure manual had been written. -- 6 of 6 --