Pediatric Consultants North

Summary Statement of 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 the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and an interview with the laboratory lead, the laboratory testing personnel and/or lab director/designee failed to sign four of six attestation statements from 2023 and 2024. The findings include: 1. A review of the laboratory's 2023 and 2024 API PT attestation statements revealed the following: - The laboratory testing personnel failed to sign Hematology 2023 event three. - The laboratory director/designee failed to sign Hematology 2024 events one and three. - The laboratory director/designee and testing personnel failed to sign Hematology 2024 event two. 2. An interview with the laboratory lead on 11.06.2024 at 10:00 a.m. confirmed the above survey findings. 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 a review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and an interview with the laboratory lead, the laboratory failed to review proficiency testing and evaluate the laboratory's results for 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 -- one of five events reviewed from 2023 and 2024. The findings include: 1. A review of the laboratory's 2023 and 2024 API proficiency testing results revealed the 2024 Hematology second event had not been reviewed and evaluated. 2. Interview with the laboratory lead on 11.06.2024 at 10 a.m. confirmed the above survey finding. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual, review of calibration verification records, and staff interview, the laboratory failed to follow its written policy for calibration verification frequency in 2023. The findings include: 1. Observation of the laboratory on 11.06.2024 at 9:30 a.m. revealed a Horiba Micros 60 hematology analyzer (serial number: 709CS97584) used for patient Complete Blood Count (CBC) testing. 2. A review of the laboratory's hematology procedure revealed calibration verification is performed and documented at least every six months. 3. A review of laboratory calibration verification records revealed calibration verification was not performed every six months in 2023. 4. Interview on 11.06.2024 at 09:50 a.m. with the laboratory lead confirmed the above survey findings. -- 2 of 2 --

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: ================================== Based on review of testing personnel competency assessment records and interview with the lead laboratory testing person, the technical consultant failed to evaluate the competency for six of six testing personnel in 2019 and 2020. The findings include: 1. Review of six testing personnel competency assessment records revealed no signature of the technical consultant for employee numbers: one (dated 12.16.2019 & 12.11.2020), two (dated 12-16.2019 & 12.11.2020), three (dated 12.16.2019 & 12.11.2020), four (initial dated 06.10.2019, interim dated 12.16.2019, and annual dated 12.11.2020), five (initial dated 02.24.2020, interim dated 06.01.2020, and annual dated 12.11.2020), and six (dated 12.16.2019 and 12.11.2020). 2. Interview with the lead laboratory testing person on 07.08.2021 at approximately 12:45 pm confirmed the technical consultant failed to evaluate the competency of six of six testing personnel in 2019 and 2020. ================================== 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 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: ==================================== Hematology: The laboratory failed to maintain satisfactory participation in two out of two events for the automated White Blood Cell (WBC) differential, resulting in the first unsuccessful proficiency testing (PT) occurrence for the automated WBC differential analyte (Refer to D2130). ==================================== D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 a desk review of the CMS 0155D report and the laboratory's 2018 Proficiency Testing (PT) records, the laboratory failed to maintain satisfactory performance for the automated WBC (White Blood Cell) Differential in the 1st and 2nd events of 2018, resulting in the first unsuccessful occurrence. The findings include: 1. Review of the CMS 0155D report revealed the 2018 automated WBC Diff event one score is 0% and event two score is 73%. 2. Review of the laboratory's 2018 PT records revealed event one sample numbers HEM-01, HEM-02, HEM-03, HEM-04 and HEM-05 had unacceptable grades for Granulocytes, Lymphocytes and Monocytes resulting in a score of 0% and event two sample numbers HEM-06, HEM-08, HEM-09 and HEM-10 had unacceptable grades for Monocytes/Mids resulting in a score of 20% for a total score of 73% for the WBC Differential, resulting in the first unsuccessful PT occurrence. =================================== -- 2 of 2 --