Advanced Heart & Vascular Institute

Summary Statement of Deficiencies D0000 A recertification survey was performed on October 23, 2024. The facility was found to be NOT in compliance with the CLIA conditions and standards for specialties /subspecialties for 42 CFR. CONDITION LEVEL: D5400 - Analytic System 493.1250 D6000 - Laboratory Director Responsibilites 493.1403 D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Inistitute (API) Proficiency Testing (PT) provider, and staff interview, the laboratory testing personnel failed to label the API PT samples during testing. 2024 event 1, Specialty Chemistry ( Ionized Calcium, Chloride, Creatnine, Glucose, Hematocrit, Hemoglobin, Potassium, Sodium, TCO2, and Urea Nitrogen). The Laboratory scored an unsatisfactory score for 4 out of 5 specimens. It was determined that the sample printouts from the instrument were not labled with the sample numbers assigned by the PT provider. A review of the Policy and Procedure manual confirmed that the laboratory did not have a Policy for labeling of sample specimens and documents. Findings: 1. Review of the API PT Performance Review and

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 21, 2024. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex Laboratory Director 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 Centers for Medicare and Medicaid (CMS) CASPER 155 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 -- report and review of the American Proficiency Institute (API) reports, the laboratory failed to successfully participate in proficiency testing (PT) in 2 consecutive testing events for Prothrombin Time resulting in the initial unsuccessful participation for Prothrombin Time. Refer to D 2130 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 CMS CASPER 155 report and review of API PT reports, the laboratory failed to demonstrate satisfactory performance in 2 consecutive testing events for Prothrombin Time, resulting in the initial unsuccessful participation for Prothrombin Time. Findings: 1. A review of Casper Report 155 disclosed the laboratory failed for Prothrombin Time on the following: 2023 Event 2 Score 0% 2023 Event 3 Score 20% 2. A review of the laboratory's API Reports confirmed the laboratory failed for Prothrombin Time with the aforementioned scores. 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 CMS CASPER 155 report and review of the API reports, the laboratory director failed to provide overall management and direction for successful participation in PT. The laboratory director failed to ensure PT samples were tested as required. Refer to D6016 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 review of the CMS CASPER Report 155 and the API 2023 events 2 & 3 PT evaluation reports, the laboratory director failed to ensure successful PT participation in 2 consecutive testing events. Refer to D 2130 -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on the intial onsite survey performed on October 25, 2022, this facility was found NOT in compliance with the CLIA conditions found at 42 CFR 493.1230 General Laboratory Systems 493.1403 Condition: Laboratory Director, (moderate complexity) 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 the lack of a written policy and procedure to assess employee training and competency, and confirmed with staff interview, the laboratory failed to perform initial training and yearly competencies, on all testing personnel (TP), performing Moderate Complexity Testing as listed on the CMS-209 Personnel Testing document. Findings include: 1. There was no written policy and procedure for requirements of initial training, 6 month training, and yearly competency for all TP. 2. When ask if there were training documents, TP-1 was able to provide a copy of her training certificate provided by the manufacturer for training on the iSTAT hand held Chemistry/Hematology/ and Coagulation instrument,. Training documents for TP-2, TP-3, TP-4, and TP-5 were not available. 3. TP-1 could not provide any copies of 6 month training, and yearly competency documents for TP-1. TP-2, TP-3, TP-4, and TP-5. 4. An interview on 10/25/2022, at 12:30pm, with TP-1 confirmed the aforementioned statements. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 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 -- 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 lack of personnel records, competency records, and staff interview, the laboratory director failed to provide overall management and direction of the laboratory. The findings include: 1. The laboratory director failed to ensure that 4 out of 5 Testing Personnel ( TP2, TP3, TP4, TP5) received the appropriate training in moderate complexity testing (Chemistry, Coagulation, and Hematology) prior to patient testing ( refer to D6029). 2. The laboratory director failed to ensure written policies and procedures were established to assess, monitor, and maintain competency for 5 out of 5 Testing Personnel (TP1, TP2, TP3,TP4, TP5) performing moderate complexity testing (refer to D6030). D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of Centers for Medicare and Medicaid Services (CMS) 209 form, testing personnel records, and staff interview, the laboratory director failed to ensure that 4 out of the 5 Testing Personnel (TP-2, TP-3, TP-4, TP-5) received the appropriate training in moderate complexity testing (Chemistry, Coagulation, Hematology) prior to patient testing. The findings include: 1. Review of the CMS 209 form revealed that TP-1, TP-2, TP-3, TP-4, TP-5 are testing personnel, performing moderately complexity laboratory testing. 2. Review of personnel records revealed the following personnel hire dates: a. TP-1 12-01-2020 b. TP-2 03-09-2021 c. TP-3 02-02- 2021 d. TP-4 02-02-2021 e. TP-5 08/26/2022 3. Personnel record review revealed there was no documentation of initial training for TP-2, TP-3, TP-4, or TP-5. 4. An Interview, on 10/25/2022, at 12:30 pm. , with TP-1 confirmed that there was no documented training for testing TP-2, TP-3, TP-4, TP-5. TP-1 provided a copy of her training Certificate from iSTAT on-site training. . 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 -- 2 of 3 -- 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 review of the CMS 209 form, lack of laboratory policy, and staff interview, confirmed the Laboratory Director failed to ensure written policies and procedures were established to assess, monitor, and maintain competency for 5 out of 5 testing persons (TP-1, TP-2, TP-3, TP-4, TP-5) performing moderate complexity testing. Findings: 1. Review of the CMS 209 form revealed 5 testing persons (TP-1, TP-2, TP- 3, TP-4, TP-5) are performing moderate complexity testing. 2. The laboratory failed to provide a policy for personnel performing moderate complexity testing upon request. 3. During an interview on 10/25/2022 at 12:35 pm., TP-1 stated that there were no laboratory policies for training or competency assessments for testing personal. . -- 3 of 3 --