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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 Proficiency Testing (PT) reports for 2023 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the specialty of Hematology, subspecialty of Routine Chemistry and for the following regulated analytes: pH Blood Gas, PO2 Blood Gas, PCO2 Blood Gas, Glucose (Non-Waived), Potassium, Sodium, Hematocrit (HCT, Non-Waived) and Hemoglobin (HGB, Non-Waived). Findings include: 1. The laboratory's PT performance was unsatisfactory for the 1st event of 2023 as indicated below: - Specialty of Hematology - 0% - Subspecialty of Chemistry - 0% - pH Blood Gas - 0% - PO2 Blood Gas - 0% - PCO2 Blood Gas - 0% - Glucose (Non-Waived) - 0% - 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 -- Potassium - 0% - Sodium - 0% - HCT, Non-Waived - 0% - HGB Non-Waived - 0% 2. The laboratory's PT performance was unsatisfactory for the 2nd event of 2023 as indicated below: - Specialty of Hematology - 0% - Subspecialty of Chemistry - 0% - pH Blood Gas - 0% - PO2 Blood Gas - 0% - PCO2 Blood Gas - 0% - Glucose (Non- Waived) - 0% - Potassium - 0% - Sodium - 0% - HCT, Non-Waived - 0% - HGB Non- Waived - 0% D2094 ROUTINE CHEMISTRY CFR(s): 493.841(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 the information furnished to the State Agency by the Proficiency Testing (PT) provider, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failures for the first and second events of 2023 for the subspecialty of Routine Chemistry and for the following regulated analytes: pH Blood Gas, PO2 Blood Gas, PCO2 Blood Gas, Glucose (Non-Waived), Potassium, and Sodium. See D2016 for findings. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the 1st and 2nd events of 2023 for the following regulated analytes: pH Blood Gas, PO2 Blood Gas, PCO2 Blood Gas, Glucose (Non-Waived), Potassium, and Sodium, resulting in unsuccessful performance. See D2016 for findings. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve an overall testing event score of satisfactory -- 2 of 4 -- performance for the subspecialty of Routine Chemistry for the 1st and 2nd events of 2023, resulting in unsuccessful performance. See D2016 for findings. 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 information the Proficiency Testing (PT) provider furnishes to the State Agency, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failures for the 1st and 2nd events of 2023 for the specialty of Hematology and for regulated analytes: Hematocrit (HCT, Non-Waived), and Hemoglobin (HGB, Non-Waived). See D2016 for findings. 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the 1st and 2nd events of 2023 for the regulated anyalytes: Hematocrit (HCT, Non-Waived), and Hemoglobin (HGB, Non-Waived), resulting in unsuccessful performance. See D2016 for findings. 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve an overall testing event score of satisfactory performance for the specialty of Hematology for the 1st and 2nd events of 2023, resulting in unsuccessful performance. See D2016 for findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 3 of 4 -- 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: The Condition of Laboratory Director was found to be not met based on the failure to provide overall management and direction as evidenced by D6016 - ensuring that the proficiency testing samples are tested as required under Subpart H. 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; This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, it was determined that the laboratory director failed to ensure that PT samples are tested in a manner that results in successful participation in a proficiency testing program for the specialty of Hematology, subspecialty of Routine Chemistry and for the following regulated analytes: pH Blood Gas, PO2 Blood Gas, PCO2 Blood Gas, Glucose (Non-Waived), Potassium, Sodium, Hematocrit (HCT, Non-Waived) and Hemoglobin (HGB, Non-Waived). See D6000 for findings. -- 4 of 4 --

Summary Statement of Deficiencies 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 lack of Proficiency Testing (PT) records for 2019, 2020 and 2021, through the date of the survey, and interview with the facility personnel, the laboratory failed to enroll in an HHS approved PT program for regulated testing performed in the specialty of Chemistry, which are included in subpart I . Findings include: 1. The laboratory began blood gas testing on the i-Stat analyzer on August 8, 2019. The laboratory utilizes the CG8+ test cartridge which includes the following analytes: pH, pCO2, pO2, HCO3, TCO2, SO2, Sodium, Potassium, ionized Calcium, Glucose, Hematocrit and Hemoglobin. 2. No documentation was presented for review during the survey conducted on November 9, 2021 to indicate the laboratory was enrolled during 2019, 2020 and the first event of 2021 in a CMS-approved PT program for regulated testing listed in subpart I, Blood gas (pH, pO2, pCO2), for which the laboratory performed patient testing. 3. The technical consultant confirmed that the laboratory failed to enroll and participate in PT for blood gas testing until the 3rd testing event of 2021. 4. The laboratory's approximate annual test volume for blood gas testing is 100. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY 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 -- CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: The Condition of Technical Consultant was found to be not met based on the failure of the laboratory to have a Technical Consultant who provides technical oversight as evidenced by: D6041 - failure to ensure that the laboratory was enrolled and participated in an HHS approved Proficiency Testing program for testing performed by the laboratory. D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on lack of Proficiency Testing (PT) records from 2019, 2020 and 2021 (through the 3rd testing event), for the regulated Blood gas (pH, pO2, pCO2) analytes and interview with the Technical Consultant, it was determined that the technical consultant failed to ensure that the laboratory was enrolled and participated in an HHS approved PT program for testing performed by the laboratory. See D2000 for findings. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of one patient test result for activated clotting time (ACT) testing performed on the i-Stat instrument on 03/07/2019 and interview with the laboratory personnel, the laboratory failed to provide evidence of liquid QC testing for ACT for the month of March 2019. Findings include: 1. The laboratory has an Individualized Quality Control Plan (IQCP) in place that indicates liquid QC testing for ACT is to be conducted whenever the following occur: monthly, new lot or new shipment. 2. No monthly liquid QC log was presented for March 2019 when the patient was run. 3. The laboratory personnel did not have an explanation for the missing QC log for March 2019. 4. It could not be determined at the time of the survey hoe many patients were tested in March 2019 for ACT. 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 3 -- 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 review of the the laboratory's quality control (QC) logs for activated clotting time (ACT) testing on the i-Stat instrument and interview with the laboratory personnel, the laboratory failed to retain the manufacturer's QC acceptable ranges for QC level 1 lot #261097 and QC level 3 lot #271097 for the ACT quality controls run on 01/25/2019. Findings include: 1. The laboratory has an individualized quality control plan (IQCP) in place that indicates liquid QC to be run on the following schedule: monthly, new lot or new shipment of controls. 2. No manufacturer's ranges for the control lot numbers referenced above were presented for review for the purpose of verifying that the QC results from the runs were acceptable. 3. At the time of the survey it could not be determined how many patients were tested under these QC lot numbers. 4. The testing personnel acknowledged that none of the manufacturer's QC lot number assay sheets retained by the laboratory matched the QC lot numbers referenced above. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: Based on lack of patient test reports for review for activated clotting time (ACT) and PT/INR testing and interview with the laboratory personnel, the laboratory failed to have an adequate system in place to track when each patient was tested and the testing that was ordered. Findings include: 1. A