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Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (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 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 review of the current, approved standard operating procedures (SOPs), the laboratory failed to draft, approve analyzer calibration protocols. FINDINGS: 1. The current, approved SOPs did not include instructions for performance and 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 -- documentation of Abbott i-STAT analyzer calibration and frequency of calibration. 2. The practice manager (PM) confirmed the findings on February 28, 2024, at approximately 11:30 A.M. 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 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 current, approved SOPs and Quality Control (QC) records, the laboratory failed to establish or verify criteria for control material acceptability as well as perform lot number verifications. FINDINGS: 1. There was no documentation of new QC lot to lot validation verification performance for the i-STAT analyzer. 2. The current, approved SOPs did not include instructions for performing such activities. 3. The PM confirmed the findings on February 28, 2024, at 11:00 A.M. -- 2 of 2 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 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 surveyor's review of the manufacturer's package inserts for Abbott i-STAT Chem 8+ cartridge and interview with the practice manager, the laboratory failed to follow the manufacturer's requirements for performing external controls with each new kit for above test. FINDINGS: 1. The surveyor reviewed the manufacturer's package insert and the quality control (QC) requirements for the Abbott i-STAT Chem 8+ cartridge at survey. 2. The practice manager confirmed on November 20, 2019 at approximately 11:00 AM, that the laboratory failed to follow the manufacturer's requirements for external QC which requires that external QC to be tested with each new shipment of cartridge, each new lot of cartridge and monthly. The external QC was not performed from September 2018 through the survey date. 3. Approximately 200 patients' samples tested for Chem 8 from September 2018 through the survey date. PLEASE NOTE: THIS IS A RECITED DEFICIENCY FROM THE SURVEY CONDUCTED ON SEPTEMBER 4, 2018. 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. 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 -- This STANDARD is not met as evidenced by: Based on a surveyor review of records and confirmed in an interview with the practice manager at the time of this survey, the laboratory failed to establish and follow a written Quality Assessment (QA) policy and procedure for an ongoing mechanism to monitor, assess, and when indicated correct problems that may occur in the laboratory testing. PLEASE NOTE: THIS IS A RECITED DEFICIENCY FROM THE SURVEY CONDUCTED ON SEPTEMBER 4, 2018. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a surveyor review of Quality Control (QC) records and confirmed in an interview with the practice manager at the time of the survey, the laboratory failed to follow the laboratory's established QC procedure for testing ACT using Hemochron Signature Elite device. Findings: 1. On November 20, 2019 at approximately 11:00 AM the practice manager confirmed surveyor's findings that the laboratory failed to perform Liquid Quality Control (LQC) as required by the manufacturer of the Hemochron Signature Elite device from March 26, 2019 through the survey date. 2. Approximately 80 patients were tested for ACT during the above time frames. PLEASE NOTE: THIS IS A RECITED DEFICIENCY FROM THE SURVEY CONDUCTED ON SEPTEMBER 4, 2018. 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 surveyor findings and interview with the practice manager, the laboratory director failed to provide overall management of the laboratory. The laboratory director failed to ensure that the laboratory: 1. Maintained the

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 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 surveyor review of waived testing supplies and an interview with the practice manager, the laboratory failed to keep records and documentation for the waived Coagu Check XS PT/INR test and for the Assure Platinum Finger Stick Glucose test. Findings: At approximately 11 AM on September 4, 2018 it was confirmed by the practice manager that the laboratory did not have the following records for the waived testing performed in the laboratory: 1. There was no package inserts available for the Coagu Check XS PT/INR test therefore it was impossible to determine if any QC was required by the manufacturer and to determine the proper steps the laboratory is required to follow to perform the PT/INR test. No records of lot numbers and expiration dates. 2. There was no package inserts available for the Assure Platinum Finger stick Glucose test and the laboratory had no documentation of lot numbers and expiration dates. 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. 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 -- This STANDARD is not met as evidenced by: Based on surveyor's review of laboratory records and an interview with the practice manager, the laboratory failed to establish a comprehensive written policy and procedure that includes the six required components that assess testing personnel's competency, twice annually during the first year of testing and annually thereafter. The six required components are: 1. direct observation of routine patient test performance, including preparation. specimen handling and testing; 2. monitoring the recording and reporting of test results; 3. review of intermediate results of worksheets, quality control records, proficiency testing results, and preventive maintenance records; 4. direct observation of performance of instrument maintenance and function checks; 5. assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, 6. assessment of problem solving skills. 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 lack of twice per year verification records and confirmed in an interview with the practice manager at the time of the survey, the laboratory failed to verify twice annually the accuracy of test results for the Activated Clotting Time (ACT) testing after initiating patient testing in 2015. FINDINGS: 1. The practice manager confirmed on 9/4/2018 at approximately 11:00 AM that the laboratory did not perform twice per year verification when initiated ACT testing using the Hemochron Signature Elite device in September 2015 up to survey date. To fulfill the twice per year verification requirement, the laboratory is currently enrolled in PT for ACT for the third event of 2018. 2. Approximately 900 patients were tested for ACT during the above time frames. 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 lack of policies and procedures and confirmed in an interview with the practice manager at the time of this survey, the laboratory failed to establish and follow a written Quality Assessment (QA) policy and procedure for an ongoing mechanism to monitor, assess, and when indicated correct problems that may occur in the laboratory testing. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test -- 2 of 8 -- procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)