Apex Cardiology Consultants

Summary Statement of Deficiencies 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 surveyor's review of the laboratory's policies and procedures, five (5) patient test record from 11/20/2024 to 02/17/2026, lack of the technical consultant (TC) competency documentation, and interview with the TC on July 14,, 2026, as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to perform and document competency assessments for the TC in subpart M. The findings included: 1. The laboratory had performed competency assessments for the testing personnel. However, no documentation for competency assessments for the TC was performed for the years 2024 and 2025. 2. TC confirmed by interview on July 14, 2026, at approximately 12:45 p.m. that the laboratory lacked competency assessments for the years 2024 and 2025 for the TC. 4. According to the testing declaration form (Lab-144) submitted at the time of survey, the laboratory performed and reported approximately 57,000 tests annually including the period when the TC competency assessment was not performed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. 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 the lack of laboratory's standard operating procedures, five (5) randomly selected patient test results, and interviews with the technical consultant (TC) and testing personnel (TP); the laboratory failed to have written procedures for all tests, assays, and examinations performed by the laboratory available and followed by laboratory personnel .The findings included: 1. The laboratory lacked written laboratory procedures approved by the laboratory director for all tests, assays, and examinations currently performed in the laboratory. 2. The laboratory did not have written procedures for the test performed in the laboratory; routine chemistry, endocrinology, and hematology. 3. Reliability of the laboratory tests' performance based on a complete written and approved laboratory procedure to follow by testing personnel to ensure compliance with federal CLIA regulations could not be assured during this survey. 4. TC and TP affirmed by an interview on July 14, 2026, at approximately 12:30 p.m. that the laboratory failed to provide LD signed, dated, and approved written laboratory procedures for all the current tests and examinations performed in the laboratory. 5. According to the testing declaration form (CMS-116) submitted at the time of survey, the laboratory processed, tested, and reported approximately a total of 57,000 patient tests annually when the laboratory lacked written and approved standard operating procedures for all tests performed in the laboratory. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's test validation records, and interview with the laboratory technical consultant and testing person on April 20, 2023, at 12:30 pm, the laboratory failed to retain the test validation records. The findings include: 1. The laboratory verified routine chemistry tests on the Alpha Wassermann Axcel instrument. The test manufacturer ran the verification tests. The laboratory required to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (A) Accuracy. (B) Precision. (C) Reportable range of test results for the test system. However, the laboratory did not have records for accuracy verification. Verification of accuracy may be accomplished by: Testing reference materials; Comparing results of tests performed by the laboratory against the results of a reference method; or Comparing split sample results with results obtained from another method, which has already been shown to provide accurate results. Therefore, it can be assured that the laboratory verified the tests accuracy. 2. The laboratory technical consultant and testing person on April 20, 2023, at 12:30 pm, affirmed that the records were not in the laboratory. 3. The laboratory's testing declaration form, signed by the laboratory director on 4/5/2023 stated that the laboratory performs approximately 40,000 tests, annually. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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 -- 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's test validation records, and interview with the laboratory technical consultant and testing person on April 20, 2023, at 12:30 pm, it was determined that the laboratory director failed to direct the overall operation and administration of the laboratory. The findings include: See D3033. -- 2 of 2 --