Summary:
Summary Statement of Deficiencies D0000 An initial survey was conducted on 8/7/20. Florida Heart and Vascular Multispecialty Group PA clinical laboratory was found not in compliance with 42 CFR 493, requirements for clinical laboratories. Based on the survey findings an Immediate Jeopardy situation was identified. The laboratory was notified of the Immediate Jeopardy at 5:20 PM on 8/7/20. The laboratory was unable to provide documentation of the validations of the Abbott i-Stat instrument received by the laboratory on 1/3/20. The laboratory was unable to provide documentation of the calibration of the Abbott i- Stat instrument received by the laboratory on 1/3/20 at least once every 6 months. The laboratory failed to perform quality controls at least daily for patient specimens tested on the Abbott i-Stat instrument from 12/6/19 to 12/20/19 and 1/5/20 to 2/6/20. (D5400) The following Conditions were not met: D5200 - 493.1230 General Laboratory Systems D5400 - 493.1250 Analytic Systems D6000 - 493.1403 Moderate Complexity Laboratory Director D6063 - 493.1421 Testing Personnel Qualifications D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to monitor and evaluate the overall quality of the general laboratory system and correct identified problems. Findings: Cross Reference D5209: Based on a review of the procedure manual and interview, the laboratory procedure manual failed to establish a procedure to assess the training and competency of 1 of 1 technical consultant and 2 out of 2 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 10 -- personnel. Cross Reference D5217: Based on record review and interview, the laboratory failed to verify the accuracy of BNP (Brain Natriuretic Peptide) and Troponin at least twice annually in 2020. Cross Reference D5291: Based on a review of the procedure manual and interview, the laboratory failed to establish a quality assessment (QA) procedure for monitoring, assessing and correcting identified problems. 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 a review of the procedure manual and interview, the laboratory procedure manual failed to establish a procedure to access the training and competency of 1 out of 1 technical consultant and 2 out of 2 testing personnel, (A, B). Findings: Review of the laboratory's procedure manual, signed by the Laboratory Director on 10/1/19, showed that there was no procedure on training and competency. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 8/7/20, the laboratory had an estimated annual test volume of 78 tests per year. The laboratory performed the following tests on the i-Stat: BNP (Brain Natriuretic Peptide) and Troponin. During an interview on 8/7/20 at 4:23 PM, the Laboratory Consultant stated there was no procedure on training and competency D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to verify the accuracy of BNP (Brain Natriuretic Peptide) and Troponin at least twice annually in 2020. Findings: Review of the American Proficiency Institute (API) proficiency testing (PT) binder showed that there was no record of PT performed on BNP and Troponin. Review of the "Relaymed - Patient Test Report" patient testing for BNP and Troponin started on 12/6/19. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed and dated by the Laboratory Director on 8 /7/20, the laboratory had an estimated annual test volume of 78 test per year. During an interview on 8/7/20 at 2:30 PM, the Laboratory Consultant stated that the laboratory did not perform any PT for BNP and Troponin. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 -- 2 of 10 -- through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the procedure manual and interview, the laboratory failed to establish a quality assessment (QA) procedure for monitoring, assessing and correcting identified problems. Findings: Review of the laboratory's procedure manual, signed by the Laboratory Director on 10/1/19, showed that there was no procedure on QA. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 8 /7/20, the laboratory had an estimated annual test volume of 78 test per year. The laboratory performed the following tests on the i-Stat: BNP (Brain Natriuretic Peptide) and Troponin. During an interview on 8/7/20 at 4:23 PM, the Laboratory Consultant stated there was no procedure on QA. 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 record review and interview, the laboratory failed to monitor and evaluate the overall quality of the analytic system and correct identified problems. Findings: Cross Reference D5403: Based on record review and interview, the laboratory's written procedure manual was incomplete. Cross Reference D5421: Based on record review and interview, the laboratory was unable to provide documentation of the validations of the Abbott i-Stat instrument received by the laboratory on 1/3/20. Cross Reference D5439: Based on record review and interview, the laboratory was unable to provide documentation of the calibration of the Abbott i-Stat instrument received by the laboratory on 1/3/20 at least once every 6 months. Cross Reference D5447: Based on record review and interview, the laboratory failed to perform quality controls at least daily for patient specimens tested on the Abbott i-Stat instrument from 12/6/19 to 12/20/19 and 1/5/20 to 2/6/20. Cross Reference D5781: Based on record review and interview, the laboratory failed to document