Heart Center Cardiology Pc, The

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 a review of the I-STAT liquid Quality Control (QC) records, and an interview with the Technical Consultant, the laboratory used expired QC reagent on the I-STAT Chemistry analyzer. The surveyor noted the laboratory utilized expired QC for 30 days of patient testing reviewed in 2024 and 2025. The findings include: 1. A review of the I-STAT liquid QC records revealed the following: a) I-STAT QC level 1 lot #301163 and level 2 #321163 expired 7/31/2024 and performed on 7/11 /2024 and 8/26/2024, a new lot of QC not expired was performed on 9/4/2024. I- STAT QC is good for 30 days, during the period of 8/12/2024 through 9/3/2024 ( 22 days) there were 26 patients that were affected. b) I-STAT QC level 1 lot #301174 and level 2 lot #321174 expired on 6/30/2025 and performed on 7/7/2025, a new lot of QC not expired was performed on 7/16/2025. I-STAT QC is good for 30 days, during the period of 7/7/2025 through 7/15/2025 (8 days) there were 27 patients affected. 2. A further review of the I-STAT Liquid QC Procedure revealed, "Be sure cartridges and quality controls are in-date." 3. During an interview on 11/19/2025, at 12:40 PM, the TC confirmed the above findings. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable 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 -- limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of the I-STAT calibration verification (C-V) records, policy and procedures, and an interview with the Technical Consultant, the laboratory failed to ensure C-V was performed and documented on the I-STAT Chemistry analyzer as per the laboratory policy. This was noted for one of two C-V's missed in 2025. The findings include: 1. A review of the C-V records for the I-STAT Chemistry analyzer revealed the I-STAT was calibrated 12/26/2024 and then eleven months later on 11/11 /2025. There was no evidence of C-V documentation for the first half of 2025. 2. A further review of the I-STAT policy revealed, "A Calibration Verification set is used to verify the calibration or recalibration of I-STAT cartridges/analyzers...Calibration is performed every 6 months...". 3. During an interview on 11/19/2025 at 1:20 PM, the TC confirmed the above findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on a review of the I-STAT QC (Quality Control) records, the Liquid QC Procedure, and an interview with the Technical Consultant (TC), the Laboratory failed to ensure testing personnel performed the I-STAT QC monthly as per the procedure. The surveyor noted two out of 26 months reviewed in 2023 through 2025 when QC was not performed as required by the laboratory's procedure. The findings include: 1. A review of the I-STAT records revealed the laboratory exceeded monthly requirements for liquid QC, as follows: a) May 2024 missed; 6 patients affected. b) April 2025 missed; 29 patients affected. 2. A review of the I-STAT Liquid QC Procedure revealed, "Liquid QC is performed monthly..." 3. During an interview on 11 /19/2025, at 12:40 PM, the TC confirmed the above 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 a review of the Chemistry Quality Control (QC) records, the ISTAT Individualized Quality Control Plan (IQCP), and an interview with Testing Personnel #2, the Laboratory failed to ensure testing personnel performed the ISTAT QC every 30 days as per the IQCP. The surveyor noted one out of ten months in 2023 when QC was not performed as required by the IQCP. The findings include: 1. A review of the ISTAT Chemistry IQCP revealed, "Liquid QC is performed monthly on each lot of in- use cartridges..." 2. A review of the ISTAT records revealed QC was performed on 6 /28/2023 and 8/1/2023. No evidence of QC performed in July 2023 was available for review. 3. During an interview on October 12, 2023, at 1:00 PM, Testing Personnel #2 confirmed the above findings. 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 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 a review of the API (American Proficiency Institute) proficiency testing (PT) records, a review of the personnel files, and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all personnel who performed patient testing. One of three testing personnel (TP) listed on the Form CMS-209 (Laboratory Personnel Report) performed all or a portion of the testing on six out of seven PT surveys in 2020 - 2022. The finding include: 1. A review of the 2020 - 2022 API PT records revealed Testing Personnel #1 had signed all attestation statements as the testing personnel on 2020 Event #1 (D-Dimer testing), and had signed as performing all the testing on 2020 Event #2 and #3, 2021 Event #1 and #2, and 2022 Event #2. Testing Personnel #2 had not performed a PT survey since January 2020. 2. A review of the personnel files revealed Testing Personnel #3 was a full time employee and had been trained to perform moderate complexity patient testing since the previous CLIA survey on 10/30 /2019. However, the laboratory had failed to include TP #1 in the rotation schedule to perform PT in 2021 and in 2022. Testing Personnel #2 was trained to perform moderate complexity patient testing in March 2021, however she had only performed one PT survey, 2021 Event #3. 3. In an interview on 9/6/2022 at 12:50 PM the surveyor reviewed the requirement for rotation of proficiency testing with Testing Personnel #1, who confirmed the above findings. . D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 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 a review of the American Proficiency Institute (API) proficiency testing (PT) records, a review of the policy and procedure manual, and an interview with Testing Personnel #1, the laboratory failed to ensure the Laboratory Director and Testing Personnel signed the attestation statement for one of eight 2020-2022 PT surveys. The findings include: 1. A review of the API 2022 Event #1 Chemistry survey records revealed the Laboratory Director and the Testing Personnel failed to sign the attestation statement. 2. During an interview on 9/6/2022, at 12:55 PM, surveyor reviewed the instructions on the attestation statement requiring the Laboratory Director (or designee) and testing personnel to sign the document; Testing Personnel #1 confirmed the Laboratory Director and Testing Personnel had failed to sign the attestation for the above survey. . 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 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records, and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to implement Quality Assurance (QA) reviews to ensure completeness of documentation and ensure PT performance was rotated between all testing personnel and instruments on which patient testing was performed. This was noted in PT surveys from 2020 through 2022. The findings include: 1. A review of QA records revealed the laboratory failed to implement PT reviews and procedures to ensure: A) Proficiency testing was rotated between all personnel who performed patient testing. (Refer to D2007.) B) Attestation statements were signed by the Laboratory Director and Testing Personnel. (Refer to D2009.) C) Proficiency testing for D-Dimer and Cardiac Profiles was performed on both Alere Triage Meters (alternate PT surveys). The surveyor noted no PT was performed using Triage Meter #1 (Serial #83099) since 2/1/2021 (API 2021 Event #1), and the laboratory had not implemented any other mechanism to compare results between the two instruments. (Refer to D5775.) During an interview on 9/6/2022 at 12:50 PM, Testing Personnel #1 stated the Triage Meters (#1 and #2) were both used equally for patient testing. 2. During the exit summation on 9/6/2022 at 4:30 PM, the above findings were reviewed and confirmed with Testing Personnel #1. . D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must -- 2 of 3 -- have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on a lack of comparison data for D-dimer and Cardiac Profile (Troponin T and CK-MB [Creatine Kinase-MB]) on Alere Triage Meter #1 (Serial #83099) and #2 (Serial #82979), and interviews with Testing Personnel #1, the laboratory failed to implement comparison activities twice a year to evaluate and compare test results between the two instruments in 2020-2022. The findings include: 1. A review of Alere Triage Meter records revealed the laboratory failed to implement a mechanism to compare D-dimer and Cardiac Profile results between Meter #1 and #2. 2. During an interview on 9/6/2022 at 12:50 PM, Testing Personnel #1 stated the Triage Meters (#1 and #2) were both used equally for patient testing. 3. During an interview on 9/6/2022 at 4:25 PM, Testing Personnel #1 confirmed the laboratory had not performed and documented any comparisons between the two Triage Meters. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 3 of 3 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the manufacturer's guidelines for the Alere Triage Meter, a review of the laboratory's policies and procedures, a review of temperature logs, a lack of documentation of humidity monitoring, and an interview with the testing personnel and technical consultant, the surveyor determined the laboratory failed to monitor and document humidity of the test environment, necessary for reliable and optimal operation of the test system. This affected two Alere Triage Meters in one laboratory space, from September 3, 2019 (when patient testing began) until the survey date. The findings include: 1. The policies and procedures [POCT (Point of Care Training) Guide] indicated room temperature, freezer and refrigerator temperatures and humidity should be recorded daily. 2. At 10:12 AM on 10/30/2019, after reviewing the temperature logs and not noticing any documentation of humidity, the surveyor inquired of Testing Personnel (TP) #2 if humidity was monitored. TP #2 stated staff had talked about monitoring humidity, but humidity was not being documented. At 10:14 AM, the surveyor discussed manufacturer requirements for environmental factors. TP #2 stated she believed the range was 10 - 85% (percent). TP #2 stated the laboratory has the monitoring device for humidity, but humidity was not documented. The technical consultant reviewed the manufacturer's guidelines; and stated there were no requirements for humidity for the cartridge use, but for Triage 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 -- system use the manufacturer indicated a humidity range of 10 -85 % is acceptable. 3. The surveyor performed an on-line search of the manufacturer's requirements for environmental factors for the Triage Meter, on November 4, 2019. The environmental factors listed in the manufacturer operation specifications included the humidity range of 10 - 85 %. -- 2 of 2 --