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Summary Statement of Deficiencies 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 (PT) records and interview with the technical consultant (TC), the laboratory failed to ensure PT records included the statements signed by the testing person (TP) and laboratory director (LD) or designee attesting to the routine integration of the PT samples into the patient workload using the laboratory's routine methods. Findings: 1. Records for six PT events were reviewed. 2. All six events were missing attestation statements that were signed by the TP and LD or designee. 3. During the survey on 10/02/2023 at 3:30 PM, the TC confirmed that the statements attesting to the routine integration of PT samples into the patient workload were not signed by the TP and LD 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. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the testing person (TP), the laboratory failed to test endocrinology PT samples the same number of times it routinely tested patient samples. Findings: 1. Records for six PT events were reviewed and showed that the PT samples tested on the Tosoh analyzer for 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 -- thyroid-stimulating hormone, free triiodothyronine, and free thyroxine were run in duplicate. 2. During the survey on 10/02/2023 at 2:58 PM, the TP confirmed that PT samples were run in duplicate when patient samples were run a single time. 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. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to ensure that the review of the PT results evaluation was documented. Findings: 1. Records for six PT events, three in 2022 and three in 2023, and two 2022 off-cycle PT events were reviewed. 2. Evaluations from all five PT events from 2022 (three regular and two off-cycle events) did not have a signature and date from the laboratory director or designee indicating that the PT results were reviewed. 3. During the survey on 10/02/2023 at 3:30 PM, the TC confirmed that the five PT events from 2022 were not signed as reviewed by the laboratory director or designee. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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 federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for hematology testing, in which the laboratory is certified under CLIA. (Refer to D2127 and D2130) D2127 HEMATOLOGY CFR(s): 493.851(d) 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 -- Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for hematology testing, the following analyte was noted as failed in the 2020 2rd event. Findings: American Proficiency Institute 2020 2nd event hematology 0% 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 review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for hematology testing, the following analyte was noted as failed in the 2020 2nd event and 2019 3rd vent. Findings: 1. American Proficiency Institute 2020 2nd event Hematocrit 0% 2. American Proficiency Institute 2019 3rd event Hematocrit 60% 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 review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory director failed to ensure the laboratory successfully participated in the API PT program for hematology testing, in which the laboratory is certified under CLIA. (Refer to D2127 and 2130) D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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 federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for hematology testing, in which the laboratory is certified under CLIA. (Refer to D2130 and D2131) D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for hematology testing, the following analyte was noted as failed in the 2020 first event and the 2019 third event. Findings: 1. American Proficiency Institute 2020 1st event hematology RBC 40% 2. American Proficiency Institute 2019 3rd event hematology RBC 40% 3. American Proficiency Institute 2020 1st event hematology HGB (non- waived) 60% 4. American Proficiency Institute 2019 3rd event hematology HGB (non- waived) 40% 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 review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for hematology testing in the 2020 first event and the 2019 third event Findings: 1. The laboratory failed to achieve an overall testing score for hematology. 2. American Proficiency Institute 2020 1st event overall hematology score 74% 3. American Proficiency Institute 2019 3rd event overall hematology score 73% 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 review of the federal proficiency testing data report and review of the performance summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory director failed to ensure the laboratory successfully participated in the API PT program for routine hematology testing, in which the laboratory is certified under CLIA. (Refer to D2130 and D2131) D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform -- 2 of 3 -- 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)(iv) Ensure that an approved

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: The laboratory failed to successfully participate in the American Proficiency Institute (API) PT program for white cell count differential (D2122); and the laboratory failed to investigate the three of four failures in hematology and implement a

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 federal proficiency testing data report and correspondence received by the technical consultant via email on November 6, 2017, the laboratory failed to successfully participate in the American Proficiency Institute proficiency testing program for chemistry testing, in which the laboratory is certified under CLIA. (Refer to D2087) Findings: Repeat Deficiency D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 -- 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 the federal proficiency testing data report and correspondence received by the technical consultant via email on November 6, 2017, the laboratory failed to attain an score of 80% for the American Proficiency Institute proficiency testing program for routine chemistry testing Findings: 1. American Proficiency Institute proficiency testing program 2017 3rd event Chloride 0% 2. American Proficiency Institute proficiency testing program 2017 2nd event Chloride 60% 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 review of the federal proficiency testing data report and correspondence received by the technical consultant via email on November 6, 2017the laboratory director failed to ensure that the laboratory successfully participated in the American Proficiency Institute proficiency testing program for chemistry testing, in which the laboratory is certified under CLIA. (Refer to D6019 and D2087) Findings: Repeat Deficiency The laboratory director has not fulfilled the duties of the director to ensure that the laboratory successfully participates in the American Proficiency Institute proficiency testing program for chemistry testing D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved