Premier Cardiology Of Boca Raton, Llp

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted on July 30. 2025 to August 12, 2025, found Premier Cardiology of Boca Raton laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to document

Summary Statement of Deficiencies D0000 A recertification survey conducted from 04/25/2023 to 04/27/2023 found the LEWIS GOTLIEB SALTZMAN EDEP & BRODSKY MD LLP clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5427 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(c) (c) Documentation. The laboratory must document all activities specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have documentation that the laboratory director reviewed and approved the ABX Micros 60 Complete Blood Counter (CBC) analyzer verification on 04/27/2022. Findings included: - Review of the ABX Micros 60 CBC analyzer verification study performed on 04/27 /2022 revealed that the study failed to have the acceptance signature of the laboratory director. The laboratory tested 2876 patients from 04/27/2023 to 04/25/2023. During an interview on 04/25/2020 at 12:30 PM, Testing Person # A confirmed that the laboratory failed to have documentation that the laboratory director reviewed and approved the ABX Micros 60 CBC analyzer verification study before patient 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 1 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 5/5/21 to 5/19/21. LEWIS GOTTLIEB SALTZMAN EDEP & BRODSKY MD LLP clinical laboratory was found not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. Based on survey findings Immediate Jeopardy was identified and the laboratory was notified of the Immediate Jeopardy on 5/19/21 at 2:00 pm, the laboratory provided a cease testing letter for coagulation tests Prothrombin Time (PT) and the Activated Partial Thromboplastin Time (APTT) from 5/13/2021. The laboratory used expired controls level 1 and 2 for PT and APTT from 7/20/19 to 5/13/21. The laboratory failed to have documentation of the range values used for these controls from 6/1/19 to 5/13/21. The laboratory used controls out of range for the tests of reference based on review from 6 /1/19 to 4/30/21. The following conditions were cited: -D5400 Analytic Systems - D6000 Moderate Complexity Laboratory Director D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of CMS 209 Laboratory Personnel form, personnel files and American Proficiency Institute (API) proficiency testing (PT) records and staff interview, the laboratory failed to have all testing personnel (TP) rotate through the testing of PT for the Chemistry and Hematology specialty for 2019 and 2020 for 1 of 2 testing personnel reviewed. Findings include: Review of CMS 209 form signed and dated by the Laboratory Director (LD) on 04/20/2021 had 2 testing personnel listed (TP A, TP B). Personnel files review revealed that TP B started working on May 2019. Review of API PT records for 2019 and 2020, revealed that, there was no documentation of PT testing in 2019 and 2020 for the Chemistry and Hematology Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- specialties for TP B. During an interview on 05/05/2021 at 3:00 pm, Testing personnel A confirmed that TP B failed to participate in PT during 2019 and 2020. 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 record review and staff interview, the laboratory failed to have a written policy on training and competency assessment, failed to have initial and 6 months competency evaluation for 1 out of 2 testing personnel (TP) from 2019 to 2021 and failed to have an approved designee to sign the competency for 2 out of 2 years reviewed. Findings include: -Review of the procedure manual signed by the laboratory director in December of 2019 revealed that there was no Personnel Policy to establish and define the competency evaluation for TP. -Review of CMS 209 Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 04 /20/2021 revealed that there were 2 TP (TP A and TP B). -Review of personnel records revealed that TP B started on 05/19, no initial and 6 months competency assessment documented for TP B. -Review of TP competency assessments for 2019 and 2020, revealed the laboratory failed to include the name of the test or task the TP performed and failed to have the signature of the laboratory director or an authorized designee. During an interview on 05/07/2021 at 3:30 pm, with office manager, she confirmed that the laboratory failed to have the policy for personnel, failed to have initial and 6 months competency for the TP B and failed to have the laboratory director sign the TP competency assessments for the period reviewed. 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 staff interview, the laboratory did not meet the condition for analytic systems. Findings include: -The laboratory failed to label complete blood cell (CBC) controls for ABX Micros 60 analyzer with open and expiration dates. The laboratory stored brain natriurectic peptide controls above the required temperature. Refer to D 5415. -The laboratory used expired controls for coagulation tests and alphalyse reagent for CBC analyzer. Refer to D5417. -The laboratory failed to perform twice a year calibration for CBC analyzer. Refer to D5437. -The laboratory failed to run 3 control level for CBC analyzer. Refer to D5441. -The laboratory failed to run CBC controls before patients testing. Refer to D5447. -The laboratory failed to have controls in range before doing patient testing. Refer to D5481. -- 2 of 8 -- D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review and staff interview, the laboratory failed to label complete blood controls (CBC) currently in use with open and expiration dates. The laboratory stored the Quidel Traige BNP B-type controls for the brain natriuretic peptide (BNP) test above the required temperature. Findings include: -Review of the Horiba Medical Hematology Devices Minotrol 16 control product insert revealed that controls are stable for 16 days after opening if properly handled. Review of the Quidel Traige BNP Control Product Insert revealed that the control has to be stored at -20 degrees C or colder in a non defrosting freezer. -Procedure manual review signed by the laboratory director in December 2019, revealed that the laboratory will label controls and reagents with open and expiration dates. -During the laboratory tour on 5 /5/21 at 10:00 am, the surveyor observed that the CBC controls in use did not have the open and expiration dates. The surveyor found the BNP controls were stored in a freezer compartment at -17 degrees C. - Record review of freezer temperature logs from 6/19 to 4/21 revealed that the storage temperature was -17 degrees C. During an interview on 5/5/21 at 2:00 p.m., the TPA confirmed that CBC controls in use should be labeled with open and expiration dates and that the storage temperature for BNP was out of manufacturer's instruction range. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory had expired controls for coagulation tests Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) from 7/21/19 to 5/13/21. The laboratory used an expired reagent for complete blood cell analyzer ABX Micros 60 from 3/18/21 to 5/5 /21. Findings include: -During the laboratory tour on 5/5/21 at 10:00 am, the surveyor observed that the laboratory was using a coagulation level 1 control expired since 6/5 /20. The laboratory had in use ABX alphalyse for the Horiba Complete Blood Cell analyzer expired since 3/18/21. - Review of coagulation controls product insert revealed that the controls should not be used beyond the expiration date. Review of C1 and C2 control levels print outs revealed that the laboratory used expired controls from 7/21/2019 to 8/7/2019 (C2), from 11/17/2019 to 2/25/2020 (C1) and from 6/6 /2020 to 5/13/2021 (C1). -Observation of Control C1 bottle in use revealed that the laboratory was using lot number K151076 with expiration date 6/5/2020. Review of C1 control print out for 6/30/2020, revealed that the laboratory changed the expiration from 6/5/2020 to 12/30/2020. Review of C1 print out on 4/17/21, revealed that the -- 3 of 8 -- laboratory changed the expiration date to 12/5/2021. - Review of controls print outs from 6/1/2019 to 4/30/2021, revealed that the laboratory changed the expiration dates to a new expiration date, for lot numbers expired, the laboratory failed to provide documentation to support the changes in expiration dates. During an interview on 05 /13/2021 at 10:30 am with testing personnel A, she confirmed the use of the expired controls and reagent. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to perform calibration of the ABX Micros 60 cell counter twice a year for 2019 and 2020. Findings include: -This is a repeated deficiency from the previous inspection, the

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory did not have documentation of signed attestations for the past two years. Findings include: Review of all proficiency records for the past two years on 05/29/2019 revealed that there were no signed attetations. During an interview with testing person A, she said that she didn't know she had to keep the attestations. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 record review and interview with laboratory personnel, the laboratory 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 -- received an unsatisfactory score for one analyte in the third testing event in routine chemistry. Findings include: Review of proficiency testing records on 05/29/2019 revealed that the laboratory received an unsatisfactory score of 20% in low density lipoprotein (LDL) cholerol in the third testing event of 2018. 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 record review and interview with laboratory personnel, the laboratory received a 0% for complete blood counts for the first testing event of 2019. Findings include: Review of proficiency testing records on 05/29/2019 revealed that the laboratory received a 0% for nonparticipation in the first testing event of 2019. During an interview with testing person A at 12:00 p.m. on 05/29/2019, she said that she might have sent them in late. After further investigation, she discovered that she had sent them in on time but had not submitted them. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory did not document all of the manufacturer defined maintenance on the Tosoh chemistry analyzer. Findings include: Review of maintenance records for the Tosoh chemistry analyzer for the past two years at 11:30 a.m. on 05/29/2019 revealed that no monthly maintenance was documented for 8/2017, 10/2017, 1/2017, 4/2018, 6/2018, or 8/2018. The trimonthly maintenance had been documented on 7/2017 and 10/2018. During an interview with testing person A at 12:00 p.m. on 05/29/2019 she confirmed that there was no documentation for that maintenance. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory did not follow the criteria for calibration frequency for the cell counter that was specified in their procedure manual. Findings include: Review of hematology records on 05/29 /2019 revealed that over the past two years, the cell counter had been calibrated once a year. The hematology procedure manual specified that calibrations should be performed quarterly, when a new control lot is put to use, after a major maintenance procedure, when control is outside of 2 standard deviations (SD) twice and procedures to correct it did not resolve the problem. During an interview with testing person A at 12:00 p.m. on 05/29/2019, she confirmed that the calibrations had been done yearly. 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