Kidzcare Pediatrics

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 a desk review of proficiency testing (PT) records from the Certification 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 -- and Survey Provider Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) 2024 and 2025 records, the laboratory failed to successfully participate in a proficiency testing program approved by Health and Human Services (HHS), for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology and for the analytes Red Blood Cell (RBC), and the White Blood Cell (WBC). Refer to D2130 and D2131. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 a proficiency testing desk review of the CASPER 0155 report and API proficiency testing 2024 and 2025 records, the laboratory failed to achieve satisfactory performance (80% or better) for the same analytes for two out of three consecutive testing events in the specialty of Hematology for the analytes Red Blood Cell (RBC) and White Blood Cell (WBC). Findings included: 1. Review of the CASPER 0155 report revealed the following results: -Hematology 2024-3rd Event: The laboratory received an unsatisfactory score of 40% for the Red Blood Cell (RBC) analyte. The laboratory received an unsatisfactory score of 60% for the White Blood Cell (WBC) analyte. -Hematology 2025-2nd Event: The laboratory received an unsatisfactory score of 0% for the Red Blood Cell (RBC) analyte. The laboratory received an unsatisfactory score of 0% for the White Blood Cell (WBC) analyte. 2. A review of the API Proficiency Testing records confirmed the laboratory received the above results. D2131 HEMATOLOGY CFR(s): 493.851(g) (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 a proficiency testing desk review of the CASPER 0155 report and API proficiency testing 2024 and 2025 records, the laboratory failed to achieve an overall satisfactory performance (80% or better) for the specialty of Hematology for two out of three consecutive testing events. Findings included: 1. A review of the CASPER 0155 report revealed the following results: Hematology 2024-3rd Event: The laboratory received an unsatisfactory score of 56% for overall Hematology. Hematology 2025-2nd Event: The laboratory received an unsatisfactory score of 0% for overall Hematology. 2. A review of the API proficiency testing records confirmed the laboratory received the above results. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 3 -- 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 a proficiency testing desk review of the CASPER 0155 report and API 2024 and 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure the overall quality of the laboratory services provided. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: . Based on a proficiency testing desk review of the CASPER 0155 report and API 2024 and 2025 records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program. Refer to D2130 and D2131. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 a desk review of proficiency testing (PT) records from the Certification 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 3 -- Survey Provider Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) 2024 and 2025 records, the laboratory failed to successfully participate in a proficiency testing program approved by Health and Human Services (HHS), for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology for the Hematocrit and Hemoglobin analytes. Refer to D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) (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 a proficiency testing desk review of the CASPER 0155 report and API proficiency testing 2024 and 2025 records, the laboratory failed to achieve satisfactory performance (80% or better) for the same analytes for two consecutive testing events in the specialty of Hematology for the analytes Hematocrit (HCT) and Hemoglobin (HGB). Findings included: 1. Review of the CASPER 0155 report revealed the following results: -Hematology 2024-3rd Event: The laboratory received an unsatisfactory score of 40% for the Hematocrit analyte (HCT). The laboratory received an unsatisfactory score of 40% for the Hemoglobin analyte (HGB). - Hematology 2025-1st Event: The laboratory received an unsatisfactory score of 40% for the Hematocrit analyte (HCT). The laboratory received an unsatisfactory score of 60% for the Hemoglobin analyte (HGB). 2. A review of the API Proficiency Testing records confirmed the laboratory received the above results. 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 a proficiency testing desk review of the CASPER 0155 report and API 2024 and 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure the overall quality of the laboratory services provided. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and API proficiency 2024 and 2025 records, the laboratory director failed to ensure the overall -- 2 of 3 -- quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 staff interview, the testing personnel and/or the laboratory 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 proficiency testing attestation statements revealed the following: - The testing personnel and laboratory director/designee failed to sign the Hematology 2023 third event and 2024 first event. - The laboratory director/designee failed to sign the Hematology 2024 second and third events. 2. An interview with the laboratory lead on 03.13.2025 at 11:15 a.m. confirmed the above survey findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 records, and staff interview, the laboratory failed to follow its 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 -- written procedure for calibration frequency in 2024. The findings include: 1. Observation of the laboratory on 03.13.2025 at 9:00 a.m. revealed a Horiba Micros 60 hematology analyzer (Serial Number: 809CS97970) used for patient Complete Blood Count (CBC) testing. 2. A review of the laboratory's Complete Blood Count procedure revealed, "Calibration is performed and documented with every lot number of reagent, at least every six months, and whenever major maintenance is done." 3. A review of laboratory calibration records revealed the laboratory failed to perform calibration every six months in 2024. 4. An interview with the laboratory lead on 03.13.2025 at 11:15 a.m. confirmed the above survey findings. -- 2 of 2 --

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: ==================================== Based on review of Laboratory Quality Control (QC) Procedure, review of August and September 2017 Complete Blood Count (CBC) Quality Control Reports, review of 2 patient reports and interview with the primary testing person and the Laboratory Director, determined the laboratory failed to follow their quality control criteria for acceptability prior to reporting patient results. The findings include: 1. Review of the QC procedure for