Brian D Ardel Md Pa

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 4/29/21 at Brian D Ardel Md Pa, a clinical laboratory in Port Charlotte, Florida. Brian D Ardel Md Pa is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the noncompliance. 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 American Proficiency Institute (API) proficiency record review, and interview with Testing Personnel #B, the laboratory failed to retain instrument printouts and documentation of signed attestation statements for the Chemistry Core proficiency testing for two of two years reviewed (2019-2021). The findings included: Review of the API instructions revealed that "Testing Personnel and the laboratory director must physically sign an attestation statement for all PT results and retain the signed statement (or a copy) for a minimum of 2 years." Review of API Chemistry core proficiency records for 2019-2021 (1st, 2nd, and 3rd Events for 2019 and 2020 and 1st Event 2021) revealed that 2 assigned attestation statements (2020 #3rd Event and 2nd Event of 2021) out of 7 (1st, 2nd, and 3rd Event 2019 and 2020, and 1st 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 -- Event 2021) were missing from the proficiency testing records. Review of the API Chemistry core proficiency records showed that 1 event (2nd Event 2019) out of 7 (1st, 2nd, and 3rd Event 2019 and 2020, and 1st Event 2021) were missing instrument printouts. Interview on 04/29/21 at 1:30 p.m., Testing Personnel #B stated she did not know that the attestation statements were missing for Chemistry core 3rd Event for 2020 and 1st Event for 2021 and the instrument printouts for the Chemistry 2nd Event for 2019. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing results, and interview with Testing Personnel # B, the laboratory director failed to review the API Chemistry Core proficiency testing results for 1 (2019 3rd Event) out of 7 API Chemistry Core (1st, 2nd, 3rd 2019 and 2020 events and 2021 1st Event) proficiency testing events The findings included: Review of API Chemistry Core proficiency testing results revealed that the Laboratory Director did not review the results for one (3rd testing event in 2019 ) out of 7 (events 1st, 2nd, and 3rd 2019 and 2020 events and, 1st event 2021). Interview on 4/29/21 at 1:35 p.m., Testing Personnel #B stated she did not know the Laboratory Director had not reviewed the API Chemistry 3rd 2019 event. 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 Chemistry Calibration Verification (linearity) record review, and interview -- 2 of 3 -- with Testing Personnel #B, the laboratory did not perform calibration verifications on the chemistry analyzer at least every six months for two out two years (2019 - 2020). The findings included: 1. Review of calibration verification records for the Chemistry analyzer revealed that calibration verifications had been performed 4/5/19 and 2/6/20. 2. Interview on 4/29/21 at 1:40 p.m., Testing Personal #B stated she thought calibration verifications needed to be performed once a year. -- 3 of 3 --

Summary Statement of Deficiencies D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory failed to get at lease 80 percent for one analyte for the first testing event of 2017 and one analyte in the first testing event of 2018. Findings include: Review of American Proficiency Institute (API) proficieincy testing records for 2017 through the present on 04/17/2019 revealed that the laboratory received a 60% for iron (Fe) for the first event of 2017, and a 60% for alanine transaminase (ALT) for the first testing event of 2018. During an interview with testing person A at 10:40 a.m. on 04/17/2019, she confirmed that they had received unsatisfactory results in these analytes. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, there was no documentation to indicate that annual competency evaluations were done in 2018 for two of two moderate complexity personnel. Findings include: Review of personnel competency and training records on 04/17/2019 revealed that there was no competency evaluation for either of the two testing personnel for 2018. During an 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 -- interview with testing person A. at 11:15 a.m. on 04/17/19, she confirmed that there were no competency evaluations in the personnel binder for either of two testing personnel for 2018. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2017 and 2018, the laboratory had subsequent unsuccessful performance in proficiency testing in the specialty of hematology. Refer to D2130. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on June 25, 2018 at 11:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, white blood cell (WBC) differential for three out of five testing events in 2017 and 2018. 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory had subsequent unsuccessful participation in proficiency testing in the specialty of hematology. Findings include: On June 25, 2018, on or about 11:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory had unsuccessful proficiency testing scores for the analyte, white blood cell (WBC) differential, for three out of five testing events in 2016, 2017, and 2018 as shown below. Event #3, 2016 WBC differential-60% Event #2, 2017 WBC differential-0% Event #1, 2018 WBC differential-73% 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 the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology. Findings include: On June 25, 2018 on or about 11:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had subsequent unsatisfactory proficiency testing score for the analyte, white blood cell (WBC) differential, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for -- 2 of 3 -- the analyte white blood cell (WBC) differential in the specialty of hematology. Findings Include: The review of the American Association of Bioanalysts (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on April 20, 2017 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for three out of five testing events in 2016, 2017, and 2018 as shown below. Event #1, 2016 WBC differential-60% Event #2, 2017 WBC differential-0% Event #1, 2018 WBC differential-73% -- 3 of 3 --