Newport Pediatrics Pc

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 a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (Form CMS-209), laboratory policy, personnel records, and staff interviews, the laboratory failed to follow the Quality Assurance policy for training and competency assessment of testing personnel that performed complete blood count (CBC) patient testing in 2024. The findings include: 1. A review of Form CMS-209 provided by the laboratory on 02.18.2025 revealed seven testing personnel (TP) that performed CBC patient testing. 2. A review of the laboratory policy titled "Quality Assurance Plan" revealed the following statements: "Assure that laboratory personnel are adequately trained" and "annually, the laboratory director and/or technical consultant will review the performance of each employee working in the laboratory to assure employee competency." 3. A review of the laboratory's personnel records revealed no documentation of initial training for TP1 prior to CBC patient testing and no documentation of annual competency assessment for TP5 in 2024. 4. Interview on 02.18.2025 at approximately 11:30 a.m. with the Practice Administrator and TP1 confirmed the above survey findings. 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 D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 review of 2020 and 2021 Proficiency Testing (PT) attestation sheets and upon interview with the lead testing person, it was determined the laboratory director and testing personnel failed to sign the attestation sheets for Hematology during the two year period. The findings include: 1. A review of PT reports for 2020 and 2021 revealed the Hematology attestation sheets for the 1st, 2nd and 3rd events for 2020 and 2021 were not signed by the laboratory director and testing personnel. 2. An interview at approximately 1:00 p. m. on 02/10/2022 with the lead testing person confirmed the Hematology attestation sheets for the 1st, 2nd and 3rd events for 2020 and 2021 were not signed by the laboratory director and testing personnel. ================================== 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 employee 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 -- personnel records for 2020 and 2021 and interview with the lead testing person, the laboratory's technical consultant failed to document the six required criteria for assessing personnel competency for all testing personnel (TP). The findings include: 1) Review of employee personnel records for 2020 and 2021 failed to include documentation of the six required criteria of competency that include: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, assessment of problem solving skills. 2) An interview with the lead testing person on February 10, 2022 at 1: 00 p.m. confirmed all testing personnel evaluated during 2020 and 2021 were not evaluated using the six criteria for competency required by Centers for Medicare and Medicaid (CMS). ================================== -- 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: =================================== Hematology: The laboratory failed to maintain satisfactory participation in two out of three events for white blood cell (WBC) analyte, resulting in the first unsuccessful proficiency testing (PT) occurrence for the WBC 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 CASPER Report 0155D and the laboratory's 2020 Proficiency Testing (PT) performance summary records from the Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing program, the laboratory failed to maintain satisfactory performance for the White Blood Cell (WBC) analyte in the 1st and 3rd events of 2020, resulting in the first unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed unsatisfactory WBC analyte scores of 20% for the 1st event of 2020 and 0% for the 3rd event of 2020. 2. A review of the laboratory's WSLH Proficiency Testing records revealed the 2020 1st event had unacceptable performance for WBC resulting in a 20% score. 3. A review of the laboratory's WSLH Proficiency Testing records revealed the 2020 3rd event had unacceptable performance for WBC resulting in a 0% score, resulting in the first unsuccessful PT occurrence. =================================== -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of the hematology analyzer troubleshooting section, a review of patient summaries reported monthly, and interview with testing personnel, the laboratory failed to follow instructions for checking fingerstick samples and proceeding to zap the aperture when results appear unsatisfactory during 2018. Findings include: 1. A review of manufacturer instructions for troubleshooting questionable sample results requires the samples be checked for clots, mix samples prior to analysis, and allow samples to sit 3-5 minutes before analysis and before proceeding to zap aperture. 2. A review of patient summaries for the past six months showed each time questionable results were obtained, the testing person proceeded to zap apertures. 3. Interviews with testing personnel at 11:00 AM on October 10, 2018 confirmed manufacturer instructions were not followed for checking sample integrity prior to instrument intervention. 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of competency checks for four testing personnel 2017 and 2018 and interview with the office managerr, the technical consultant failed to follow the 6 elements of competency required by the Centers for Medicare and Medicaid Services (CMS). Findings include: 1. Four of four testing personnel evaluated during 2017 and 2018 were not evaluated using the 6 elements of competency required by CMS. 2. An interview witht the office manager at 11:30 AM on October 10, 2018 confirmed four of four testing personnel evaluated during 2017 and 2018 were not evaluated using the 6 elements of competency required by CMS. -- 2 of 2 --