University Of Miami Chds Pediatrics

Summary Statement of Deficiencies D0000 A recertification survey conducted on 04/08/2021 to 4/14/2021 found that the clinical laboratory UNIVERSITY OF MIAMI CHDS PEDIATRICS was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 review of American Proficiency Institute (API) proficiency testing (PT) records and staff interview, the laboratory failed to score at least 80 % on Hematocrit (HCT) and Platelets (PLT) analytes on 2nd event 2020 and on Red Blood Cell (RBC) analyte on 3rd event 2020. Findings include: Review of API PT records revealed a score of 60 % for HCT and 40 % for Platelets on 2nd event of 2020 and for RBC received a score of 40 % in the 3rd event of 2020. During an interview on 04/08/2021 at 12:30 PM, the testing personnel A confirmed the proficiency testing failure. 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 (PT) records and staff interview, the laboratory received an unsatisfactory score for 1 (2nd event 2020) out of 3 events for Hematology reviewed. Findings include: Review of 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 -- API PT records revealed a score of 56 % for White Blood Cells (WBC), 60 % on Hematocrit (HCT) and 40 % Platelets (PLT) tests resulting in an overall score of 69 % for the specialty of Hematology in the 2nd event of 2020. During an interview on 10 /15/2020 at 12:30 PM, the testing personnel A confirmed the proficiency testing failure score. 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 record review and staff interview, the laboratory failed to document remedial action for 3 out of 3 Hematology analyte unsatisfactory scores in 2nd and 3rd events of 2020: Red Blood Cells (RBC), Hematocrit (HCT) and Platelets (PLT) and for 1 Hematology specialty failure on the 2nd event of 2020 in proficiency testing (PT). Findings include: -Review of American Proficiency Institute (API) proficiency testing results in 2020, showed that the laboratory had analyte unsatisfactory score for HCT with 60 %, PLT 40 % for the 2nd event of 2020 resulting in an Hematology specialty failure of 69 % and for RBC 40% in the 3rd event. -No documentation of the remedial and

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on September 28, 2020 for University of Miami CHDS Pediatrics. The University of Miami CHDS Pediatrics 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 2019 and 2020, the laboratory did not have successful performance in proficiency testing for the analyte white blood differential in the specialty of hematology. Refer to D 2130. Findings include: Review of the American Proficiency Institute (API) proficiency testing 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 -- records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on September 28, 2020 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, white blood cell differential, for two out of two 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 hemtology. Findings include: On September 28, 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, white blood cell differential, as shown below. Event #1, 2020 white blood cell differential-72% Event #2, 2020 white blood cell differential-56% 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 September 28, 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 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 for the analyte, white blood cell differential 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 September 28, 2020 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #1, 2020 white blood cell differential-72% Event #2, 2020 white blood cell differential-56% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on October 24, 2019. University of Miami CHDS Pediatrics clinical laboratory was found not in compliance with 42 CFR 493, requirements for clinical 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 run proficiency testing samples the same number of times, as it routinely tests patient samples for 2018 (3rd event) and 2019 (1st, 2nd and 3rd event) for the specialty of Hematology. Findings: Review of the laboratory's proficiency testing with American Proficiency Institute (API) for 2018 3rd event and 2019 1st, 2nd and 3rd events showed that the laboratory re-ran proficiency sample more than once by different testing personnel. Review of the hematology analyzer's instrument printout for the 1st and 2nd events in 2019 showed two sets of results from the same date with the names of the testing personnel written on it. During an interview on 10/24/19 at 1:50 PM, Laboratory Director stated that they rotated whose proficiency testing results were submitted, but that all testing personnel present when the proficiency testing samples arrived ran the proficiency samples. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When 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 -- control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform quality control lot to lot comparisons from 7/18 to 10/24/19 for hematology controls. Findings: Review of the quality control logs showed that there were no lot to lot comparisons of the hematology controls for the Cell Dyn 3200 hematology analyzer. The "Cell Dyn 3200 System Operators Manual" states "New lots of controls should be analyzed in parallel with the current lots prior to their expiration. During an interview on 10/24/19 at 3:57 PM, Laboratory Director acknowledged that the laboratory did not perform control lot to lot comparisons of the hematology controls. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory's patient reports failed to list the reference ranges used to interpret the hematology test results for 2 (A, C) out of 3 (A, B, C) patients. Findings: Review of the laboratory test results showed the reference ranges used to interpret test results for 2 (A,C) out of 3 (A, B, C) patients were missing. During an interview on 10/24/19 at 3:57 PM, the Testing Personnel A acknowledged that the patient reports did not have the reference ranges listed. -- 2 of 2 --

Summary Statement of Deficiencies 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 2017 and 2018, the laboratory did not have successful performance in proficiency testing for the specialty of hematology. Refer to D2130. Findings include: Review of the College of American Pathologists (CAP) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on April 16, 2018 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the following analytes, white blood cell count (WBC), red blood cell count (RBC), hemoglobin (HGB), hematocrit (HCT), platelet count (PLT), and white blood cell differential (WBC Diff) for two out of three testing events in 2017 and 2018. 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 -- D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing 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 participation in proficiency testing for the specialty of hematology. Findings include: On April 16, 2018 on or about 10:00 AM the College of American Pathologists (CAP) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for each of the analytes, shown below. Event #2, 2017 White blood cell count (WBC)-0% Red blood cell count (RBC)-0% Hemoglobin (HGB)-0% Hematocrit (HCT)-0% Platelet count (PLT)-0% WBC differential-0% Event #1, 2018 White blood cell count (WBC)-0% Red blood cell count (RBC)-0% Hemoglobin (HGB)-0% Hematocrit (HCT)-0% Platelet count (PLT)-0% WBC differential-0% 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 April 16, 2018, on or about 10:00 AM, the College of American Pathologists (CAP) 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 out of three testing events for the following analytes, white blood cell count (WBC), red blood cell count (RBC), hemoglobin (HGB), hematocrit (HCT), platelet count (PLT), and white blood cell differential (WBC Diff) for two out of three testing events in 2017 and 2018 in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2131. 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 College of American Pathologists (CAP) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on April 16, 2018 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #2, 2017 White blood cell count (WBC)-0% Red blood cell count (RBC)-0% Hemoglobin (HGB)-0% Hematocrit (HCT)-0% Platelet count (PLT) -0% WBC differential-0% Event #1, 2018 White blood cell count (WBC)-0% Red blood cell count (RBC)-0% Hemoglobin (HGB)-0% Hematocrit (HCT)-0% Platelet count (PLT)-0% WBC differential-0% -- 3 of 3 --