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Summary Statement of Deficiencies D0000 A recertification survey was performed on October 31, 2024. The facility was found to be NOT in compliance with the CLIA conditions and standards for specialties /subspecialties for 42 CFR. CONDITION LEVEL: D2016 - Successful Participation CONDITION 493.803(a)(b)(c) D6000 - Moderate Complexity Laboratory Director CONDITION 493.1403 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 American Proficiency Institute (API) Proficiency Testing (PT) provider, and staff interview the laboratory failed to achieve a satisfactory performance for Specialty Hematology, Subspeciality Monocyte (Mono) for 2023, 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 1, and event 3, and for the 1st event of 2024. This is a Condition Level Citation REFERENCE: D2130 - Hematology 493.851(f) 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 review of the American Proficiency Institute (API) Proficiency Testing (PT) provider, and staff interview the laboratory failed to achieve a satisfactory performance for Specialty Hematology, subspeciality Monocyte (Mono) for 2023, event 1, and event 3, and also for 2024 event 1. Findings: 1. On review of the API PT evaluation reports for the Specialty of Hematology, for 2023 and 2024. the laboratory received the following scores: 2023 - Event 1, subspecialty Mono, the laboratory scored 60% Event 3, subspeciality Mono, the laboratory scored 40% 2024 - Event 1, subspeciality Mono, the laboratory scored 60% 2. Interview with the Laboratory Manager on 10/31/2024 at approximately 12 pm in the breakroom, confirmed the statements as listed above. 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 review of the American Proficiency Institute (API) Proficiency Testing (PT) provider, and staff interview the Laboratory Director failed to provide overall management and direction. The laboratory failed to achieve a satisfactory performance for Specialty Hematology, Subspeciality Monocyte (Mono) for 2023, event 1, and event 3, and for 2024 event 1. This is a Condition Level Citation Reference: D6016 - Laboratory Director Responsibilities. 493.1407(e)(H)(i) 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 review of the American Proficiency Institute (API) Proficiency Testing (PT) provider, and staff interview the Laboratory Director(LD) is responsible for the overall operation and administration of the laboratory. The LD failed to ensure that -- 2 of 3 -- the proficiency testing samples are tested as required. The laboratory failed to achieve a satisfactory performance for Specialty Hematology, Subspeciality Monocyte (Mono) for 2023, event 1, and event 3, and for event 1 of 2024 Findings: 1. On review of the API PT evaluation reports for the Specialty of Hematology, for 2023 and 2024. the laboratory received the following scores: 2023 - Event 1, Subspeciality Mono, the laboratory scored 60% 2023 - Event 3, Subspeciality Mono, the laboratory scored 40% 2024 - Event 1, Subspeciality Mono, the laboratory scored 60% 2. Interview with the Laboratory Manager on 10/31/2024 at approximately 12 pm in the breakroom, confirmed the statements as listed above. . -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on July 21, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 review of the American Proficiency Institute (API) Proficiency Testing (PT) document and staff interview, the laboratory had no documentation of the results that were sent in for 2020, 2021, or 2022, for the Specialties of Chemistry, Hematology, and Microbiology. Findings: 1. Review of the API PT documents, the laboratory did not have any documentation of the results that were sent from the facility or instrument printouts for 2020, 2021, and 2022. For Speciaties - Chemistry, Hematology, and Mircobiology, there was no proof of documentation for the results that were sent to API for evaluation for the following years and events: 2020 - Chemistry, Event 2 and 3, there were no result sheets available Hematology Event 1, there were no result sheets or instrument printouts available Microbiology Event 1 and 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 -- 2, there were no result sheets available 2021- Hematology, Event 1,2,and 3, there were no result sheets or instrument printouts available 2022- Chemistry, Event 2, there were no results sheets available 3. Interview with the laboratory manager, on July 21, 2022 at approimately 1:30 pm, in the office, confirmed the aforementioned statements 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 review of the American Proficiency Institute (API) Proficiency Testing (PT) document and staff interview, The Laboratory Director (LD) failed to ensure that the laboratory was performing the PT sampes as they should and verify the documentation of the results that were sent in for 2020, 2021,and 2022, for the Specialties-Chemistry, Hematology, and Microbiology. Findings: 1. Review of the API PT documents, the laboratory did not have any documentation of the results that were sent from the facility or instrument printouts for 2020, 2021, and 2022. For Specialty- Chemistry, Hematology, and Mircobiology, the lab did not have documentation of the results that were sent to API for evaluation for the following years and Events: 2020 - Chemistry, Event 2 and 3, there were no result sheets available Hematology Event 1, there were no result sheets or instrument printouts available Microbioloty Event 1 and 2, there were no result sheets available 2021- Hematology, Event 1,2,and 3, there were no result sheets or instrument printouts available 2022- Chemistry, Event 2, there were no results sheets available 3. Interview with the laboratory manager, on July 21, 2022 at approimately 1:30 pm, in the office, confirmed the aforementioned statements -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on a CLIA recertification survey performed on October 14, 2020, this facility was found to not be in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API), Proficiency Testing (PT) evaluation reports, for Erothycyte Sedimentation Rate (ESR) and Bacteriology, Urine Colony Counts(UCC), and staff interview, the laboratory failed to verify the accuracy twice yearly for the ESR, and UCC for non-regulated analytes. Findings: 1. Review of the API, PT evaluation reports for Bacteriology, Urine Cology Counts, for the third event of 2019, and the second event of 2020, showed that the laboratory received scores of 50% for both events. 2. Review of the API, PT evaluation reports for Hematology, ESR, for the second and third event of 2019, and the first and second event of 2020, showed that the laboratory received scores of 50% for all four events. 2. Interview with the laboratory coordinator, on 10/14/2020, at approximately 1:10pm in the office, confirmed that the laboratory had unsuccessful events for the third event of 2019 and second event of 2020 in Bacteriology. The laboratory also confirmed unsuccessful events for the second and third event of 2019 as well as the first and second event of 2020 for the ESR. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the 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 -- 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 review of the Abbott Emerald Hematology Analyzer (Emerald) calibration documents and staff interview the laboratory failed to provide documentation for bi- annual calibrations as required. Findings: 1. A review of the Emerald calibration documents confirmed that the laboratory failed to provide calibration documents for Bi-annual calibrations. Calibrations were as follows: 2/2019 NO DOCUMENTATION 8/2019 performed 2/2020 NO DOCUMENTATION 8/2020 NO DOCUMENTATION 10/2020 Performed 2. Interview with the Laboratory Coordinator, on 10/14/2020, at approximately 12/20/2020 in the office, confirmed the aforementioned document review. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved