Ny Cardiology Associates Pc

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on surveyor's review of the Sekisui OSOM Ultra Influenza A & B records and an interview with the technical consultant and testing person, the laboratory failed to enroll in the NYC Communicable Disease program for reporting both positive and negative Influenza A & B test results from January 1, 2020 through March 20, 2020. FINDINGS: 1. On September 18, 2020, Executive Order 202.61 was issued requiring the following. All clinical labs and POLs or healthcare providers conducting point of care (POC) influenza testing must report influenza test results immediately (within 3 hours of receiving results) through New York State Electronic Clinical Laboratory Reporting System (ECLRS). a. Following up on the recent New York State Executive Order No. 202.61, on September 18, 2020, the New York City Department of Health and Mental Hygiene issued an alert advising providers that perform all point-of-care (POC) influenza testing must report influenza test results electronically via the New York State Electronic Clinical Laboratory Reporting System (ECLRS). 2. The laboratory implemented the Influenza A & B testing using the OSOM Ultra Influenza A & B on January 1, 2020. 20 patients were tested from January 1, 2020 through January 31, 2020, with 2 positive and 18 negatives reported. 15 patients were tested from February 3, 2020 through February 27, 2020, with 2 positive and 13 negatives reported. 12 patients were tested from March 2, 2020 through March 20, 2020, with 12 reported as negative. 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 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 a review of calibration verification records and an interview with the technical consultant, the laboratory failed to perform calibration verification. Findings Include: It was confirmed with the technical consultant on March 16, 2018 at approximately 2:15 pm that the laboratory failed to perform calibration verification 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 -- for the Triage Biosite when it was due in September 2017. The laboratory was out of calibration from September 22, 2017 through March 6, 2018. Approximately 2580 patient specimens were tested and results released during this time. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's QC procedures and records and an interview with the technical consultant, the laboratory director failed to ensure that the QC program was maintained for chemistry tests performed on the Biosite instrument. Refer to: D5439 -- 2 of 2 --