North Pinellas Childrens Medical Center Inc

Summary Statement of Deficiencies D0000 An onsite announced CLIA recertification survey was conducted at North Pinellas Children's Medical Center Inc., a laboratory in New Port Richey, FL, on 12/05/2023. The laboratory is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the standard level deficiencies: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 American Proficiency Institute (API) proficiency testing and interview with the Office Manager, the laboratory failed to have attestation statements signed by the Testing Person and the Laboratory Director for 3 out of 5 events for Hematology/Coagulation Proficiency Testing. (2nd and 3rd event 2022 and 2nd event 2023) The findings include: During a review of API proficiency testing for Hematology/Coagulation for the 3rd Event for 2021, the 1st, 2nd, and 3rd Events for 2022, and the 2nd Event for 2023, it was discovered that attestation statements had not been signed by the Testing Person and the Laboratory Director for the 2nd and 3rd Event for 2022 and the 2nd Event for 2023. A record review of the laboratory's procedure manual revealed a "Proficiency Testing Policy" (dated 8/1/23) that stated, "The individual testing or examining the samples and the Medical Director must attest to the routine integration of samples into the patients' workload using the laboratory's routine methods." On 12/05/23 at 01:30 PM, the Office Manager confirmed she did not have the Testing Person or the Laboratory Director sign the attestation statements. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 -- CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based upon a record review of American Proficiency Institute (API) proficiency testing and an interview with the Office Manager, the Laboratory Director failed to document evaluation of proficiency testing for hematology for two out of five proficiency testing events reviewed. (3rd Event 2021, 1st, 2nd, and 3rd Events 2022, and 2nd Event 2023 ) The findings include: A record review of the API hematology proficiency testing results for the 3rd Event for 2021, the 1st, 2nd, and 3rd Events for 2022, and the 2nd Event for 2023 revealed the Laboratory Director failed to document evaluation of proficiency testing for hematology for the 2nd Event and 3rd Event of 2022. A record review of the laboratory's procedure manual revealed "Proficiency Testing Policy" (dated 8/1/23), that stated "All proficiency testing results should be reviewed by the persons performing the testing and the Medical Director. Signatures attesting this review should be noted on each report summary." On 12/05/23 at 1:35 PM, the Office Manager stated she provided the proficiency testing results to the Laboratory Director but the Laboratory Director had not signed the proficiency tests results. -- 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, the laboratory did not have successful performance in proficiency testing for the specialty of hematology. Refer to D2131. 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 February 20, 2018 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, white blood cell differential for two out of three testing events in 2017. 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 -- D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing 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 did not have successful participation in proficiency testing for the specialty of hematology. Findings include: On February 20, 2018 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, white blood cell differential, as shown below. Event #1, 2017 white blood cell differential-73% Event #3, 2017 white blood cell differential-27% 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 February 20, 2018, on or about 10:00 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 unsatisfactory testing scores for two out of three testing events for the analyte, white blood cell differential, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2131. 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 -- 2 of 3 -- manner as to achieve and maintain successful participation in proficiency testing in the specialty of hematology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on February 20, 2018 on or about 10: 00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #1, 2017 white blood cell differential-73% Event #3, 2017 white blood cell differential-27% -- 3 of 3 --